Structured Abstract

Background

Chronic obstructive pulmonary disease (COPD) is a chronic progressive lung condition that results in substantial mortality, morbidity, and disability.^1-3 COPD is the fourth leading cause of death in the United States and a leading cause of hospitalizations.³ Patients with COPD report unmet needs for information about their disease and guidance on how to manage and cope at “intellectual, emotional, and social levels.”^4-6 Many patients with COPD lack the information and skills to correctly use inhaled medications,^7,8 manage breathlessness episodes, and recognize early signs of COPD exacerbation.^9-12

In a survey of 1102 people aged >40 years who have COPD in the United States, >77% reported an inability to perform daily activities, including exercising, climbing stairs, and walking.¹³ A concurrent survey of 1051 physicians revealed that 54% of primary care providers had inadequate knowledge about COPD practice guidelines and effective treatment options, including supplemental oxygen use and pulmonary rehabilitation.¹³ Deficits in general nurses' knowledge of COPD and proper inhaler use technique have also been reported.^14,15 Recommendations to improve care for patients with COPD and reduce acute-care use include an increased focus on advancing patients' self-management skills (eg, proper use of inhalers and smoking cessation) and a call for initiatives that incorporate patients' and family caregivers' perspectives into the design of supportive, patient-centered programs to improve health outcomes.^16,17 In a qualitative study of 34 participants with a range of quality of life (QOL) levels, the majority had significant challenges with coping and COPD self-management and asked for supportive services beyond pharmacologic interventions.¹⁸ Family caregivers of patients with COPD also report distress that affects their emotional well-being, professional life, and QOL overall.^19-21 These caregivers, the majority of whom are spouses, frequently have their own life and health challenges.²² They commonly adopt a “1 day at a time” attitude to cope with the burden of caregiving,²³ and their caregiving has been associated with improved patient outcomes.²⁴

One approach to helping patients with COPD and their caregivers is to provide self-management support interventions in a manner that is sensitive to their needs and preferences. A systematic review of 29 COPD self-management studies concluded that COPD self-management education and support resulted in improved health-related QOL (HRQOL) and reduced hospitalizations and emergency department (ED) visits.²⁵ Nonetheless, it remains unclear how most effectively to provide self-management support to patients with COPD and their caregivers in health care settings so that an improvement in patient outcomes can be realized.^26,27

Medical guidelines for COPD management vary in regards to incorporating recommendations for provision of self-management support by health care professionals (HCPs).^28-30 The Global Initiative for Chronic Obstructive Lung Disease recommends self-management interventions in communication with an HCP, given evidence of its impact on improving health status and reducing acute-care use.²⁹ Self-management interventions aim to help patients improve their ability to manage COPD in their daily life and adopt desired health behaviors, including medication adherence, smoking cessation, adopting an active lifestyle, and participation in pulmonary rehabilitation.³¹ To help patients adopt these behaviors, coordinated follow-up and support from well-trained HCPs is needed, along with services to help patients overcome any barriers.^17,31 Well-coordinated communication between providers is a challenging aspect of COPD care, as most patients with COPD have multiple comorbidities and see several providers.^32,33 With the increased demand for pulmonologists' services in an aging population, most of the care for patients with COPD in the United States is provided by primary care clinicians.^13,34 In 1 study, only 30% of patients with COPD reported that a pulmonologist was the main provider treating their respiratory problems.¹³ The majority of patients with COPD are treated in primary care clinics, where providers typically have less access to specialized respiratory care services or staff who are knowledgeable about inhaled treatments, supplemental oxygen devices, and the unique challenges that patients with COPD and their caregivers confront daily. The quality of health care and support services received by patients with COPD is variable and depends on treatment setting and available resources.^17,35-37

Peer support (ie, support provided by a person with a similar medical condition) has been used to provide self-management support for patients with various medical conditions. Studies that use peer support for patients with obesity, mental health issues, addiction, diabetes, and cancer have shown increased self-efficacy and self-care behaviors as well as improved clinical outcomes and QOL.^38-50 Examples of these programs include peer-led support groups, dyadic peer-to-peer mentorship, and online networks. Peer support benefits are attributed to the provision of emotional, informational, and appraisal support (ie, peer affirmation of the “appropriateness of one's emotions, cognitions, and behaviors”).⁵¹ Peer support benefits both those who provide it and those who receive it. Using peer support to improve self-management is particularly promising because the peer supporters (or peer mentors/persons providing support) have credibility as people “who understand, have been there, and done that.” Peer supporters can also model desirable health behaviors. These elements are key to achieving behavior change, according to the social learning theory.⁵² Peer support strengthens patients' social support while reducing isolation and may offer important benefits for patients who are hard to reach.⁵³ Social support is particularly relevant to patients with COPD, whose medical illness often makes them reluctant to go out with family and friends because of functional limitations and the need for portable oxygen. Among patients with COPD, social support is associated with reduced hospitalizations, fewer exacerbations, and better health status.^54-56

It is important to consider family members' involvement in self-management support interventions for patients with COPD. Family members play important roles as caregivers, and their support becomes increasingly important as patients become more dependent.^19,23 Family caregivers may positively impact patients' health care behaviors. Among patients with COPD, those who have caregivers are less likely to smoke and more likely to adhere to medication regimens; they also use acute care less often.^24,57 However, caregivers can also have a negative impact by being overprotective, which can lead patients to be more dependent and less active.²⁰ Family-centered interventions to improve self-management among patients with chronic conditions have been reported to improve adoption of positive health care behaviors and reduce acute-care use.^58,59

The Better Respiratory Education and Treatment Help Empower 2 (BREATHE2) study was a randomized controlled trial (RCT) that compared the effect of self-management support interventions that incorporate HCP and peer support on HRQOL and acute-care use for patients with COPD.⁶⁰ Our overall goal was to compare the effectiveness of 2 health communication and dissemination strategies designed to engage patients and family caregivers in successfully managing COPD in “real-world” settings. Both strategies aimed to advance patient understanding of COPD, its treatment options, and self-care tasks; support participants in coping with the disease; and enable them to adopt a variety of positive behaviors (eg, adherence to treatment plans; smoking cessation; joining pulmonary rehabilitation programs; assuming an active, healthy lifestyle). One strategy relied on the HCP as the primary communicator about COPD self-management (HCP Support arm), whereas the other used a dual approach that involved both HCPs and peer mentors delivering such communication (HCP Plus Peer Support arm). Peer mentors were patients with COPD and caregivers who successfully managed COPD and had received foundational training on peer mentoring. Specifically, we aimed to (1) conduct an RCT in which the HCP Support and HCP Plus Peer Support strategies were tested in real-world health care settings; (2) compare the impact of these strategies on patient satisfaction, experience, activation, self-efficacy, self-care behavior, health status, QOL, use of ED and hospital services, and survival; and (3) compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, stress, and coping skills.

Patient and Stakeholder Engagement

In the BREATHE2 study, we used a participatory research approach in which we partnered with patients, caregivers, and stakeholders throughout all phases of the research. We started by composing a research team that included 1 patient and 1 caregiver as co-investigators who closely worked with the researcher co-investigators, attending research team meetings and making decisions as needed throughout the study period. The patient co-investigator has COPD and is an active member of the COPD Foundation and a strong advocate for patients with COPD. The caregiver co-investigator has been a caregiver for someone who had severe COPD for more than 30 years, and she served as a partner on 1 of our earlier studies.

To further ensure meaningful engagement of patients, caregivers, and stakeholders in this study, we closely worked with a patient and family partners (PFP) group that held its own meetings throughout the study period, as well as a group of health care and community stakeholders who were invited to joint study meetings held periodically, with all the PFP and the research team members invited. The PFP group was assembled at the start of an earlier PCORI-funded trial (the BREATHE study) and had an average of 12 members (patients with COPD and caregivers). Four of its original members have since passed away, and new members have joined. At the time of writing this report, the PFP group included 7 patients (4 women and 3 men) and 5 caregivers (3 women and 2 men). The PFP group weighed in on all research plans and helped develop study recruitment materials and study interventions.

The PFP group meetings were regularly attended by the study principal investigator (PI) and the patient and caregiver co-investigators. Agenda items were decided jointly with group members, discussions took place freely, and all members were encouraged to express their opinions. The idea for the BREATHE2 study originated from ongoing work over the past several years with the PFP group and various stakeholders, including physicians, social workers, respiratory therapists, homecare nurses, case managers, health care administrators, patient advocacy organizations, policy makers, and payers. During PFP meetings, the partners repeatedly voiced the need to connect with peers and receive information about COPD, its treatment, and ways to self-manage it. They proposed using groups “like this one” to communicate about these issues and support each other. All study recruitment materials were co-developed with the study partners and stakeholders. For example, the PFP group proposed creating a video to help with participant recruitment. The video described goals of the study and its interventions and provided first-person narratives related to COPD management. The partners proposed ideas about the key message for that video—namely, that “there is hope after COPD diagnosis and one may have good quality of life while living with COPD.” Patient and stakeholder perspectives also shaped the content of the informed consent document and the way we presented the study to potential participants.

Close work with the patient and caregiver co-investigators and the PFP group led to the interventions tested in this study. For example, the research team, including the patient and caregiver co-investigators, developed an initial set of opening questions for each group event and proposed icebreaker activities for the peer support program get-togethers. The initial plan was drafted as a table by the Intervention Development Workgroup, which included patient and caregiver co-investigators and researchers. This draft was then reviewed in detail at the study's joint team meeting, which included researchers, all PFPs, and stakeholders. We received further feedback from the PFP group on how to phrase the questions pertaining to patient-caregiver relationships and on specific icebreaker activities that the partners thought were worth using at multiple sessions. Based on this feedback, a final set of opening questions and icebreaker activities was developed.

The study partners and stakeholders also helped shape intervention design, choice of study outcomes, and planning for sustainability of study interventions. For example, the partners and stakeholders believed that QOL is an important outcome and supported its use as the primary outcome of this study. Toward the end of the study, the study partners and stakeholders were engaged in discussions about mechanisms for sustaining peer support delivery to interested study participants after the end of the research period. Together, we identified available peer support options in the areas where participants resided and informed participants about those options at the end of the study. These options included the COPD Foundation support line; Better Breathers clubs (sponsored by the American Lung Association); and a local support group facilitated by one of the BREATHE Pals, with support from 1 of the study sites (Howard County General Hospital [HCGH]). (See Table 2A in Appendix A for detailed examples of patients' and stakeholders' engagement impact on this study.)

More broadly, the elaborate, multipronged structure for patient and stakeholder engagement in this study—patient and caregiver co-investigators working with researchers; a separate partners group that met throughout the study period concurrent with research team meetings; and the joint meetings of partners, stakeholders, and researchers—affected all study team members by helping foster collegial relationships, open conversations, and iterative cycles of discussions and actions to address study challenges. The study structure allowed for relationship building among academic researchers, patient and family co-investigators and partners, and stakeholders; it also fostered empathy and understanding for the struggles of patients and caregivers who are striving to cope with COPD.

Methods

Study Overview

Helping patients follow treatment recommendations and adopt desired behavior is viewed as the responsibility of HCPs. Evidence-based guidelines for COPD management, provided by the American Thoracic Society and European Respiratory Society, include recommendations for smoking cessation, active lifestyle counseling, and education and self-management support.⁶¹ These guidelines are followed to a varying extent, depending on the care setting and the availability of health care team members who can implement them.

Reliance on HCPs to provide self-management support and promote behavior change, however, is limited by the lack of key features of behavior change theories, such as role modeling.⁵² Peer supporters (sometimes also called mentors) who share the same condition with patients can be effective and influential communicators. Studies that bring peers together and have peer supporters or mentors communicate about self-management have been successful in improving self-efficacy and clinical outcomes among patients with chronic diseases.^38,40,62-65

The BREATHE2 study was a 2-arm, single-blinded RCT comparing the effectiveness of 2 strategies intended to engage patients and family caregivers in self-management of COPD in a real-world setting. One strategy relied on the HCP as the primary communicator about COPD self-management (HCP Support arm); the other strategy used a dual approach involving HCPs in conjunction with peer supporters to deliver tailored COPD self-management support (HCP Plus Peer Support arm). Both strategies aimed to advance patient and caregiver understanding of COPD, treatment options, and self-care and to encourage adoption of positive health behaviors, such as adherence to treatment plans, smoking cessation, participation in pulmonary rehabilitation programs, and active lifestyles.

The BREATHE2 study conceptual model, depicted in Figure 1, displays the mechanism by which HCPs and peers can help improve patient and caregiver outcomes. In the traditional medical expert model, HCPs are tasked with providing information about COPD, referring patients to treatment services and programs (eg, pulmonary rehabilitation, smoking-cessation programs), and supplying encouragement and support for patients to implement recommended self-care practices and desired behaviors (depicted in the blue arrow and box in Figure 1).

Figure 1

BREATHE2 Study Conceptual Model.

Although all these HCP contributions are essential to caring for patients with COPD, they may be insufficient to provide the needed support to induce and maintain positive behavior changes. According to social cognitive theory, self-efficacy mediates behavior change, and achieving self-efficacy requires the practice and mastery of necessary skills, modeling of desired behaviors, and social persuasion.⁵² Patients who have successfully learned to manage their COPD by adopting the necessary skills and desired behaviors (such as quitting smoking and completing a pulmonary rehabilitation program, both of which were requirements for being a peer supporter in this study) are consequently well positioned to help other patients with COPD (and their caregivers) by sharing personal experiences in managing COPD and the everyday challenges that it imposes. The ways in which peer support can help are depicted in the green arrow and box in the model. Peer supporters are uniquely able to provide other patients with COPD what HCPs cannot: the role modeling of desired behaviors and a hopeful and persuasive message that these behaviors are achievable.⁶⁶ Peer support involves provision of relevant and credible information, delivered by positive role models who also experience reciprocal gains from this work in giving back and helping other patients who are experiencing a similar condition.^51,67

A dual-support approach that involves pairing expert HCP services with peer support enables patients to receive (1) the technical information they need from HCPs and referrals to services that will enable them to adopt recommended behaviors; and (2) additional support from peers in the form of informational, instrumental, emotional, and social support as well as hopeful messages that increase the likelihood that they will become more activated and achieve the self-efficacy needed to successfully manage COPD. Although the self-management support that HCPs provide would be expected to increase self-efficacy and improve behaviors and outcomes,^25,68-70 we expected the dual-support approach (HCP Plus Peer Support) would lead to more benefits than an approach that relied only on HCPs (HCP Support). Figure 1 depicts the intermediate outcomes where the dual-support approach is likely to exert its additional benefits on patient and caregiver outcomes (see the green highlighted text in model).

Study Hypotheses

The primary study hypothesis was that patients in the HCP Plus Peer Support arm would have a greater improvement in HRQOL (ie, a greater negative change in total score on the St. George's Respiratory Questionnaire [SGRQ]) at 6 months after discharge compared with baseline than would patients in the HCP Support arm (study aim 2). Our secondary hypotheses were that in a comparison with participants in the HCP Support arm, patient participants in the HCP Plus Peer Support arm (1) would have better HRQOL (ie, a greater negative change in total SGRQ score) at 9 months after enrollment and (2) would have reduced numbers of COPD-related acute-care visits (hospital and ED visits) at 3, 6, and 9 months. Additionally, we expected that these participants would have improved activation, self-efficacy, and self-care behaviors; a higher level of informational, instrumental, and emotional support; and less social isolation (study aim 2). We also expected that caregiver participants in the HCP Plus Peer Support arm would report a greater understanding of COPD and preparedness for caregiving than the caregivers in the HCP Support arm (study aim 3).

Study Design

A schematic of the study design is shown in Figure 2. The study used an RCT design with 2 arms. Patient participants were randomly assigned to either the HCP Support or HCP Plus Peer Support arm. Each patient participant was invited to have 1 adult family caregiver enroll with him or her in the same study arm, but this was not a requirement for study enrollment. The target for enrollment was 290 patients with COPD; we ultimately enrolled 292 patients. Fifty caregiver participants were also enrolled.

Figure 2

Schematic of Study Design.

All study participants received a written educational guide and a 1-hour session with a respiratory care practitioner (RCP), with the option to further contact the RCP by phone as they desired during the 6-month intervention period. Additionally, participants who had been randomly assigned to the HCP Plus Peer Support arm were invited to join a peer support program.

Patient and caregiver participants could not be blinded to their study arm assignment because of the design of the interventions, but the randomization assignment was concealed from all research team members performing data collection, medical records abstraction, and outcomes assessments. We also used standardized instruments to collect data and instructed the data collectors not to take notes that included patient information (to minimize recall in case of inadvertent disclosure of intervention arm assignment by a study participant to a data collector during data-collection interviews).

The study was approved by the Johns Hopkins Institutional Review Board, and written consent was obtained from all the study participants. The study is registered at ClinicalTrials.gov (NCT02891200: https://clinicaltrials.gov/ct2/show/NCT02891200?term=NCT02891200&draw=2&rank=1).

Study Setting

The study was conducted at 2 sites within the Johns Hopkins Health System: Johns Hopkins Bayview Medical Center (JHBMC) and HCGH, along with their affiliated pulmonary and primary care clinics. JHBMC is an academic medical center in Baltimore, Maryland, with 550 inpatient beds; it serves an urban population that has a large percentage of patients with low income. HCGH is a 300-bed community hospital in Columbia, Maryland, that serves a more affluent suburban population. Both sites have pulmonary specialty clinics on campus and operate large on-site pulmonary rehabilitation programs. The 2 sites also serve patients with pulmonary disease who receive care at primary care clinics that are part of the Johns Hopkins Community Physicians network.

Participants

Participant inclusion criteria were having a physician-provided diagnosis of COPD and receiving treatment for it (defined as receiving treatment at a hospital or clinic for COPD); being aged ≥40 years; having no non-COPD–related terminal illness (ie, life expectancy <6 months); and having no severe cognitive dysfunction, determined based on the patient's ability to follow instructions (ie, patient could provide informed consent). Exclusion criteria were inability to speak English; cognitive dysfunction impairing the patient's ability to provide informed consent and follow instructions; active substance abuse or unstable major psychiatric condition (as determined by the patient's health care team); a non-COPD–related terminal illness (ie, life expectancy <6 months); planning to move from the area; living in hospice care or long-term nursing home; or inability to provide contact information.

If patient participants had an adult family member (aged ≥18 years) involved in their health care, they were encouraged to invite that family member to enroll along with them in the study. Caregivers were excluded if they did not speak English or were unable to provide contact information.

Recruitment and Randomization

Participants were recruited from inpatient and outpatient settings. In the inpatient setting, a proactive approach was used to ensure that all patients with COPD who were admitted to the 2 study site hospitals were informed about the study. Materials about the study were distributed at the outpatient clinics, and providers were encouraged to refer their eligible patients to the study. For hospitalized patients, we used hospital patient censuses and diagnosis lists to identify potentially eligible candidates. These candidates were then approached by a study team member, who shared detailed information about the study and answered patients' questions. Candidates who were interested were consented and enrolled during their hospital stay and before their hospital discharge, whenever possible. The study start date for participants enrolled from the hospital was established as the date of their hospital discharge. Interested patients who could not be enrolled before discharge were subsequently contacted by phone to schedule an enrollment visit.

At the outpatient clinics, recruitment materials were available in waiting areas and distributed by health care providers to patients. Interested patients filled out an information card; a study team member then contacted them by phone to determine eligibility and schedule an enrollment visit. Study team members were also available at select outpatient sites to meet patients directly referred to the study by their health care provider. Later in the course of the study, patients with COPD who visited the pulmonary clinic at 1 of the study sites were mailed a letter informing them about the study.

If patient participants had an adult family member involved in their health care, they were encouraged to invite that family member to enroll with them in the study. If the participant approved, the family caregiver was approached for consent. Caregivers could be consented at the hospital, at the enrollment visit with the patient, or at a separate enrollment visit, depending on their availability.

After patient consent had been obtained, baseline data were then collected, a cognitive assessment and spirometry testing were conducted, and patients were randomly assigned in a 1:1 ratio to 1 of the study arms based on a pregenerated sequence of assignments. Randomization was stratified by 4 site-setting strata (JHBMC inpatient, JHBMC outpatient, HCGH inpatient, and HCGH outpatient), and a computer algorithm was then used to perform a blocked randomization assignment within strata, with randomly selected block sizes of 2, 4, or 6 participants. If a patient had a caregiver enrolled with them in the study, that caregiver was assigned to the same study arm as the patient.

Both patient and caregiver participants were compensated for their participation. Compensation was contingent on completion of a survey at each of the 4 data-collection time points (baseline, 3 months, 6 months, and 9 months). Patient participants were paid $20 at baseline, $15 at 3 months and 6 months, and $30 at 9 months. Caregiver participants were paid $15 at each time point.

Results

In our initial research proposal, we asked the following research question: Among patients with COPD and their caregivers, would a dual strategy that combines HCP and peer mentor delivery of COPD self-management education and support (HCP Plus Peer Support) result in greater improvements in health status and QOL as well as reductions in use of acute health care services compared with relying on HCPs alone (HCP Support) in these communications? Would such a dual strategy result in reduced caregiver stress and improved coping and satisfaction?

Research Question 1

Would a dual strategy that combines HCP and peer mentor delivery of COPD self-management education and support (HCP Plus Peer Support) result in greater improvements in health status and QOL as well as reductions in use of acute health care services?

Overview of Patient Participant Flow and Baseline Characteristics

Figure 3 depicts patient participant flow. From April 2017 to December 2018, we screened 1464 patients at JHBMC, HCGH, and their affiliated clinics, of whom 1061 patients were eligible for enrollment in the study. Among eligible patients, 434 declined to participate, and we were unable to contact 335 patients for enrollment. Reasons for declining to participate included lack of time or interest, concomitant medical problems, and family issues. Reasons for excluding participants included no COPD diagnosis by a physician or not receiving daily treatment for COPD (n = 79), severe cognitive dysfunction (n = 65), smoking history <10 pack-years (n = 50; this was an exclusion criterion at study start and was removed in July 2018 to expedite the recruitment timeline), active substance use (n = 45), living in a facility (n = 39), and unstable major psychiatric condition (n = 26). Nine patients were excluded because of homelessness, and 22 patients were excluded because they did not understand English. (See Table 5A and Table 6A in Appendix A for more details on the demographic characteristics of eligible, enrolled, and declined patients and reasons for eligible patients declining to participate.)

Figure 3

Patient Participant CONSORT Diagram.

Table 1 summarizes the baseline characteristics of enrolled participants by study arm. Most patient characteristics were similar in the 2 study arms. The majority of patients were White (70.9%) and female (61.3%). About half (51%) had an education level of some college or above. In total, 41% had an annual income <$20 000. At baseline, 26.4% of patients were on continuous home oxygen therapy, and 24.7% had participated in pulmonary rehabilitation. In total, 60% of patients reported a Modified Medical Research Council (mMRC) Dyspnea Scale breathlessness grade of 3 or 4, meaning that they stop for breath after walking short distances, are too breathless to leave the house, or are breathless while dressing. About 30% of participants were living alone, and 25% were currently smoking. There was a small difference in the percentage of smokers at baseline between the 2 study arms (27.9% in the HCP Plus Peer Support arm compared with 21.4% in the HCP Support arm) and a large difference in the percentage of patients with a diagnosis of CHF (42.9% in the HCP Plus Peer Support arm compared with 26.9% in the HCP Support arm).

Table 1

Patient Baseline Characteristics.

The baseline characteristics of patient participants who completed the study's 6-month follow-up surveys were compared with those who did not complete them. There were statistically significant differences between those observed and not observed at 6 months in terms of continuous oxygen treatment (21.8% among those observed, 40.3% among those missing; P = .002) and in terms of current smokers (20.9% among those observed, 36.1% among those missing; P = .009). We found similar differences for these 2 variables in each study arm (17.8% vs 45.0% on continuous oxygen among those observed vs missing in the HCP Plus Peer Support arm and 25.7% vs 34.4% in the HCP Support arm; 24.3% vs 37.5% smokers among those observed vs missing in the HCP Plus Peer Support arm and 17.7% vs 34.4% in the HCP Support arm). Because our questions of interest focused on differences in the change over time between the 2 treatment arms, it is likely that this missingness would affect the 2 treatment arms in a similar way. No other significant differences were found. (See Table 7A in Appendix A for patient characteristics by missingness at 6 months for the primary outcome.)

Impact on HRQOL

Our primary outcome in this study was change in HRQOL, as measured using the SGRQ total score, from baseline to 6 months after enrollment.

Table 2 compares the baseline scores and unadjusted raw differences from baseline to 6 months after enrollment for a total SGRQ score between the study arms among participants who had data at both time points. There were 113 and 107 participants with SGRQ data at both baseline and 6 months in the HCP Support and HCP Plus Peer Support arms, respectively. The participants with missing SGRQ data at 6 months were significantly more likely to be smokers (36.1% compared with 20.9%; P = .009) and to be on continuous oxygen (40.3% compared with 21.8%; P = .002) but were otherwise not significantly different in terms of baseline characteristics from the rest of the study participants. From baseline to 6 months, the mean change in total SGRQ score was −0.52 points in the HCP Plus Peer Support arm and −1.78 in the HCP Support arm (unadjusted difference of 1.26 points, with 95% CI, −5.44 to 7.96; P = .591).

Table 2

Unadjusted Change in HRQOL as Measured by Total SGRQ Score From Baseline to 6 Months After Enrollment.

Adjusted differences for mean change in total SGRQ score from baseline to 6 months were estimated using linear mixed-effects models that considered SGRQ scores at all 3 time points (baseline, 6 months, and 9 months) to take advantage of all available SGRQ patient data. Table 3 shows the adjusted differences between the treatment arms. After adjustment for baseline SGRQ domain scores, hospital site, and enrollment setting, there was no significant difference between the treatment arms (adjusted difference of 1.46 points, with 95% CI, −2.47 to 5.38; P = .467). This remained true with additional adjustment for a set of baseline patient characteristics (adjusted difference of 1.82 points, with 95% CI, −1.76 to 5.40; P = .319).

Table 3

Mean Change in HRQOL, as Measured by SGRQ Total Score From Baseline to 6 and 9 Months After Enrollment.

As a secondary outcome, we considered the change in SGRQ total score at 9 months after enrollment; adjusted differences between the study arms for this outcome are included in Table 3. We saw similar results to what was observed at the 6-month time point: no statistically significant differences in the mean change in total SGRQ score between the study arms when adjusted for baseline score, hospital site, and enrollment setting (P = .404) or when further adjusted for additional baseline patient characteristics (P = .219). Table 8A in Appendix A shows the SGRQ domain scores by study arm.

Impact on Use of ED and Hospital Services

As secondary outcomes, we assessed the study interventions' impact on use of ED and hospital services. Data on use of these services were available for all participants who enrolled in this study. Table 4 shows the mean number of COPD-related acute-care visits per participant at 1, 3, 6, and 9 months for the study arms. Patients who had died or withdrawn from the study were excluded from analysis starting from the time in which they died or decided to withdraw from the study. At 6 months, the mean number of visits was 0.62 in the HCP Plus Peer Support arm compared with 0.79 in the HCP Support arm (absolute difference, −0.17 visits [95% CI, −0.62 to 0.28; P = .312]).

Table 4

COPD-Related Hospitalizations and ED Visits Over the 6 Months After Enrollment, by Study Arm.

Table 5 shows COPD-related and all-cause event rates by study arm and incidence rate ratios (IRRs) comparing the study arms at 1, 3, 6, and 9 months after enrollment. Patients who had died or withdrawn from the study were excluded from analysis starting from the time in which they died or decided to withdraw from the study. IRRs were calculated after adjustment for hospital site and enrollment setting and after additional adjustment for baseline patient characteristics. After adjustment for baseline patient characteristics, the IRR of COPD-related visits at 1 month, comparing the HCP Plus Peer Support arm with the HCP Support arm, was 0.46 (95% CI, 0.30-0.70; P < .001). The IRR of COPD-related visits at 3 months, comparing the HCP Plus Peer Support arm with the HCP Support arm, was 0.68 (95% CI, 0.50-0.93; P = .016). The adjusted IRR of COPD-related visits at 6 months was 0.83 (95% CI, 0.70-0.98; P = .028). There was no significant difference in the rate of COPD-related visits between the study arms at 9 months. There was a significant difference in the rates of all-cause visits at the 1-month time point between the study arms (IRR, 0.65; 95% CI, 0.51-0.83; P = .001). There were no significant differences in all-cause visits at the 3-, 6-, or 9-month time points.

Table 5

IRRs of COPD-Related and All-Cause Acute-Care Visits Across the Study Arms at 1, 3, 6, and 9 Months.

Figure 4 shows the Kaplan-Meier survival curves for the time-to-event survival analysis, with the combined event of death or first COPD-related acute-care event (hospitalization or ED visit, whichever occurred first). The separation in survival curves is mostly seen in the 30- to 60-day period after enrollment; however, this difference was not statistically significant (log rank test; P = .834).

Figure 4

Time to First COPD-Related Acute-Care Event or Death.

Impact on Mortality

There were no significant differences in mortality rates between the study arms at any of the 3 study time points (Table 6). At 3 months, there were 5 (3.5%) deaths in each arm. At 6 months, there were 9 (6.3%) deaths in the HCP Plus Peer Support arm compared with 10 (6.9%) in the HCP Support arm. At 9 months, there were 13 (9.1%) deaths in the HCP Plus Peer Support arm compared with 15 (10.4%) in the HCP Support arm.

Table 6

Mortality Rate.

Research Question 2

Would the dual strategy (HCP Plus Peer Support) result in reduced caregiver stress and improved coping and satisfaction?

Caregiver Participant Flow and Baseline Characteristics

Figure 5 shows caregiver participant flow. Among 292 enrolled patient participants, 155 declined to have a caregiver enrolled, and 45 reported they did not have a caregiver. Among the remaining 92 patients who were interested in having a caregiver enrolled, 37 named a caregiver who was not afterwards available to enroll, and 5 named a caregiver who later declined to enroll. Fifty caregivers were enrolled in the same arm as the respective patient (21 in the HCP Support arm; 29 in the HCP Plus Peer Support arm). More caregivers enrolled and more were lost to follow-up in the HCP Plus Peer Support arm, likely because we allowed caregivers to continue to enroll after randomization of the patient participant (as many were not available because of work commitments to be present at the patient enrollment visit). Although more caregivers were interested in enrolling when they knew that their loved one had been randomly assigned to the HCP Plus Peer Support arm (as they were invited to participate in all intervention activities), they were less interested in participating in study assessments.

Figure 5

Caregiver CONSORT Diagram.

Table 7 shows the baseline characteristics of the caregivers enrolled (n = 50) by study arm. Average age of the caregivers was 60 years, and 66% were women. More than half of the caregivers were spouses or partners (58%). In total, 28% of the caregivers were employed, and 32% were current smokers. Among enrolled caregivers, 72% reported having their own health challenges, and 38% reported a medium level of stress.

Table 7

Caregiver Baseline Characteristics.

Caregiver Outcomes

Table 8 shows differences in caregiver outcomes between the study arms. There was no statistically significant difference between the 2 study arms in caregiver stress level or seeking social support.

Table 8

Caregiver Measures by Study Arm at 6 Months Compared With Baseline.

There was a statistically significant difference in reported emotional support at 6 months compared with baseline between the 2 study arms, with caregivers in the HCP Plus Peer Support arm reporting higher levels of emotional support (adjusted difference of 6.23 [95% CI, 1.52-10.94]; P = .01). No significant differences were found for informational support. There was a small difference in the PCS, with caregivers in the HCP Support arm reporting more preparedness at 6 months. Of note, the caregivers in this arm also had higher preparedness levels at baseline compared with those in the HCP Plus Peer Support arm.

Intermediate Outcomes

Impact on Self-efficacy and Self-care Behaviors

Table 9 shows changes in adapted UCOPD total and domain scores from baseline by study arm for each of the 3 study time points. After adjustment for baseline score, hospital site, and enrollment setting, there was a significant interaction between time and study arm for total UCOPD score (overall P < .001) and for the About COPD and Managing Symptoms domain scores (overall P < .001 for each). Looking individually at the 3 study time points for these outcomes using a Bonferroni-adjusted significance level of .05/3 = .0167, we found significant improvements from baseline to 6 months for total UCOPD score (difference of 3.91; 95% CI, 1.63-6.19; P = .001) and the About COPD (difference of 3.01; 95% CI, 1.55-4.74; P < .001) and Managing Symptoms domain scores (difference of 3.22; 95% CI, 1.18-5.27; P = .002). After adjustment for additional baseline patient characteristics, the improvement in the About COPD domain score remained statistically significant at this Bonferroni-adjusted significance level (Table 9).

Table 9

Change in UCOPD, Self-efficacy, and Self-care Behaviors.

There was no statistically significant difference in patient activation, as measured by the PAM score between the 2 study arms at 6 months (see Table 9A in Appendix A). There was a slightly higher number of participants in the HCP Plus Peer Support arm who had quit smoking or were attending a pulmonary rehabilitation program at 6 months compared with the HCP Support arm (6 vs 3 participants who had stopped smoking; 5 vs 3 participants attending a rehabilitation program), but those differences were not statistically significant.

Impact on Patient Perception of Support

Table 10 shows changes in PROMIS patient perception of support measures from baseline by study arm for each of the 3 study time points. After adjustment for baseline score, hospital site, and enrollment setting, there was a significant interaction between time and study arm for the Informational Support domain (overall P = .026). Using a Bonferroni-adjusted significance level of .05/3 = .0167, we saw no significant differences in change from baseline between the study arms for any individual time point. There was also a significant interaction between time and study arm for the Instrumental Support domain after adjustment for baseline score, hospital site, enrollment setting, and baseline patient characteristics (P = .023). We found a significantly larger improvement in instrumental support from baseline to 9 months in the HCP Plus Peer Support arm compared with the HCP Support arm (difference, 1.32; 95% CI, 0.30-2.34; P = .011).

Table 10

Change in PROMIS Support Measures.

Impact on Hope

Table 11 shows changes in hope, as measured by the HHI, by study arm at the 3 study time points (3 months, 6 months, 9 months). The HHI total scores range from 12 to 48, with higher scores indicating higher levels of hope. At 6 months, patients in the HCP Plus Peer Support arm had a mean improvement of 0.87 points in their HHI score compared with a mean decline of 1.18 points in the HCP Support arm (Table 11). There was a significant interaction between time point and study arm after adjustment for baseline score, hospital site, and enrollment setting (P = .001) and after additional adjustment for baseline patient characteristics (P < .001). Looking at the individual time points (with a Bonferroni-adjusted significance level of .0167), patients in the HCP Plus Peer Support arm had a significantly better change in HHI score from baseline to 6 months compared with those in the HCP Support arm (difference, 1.58; 95% CI, 0.42-2.74; P = .007) after adjustment for baseline score, hospital site, and enrollment setting. This difference was similar after additional adjustment for patient baseline characteristics (difference, 1.91; 95% CI, 0.87-2.96; P < .001). With the full set of adjusters, we also observed a significantly better but smaller change in HHI score from baseline to 3 months for the HCP Plus Peer Support arm than for the HCP Support arm (difference, 0.78; 95% CI, 0.41-1.15; P < .001).

Table 11

Changes in Hope Measured by the HHI.

Participant Experiences With the HCP Plus Peer Support Strategy

Survey responses were collected via phone from 49 participants out of 130 active HCP Plus Peer Support arm participants at the end of the study. On a scale of 1 to 10, where 1 was not useful and 10 was extremely useful, the participants rated the HCP session, BREATHE Pals calls, and get-together events. The mean ratings were 9.1 (SD, 1.6), 8.9 (SD, 1.4), and 9.3 (SD, 1.2) for the HCP session, BREATHE Pals calls, and get-together events, respectively. Table 12 shows themes and select quotes from participants' feedback on the BREATHE2 Peer Support program.

Table 12

Themes and Select Quotes From Participants' Feedback on the BREATHE2 Peer Support Program.

Intervention Implementation in the HCP Support and HCP Plus Peer Support arms

Table 13 shows the implementation of intervention services in each study arm by hospital site and enrollment setting. More than 99% of all participants in each study arm had an initial RCP session; 27.1% and 19.2% of participants in the HCP Support and HCP Plus Peer Support arms, respectively, contacted the RCP for a follow-up call during the 6-month follow-up period. Table 10A in Appendix A summarizes the themes from the RCP follow-up calls with participants.

Table 13

Intervention Implementation by Hospital Site and Enrollment Setting.

For participants randomly assigned to the HCP Plus Peer Support arm, the average number of peer support encounters (attending a BREATHE get-together or having a phone interaction with a BREATHE Pal) was 4.4 total encounters per participant. Based on our prespecified definition of adherence (having had at least 4 interactions with the peer program by either attending a BREATHE get-together or having a phone conversation with a BREATHE Pal), 67 (48.9%) participants in the HCP Plus Peer Support arm adhered to treatment, with the lowest adherence among JHBMC inpatients, particularly for attending group events. Reasons why participants reported not attending get-together events included being too sick to attend (marked as reason by 26% of respondents), having transportation issues (24%), and having other medical problems that were more important at the time. The odds of adherence to the intervention in the HCP Plus Peer Support arm was significantly lower for those enrolled from JHBMC inpatient (odds ratio [OR], 0.08; P < .001) and JHBMC outpatient (OR, 0.57; P = .031) settings than for HCGH inpatients.

The peer support program coordinator had a median of 3 calls per participant (ie, contacted 135 participants at least once during the study), with three-fourths of these contacts being of an administrative nature (mostly contacting patients about upcoming get-togethers) and 13% involving problem solving for transportation challenges (eg, connecting patients with Mobility Paratransit services, providing taxi coupons to participants for get-togethers). Table 11A in Appendix A summarizes the themes from the peer support program coordinator's calls with participants.

Using a prespecified adherence definition of having at least 4 interactions with peers via attending a get-together or having a phone conversation with a BREATHE Pal, we compared the baseline characteristics among participants who had adhered to the intervention and those who had low adherence. There were more participants with low income and education levels and higher comorbidities among the low-adherence group compared with the adherent group. Table 12A in Appendix A shows the baseline characteristics by adherence group.

Table 14 shows key patient outcomes by adherence group. For SGRQ total score, participants who adhered to the intervention had, on average, an improvement in HRQOL, while participants with low adherence had, on average, a reduction in HRQOL (mean differences at 6 months of −3.33 and 2.80, respectively). Participants who adhered to the intervention also had better HRQOL than those in in the HCP Support arm. This pattern holds for both SGRQ Activity and Impact domain scores. Additionally, acute-care use was lower among participants who adhered to the intervention compared with those who had low adherence and those in the HCP Support arm. This pattern holds for both all-cause and COPD-related acute-care events.

Table 14

Patient Outcomes by Intervention Reception.

Table 13A in Appendix A shows the intermediate patient outcomes by adherence group. There was an increase in emotional and informational support, patient activation, and UCOPD scores and a decrease in social isolation at 3 months and 6 months among participants who adhered to the intervention compared with those who had low adherence and those in the HCP Support arm.

HTE Analyses

Table 15 shows the results of HTE analyses for the primary outcome of HRQOL. We found a significant interaction between study arm and site (P < .001) in the total score for the SGRQ, with an adjusted difference in the primary outcome of −1.94 (95% CI, −2.18 to −1.70) at HCGH and 4.61 (95% CI, 2.82-6.41) at JHBMC (lower scores on the SGRQ indicate better HRQOL). No other significant interactions were found between study arm and other subgroup variables.

Table 15

Subgroup Analysis for the Mean Difference in HRQOL, as Measured by the SGRQ Total Score at 6 Months After Enrollment.

Table 14A and Table 15A in Appendix A show the patient baseline characteristics and the main study outcomes by hospital site and enrollment setting.

Discussion

In this trial, we compared the effectiveness of a dual strategy for provision of self-management support that incorporated HCP and peer support (HCP Plus Peer Support) with another that used only HCP support. We measured HRQOL over a 9-month period and found no significant differences between the study arms at 6 or 9 months. The HCP Plus Peer Support arm had less COPD-related acute-care events at 1, 3, and 6 months. The study findings are consistent with prior studies on self-management support interventions showing reductions in COPD-related acute-care use and marginal effects on HRQOL.^86-89 Participants in the HCP Plus Peer Support arm had significant improvements in self-efficacy and hope levels compared with those in the HCP Support arm at the 6 -month time point. The effects on acute-care events, hope, and self-efficacy were observed only during the intervention period and were not seen at 9 months, suggesting that a longer intervention duration may be needed. Earlier studies on self-management and behavioral interventions for COPD, CHF, and other conditions have reported that longer intervention durations result in more lasting behavior changes and improvements in outcomes.^88,90,91

In this trial, there was a higher percentage of participants who smoked or had CHF in the HCP Plus Peer Support arm than in the HCP Support arm (27.9% who smoked in the HCP Plus Peer Support arm compared with 21.4% in the HCP Support arm; 42.9% who had CHF in the HCP Plus Peer Support arm compared with 26.9% in the HCP Support arm). Although we have adjusted for these variables in our models, they indicate that at baseline, HCP Plus Peer Support arm participants were less healthy than HCP Support arm participants. Furthermore, in examining missingness of the QOL measure at 6 months between the 2 study arms, 18% of those observed vs 45% missing in the HCP Plus Peer Support arm were using continuous oxygen at baseline compared with 26% observed vs 34% missing in the HCP Support arm. This finding shows that the impact of missingness for this marker of severe COPD was greater in the HCP Plus Peer Support arm. Alternatively, it shows that the observed group assigned to the HCP Plus Peer Support arm was healthier than the missing group and perhaps had less to gain from the intervention. This hypothesis might have biased the comparison of the HCP Plus Peer and HCP Support arms toward the null.

The trial was conducted in real-life settings; although participants were encouraged to participate in all study interventions, they were not required to do so. To facilitate tailoring the intervention to patient preferences, the peer support program incorporated different modalities for provision of peer support, including group events and phone interactions. Counting both modalities of peer support provision, about half of the study participants had <4 interactions with peers. The number of interactions was particularly low among participants enrolled from the JHBMC inpatient population, from which approximately 40% of study participants were recruited. Notably, this population also had sicker patients with more comorbidities and lower socioeconomic and education levels. Though the number of peer interactions among participants from the JHBMC site by phone was similar between those participants recruited from the inpatient and outpatient settings, few participants recruited from the inpatient setting attended group events, despite intensive outreach efforts. Being too sick, having transportation challenges, and having other medical problems were reported as reasons for not attending group events, and these issues were more common among participants at the JHBMC site.

In this study, “expert patients” served as peer supporters, providing peer-to-peer support to help study participants self-manage COPD and minimize its impact on their QOL. The peer supporters had successfully stopped smoking and completed an acute pulmonary rehabilitation program; thus, they served as realistic role models who could provide a success story, hope, and evidence of a person's capacity to cope with COPD. Peer support has been shown to improve outcomes for several diseases and may reduce hospitalizations among patients with diabetes, mental health, and addiction problems.^92-95 Peer support services are now commonly provided in mental health and addiction treatment programs, and payment mechanisms exist to pay for peer support services.^96,97

To our knowledge, this is the first RCT to have studied the effect of peer support among patients with COPD. Generic (not condition-specific) programs to advance chronic disease self-management via structured education programs offered by peers have shown modest benefits on psychosocial outcomes, health behaviors, and utilization.^42,98 These programs have mostly used passive recruitment approaches—mainly flyers and advertisements—and thus the reported outcomes likely represent treatment effects on that subset of patients who are interested, ready, and seeking such programs. In this study, however, we used systematic, proactive approaches for recruitment and enrolled participants during their inpatient stays once they expressed interest in joining the study. The tested population likely represents a broader population of patients with COPD at various stages of disease and variable readiness for receiving peer support and engaging in COPD self-management. The study's recruitment approach likely affected adherence rates to planned study interventions and limited our ability to show intervention effects based on ITT analysis. In an exploratory analysis comparing patient outcomes based on adherence group, participants who adhered to the HCP Plus Peer Support interventions had better QOL than did those who did not adhere at 6 months compared with baseline. They also had better QOL than the participants who were randomly assigned to the HCP Support arm. Similarly, we found better outcomes among participants who adhered to the HCP Plus Peer Support intervention (compared with those who did not adhere and those who were randomly assigned to the HCP Support arm), with less COPD-related and all-cause acute-care use, improved patient-reported emotional and informational support and UCOPD scores, higher patient activation, and decreased social isolation at 3 and 6 months compared with baseline. These findings are consistent with the anticipated changes according to the study's conceptual model (Figure 1).

Interestingly, caregivers in the HCP Plus Peer Support arm had significant increases in self-reported emotional support compared with those in the HCP Support arm, without significant changes in informational support or preparedness for caregiving. The study findings on the caregiver outcomes are limited by the low sample size, which reduces the study's power to detect statistically significant differences.

Conclusions

In this RCT, we compared the effectiveness of HCP support alone vs HCP paired with peer support (HCP Plus Peer Support) for patients with COPD. We found no significant differences in QOL between the study arms; however, participants randomly assigned to the HCP Plus Peer Support arm had fewer COPD-related acute-care events and higher self-efficacy and hope scores than those in the HCP Support arm. Given the low participation in peer support activities and the substantial missing HRQOL outcome data, the study conclusions should be interpreted with caution. More research is needed to examine how peer support interventions can best be delivered and their treatment effects assessed among various patient subgroups.

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Acknowledgments

We are deeply grateful to all members of our patient and family partners group for their valuable contributions to the development of the BREATHE2 study.

We also thank all our study participants and study partners, including Johns Hopkins Bayview Medical Center (JHBMC), Howard County General Hospital (HCGH), and Johns Hopkins Community Physicians. We highly appreciate the contributions and support of the Respiratory Care group and the Pulmonary Rehabilitation programs at JHBMC and HCGH.

The BREATHE2 Study was possible through funding from PCORI (award no. CDR-1507-31247). The opinions in this publication are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its Board of Governors, or the Methodology Committee.

Research reported in this report was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (CDR-1507-31247). Further information available at: https://www.pcori.org/research-results/2016/comparing-self-management-program-and-without-peer-support-improve-quality

Appendices

Suggested citation:

Aboumatar H, Naqibuddin M, Saunders J, et al. (2021). Comparing a Self-Management Program with and without Peer Support to Improve Quality of Life for Patients with COPD. Patient-Centered Outcomes Research Institute (PCORI). https://doi.org/10.25302/06.2021.CDR.150731247

Disclaimer

The [views, statements, opinions] presented in this report are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee.