Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial.

Rationale: Self-management support (SMS) is an essential component of care for patients who have chronic obstructive pulmonary disease (COPD), but there is little evidence on how to provide SMS most effectively to these patients. Peer support (i.e., support provided by a person with a similar medical condition) has been successfully used to promote self-management among patients with various chronic conditions, yet no randomized studies have focused on testing its effects for patients with COPD. Objectives: To assess whether adding peer support to healthcare professional (HCP) support to help patients with COPD self-management results in better health-related quality of life (HRQoL) and less acute care use. Methods: A two-arm randomized controlled trial was performed at one academic and one community hospital and their affiliate clinics. The study population included patients aged ⩾40 years who had been diagnosed with COPD by a physician and were currently receiving daily treatment for it. Two self-management support strategies were compared over 6 months. One strategy relied on the HCP for COPD self-management (HCP support); the other used a dual approach involving both HCPs and peer supporters (HCP Plus Peer). The primary outcome was change in HRQoL measured by the St. George's Respiratory Questionnaire at 6 months (range, 0-100, lower is better; four-point meaningful difference). Secondary outcomes included COPD-related and all-cause hospitalizations and emergency department visits. Analysis was conducted under intention to treat. Results: The number of enrolled participants was 292. Mean age was 67.7 (standard deviation, 9.4) years; 70.9% of participants were White, and 61.3% were female. St. George's Respiratory Questionnaire scores were not significantly different between the study arms at 6 months. HCP Plus Peer arm participants had fewer COPD-related acute care events at 3 months (incidence rate ratio, 0.68; 95% confidence interval [CI], 0.50-0.93) and 6 months (incidence rate ratio, 0.84; 95% CI, 0.71-0.99). Conclusions: Adding peer support to HCP support to help patients self-manage COPD did not further improve HRQoL in this study. However, it did result in fewer COPD-related acute care events during the 6-month intervention period. Clinical trial registered with www.clinicaltrials.gov (NCT02891200).

Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study.

BACKGROUND: Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. METHODS: We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping. RESULTS: A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%). DISCUSSION: This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.

Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer.

BACKGROUND: African Americans in the United States have worse end-of-life care and cancer outcomes than whites. Palliative care may improve this disparity. Community Health Workers may provide a means to improve palliative care disparities. METHODS: Semistructured in-depth interviews (five) and stakeholder focus groups (four) were conducted with cancer patients, caregivers, health care administrators, oncologists, and community health workers (CHWs). Patients were recruited through snowball sampling. Three raters coded interviews independently. Data were analyzed using interpretative phenomenological analysis. RESULTS: Seventy-one individuals were contacted to participate with 24 stakeholders (34%) participating in individual interviews or across 4 stakeholder engagements. Eleven constructs were identified and grouped in three broader themes: "hub of the wheel," understanding palliative care, and patient-provider relationships. Participants felt that the role of a CHW should be central, bridging patients with their providers, information, and resources, including psychosocial support and advance care planning documents. They also placed an emphasis on the background of CHWs, saying individuals selected should be familiar with the history, culture, and norms of the communities from which they operate. Stakeholders reported that a CHW could activate a patient to contact their primary care physician or oncologist who may refer to or provide palliative care. Stakeholders reported that given the barriers to palliative care, a CHW could contribute to patient-centered multidisciplinary care while addressing palliative care domains with patients and families in a culturally sensitive manner. CONCLUSION: Based on feedback from patients, caregivers, and providers, a culturally adapted CHW intervention may improve palliative care use for African American patients with advanced malignancies.

Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.

BACKGROUND: Pivotal trials, the clinical studies that inform U.S. Food and Drug Administration (FDA) approval decisions, provide the foundational evidence supporting the safety and efficacy of novel therapeutics. We determined the representation of the elderly, women, and patients from racial and ethnic minorities in pivotal trials and whether the FDA is making subgroup efficacy analyses among these subpopulations available to the public. METHODS: We conducted a cross-sectional study of novel therapeutics approved by the FDA between 2011 and 2013. Using publicly available FDA documents, we collected information on the demographic characteristics of pivotal trial participants (age ≥65 years, sex [male, female], race [white, black, Asian, other], and ethnicity [Hispanic, non-Hispanic]) and determined the availability of subgroup analyses by age, sex, race, and ethnicity. RESULTS: We identified 86 novel therapeutic that were approved by the FDA between 2011 and 2013 for 92 indications on the basis of 206 pivotal trials. The median age of pivotal trial patients was 53.1 years (interquartile range 40.6-60.6), and the mean proportion of patients ≥65 years of age was 28.9 % (95 % CI 23.5-34.4 %). Similar proportions of pivotal trial participants were male (mean 50.3 %, 95 % CI 45.3-55.2 %) and female (mean 49.7 %, 95 % CI 44.7-54.7 %). Most participants were white (mean 79.2 %, 95 % CI 75.9-82.6 %), while the mean proportion of black patients was 7.4 % (95 % CI 5.5-9.3 %), that of Asian patients was 7.4 % (95 % CI 5.2-9.7 %), and that of patients of other races was 5.9 % (95 % CI 4.4-7.5 %). Information about ethnicity was available for only 59.8 % of indications, and where such data were available, the mean proportion of Hispanic participants was 13.3 % (95 % CI 10.3-16.3 %). FDA reviewers performed and made available subgroup efficacy analyses by age, sex, and race for at least one of the pivotal trials used as the basis of approval for over 80 % of indications. CONCLUSIONS: Although women are equally represented in pivotal trials supporting recent novel therapeutic approvals by the FDA, elderly patients and those from racial and ethnic minorities are underrepresented. FDA reviewers generally perform subgroup efficacy analyses by age, sex, and race and make these subgroup analyses available to the public.