Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial.

BACKGROUND: Recruitment and retention are two significant barriers in research, particularly for historically underrepresented groups, including racial and ethnic minorities, patients who are low-income, or people with substance use or mental health issues. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death and disproportionately affects many underrepresented groups. The lack of representation of these groups in research limits the generalizability and applicability of clinical research and results. In this paper we describe our experience and rates of recruitment and retention of underrepresented groups for the Aides in Respiration (AIR) COPD Health Coaching Study. METHODS: A priori design strategies included minimizing exclusion criteria, including patients in the study process, establishing partnerships with the community clinics, and ensuring that the health coaching intervention was flexible enough to accommodate patient needs. RESULTS: Challenges to recruitment included lack of spirometric data in patient records, space constraints at the clinic sites, barriers to patient access to clinic sites, lack of current patient contact information and poor patient health. Of 282 patients identified as eligible, 192 (68%) were enrolled in the study and 158 (82%) completed the study. Race, gender, educational attainment, severity of disease, health literacy, and clinic site were not associated with recruitment or retention. However, older patients were less likely to enroll in the study and patients who used home oxygen or had more than one hospitalization during the study period were less likely to complete the study. Three key strategies to maximize recruitment and retention were identified during the study: incorporating the patient perspective, partnering with the community clinics, and building patient rapport. CONCLUSIONS: While the AIR study included design features to maximize the recruitment and retention of patients from underrepresented groups, additional challenges were encountered and responded to during the study. We also identified three key strategies recommended for future studies of COPD and similar conditions. Incorporating the approaches described into future studies may increase participation rates from underrepresented groups, providing results that can be more accurately applied to patients who carry a disparate burden of disease. TRIAL REGISTRATION: This trial was registered at ClinicalTrial.gov at identifier NCT02234284 on August 12, 2014. Descriptor number: 2.9 Racial, ethnic, or social disparities in lung disease and treatment.

Correction to: Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial.

In the original article [1], the authors reference their intention to use the 'Morisky Medication Adherence Scale'.

Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) severely hinders quality of life for those affected and is costly to the health care system. Care gaps in areas such as pharmacotherapy, inhaler technique, and knowledge of disease are prevalent, particularly for vulnerable populations served by community clinics. Non-professionally licensed health coaches have been shown to be an effective and cost-efficient solution in bridging care gaps and facilitating self-management for patients with other chronic diseases, but no research to date has explored their efficacy in improving care for people living with COPD. METHOD: This is multi-site, single blinded, randomized controlled trial evaluates the efficacy of health coaches to facilitate patient self-management of disease and improve quality of life for patients with moderate to severe COPD. Spirometry, survey, and an exercise capacity test are conducted at baseline and at 9 months. A short survey is administered by phone at 3 and 6 months post-enrollment. The nine month health coaching intervention focuses on enhancing disease understanding and symptom awareness, improving use of inhalers; making personalized plans to increase physical activity, smoking cessation, or otherwise improve disease management; and facilitating care coordination. DISCUSSION: The results of this study will provide evidence regarding the efficacy and feasibility of health coaching to improve self-management and quality of life for urban underserved patients with moderate to severe COPD. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02234284 . Registered 12 August 2014.

Implementation and Impact of the Pulmonary Specialist Health Coach Consultation Model to Improve Care for Patients with COPD.

BACKGROUND: Health coaching has emerged as an important tool for improving patient-centered care in primary care practice but has not specifically been evaluated for patients whose care is shared by a primary care provider (PCP) and specialist. METHODS: As part of a nine-month randomized controlled trial comparing health coaching to usual care for patients with chronic obstructive pulmonary disease (COPD), the authors developed the Pulmonary Specialist Health Coach Consultation (PuSHCon). In this novel model, health coaches facilitated pulmonary specialist consultations for patients with COPD without the need for an in-person visit. Observational data from the randomized controlled trial were analyzed to study the implementation, adoption, and impact of the PuSHCon model for 70 of 92 patients randomized to the health coaching arm and for 17 of 100 patients in the control arm (who received PuSHCon after the end of the study). Quality of care was measured using the Patient Assessment of Chronic Illness Care (PACIC). RESULTS: Of 87 patients who participated in PuSHCon, 74 (85.1%) received one or more specialist recommendations, of which 86.8% were implemented. Only 12 patients (13.8%) subsequently required an in-person visit with the PuSHCon specialist. The proportion of PuSHCon participants receiving guideline-concordant care increased from 64.7% to 94.1% (p < 0.001). The mean PACIC item score increased from 3.48 to 3.74 (p = 0.03). CONCLUSION: The PuSHCon model facilitated consultations that resulted in changes in care, which were implemented for a majority of patients. Guideline-concordant care and patient-reported quality of care increased over nine months. This model could potentially be expanded to help patients with other chronic conditions when PCPs and specialists share patient care.