Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Official title

Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD

Overview

Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation. The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.

Detailed description

The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.

Interventions

• Behavioral COPD Wellness
  COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (\~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.
• Behavioral COPD Wellness Plus+
  Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/con
• Behavioral Usual Care
  Includes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.

Primary outcome measures

• Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit [Time frame: 3-month (End of intervention) visit]

Secondary outcome measures (8)

• Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention [Time frame: Baseline, 6-month, and 9-month visit following end-of-intervention]
• Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit [Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit]
• Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit [Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit]
• Intervention Adherence at End-of-intervention (3 month) [Time frame: Assessed during 10-week COPD Wellness Intervention]
• Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up [Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit]
• Health System Proportion of patients referred to the intervention [Time frame: Baseline, 24-months after study implementation]
• Health System Adoption of intervention for patients referred [Time frame: Baseline, 24-months after study implementation]
• Healthy System Maintenance of intervention from start of study to end of study activities [Time frame: Baseline, Year 3 of study period (end of study activities)]

Eligibility criteria

Inclusion criteria

• Provision of signed and dated informed consent form
• Willingness to participate in the COPD Wellness program
• 40 to 90 years old
• English or Spanish speaking
• Physician-diagnosed COPD
• Spirometry-confirmed FEV1/FVC ratio <= 0.7 and FEV1% predicted <80% based on GLI-O prediction equation
• COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
• Currently prescribed COPD medication(s)
• Ability to exercise with lower extremities
• No COPD exacerbations for ≥ 6 weeks
• Currently receiving care within SFHN

• Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)

Exclusion criteria

• Pregnancy
• Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
• Unstable cardiovascular disease (includes recent \[<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
• Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
• Transmittable pulmonary infection (tuberculosis, COVID19)
• Participated in pulmonary rehabilitation in the past 12-months
• COPD exacerbation in the past 6 weeks
• Activities restrictions that limit one's ability to engage in moderate physical activity
• Other diagnosis or condition that carry a prognosis of death within the next year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 3 centers

• Zuckerberg San Francisco General (ZSFG) Hospital — San Francisco
• Maxine Hall Health Center (MHHC) — San Francisco
• Southeast Health Center (SEHC) — San Francisco

Publications

• Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am J Med. 2000 Aug 15;109(3):207-12. doi: 10.1016/s0002-9343(00)00472-1. PMID 10974183
• Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86. PMID 23017153
• Selzler AM, Simmonds L, Rodgers WM, Wong EY, Stickland MK. Pulmonary rehabilitation in chronic obstructive pulmonary disease: predictors of program completion and success. COPD. 2012 Aug;9(5):538-45. doi: 10.3109/15412555.2012.705365. PMID 23030585
• Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, Weinman J, Rabe KF, Kaptein AA. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med. 2009 Oct;103(10):1564-71. doi: 10.1016/j.rmed.2008.11.020. Epub 2009 May 29. PMID 19481919
• Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society PMID 26623686

Identifiers

NCT: NCT05572632 · 21-35495 · R01HL161049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗