Clinical trial NCT06244199: Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
Official title: Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Rehabilitation
Transition of Care
Keywords: cardiovascular diseases
cardiac rehabilitation
transition of care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-02-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 4-year, 2-site, type 1 hybrid-effectiveness-implementation trial using a randomized controlled design to compare T2CR-facilitated HBCR to Usual Care, an option that can include Promising Practice HBCR (henceforth called "usual HBCR") but without a transition to HBCR.
Primary purpose: TREATMENT

Brief summary: Cardiac rehabilitation (CR) is a secondary prevention program for patients with cardiovascular disease (CVD). It is especially valuable as CVD increasingly occurs in combination with comorbidity, frailty, and complexities of care that predispose patients to functional decline, disability, and high costs. Still, few Veterans participate in CR, in part because of the difficult logistics to attend. Promising Practice home-based CR (HBCR) was developed to increase CR participation, but many Veterans remain too limited by comorbidity and frailty for participation. A Transition to CR (T2CR) intervention is a face-to-face program that fosters vital skills, education, insights, motivation, and patient-provider relationships conducive to successful HBCR thereafter. This study compares Veterans eligible for CR who are randomized to T2CR intervention versus usual care. Differences in functional capacity, HBCR participation, and healthy days at home are compared over one year. Patients' experiences and providers' perspectives of barriers and facilitators to T2CR are also compared.

Detailed description: Cardiac rehabilitation (CR) is an evidence-based secondary prevention program for patients with cardiovascular disease (CVD) that aims to stabilize patients clinically and to restore physical function and health after a CVD event. It is well-suited to the needs of the aging Veterans Health Administration's (VHA) aging population which is prone to CVD in a context of comorbidity, frailty, and associated functional decline. Unfortunately, few eligible Veterans participate. Logistic challenges are a key barrier as few VHA site-based CR programs are available. The Promising Practice home-based CR (HBCR) is a VHA initiative that was designed to improve CR participation using a novel home-based approach. While HBCR has been demonstrated to be effective for Veterans who attend, only few participate. Many Veterans eligible for HBCR remain encumbered by comorbidity and frailty, and often lack confidence and/or perceived capacity for home-based formats of care. The Transition to CR (T2CR) intervention is a 2-phase program that aims to improve the process of HBCR and to thereby better respond to Veterans' needs. T2CR Phase 1 is a \~2 day face-to-face program between the initial CVD hospitalization and home that includes comprehensive assessment of holistic risks (CVD and non-CVD), functional limitations, and psychosocial circumstances. Individualized pragmatic plans are formulated to ensure HBCR is feasible, safe, and practical despite aggregate complexity. Goal setting, adherence reinforcements, and education are integrated; exercise practice is emphasized; and consultations for comorbid issues and telemedicine video facilitation are arranged. T2CR Phase 2 is HBCR that is enriched by the orientation, practice, consultations, supports, and goal setting that were initiated in T2CR Phase 1, as well as innovative exercise training techniques for patients who are frail and/or functionally impaired. T2CR is aligned with the already existing Coordinated Transitional Care (C-TraC) Program. C-TraC nurse practitioners currently hone medication management, medical follow-up, and education as hospitalized Veterans transition to home, but do little to guide recovery of physical function. By facilitating referral to the T2CR intervention, C-TraC care will be enhanced. Using a hybrid efficacy-implementation (type 1) design, the Transition to Cardiac Rehabilitation to Address Barriers of Multimorbidity and Frailty study is a randomized controlled trial to study T2CR versus usual HBCR in the VA Pittsburgh and Boston Healthcare Systems. Quantitative endpoints include functional gains (assessed using the Patient Reported Outcomes Measurement Information System \[PROMIS\] Physical Function measure) over 365 days as well as a 5-Times Sit-To-Stand performance measure. The number of CR sessions attended, rehospitalizations, and Healthy Days at Home will be assessed. Patients' perceptions of feasibility and acceptability of T2CR will also be evaluated. Providers' perceptions of T2CR will be evaluated as well; the Consolidated Framework for Implementation Research (CFIR) framework will be used to structure their insights. Patient and provider feedback will be applied to refine implementation strategies with the goal to ultimately extend T2CR throughout the entire ORH Promising Practices network.

Eligibility criteria: Inclusion Criteria:

* Eligible candidates will consist of male and female Veterans hospitalized with:

  * ischemic heart disease (acute myocardial infarction or stable ischemia)
* revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
* valvular heart disease (surgical or percutaneous intervention for mitral regurgitation or aortic stenosis)
* or heart failure (with reduced or preserved ejection fraction)
* All will be recruited while initially hospitalized and must express willingness to consider cardiac rehabilitation as a treatment option, including the possibility of the intervention which could possibly extend the length of their hospitalization (for 2 days maximum).
* Study candidates must also be English speaking and able to provide written informed consent

Exclusion Criteria:

* Veterans with unstable medical condition as indicated by history, physical exam, and/or laboratory findings end-stage disease likely to be fatal within 12 months
* severe cognitive impairment (MiniCog score 0-2)
* history of addictive or behavioral issues that confound safe administration of HBCR
* hearing loss that interferes with participation in the trial
* living in a long-term care living situation prior to the time of hospitalization, no plans to return to independent living after the hospitalization

Primary outcomes:
measure: PROMIS Physical Function SF 10a
timeFrame: 3 months, i.e., baseline to 3-month change
Secondary outcomes:
measure: PROMIS Physical Function SF 10a
timeFrame: Baseline to 6-month and 12-month change
measure: 5-Times Sit-to-Stand
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Mini-Cog
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Veterans Specific Activity Questionnaire (VSAQ)
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Morley Frailty Scale
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Cardiac Self-Efficacy Scale
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Pain, Enjoyment, General Activity (PEG)
timeFrame: Baseline to 3-, 6-, and 12-month change
measure: Rehospitalizations and Emergency Room Visits
timeFrame: 3-months, 6-months, and 12-months
measure: Healthy Days at Home
timeFrame: 12-months
measure: Cardiac Rehabilitation Participatory Metrics
timeFrame: 3-months, 6-months, 12-months
measure: Perception Metrics
timeFrame: 3-months, 6-months, 12-months
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Baseline to 3-, 6-, and 12-month change
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Daniel E Forman, MD
role: PRINCIPAL_INVESTIGATOR
References: