Clinical trial NCT03834155: Enhancing Cardiac Rehabilitation Through Behavioral Nudges
Official title: Enhancing Cardiac Rehabilitation Adherence Through Home-based Rehabilitation and Behavioral Nudges: ERA Nudge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Percutaneous Coronary Intervention
Coronary Artery Disease
Valvular Disease
Chronic Stable Angina
Chronic Stable Heart Failure
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adherence to cardiac rehabilitation is poor, and worse for minorities, women, and those with lower levels of education. Patients less likely to be referred to and complete cardiac rehab are at highest risk of adverse outcomes and thus have the most to gain from participation in cardiac rehab. To improve participation, healthcare systems need to limit barriers to enrollment and promote adherence to rehabilitation.

Detailed description: This study aims to (1) iteratively develop and program a theoretically informed technology-based nudge message library for a diverse patient population using multiple and iterative N of 1 within subject studies. Investigators will also engage patient, provider and health systems stakeholders in designing and refining the messages. (2)Develop a one-page decision aid tool to present information designed with principles of shared decision making including pros and cons of hospital and home-based rehabilitation. Investigators will engage patients, providers, and health systems stakeholders to provide feedback on the information sheet. (3) Conduct a 2x2 factorial design randomized trial of a) choice and b) nudge messaging to improve primary outcome of CR adherence. Secondary outcomes will include enrollment and completion of CR, exercise capacity, patient engagement, quality of life, hospitalizations, and healthcare utilization. The study will additionally evaluate the interventions using a mixed methods approach applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework and a cost-effectiveness analysis. The cost-effectiveness analysis sub-study will evaluate the implementation cost of home-based and hospital-based cardiac rehabilitation programs in addition to the incremental cost effectiveness ratios for each intervention.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, valvular heart surgery, chronic stable angina, and/or chronic stable heart failure with left ventricular systolic dysfunction.
* 18 year of age or older
* Access to a cell phone with text messaging capability
* English or Spanish speaking

Exclusion Criteria:

* Medical director's decision based on high-risk assessment
* Enrolled in hospice or palliative care
* Being intoxicated or otherwise unable to consent to participate

Primary outcomes:
measure: Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap
timeFrame: 12 weeks
Secondary outcomes:
measure: Active enrollment of 280 DH participants
timeFrame: 3.5 yrs
measure: Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions
timeFrame: 12 weeks
measure: Exercise capacity measured by a 6-minute walk test.
timeFrame: 12 weeks
measure: Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM)
timeFrame: 12 weeks
measure: Reported quality of life measured by Ferrans and Powers Quality of Life Index
timeFrame: 12 weeks
measure: Number of participants hospitalized over four months using EHR review and ICD-10s
timeFrame: 6 months
measure: Number of participants who attend or log of 36 cardiovascular rehabilitation sessions measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap
timeFrame: 12 weeks
measure: Type of healthcare utilization by individual participants, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.
timeFrame: 6 months
measure: Safety measures to track injury from exercise will be assessed using EHR
timeFrame: 12 weeks
measure: Socioeconomic and clinical data will be collected from EHR.
timeFrame: 3.5 yrs
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Pamela Peterson, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: