The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance

Not Applicable

Recruiting

• Conditions: Ethics; Cardiac Rehabilitation; Aortic Valve Replacement; Coronary Heart Disease (CHD); Heart Failure; Percutaneous Coronary Intervention (PCI); Myocardial Infarction (MI)

• Registration Number: NCT07123480
• Lead Sponsor: Baystate Medical Center

Brief Summary

Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.

New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation.

In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project.

The two main goals of this study is to understand:

1. If the consent approach type impacts participation rates in the research study

2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Detailed Description

Cardiac Rehabilitation (CR) is a guideline-recommended therapy that helps patients improve their health and longevity. It is underused, especially among older, sicker, and minority populations. Guidelines make strong recommendations for use among all patients, and there are ongoing national initiatives to improve utilization. At Baystate, cardiac rehabilitation attendance rates are improving, but investigators are still seeking additional strategies to further encourage participation. If the investigators succeed, patients will live longer, healthier lives, thus embodying beneficence.

However, the typical 10-12 page consent form is a major barrier to successful study completion with participation rates in typical clinical trials of 20% of eligible patients. More importantly, it introduces an important selection bias in the population by finding patients who are more responsive to interventions. It also shifts the population towards patients away from underrepresented minorities and yields results that are less applicable to real-world settings with clinical populations. In short, this selection bias is inconsistent with the ethical principle of justice, which states that the same population that is expected to benefit from the research should also be the population that bears the burden of the research. Thus, alternate forms of informed consent are needed to assure a representative population and scientific results that can be confidently generalized.

First, to address issues of consent, the investigators will determine the impact of four different ethical approaches to consent (full consent with signature, 3-page summary consent with signature, 1-page opt-out waiver - no signature, or Non-Consenting (NC) cohort - where patients can refuse any intervention) on study enrollment rate and population representativeness.

Second, the investigators will assess the feasibility and utilization of a multi-dimensional intervention to increase CR enrollment. These will include combining a financial incentive, case management, text messaging program, and physical activity coaching, all with the goal of increasing CR enrollment. The investigators will assess the acceptance rate of intervention components and the overall feasibility of the proposed intervention in preparation for larger clinical trials.

Patients will be randomized to 1 of 4 consent approaches shown below. All consent documents and corresponding waivers were submitted to a full board IRB and approved.

* Full consent form. This is the typical 10 to 12-page consent form at Baystate Medical Center. This has the 3-4-page summary and the 6-8 pages of technical details. It has unalterable language provided by the Baystate Institutional Review Board (IRB) and Baystate Legal with an 11th-grade Keiser-Fleischer reading grade level. All elements of consent are included. A full HIPPA waiver is included. Signature is required.

* Brief consent form. This 3-4-page consent form summarizes the study in a shorter form. All essential information is retained, and there is considerably less required legal language. Signature is required. The investigators provided a justification for alteration of consent to our IRB.

* 1 page opt-out Waiver. This 1-page description includes a brief description of the study, its purposes, and goals. It gives the patient a chance to opt-out, but does not require a signature. Patients' consent is implied unless they indicate otherwise. The investigators provided a justification for alteration of consent to their IRB.

* Non-Consenting (NC) Cohort. Patients are told they are participating in a Cardiac Rehabilitation Project, but are given the option to decline any intervention they are not interested in. The investigators will not provide written or explicit verbal consent prior to participating. The investigators provided a Justification for alteration of consent to their IRB.

Patients who agree to participate by signing a consent form, by not opting out, or by being randomized to the non-consent group will be re-randomized to either the Usual Care or MOST group. Additional details of these interventions are found below.

If patients consent, do not opt-out, or are randomized to the non-consenting cohort, they will be re-randomized 1:1 to either usual care or a multifactorial CR intervention. This intervention will include four components: financial incentives, text messaging, case management, and physical activity coaching, combined as a single intervention.

The primary outcome will be the proportion of patients (%) participating in the clinical trial. The secondary outcome will be enrollment in CR within 3 months of hospital discharge.

All interventions are minimal risk. They are typically found in routine clinical medicine and have been used without difficulty in other settings. In any group, patients can refuse any or all components of the intervention, thus respecting patient autonomy. If patients respond and attend CR, they will gain health benefits, which is consistent with the ethical principle of beneficence.

Study Timeline

• Study Start: 2025-07-16
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-01-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Only Baystate Medical Center (Springfield, Massachusetts ) adult patients over age 18 who are admitted to Baystate Medical Center Hospital with a non-surgical qualifying diagnosis for outpatient CR will be included. Common diagnoses include all patients with myocardial infarction, stable angina, percutaneous coronary intervention, transcutaneous aortic/mitral valve replacement, and heart failure.

Exclusion Criteria

• Patients with coronary artery bypass graft surgery, heart valve surgery, or other open-heart surgical procedures will be excluded, as these patients are much more likely attend CR, typically around 70%. In addition, patients who are referred to CR programs outside the region, where enrollment cannot be tracked, will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Informed Consent Approach Participation	Baseline	The proportion of patients (%) participating in the clinical trial.

Secondary Outcome Measures

Name	Time	Method
Sex Representativeness of Consenting Groups	Baseline	Each consent group will be analyzed based on the demographics of patients participating. The sex characteristics of each consent group will be measured as male, female, or other.
Cardiac Rehabilitation Qualifying Diagnosis Representativeness of Consenting Groups	Baseline	Each consent group will be analyzed based on the demographics of patients participating. The cardiac rehabilitation qualifying diagnosis characteristic of each consent will be measured.
The Porportion of Intervention Accepted	Up to to 3 months after hospital discharge, or cardiac rehabilitation attendance, whichever comes first	The proportion of patients (%) who accept each intervention (financial incentives, case management, physical activity coaching, and text messaging) will be measured.
Cardiac Rehabilitation Attendance	Up to to 3 months after hospital discharge, or cardiac rehabilitation attendance, whichever comes first.	The proportion (%) of patients who attend 1 or more sessions of cardiac rehabilitation
Age Representativeness of Consenting Groups	Baseline	Each consent group will be analyzed based on the demographics of patients participating. The age characteristics of each consent group will be measured in years.
Ethnicity Representativeness of Consenting Groups	Baseline	Each consent group will be analyzed based on the demographics of patients participating. The ethnicity characteristic of each consent group will be measured using the NIH defined categories (Hispanic or Latino, and Not Hispanic or Latino).
Race Representativeness of Consenting Groups	Baseline	Each consent group will be analyzed based on the demographics of patients participating. The race characteristics of each consent group will be measured using the five NIH racial categories (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White).

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States