The Impact of Informed Consent Type on Participation in an Implementation Science Pilot Study to Improve Cardiac Rehabilitation Participation

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.