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

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.