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.
