In a multicenter, randomized clinical trial of attitudes towards research participation, we will evaluate the ethics, effectiveness, and cost- effectiveness of three recruitment strategies for research participation in a mobility trial among hospitalized patients and a smoking cessation trial among patients with depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
1,296
Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy
Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.
Consent rates in each of the two parent RCTs
Time frame: Immediate- Several Days
Attitudes towards research
Attitudes towards research will be measured using the Research Attitudes Questionnaire-7 (RAQ-7). Originally designed with 11 items, a shorter 7-item version (RAQ-7) has been shown to have improved internal consistency and factorial validity.
Time frame: Immediate
Attention to informed consent
We will assess the amount of time patients spend reading each part of the parent RCT consent forms. On-site research coordinators will facilitate the collection of this data as patients read the document via the recruitment strategy study's electronic database.
Time frame: Immediate
Perceived risks of the research
Perceived risks of the research will be measured by the 9-item compared riskiness scale, which assesses perceptions of research risk. Using this approach, patients compare their assessment of the riskiness of the RCTs to other salient and more commonly encountered risks. Such comparative assessments have been shown to be less susceptible to errors in scale calibration than isolated ratings of risks.
Time frame: Immediate
Incidence of therapeutic misconceptions
We will assess patients' ability to distinguish research from individualized patient care by measuring rates of therapeutic misconception across recruitment strategies among patients considering participation in the parent RCTs. We will assess this outcome with a 4-item tool developed by Dr. Scott Kim, which has been used for similar purposes in several research contexts.
Time frame: Immediate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Understanding of the trial
To assess whether increased attention translates into improved understanding of the parent RCTs, we will use a 6-item Trial Elements Quiz, featuring core elements of the parent RCTs' consent form.
Time frame: Immediate
Perceptions of influence or coercion
To measure general perception of coercion and voluntariness of research participation, we will use the five-item Perceived Coercion Scale of the MacArthur Admission Experience Survey. The true/false scale is tailored to measure patients' perceptions of coercion in the inpatient psychiatric treatment admission process; we have edited the wording to make it relevant to participation in the parent RCTs.
Time frame: Immediate
Retention through the end of treatment sessions
We will assess the impact of the recruitment strategies on retention status in the protocol of the parent RCTs.
Time frame: 8 - 27 weeks