A Randomized Trial of Recruitment Strategies for Research Participation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 1,296
- Locations
- 4
- Primary Endpoint
- The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible for parent RCT
- •18 years or older
- •No prior knowledge of recruitment strategies used for this trial
- •Speaks English
Exclusion Criteria
- •Prior knowledge of recruitment strategies used for this trial
Arms & Interventions
High-level recruitment strategy
Subjects in this group will receive pre-consent messaging and a consent form with a high-level recruitment strategy for research participation in the parent study. The consent form will provide information on the first page, under the header that describes the purpose of the study, as well as in the consent sections describing the cost to participate in the study.
Intervention: High-level recruitment strategy consent form (Behavioral)
Mid-level recruitment strategy
Subjects in this group will receive pre-consent messaging and a consent form with a mid-level recruitment strategy for research participation in the parent study. The consent form will provide information on the first page, under the header that describes the purpose of the study, as well as in the consent sections describing the cost to participate in the study.
Intervention: Mid-level recruitment strategy consent form (Behavioral)
No modified recruitment strategy
Subjects in this group will receive consent form without a modified recruitment strategy for research participation in the parent study.
Outcomes
Primary Outcomes
The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.
Time Frame: Immediate- Several Days
Consent rates in each of the two parent RCTs
Secondary Outcomes
- Perceptions of influence or coercion(Immediate)
- Retention through the end of treatment sessions(8 - 27 weeks)
- Attitudes towards research(Immediate)
- Attention to informed consent(Immediate)
- Perceived risks of the research(Immediate)
- Incidence of therapeutic misconceptions(Immediate)
- Understanding of the trial(Immediate)
Investigators
Scott Halpern
Associate Professor of Medicine
University of Pennsylvania