A Randomized Trial of Recruitment Strategies for Research Participation
1 other identifier
interventional
1,296
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedOctober 8, 2024
October 1, 2024
3.1 years
February 25, 2016
October 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Immediate- Several Days
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
High-level recruitment strategy
EXPERIMENTALSubjects 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.
Mid-level recruitment strategy
EXPERIMENTALSubjects 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.
No modified recruitment strategy
NO INTERVENTIONSubjects in this group will receive consent form without a modified recruitment strategy for research participation in the parent study.
Interventions
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
Eligibility Criteria
You may qualify if:
- Eligible for parent RCT
- years or older
- No prior knowledge of recruitment strategies used for this trial
- Speaks English
You may not qualify if:
- )Prior knowledge of recruitment strategies used for this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Massachusetts General Hospitalcollaborator
- Washington University School of Medicinecollaborator
- M.D. Anderson Cancer Centercollaborator
- Northwestern Universitycollaborator
Study Sites (4)
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
Krutsinger DC, McMahon J, Stephens-Shields AJ, Bayes B, Brooks S, Hitsman BL, Lubitz SF, Reyes C, Schnoll RA, Ryan Greysen S, Mercede A, Patel MS, Reale C, Barg F, Karlawish J, Polsky D, Volpp KG, Halpern SD. Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials. Contemp Clin Trials. 2019 Jan;76:1-8. doi: 10.1016/j.cct.2018.11.007. Epub 2018 Nov 8.
PMID: 30414865BACKGROUNDHalpern SD, Chowdhury M, Bayes B, Cooney E, Hitsman BL, Schnoll RA, Lubitz SF, Reyes C, Patel MS, Greysen SR, Mercede A, Reale C, Barg FK, Volpp KG, Karlawish J, Stephens-Shields AJ. Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials. JAMA Intern Med. 2021 Nov 1;181(11):1479-1488. doi: 10.1001/jamainternmed.2021.5450.
PMID: 34542553RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Halpern, MD, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 3, 2016
Study Start
August 1, 2016
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share