Clinical trial NCT02697799: A Randomized Trial of Recruitment Strategies for Research Participation
Official title: A Randomized Trial of Recruitment Strategies for Research Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incentives
Research Ethics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Washington University School of Medicine
name: M.D. Anderson Cancer Center
name: Northwestern University
First posted: 2016-03-03
Enrollment: 1296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. Eligible for parent RCT
2. 18 years or older
3. No prior knowledge of recruitment strategies used for this trial
4. Speaks English

Exclusion Criteria:

1)Prior knowledge of recruitment strategies used for this trial

Primary outcomes:
measure: The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.
timeFrame: Immediate- Several Days
Secondary outcomes:
measure: Attitudes towards research
timeFrame: Immediate
measure: Attention to informed consent
timeFrame: Immediate
measure: Perceived risks of the research
timeFrame: Immediate
measure: Incidence of therapeutic misconceptions
timeFrame: Immediate
measure: Understanding of the trial
timeFrame: Immediate
measure: Perceptions of influence or coercion
timeFrame: Immediate
measure: Retention through the end of treatment sessions
timeFrame: 8 - 27 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University - Feinberg School of Medicine
state: Illinois
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Halpern 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.