A Randomized Trial of Recruitment Strategies for Research Participation

NCT ID: NCT02697799

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Incentives Research Ethics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

High-level recruitment strategy consent form

Intervention Type BEHAVIORAL

Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy

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.

Group Type EXPERIMENTAL

Mid-level recruitment strategy consent form

Intervention Type BEHAVIORAL

Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy

No modified recruitment strategy

Subjects in this group will receive consent form without a modified recruitment strategy for research participation in the parent study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-level recruitment strategy consent form

Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy

Intervention Type BEHAVIORAL

Mid-level recruitment strategy consent form

Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Scott Halpern

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott D Halpern, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

The Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30414865 (View on PubMed)

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.

Reference Type RESULT
PMID: 34542553 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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823491

Identifier Type: -

Identifier Source: org_study_id

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