A Randomized Trial of Recruitment Strategies for Research Participation

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 Overview

• Status: Completed
• Conditions: Incentives; Research Ethics
• Intervention / Treatment: Behavioral: High-level recruitment strategy consent form; Behavioral: Mid-level recruitment strategy consent form

• Study Type: Interventional
• Enrollment (Actual): 1296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University - Feinberg School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Perelman Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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.	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
No Intervention: No modified recruitment strategy; Subjects in this group will receive consent form without a modified recruitment strategy for research participation in the parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Immediate
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.	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.	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.	8 - 27 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: M.D. Anderson Cancer Center; Massachusetts General Hospital; Washington University School of Medicine; Northwestern University
• Investigators: Principal Investigator: Scott D Halpern, MD, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimated): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 823491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO