A Randomized Trial of Recruitment Strategies for Research Participation

Not Applicable

Completed

• Conditions: Incentives; Research Ethics
• Interventions: Behavioral: Mid-level recruitment strategy consent form; Behavioral: High-level recruitment strategy consent form

• Registration Number: NCT02697799
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-03
• Study Start: 2016-08
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1296

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

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Exclusion Criteria

1)Prior knowledge of recruitment strategies used for this trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid-level recruitment strategy	Mid-level recruitment strategy consent form	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.
High-level recruitment strategy	High-level recruitment strategy consent form	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.	Immediate- Several Days	Consent rates in each of the two parent RCTs

Secondary Outcome Measures

Name	Time	Method
Perceptions of influence or coercion	Immediate	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.
Retention through the end of treatment sessions	8 - 27 weeks	We will assess the impact of the recruitment strategies on retention status in the protocol of the parent RCTs.
Attitudes towards research	Immediate	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.
Attention to informed consent	Immediate	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.
Perceived risks of the research	Immediate	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.
Incidence of therapeutic misconceptions	Immediate	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.
Understanding of the trial	Immediate	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.

Trial Locations

Locations (4)

Northwestern University - Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

The Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

The Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States