A Randomized Trial of Recruitment Strategies for Research Participation

Study Overview
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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.

Official Title
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A Randomized Trial of Recruitment Strategies for Research Participation

Conditions
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Cancer, This Study Will Focus on Recruitment Strategies and Attitudes Towards Research Among Patients Considering Participation in 2 Parent Randomized Controlled Trials, Research Ethics

Intervention / Treatment
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* Behavioral: High-level recruitment strategy consent form
* Behavioral: Mid-level recruitment strategy consent form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for parent RCT 18 years or older No prior knowledge of recruitment strategies used for this trial Speaks English Exclusion Criteria: 1)Prior knowledge of recruitment strategies used for this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-level recruitment strategy<br>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<br>* Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy<br>|
| Experimental: Mid-level recruitment strategy<br>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<br>* Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy<br>|
| No Intervention: No modified recruitment strategy<br>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?
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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 three 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 |