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A Randomized Trial of Recruitment Strategies for Research Participation

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ClinicalTrials.gov Identifier: NCT02697799
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
Washington University School of Medicine
M.D. Anderson Cancer Center
Northwestern University
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
This Study Will Focus on Recruitment Strategies and Attitudes Towards Research Among Patients Considering Participation in 2 Parent Randomized Controlled Trials Cancer Research Ethics Behavioral: High-level recruitment strategy consent form Behavioral: Mid-level recruitment strategy consent form Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Recruitment Strategies for Research Participation
Study Start Date : August 2016
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the three parent RCTs. [ Time Frame: Immediate- Several Days ]

Secondary Outcome Measures :
  1. Attitudes towards research [ Time Frame: 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.

  2. Attention to informed consent [ Time Frame: 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.

  3. Perceived risks of the research [ Time Frame: 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.

  4. Incidence of therapeutic misconceptions [ Time Frame: 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.

  5. Understanding of the trial [ Time Frame: 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.

  6. Perceptions of influence or coercion [ Time Frame: 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.

  7. Retention through the end of treatment sessions [ Time Frame: 8 - 27 weeks ]
    We will assess the impact of the recruitment strategies on retention status in the protocol of the parent RCTs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697799


Locations
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United States, Illinois
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University Siteman Cancer Center
Saint Louis, Missouri, United States, 63108
United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
The Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Pennsylvania
Massachusetts General Hospital
Washington University School of Medicine
M.D. Anderson Cancer Center
Northwestern University
Investigators
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Principal Investigator: Scott D Halpern, MD, PhD University of Pennsylvania
More Information
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Responsible Party: Scott Halpern, Associate Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02697799    
Other Study ID Numbers: 823491
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No