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Completed

NCT Number: NCT02697799

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.

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Key information

Conditions

Incentives Research Ethics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-level recruitment strategy consent form

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 consent form

Behavioral

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

Primary outcomes

  1. The primary outcome is the proportion of people assigned to each recruitment strategy that consent to participate in the two parent RCTs.

    Time frame: Immediate- Several Days

    Consent rates in each of the two parent RCTs

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • M.D. Anderson Cancer Center
  • Massachusetts General Hospital
  • Northwestern University
  • Washington University School of Medicine

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2016
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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