Incentives, Research Ethics
Conditions
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.
Interventions
BEHAVIORALHigh-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
BEHAVIORALMid-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
Sponsors
Massachusetts General Hospital
Washington University School of Medicine
M.D. Anderson Cancer Center
Northwestern University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed