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IncentivesNCT02697799

A Randomized Trial of Recruitment Strategies for Research Participation

A study testing High-level recruitment strategy consent form and Mid-level recruitment strategy consent form in people with Incentives and Research Ethics, run by University of Pennsylvania at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Incentives, Research Ethics
What is being tested?
High-level recruitment strategy consent form and Mid-level recruitment strategy consent form
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,296 participants
Where
4 sitesUnited States
Study dates
Aug 2016to 31 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible for parent RCT
  • 18 years or older
  • No prior knowledge of recruitment strategies used for this trial
  • Speaks English

Who cannot join

  • 1)Prior knowledge of recruitment strategies used for this trial

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • The Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Being tested
High-level recruitment strategy consent form, Mid-level recruitment strategy consent form

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-level recruitment strategy consent formBehavioural

    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 formBehavioural

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

Study groups in NCT02697799
Study groupRoleWhat they receive
High-level recruitment strategyExperimentalSubjects 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.
Receives: Behavioral: High-level recruitment strategy consent form
Mid-level recruitment strategyExperimentalSubjects 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.
Receives: Behavioral: Mid-level recruitment strategy consent form
No modified recruitment strategyNo interventionSubjects in this group will receive consent form without a modified recruitment strategy for research participation in the parent study.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Consent rates in each of the two parent RCTs

    Measured: Immediate- Several Days

Secondary outcomes (7)

  1. 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.

    Measured: Immediate

  2. 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.

    Measured: Immediate

  3. 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.

    Measured: Immediate

  4. 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.

    Measured: Immediate

  5. 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.

    Measured: Immediate

  6. 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.

    Measured: Immediate

  7. 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.

    Measured: 8 - 27 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697799
Sponsor's protocol ID
823491
Status last verified
Oct 2024
First submitted
25 Feb 2016
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Krutsinger DC, McMahon J, Stephens-Shields AJ, Bayes B, Brooks S, Hitsman BL, Lubitz SF, Reyes C, Schnoll RA, Ryan Greysen S, Mercede A, Patel MS, Reale C, Barg F, Karlawish J, Polsky D, Volpp KG, Halpern SD. Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials. Contemp Clin Trials. 2019 Jan;76:1-8. doi: 10.1016/j.cct.2018.11.007. Epub 2018 Nov 8.

    PubMed 30414865

  • Halpern SD, Chowdhury M, Bayes B, Cooney E, Hitsman BL, Schnoll RA, Lubitz SF, Reyes C, Patel MS, Greysen SR, Mercede A, Reale C, Barg FK, Volpp KG, Karlawish J, Stephens-Shields AJ. Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials. JAMA Intern Med. 2021 Nov 1;181(11):1479-1488. doi: 10.1001/jamainternmed.2021.5450.

    PubMed 34542553

Questions about this trial

What is this clinical trial studying?

A study testing High-level recruitment strategy consent form and Mid-level recruitment strategy consent form in people with Incentives and Research Ethics, run by University of Pennsylvania at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02697799, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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