Optimizing Strategies to Maximize Patient Recruitment Yield

NCT ID: NCT07290335

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-04-30

Brief Summary

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This platform trial aims to evaluate the effectiveness of different messaging strategies within a MyChart messaging program for research recruitment. MyChart is a patient portal system within the Electronic Medical Record (EMR), and messages can be sent directly to patients about research opportunities.

Detailed Description

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Recruitment of participants presents a significant and persistent bottle neck in the research process. Failure to reach participant enrollment targets may delay or halt study progression, wasting limited resources. Insufficient rates of participant accrual are the leading cause for termination among clinical trials with results posted on ClinicalTrials.gov. Additionally, studies must enroll representative samples to ensure generalizability and comply with NIH guidelines. Investigators often cite recruitment difficulties - including lack of interest, difficulty reaching specific populations, and limited resources - to explain failure to reach enrollment goals. However, these recruitment difficulties may not actually be due to a lack of willingness to participate among eligible patients. A national survey conducted by Harris Interactive in 2001 found that 85% of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis. 75% of these patients said they would have been willing to enroll had they known it was possible. Innovation in recruitment is sorely needed to make recruitment more efficient and more representative.

In recent years, researchers have begun to leverage patient portals and electronic health records (EHRs) for recruitment. This method allows for engagement of broad populations within a health system in a cost-effective way. Emerging evidence of EHR recruitment shows promise. The researchers of this study have examined the use of EHR recruitment to identify and contact eligible patients via MyChart direct-to-patient messaging across a range studies within Emory Healthcare. Having completed a pilot program within the Emory system, this service is now available to all Emory investigators for whom MyChart recruitment is appropriate.

While the feasibility of MyChart messaging has been documented, little is known about best practices for how recruitment messages should be designed. There are, however, good reasons to believe that how messages are designed and framed may impact potential participants' responses to them.

This project is a platform trial that will allow for serial testing of various aspects of portal-based messaging. Consistent with platform trial design, the researchers will use a common set of outcome measures across various studies, and the portal-based messaging strategy allows for easy randomization (generally at the patient level) of patients to specific messaging approaches.

In the context of broader use of MyChart messaging, the researchers have designed this study to examine the impact of message design on patients' responses. Specifically, this study will examine the impact of including positively-valenced language that describes the value of the study and the impact of inclusion of information regarding any payments that participants will receive in the study. Both of these factors are ones that are grounded in behavioral economics and may be meaningful to potential participants.

The first proposed trial will involve randomly assigning patients who are identified as potentially eligible for studies using the MyChart recruitment mechanism to receive a recruitment message using 1 of 4 templates: 1) the current standard template; 2) a template with inclusion of positively-valenced language describing the study's value; 3) a template containing information about payment to participants; and 4) a template with both positively-valenced language and payment information. For all studies using the MyChart mechanism, all 4 messages will be created, and assignment will be done based on the last two digits of the patient's medical record number (MRN).

The primary endpoint is the rate at which individuals respond that they are interested in participating in the study to which they are invited. Additionally, this study will examine the non-response rate and the rate of individuals responding that they are not interested in the study. It will also track the rate at which individuals exposed to a MyChart recruitment message change their permission settings for contact about research opportunities. Study teams whose study invitations are used in this trial will be contacted about the rate of enrollment among patients who responded as "interested" to the message so that the researchers can estimate enrollment rate within each intervention group. Finally, select patients will participate in short interviews to understand their impressions of the message they were sent and their attitudes towards research more generally.

Conditions

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Recruitment

Keywords

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Research recruitment Patient portal-based communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Baseline (control) message

Patients in the Emory Healthcare system, who have not opted out of research contact, receiving MyChart messaging for research recruitment using the current standard template.

Group Type ACTIVE_COMPARATOR

Baseline (control) message

Intervention Type BEHAVIORAL

The MyChart study recruitment program will send a message based on the current template, which is a brief message with a neutral tone.

Positively-valenced message

Patients in the Emory Healthcare system, who have not opted out of research contact, receiving MyChart messaging for research recruitment using a template with inclusion of positively-valenced language describing the study's value.

Group Type EXPERIMENTAL

Positively-valenced message

Intervention Type BEHAVIORAL

The MyChart study recruitment program will send a message based on a template that contains positively-valenced language related to the value/importance of the study.

Payment-inclusive message

Patients in the Emory Healthcare system, who have not opted out of research contact, receiving MyChart messaging for research recruitment using a template containing information about payment to participants.

Group Type EXPERIMENTAL

Payment-inclusive message

Intervention Type BEHAVIORAL

The MyChart study recruitment program will send a message based on a template that includes more detailed information about participant payment.

Positively-valenced, payment-inclusive message

Patients in the Emory Healthcare system, who have not opted out of research contact, receiving MyChart messaging for research recruitment using a template with both positively-valenced language and payment information.

Group Type EXPERIMENTAL

Positively-valenced, payment-inclusive message

Intervention Type BEHAVIORAL

The MyChart study recruitment program will send a message based on a template that includes both positively-valenced language and detailed information about participant payment.

Interventions

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Baseline (control) message

The MyChart study recruitment program will send a message based on the current template, which is a brief message with a neutral tone.

Intervention Type BEHAVIORAL

Positively-valenced message

The MyChart study recruitment program will send a message based on a template that contains positively-valenced language related to the value/importance of the study.

Intervention Type BEHAVIORAL

Payment-inclusive message

The MyChart study recruitment program will send a message based on a template that includes more detailed information about participant payment.

Intervention Type BEHAVIORAL

Positively-valenced, payment-inclusive message

The MyChart study recruitment program will send a message based on a template that includes both positively-valenced language and detailed information about participant payment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All studies using the MyChart recruitment service are eligible, including both clinical trials and observational studies.

Exclusion Criterion for primary studies that are recruiting participants:

* Not using MyChart for recruitment.
* At least 500 messages sent, 125 for each arm


* All patients receiving messages via MyChart will be included
* Potential eligibility for a study using MyChart requirement based on the planned query/criteria for that study.

Exclusion Criteria

* Minor
* Excluded from primary study that is recruiting participants.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Georgia Clinical and Translational Science Alliance (GaCTSA)

UNKNOWN

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Neal Dickert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neal Dickert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Healthcare System

Atlanta, Georgia, United States

Site Status

Countries

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United States

Central Contacts

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Neal Dickert, MD, PhD

Role: CONTACT

Phone: (404) 712-6834

Email: [email protected]

Other Identifiers

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UL1TR002378

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P013508

Identifier Type: -

Identifier Source: org_study_id