- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290335
Optimizing Strategies to Maximize Patient Recruitment Yield (OSPREY)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neal Dickert, MD, PhD
- Phone Number: (404) 712-6834
- Email: njr@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for primary studies that are recruiting participants:
- 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
Inclusion Criteria for patients:
- 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 for patients:
- Minor
- Excluded from primary study that is recruiting participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
The MyChart study recruitment program will send a message based on the current template, which is a brief message with a neutral tone.
|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
The MyChart study recruitment program will send a message based on a template that includes more detailed information about participant payment.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of "interested" response to recruitment messages
Time Frame: Month 12
|
The primary endpoint is the rate at which individuals respond that they are interested in participating in the study to which they are invited.
The primary outcome is a binary variable of "interested" response.
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of non-response
Time Frame: Month 12
|
This study will examine the rate of non-response to recruitment messages.
|
Month 12
|
|
Rate of "not interested" responses
Time Frame: Month 12
|
This study will examine the rate of individuals responding that they are not interested in the study.
|
Month 12
|
|
Rate of change in MyChart permissions to contact
Time Frame: Month 12
|
This study will examine the rate at which individuals exposed to a MyChart recruitment message change their permission settings for contact about research opportunities.
|
Month 12
|
|
Rate of enrollment among "interested" patients
Time Frame: Month 12
|
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.
|
Month 12
|
|
Patient impressions on recruitment messages
Time Frame: Month 12
|
Some patients will participate in short interviews to understand their impressions of the message they were sent.
Qualitative data are collected during the interviews and there is not a standardized questionnaire or scale that will be used.
|
Month 12
|
|
Patient impressions on research in general
Time Frame: Month 12
|
Some patients will participate in short interviews to understand their attitudes towards research more generally.
Qualitative data are collected during the interviews and there is not a standardized questionnaire or scale that will be used.
|
Month 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neal Dickert, MD, PhD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025P013508
- UL1TR002378 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recruitment
-
NYU Langone HealthCompleted
-
University of California, San FranciscoCompleted
-
Assistance Publique - Hôpitaux de ParisTerminated
-
Centre Hospitalier Universitaire de Saint EtienneNot yet recruiting
-
Fayoum University HospitalCompleted
-
Peking Union Medical College HospitalUnknown
-
Mansoura UniversityCompleted
-
The Royal Wolverhampton Hospitals NHS TrustWithdrawn
-
Lady Davis InstituteCanadian Institutes of Health Research (CIHR)RecruitingRecruitment | Recruitment of Participants | Family Members | Retention | Clinical Study | Compensation Incentives | Study Enrollment | Retention of ParticipantsCanada
Clinical Trials on Baseline (control) message
-
Emory UniversityCompleted
-
Emory UniversityCompleted
-
Riphah International UniversityRecruitingHemiplegic Cerebral PalsyPakistan
-
University of Central FloridaNational Institute of Drug Abuse; Sunserve; Survivor's Pathway; 26HealthRecruitingTransgender Women | Hiv | AidsUnited States
-
Olivier HugliUniversity of Lausanne HospitalsCompletedPain, Acute | Catheterization, PeripheralSwitzerland
-
University of PennsylvaniaTerminated
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedCigarette Smoking BehaviorUnited States
-
Northwestern UniversityNational Institute on Aging (NIA)CompletedInfluenza VaccinationUnited States
-
University of WinchesterUniversity College DublinCompletedStroke | Physical Activity | Gait, HemiplegicUnited Kingdom