Patient ParticipationNCT05348603
Electronic Health Record Strategies to Promote Diverse Participation in Research
A study testing Traditional Letter, Direct to Patient Message and Chatbot in people with Patient Participation, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of enhanced features in an online patient portal including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Participation
- What is being tested?
- Traditional Letter, Direct to Patient Message and Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726,199 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 14 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has an account with the online patient portal
- Has logged into the online patient portal at least once in the past year
- Has not set up a research profile
Who cannot join
- Currently enrolled in a clinical trial
- Opted out of research
- Has received a direct to patient recruitment message within the past year
- On active cancer treatment
- Active member of the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in Clinical Research
The purpose of this study is to determine the effectiveness of enhanced features in an online patient portal including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users.
Read the detailed description
The primary objective is to examine the effectiveness of enhanced online patient portal features including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users, as measured by the user's creation of a research profile.
The secondary objective is to examine the effectiveness of two enhanced online patient portal features including banners, a chatbot and direct-to-patient messages and traditional mailed letters on increasing participation in research among online patient portal users, as measured by the user joining a research study.
This study tests the hypothesis that at one year follow-up, various user engagement tools (e.g. messaging, banners) will increase the proportion of research profiles created by online patient portal users over profiles created by online patient portal users in the absence of those interventions.
- Conditions
- Patient Participation
- Being tested
- Traditional Letter, Direct to Patient Message, Chatbot, Banner
- Keywords
- Online Patient Portal
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional LetterOther
Patients receive a traditional letter.
Direct to Patient MessageOther
Patients receive a direct to patient message via the portal.
ChatbotOther
Patients are contacted by a chatbot via the portal.
BannerOther
Patients are exposed to a banner ad via the portal.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | *No intervention. |
| Traditional Letter Only | Experimental | *A mailed letter will invite the patient to set up a research profile in their patient portal. Receives: Other: Traditional Letter |
| Direct to Patient Message Only | Experimental | *An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research. Receives: Other: Direct to Patient Message |
| Chatbot Only | Experimental | *A real-time, interactive chatbot on the patient portal will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. Receives: Other: Chatbot |
| Banner Only | Experimental | *Banner-type "advertisements" will appear during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Banner |
| Traditional Letter + Direct to Patient Message | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research. Receives: Other: Traditional Letter; Other: Direct to Patient Message |
| Traditional Letter + Chatbot | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. Receives: Other: Traditional Letter; Other: Chatbot |
| Traditional Letter + Banner | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Traditional Letter; Other: Banner |
| Direct to Patient Message + Chatbot | Experimental | * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. Receives: Other: Direct to Patient Message; Other: Chatbot |
| Direct to Patient Message + Banner | Experimental | * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Direct to Patient Message; Other: Banner |
| Chatbot + Banner | Experimental | * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about clinical trial opportunities and trials that match their interests; AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care will inform patients of research opportunities. Receives: Other: Chatbot; Other: Banner |
| Traditional Letter + Direct to Patient Message + Chatbot | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. Receives: Other: Traditional Letter; Other: Direct to Patient Message; Other: Chatbot |
| Traditional Letter + Direct to Patient Message + Banner | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Traditional Letter; Other: Direct to Patient Message; Other: Banner |
| Traditional Letter + Chatbot + Banner | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests.
AND
*Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Traditional Letter; Other: Chatbot; Other: Banner |
| Direct to Patient Message + Chatbot + Banner | Experimental | * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Direct to Patient Message; Other: Chatbot; Other: Banner |
| Traditional Letter + Direct to Patient Message + Chatbot + Banner | Experimental | * A mailed letter will invite the patient to set up a research profile in their patient portal; AND
* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND
* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND
* Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. Receives: Other: Traditional Letter; Other: Direct to Patient Message; Other: Chatbot; Other: Banner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who create a research profile
The outcome will be assessed by querying the patient's electronic medical record to determine whether the patient has registered in the Yale University Volunteer Database. This database is comprised of patients who agree to be contacted if there is a study at Yale that meets their interests.
Measured: 12 months
Secondary outcomes (1)
Number of patients who enroll in a research study
The outcome will be assessed by querying our clinical trials management system or electronic health record system to determine if the patient has consented to participate in a research study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start13 Sep 2022
- Primary completion15 May 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ParticipationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- To examine the effectiveness of enhanced online patient portal features in increasing interest and participation in clinical trials, a randomized trial that will employ a full 2X2X2X2 factorial design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 726,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Brian Smith, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348603
- Sponsor's protocol ID
- 2000032716
- Other IDs
- 75F40120C00174
- Status last verified
- Dec 2023
- First submitted
- 19 Apr 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in Clinical Research
- ClinicalTrials.gov ID
- NCT05348603
- Acronym / sponsor ID
- 2000032716
- Conditions
- Patient Participation
- Keywords
- Online Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726,199 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of enhanced features in an online patient portal including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users.
Detailed description
The primary objective is to examine the effectiveness of enhanced online patient portal features including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users, as measured by the user's creation of a research profile.
The secondary objective is to examine the effectiveness of two enhanced online patient portal features including banners, a chatbot and direct-to-patient messages and traditional mailed letters on increasing participation in research among online patient portal users, as measured by the user joining a research study.
This study tests the hypothesis that at one year follow-up, various user engagement tools (e.g. messaging, banners) will increase the proportion of research profiles created by online patient portal users over profiles created by online patient portal users in the absence of those interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 16
- Model description
- To examine the effectiveness of enhanced online patient portal features in increasing interest and participation in clinical trials, a randomized trial that will employ a full 2X2X2X2 factorial design.
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –*No intervention. |
| Traditional Letter Only | Experimental | Other: Traditional Letter*A mailed letter will invite the patient to set up a research profile in their patient portal. |
| Direct to Patient Message Only | Experimental | Other: Direct to Patient Message*An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research. |
| Chatbot Only | Experimental | Other: Chatbot*A real-time, interactive chatbot on the patient portal will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. |
| Banner Only | Experimental | Other: Banner*Banner-type "advertisements" will appear during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Traditional Letter + Direct to Patient Message | Experimental | Other: Traditional Letter, Other: Direct to Patient Message* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research. |
| Traditional Letter + Chatbot | Experimental | Other: Traditional Letter, Other: Chatbot* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. |
| Traditional Letter + Banner | Experimental | Other: Traditional Letter, Other: Banner* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Direct to Patient Message + Chatbot | Experimental | Other: Direct to Patient Message, Other: Chatbot* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. |
| Direct to Patient Message + Banner | Experimental | Other: Direct to Patient Message, Other: Banner* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Chatbot + Banner | Experimental | Other: Chatbot, Other: Banner* A real-time, interactive chatbot will encourage research participation and direct patients to learn more about clinical trial opportunities and trials that match their interests; AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care will inform patients of research opportunities. |
| Traditional Letter + Direct to Patient Message + Chatbot | Experimental | Other: Traditional Letter, Other: Direct to Patient Message, Other: Chatbot* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. |
| Traditional Letter + Direct to Patient Message + Banner | Experimental | Other: Traditional Letter, Other: Direct to Patient Message, Other: Banner* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Traditional Letter + Chatbot + Banner | Experimental | Other: Traditional Letter, Other: Chatbot, Other: Banner* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests. AND *Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Direct to Patient Message + Chatbot + Banner | Experimental | Other: Direct to Patient Message, Other: Chatbot, Other: Banner* An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
| Traditional Letter + Direct to Patient Message + Chatbot + Banner | Experimental | Other: Traditional Letter, Other: Direct to Patient Message, Other: Chatbot, Other: Banner* A mailed letter will invite the patient to set up a research profile in their patient portal; AND * An e-mail sent to the patient will inform the patient that there is a message pending in their patient portal regarding opportunities to participate in research; AND * A real-time, interactive chatbot will encourage research participation and direct patients to learn more about research opportunities and trials that match their interests; AND * Banner-type "advertisements" during routine viewing and use of of the patient's portal for their our medical/clinical care inform patients of research opportunities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has an account with the online patient portal
- Has logged into the online patient portal at least once in the past year
- Has not set up a research profile
Key exclusion criteria (5 listed)
- Currently enrolled in a clinical trial
- Opted out of research
- Has received a direct to patient recruitment message within the past year
- On active cancer treatment
- Active member of the study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional LetterPatients receive a traditional letter. | Other | Traditional Letter + Banner, Traditional Letter + Chatbot, Traditional Letter + Chatbot + Banner, Traditional Letter + Direct to Patient Message, Traditional Letter + Direct to Patient Message + Banner, Traditional Letter + Direct to Patient Message + Chatbot, Traditional Letter + Direct to Patient Message + Chatbot + Banner, Traditional Letter Only |
| Direct to Patient MessagePatients receive a direct to patient message via the portal. | Other | Direct to Patient Message + Banner, Direct to Patient Message + Chatbot, Direct to Patient Message + Chatbot + Banner, Direct to Patient Message Only, Traditional Letter + Direct to Patient Message, Traditional Letter + Direct to Patient Message + Banner, Traditional Letter + Direct to Patient Message + Chatbot, Traditional Letter + Direct to Patient Message + Chatbot + Banner |
| ChatbotPatients are contacted by a chatbot via the portal. | Other | Chatbot + Banner, Chatbot Only, Direct to Patient Message + Chatbot, Direct to Patient Message + Chatbot + Banner, Traditional Letter + Chatbot, Traditional Letter + Chatbot + Banner, Traditional Letter + Direct to Patient Message + Chatbot, Traditional Letter + Direct to Patient Message + Chatbot + Banner |
| BannerPatients are exposed to a banner ad via the portal. | Other | Banner Only, Chatbot + Banner, Direct to Patient Message + Banner, Direct to Patient Message + Chatbot + Banner, Traditional Letter + Banner, Traditional Letter + Chatbot + Banner, Traditional Letter + Direct to Patient Message + Banner, Traditional Letter + Direct to Patient Message + Chatbot + Banner |
Primary outcome
Number of patients who create a research profile
Time frame: 12 months
The outcome will be assessed by querying the patient's electronic medical record to determine whether the patient has registered in the Yale University Volunteer Database. This database is comprised of patients who agree to be contacted if there is a study at Yale that meets their interests.
1 secondary outcome
Number of patients who enroll in a research study
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
Related trials for Patient Participation
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingObservational study
Implementing Dynamic Consent for Rare Disease Patients
Rare Disorders
Recruiting
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
Shared Decision Making
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Smith, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Letter, Direct to Patient Message and Chatbot in people with Patient Participation, run by Yale University at 1 site 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 3 inclusion and 5 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients who create a research profile (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.