Patient ParticipationNCT06467487
Electronic Health Record Strategies to Promote Diverse Participation in Research AIM 2
A study testing Traditional Letter, Direct to Patient Message and Optimized Letter in people with Patient Participation, run by Yale University at 1 site in United States.
Trial summary
Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. 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 Optimized Letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214,526 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 6 Jan 2025
- 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
- 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 COVID-19 Clinical Trials -2
Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.
Read the detailed description
The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.
The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.
- Conditions
- Patient Participation
- Being tested
- Traditional Letter, Direct to Patient Message, Optimized Letter, Direct to Patient Message - Optimized
- 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.
Optimized LetterOther
Patients receive an optimized letter.
Direct to Patient Message - OptimizedOther
Patients receive an optimized direct to patient message via the portal.
| Study group | Role | What they receive |
|---|---|---|
| Optimized Letter | Experimental | Participants receive an 'optimized' letter. Receives: Other: Optimized Letter |
| Optimized Message | Experimental | Participants receive an 'optimized' message. Receives: Other: Direct to Patient Message - Optimized |
| Optimized Letter + Optimized Message | Experimental | Participants receive both a 'optimized' letter and a 'optimized' message. Receives: Other: Optimized Letter; Other: Direct to Patient Message - Optimized |
| Generic Letter | Active comparator | Participants receive a 'usual' letter. Receives: Other: Traditional Letter |
| Generic Message | Active comparator | Participants receive a 'usual' message. Receives: Other: Direct to Patient Message |
| Generic Letter + Generic Message | Experimental | Participants receive both a 'usual' letter and a 'usual' message. Receives: Other: Traditional Letter; Other: Direct to Patient Message |
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 posted21 Jun 2024
- Study start4 Sep 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214,526 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
- NCT06467487
- Sponsor's protocol ID
- 2000032716_a
- Other IDs
- 75F40120C00174
- Status last verified
- Jan 2025
- First submitted
- 14 Jun 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. 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 COVID-19 Clinical Trials -2
- ClinicalTrials.gov ID
- NCT06467487
- Acronym / sponsor ID
- 2000032716_a
- Conditions
- Patient Participation
- Keywords
- Online Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214,526 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 21 Jun 2024 (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.
Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.
Detailed description
The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.
The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Optimized Letter | Experimental | Other: Optimized LetterParticipants receive an 'optimized' letter. |
| Optimized Message | Experimental | Other: Direct to Patient Message - OptimizedParticipants receive an 'optimized' message. |
| Optimized Letter + Optimized Message | Experimental | Other: Optimized Letter, Other: Direct to Patient Message - OptimizedParticipants receive both a 'optimized' letter and a 'optimized' message. |
| Generic Letter | Active comparator | Other: Traditional LetterParticipants receive a 'usual' letter. |
| Generic Message | Active comparator | Other: Direct to Patient MessageParticipants receive a 'usual' message. |
| Generic Letter + Generic Message | Experimental | Other: Traditional Letter, Other: Direct to Patient MessageParticipants receive both a 'usual' letter and a 'usual' message. |
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 (4 listed)
- Currently enrolled in a clinical trial
- Opted out of research
- 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 | Generic Letter, Generic Letter + Generic Message |
| Direct to Patient MessagePatients receive a direct to patient message via the portal. | Other | Generic Letter + Generic Message, Generic Message |
| Optimized LetterPatients receive an optimized letter. | Other | Optimized Letter, Optimized Letter + Optimized Message |
| Direct to Patient Message - OptimizedPatients receive an optimized direct to patient message via the portal. | Other | Optimized Letter + Optimized Message, Optimized Message |
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 13 Jan 2025.
- Individual participant dataSharing planned: No
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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 Optimized Letter 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 4 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 13 Jan 2025. 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 13 Jan 2025.