HemoglobinsNCT04869319
Electronic Triggers: Messaging After A1C EHR Alert
An observational study of Hemoglobins and Diagnostic Tests, run by NYU Langone Health at 1 site in United States.
Trial summary
Studying subjects with HbA1C tests >10 and no follow-up test within 6 months and appointments scheduled in the next 60 days from data run date. Subjects who receive intervention message may be more likely to follow up with their provider to schedule a follow up HbA1C test. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemoglobins, Diagnostic Tests
- What is being tested?
- MyChart message
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,403 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 28 Mar 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MyChart active patients with HbA1C tests >10 and no follow-up test within 6 months and no appointments scheduled in the next 60 days from data run date
Who may be able to join
- MyChart active patients with HbA1C tests >10 and no follow-up test within 6 months and no appointments scheduled in the next 60 days from data run date
Who cannot join
- Patients with a scheduled appointment within 60 days from time algorithm is run; hospital encounters; non English or Spanish patients as indicated by primary language in Epic
Trial locations and contacts
1 site in 1 country.
About this study
Studying subjects with HbA1C tests >10 and no follow-up test within 6 months and appointments scheduled in the next 60 days from data run date. Subjects who receive intervention message may be more likely to follow up with their provider to schedule a follow up HbA1C test.
- Conditions
- Hemoglobins, Diagnostic Tests
- Being tested
- MyChart message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart messageBehavioural
Message subjects through MyChart to follow-up with their provider to schedule a follow up HbA1C test.
| Study group | Role | What they receive |
|---|---|---|
| MyChart message | MyChart message subjects with high A1C blood tests to help manage their diabetes and prevent some of the complications caused by high sugars. The message recommends that they schedule a visit with their doctor who can recheck the blood test and help get their diabetes under control. Receives: Behavioral: MyChart message | |
| No MyChart message | No message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of follow up A1C within 9 months after original A1C (allowing 3 months after email is sent)
This outcome measures the rate at which participants complete an A1C test within 3 months of the message intervention being sent and 9 months of their original test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start13 Jul 2020
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,403 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869319
- Sponsor's protocol ID
- QI-A1C
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2021
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Triggers: Messaging After A1C EHR Alert
- ClinicalTrials.gov ID
- NCT04869319
- Acronym / sponsor ID
- QI-A1C
- Conditions
- Hemoglobins, Diagnostic Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,403 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 3 May 2021 (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.
Studying subjects with HbA1C tests >10 and no follow-up test within 6 months and appointments scheduled in the next 60 days from data run date. Subjects who receive intervention message may be more likely to follow up with their provider to schedule a follow up HbA1C test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyChart message | – | Behavioral: MyChart messageMyChart message subjects with high A1C blood tests to help manage their diabetes and prevent some of the complications caused by high sugars. The message recommends that they schedule a visit with their doctor who can recheck the blood test and help get their diabetes under control. |
| No MyChart message | – | –No message |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MyChart active patients with HbA1C tests >10 and no follow-up test within 6 months and no appointments scheduled in the next 60 days from data run date
Key inclusion criteria (1 listed)
- MyChart active patients with HbA1C tests >10 and no follow-up test within 6 months and no appointments scheduled in the next 60 days from data run date
Key exclusion criteria (1 listed)
- Patients with a scheduled appointment within 60 days from time algorithm is run; hospital encounters; non English or Spanish patients as indicated by primary language in Epic
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 |
|---|---|---|
| MyChart messageMessage subjects through MyChart to follow-up with their provider to schedule a follow up HbA1C test. | Behavioural | MyChart message |
Primary outcome
Rate of follow up A1C within 9 months after original A1C (allowing 3 months after email is sent)
Time frame: 2 years
This outcome measures the rate at which participants complete an A1C test within 3 months of the message intervention being sent and 9 months of their original test.
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 10 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobins and Diagnostic Tests, run by NYU Langone Health 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 1 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 10 Apr 2024. 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?
Rate of follow up A1C within 9 months after original A1C (allowing 3 months after email is sent) (time frame: 2 years). 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 10 Apr 2024.