Diabetes MellitusNCT03542487
Blood Glucose Monitoring in Electronic Health Records
A study testing Practice Orientation, Standard Reminder and Gift Card Reminder in people with Diabetes Mellitus, run by Inova Health Care Services at 1 site in United States.
Trial summary
This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of wide-scale adoption on health status of patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Practice Orientation, Standard Reminder and Gift Card Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,052 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients of Inova physicians at primary care sites other than Ashburn II Primary Care, Lake Ridge Primary Care and Springfield Primary Care
- Current diabetes mellitus diagnosis
- Active MyChart account at time of treatment administration
Who cannot join
- Patients who participating physicians identify as pregnant
- Patients who participating physicians identify as having contraindications for tracking of blood glucose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Blood Glucose Monitoring Into Electronic Health Records
This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of wide-scale adoption on health status of patients with diabetes. To investigate determinants of adoption, the research will combine and test doctor and patient focused approaches to encouraging patient use of blood glucose flow sheets through the online patient portal, MyChart. Adoption will be measured on both the extensive and intensive margin: the number of patients who enter data into the flowsheets at all during the study period, and the mean number of entries per patient during the study period. Conditional on statistically significant increases in adoption, the study will examine corresponding intent-to-treat effects on patient A1c, and consider other indicators of possible mechanisms through which A1c improves or does not improve.
- Conditions
- Diabetes Mellitus
- Being tested
- Practice Orientation, Standard Reminder, Gift Card Reminder, Physician Reminders
- Keywords
- Self Monitoring of Blood Glucose, Electronic Medical Records, Nudge, Secure Messaging, Behavioral Economics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice OrientationBehavioural
Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. This will allow diabetic patients at these practices to enter any self-monitored glucose measurements. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose.
Standard ReminderBehavioural
Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets
Gift Card ReminderBehavioural
Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. In these reminders, they will also be notified that that they will be entered to win a $50 gift card for each day entering data.
Physician RemindersBehavioural
Patients receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT)
| Study group | Role | What they receive |
|---|---|---|
| 1: Control | No intervention | A randomly selected half of primary care practices in the study sample at Inova Health Care Services will not receive any intervention and patients/physicians located at these practices will continue with business as usual. |
| 2a: Practice Orientation- No Reminder | Experimental | In the other randomly selected half of primary care practices in the study sample at Inova Health Care Services, practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2a will receive no additional reminder messaging to enter glucose measurements in the electronic flowsheets. Receives: Behavioral: Practice Orientation |
| 2b: Practice Orientation- Standard Reminder | Experimental | Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2b will receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. Receives: Behavioral: Practice Orientation; Behavioral: Standard Reminder |
| 2c: Practice Orientation- Gift Card Reminder | Experimental | Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2c will receive generic biweekly reminders to enter data, addressed from Inova Medical Group, that will also notify that the patient will be entered to win a $50 gift card for each day entering data. Receives: Behavioral: Practice Orientation; Behavioral: Gift Card Reminder |
| 2d: Practice Orientation- Physician Reminder | Experimental | Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2d will receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT). Receives: Behavioral: Practice Orientation; Behavioral: Physician Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)
Measured: (1-14) weeks after initial practice orientation
Participant A1c Test Results (as Percent A1c) at 26 Weeks
Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test.
The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated.
The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used.
Measured: 26 weeks after initial practice orientation
Secondary outcomes (15)
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)
Measured: Beginning of week 15 to 26 weeks after initial practice orientation
Number of Days Participant Used Flowsheet, Intensive
The total number of days of participant use of the electronic glucose flowsheet during the measurement period.
A day of Participant use of electronic glucose flowsheet is defined here as as day (24 hours) in which the participant performed an entry into an electronic glucose flowsheet.
Measured: (1-14); (15-26) weeks after initial practice orientation
Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet
Count of participants that have an open physician order for electronic glucose flowsheet end of the measurement period (Count of participants determined with a binary aggregation method; 1= Participant had an open physician order for electronic Glucose Flow Sheet at end of measurement period; 0= Participant did not have an open physician order for electronic Glucose Flow Sheet at end of measurement period)
Measured: at 14 and 26 weeks after initial practice orientation
Number of Days Since Last HbA1c Test
The total number of days that elapsed since participant last had and HbA1c test.
The number of days was measured by the number of days that passed from the date of the most recent HbA1c test in the Electronic Medical Record and the date of the data extraction at the specified time point.
Measured: 14; 26 weeks after initial practice orientation
Participant A1c Test Results (as Percent A1c) at 14 Weeks
Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test.
The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated.
The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used
Measured: 14 weeks after initial practice orientation
Count of Participants With Improvement of HbA1c Test Results
Count of participants with improved HbA1c test result values in most recent Electronic Medical Record (EMR) during measurement period as compared to HbA1c test value at baseline. (Count of participants determined with a binary aggregation method; 1= Participant Improved, most recent A1c test value less than baseline A1c test value; 0= Participant did not Improve; most recent A1c test value greater than or equal to baseline A1c test value)
Improvement of HbA1c test results is defined as a reduction of the most recent and available HbA1c test value (a lower percent A1c) in the EMR at appropriate time period relative to the baseline.
Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated.
Higher percent A1c levels are associated with poor blood sugar control and increased risk of of diabetes-related complications.
Measured: 14; 26 weeks after initial practice orientation
Count of Participants With Percent A1c Below Benchmark of 7
Count of participants with most recent HbA1c test value (percent A1c) in Electronic Medical Records below target benchmark of 7 at appropriate time point (Count of participants determined with a binary aggregation method; 1= Participant HbA1c test value less than 7; 0= Participant Hb1Ac test value greater than or equal to 7).
Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test.
The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated.
A percent A1c level less than 7 is a common treatment target and is associated with with a lower risk of diabetes-related complications.
Measured: 14; 26 weeks after initial practice orientation
Total Secure Messages Sent by Participant
Total number of messages sent by participant via MyChart Electronic medical records system during the measurement period
Measured: (1-14); (15-26) weeks after initial practice orientation
Total Secure Messages Sent by Patient to Primary Care Provider
Total number of MyChart messages sent by patient to the Primary Care Provider (PCP) during the measurement period. Not reported separately from Total number of messages sent by patient, so outcomes not reported here.
Measured: (1-14); (15-26) weeks after initial practice orientation
Total Secure Messages Sent by PCP to Patient
Total number of MyChart messages sent by PCP to the patient during the measurement period
Measured: (1-14); (15-26) weeks after initial practice orientation
Total Number of Participant Phone Appointments
Total number of participant phone appointments during the measurement period
Measured: (1-14); (1-26) weeks after initial practice orientation
Total Number of Participant In-person Appointments
Total number of participant in-person appointments during the measurement period
Measured: (1-14); (1-26) weeks after initial practice orientation
Count of Participants With Changes to Active Medication List
Count of Participants with Changes (Any; Addition; Removal) to list of active medications in EMR during measurement period. Active medication lists is comprised of prescription ordered medications for participants.
Count of participants determined with a binary aggregation method:
Any Change is defined as medications added or removed from active list ( 1= Participant had medications added to or removed from active medication list; 0= Participant did not have medication added to or removed from active medication list).
Medications Added is defined as the addition of medications to active medication list ( 1= Participant had medications added to active medication list; 0= Participant did not have medications added to active medication list).
Medications Removed is defined as the removal of medications to active medication list ( 1= Participant had medications removed from active medication list; 0= Participant did not have medications removed from active medication list).
Measured: (1-14); (1-26) weeks after initial practice orientation
Prescription Orders
Number of prescription ordered medications for participant during measurement period (Total all; Total new/non-refill; Total diabetes related)
Measured: (1-14); (1-26) weeks after initial practice orientation
Flowsheet Entry Values (Descriptive)
Value of blood glucose entered into flowsheet (descriptive analysis). No systematic outcomes recorded to report.
Measured: 2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 May 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Primary care practices will be assigned to a provider-side treatment (physician orientation) or to control. Within treatment assigned practices, individual patients will be assigned to one of four reminder messaging groups (one of which is no messaging).
- Masking
- None (open label)
- Enrolment
- 7,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Abdul Latif Jameel Poverty Action Lab, General Services Administration (GSA), Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Allyson B Root, MS, Principal investigator, General Services Administration, UC BerkeleySeason Majors, MSN,RN, Principal investigator, Inova Health Care ServicesMary Ann Friesen, PhD, Principal investigator, Inova Health Care ServicesChristopher P Connolly, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542487
- Sponsor's protocol ID
- 17-2642
- Other IDs
- Project Code: 1729
- Status last verified
- May 2024
- First submitted
- 15 May 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Blood Glucose Monitoring Into Electronic Health Records
- ClinicalTrials.gov ID
- NCT03542487
- Acronym / sponsor ID
- 17-2642
- Conditions
- Diabetes Mellitus
- Keywords
- Self Monitoring of Blood Glucose, Electronic Medical Records, Nudge, Secure Messaging, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,052 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Abdul Latif Jameel Poverty Action Lab, General Services Administration (GSA), Department of Health and Human Services
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of wide-scale adoption on health status of patients with diabetes. To investigate determinants of adoption, the research will combine and test doctor and patient focused approaches to encouraging patient use of blood glucose flow sheets through the online patient portal, MyChart. Adoption will be measured on both the extensive and intensive margin: the number of patients who enter data into the flowsheets at all during the study period, and the mean number of entries per patient during the study period. Conditional on statistically significant increases in adoption, the study will examine corresponding intent-to-treat effects on patient A1c, and consider other indicators of possible mechanisms through which A1c improves or does not improve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Primary care practices will be assigned to a provider-side treatment (physician orientation) or to control. Within treatment assigned practices, individual patients will be assigned to one of four reminder messaging groups (one of which is no messaging).
| Arm | Type | Receives |
|---|---|---|
| 1: Control | No intervention | –A randomly selected half of primary care practices in the study sample at Inova Health Care Services will not receive any intervention and patients/physicians located at these practices will continue with business as usual. |
| 2a: Practice Orientation- No Reminder | Experimental | Behavioral: Practice OrientationIn the other randomly selected half of primary care practices in the study sample at Inova Health Care Services, practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2a will receive no additional reminder messaging to enter glucose measurements in the electronic flowsheets. |
| 2b: Practice Orientation- Standard Reminder | Experimental | Behavioral: Practice Orientation, Behavioral: Standard ReminderPractices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2b will receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. |
| 2c: Practice Orientation- Gift Card Reminder | Experimental | Behavioral: Practice Orientation, Behavioral: Gift Card ReminderPractices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2c will receive generic biweekly reminders to enter data, addressed from Inova Medical Group, that will also notify that the patient will be entered to win a $50 gift card for each day entering data. |
| 2d: Practice Orientation- Physician Reminder | Experimental | Behavioral: Practice Orientation, Behavioral: Physician RemindersPractices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. Of this group of practices, patients will be divided at the individual level into 4 reminder groups. Arm 2d will receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of Inova physicians at primary care sites other than Ashburn II Primary Care, Lake Ridge Primary Care and Springfield Primary Care
- Current diabetes mellitus diagnosis
- Active MyChart account at time of treatment administration
Key exclusion criteria (2 listed)
- Patients who participating physicians identify as pregnant
- Patients who participating physicians identify as having contraindications for tracking of blood glucose
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 |
|---|---|---|
| Practice OrientationPractices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. This will allow diabetic patients at these practices to enter any self-monitored glucose measurements. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose. | Behavioural | 2a: Practice Orientation- No Reminder, 2b: Practice Orientation- Standard Reminder, 2c: Practice Orientation- Gift Card Reminder, 2d: Practice Orientation- Physician Reminder |
| Standard ReminderPatients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets | Behavioural | 2b: Practice Orientation- Standard Reminder |
| Gift Card ReminderPatients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. In these reminders, they will also be notified that that they will be entered to win a $50 gift card for each day entering data. | Behavioural | 2c: Practice Orientation- Gift Card Reminder |
| Physician RemindersPatients receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT) | Behavioural | 2d: Practice Orientation- Physician Reminder |
Primary outcome
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
Time frame: (1-14) weeks after initial practice orientation
Count of participants that entered data to an electronic glucose flowsheet during the measurement period (Count of participants determined with a binary aggregation method; 1= Participant used Flow Sheet at least once during measurement period; 0= Participant did not use Flow Sheet during Measurement Period)
Participant A1c Test Results (as Percent A1c) at 26 Weeks
Time frame: 26 weeks after initial practice orientation
Percent A1c represents average blood sugar levels as determined by Hemoglobin A1c (HbA1c) test. The HbA1c test measures what percentage of hemoglobin proteins in blood are glycated. The most recent and available HbA1c test value (percent A1c) in electronic medical records at appropriate time period was used.
15 secondary outcomes
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin
Time frame: Beginning of week 15 to 26 weeks after initial practice orientation
Number of Days Participant Used Flowsheet, Intensive
Time frame: (1-14); (15-26) weeks after initial practice orientation
Count of Participants With an Open Physician Order for Electronic Glucose Flowsheet
Time frame: at 14 and 26 weeks after initial practice orientation
Number of Days Since Last HbA1c Test
Time frame: 14; 26 weeks after initial practice orientation
Participant A1c Test Results (as Percent A1c) at 14 Weeks
Time frame: 14 weeks after initial practice orientation
Count of Participants With Improvement of HbA1c Test Results
Time frame: 14; 26 weeks after initial practice orientation
Count of Participants With Percent A1c Below Benchmark of 7
Time frame: 14; 26 weeks after initial practice orientation
Total Secure Messages Sent by Participant
Time frame: (1-14); (15-26) weeks after initial practice orientation
Total Secure Messages Sent by Patient to Primary Care Provider
Time frame: (1-14); (15-26) weeks after initial practice orientation
Total Secure Messages Sent by PCP to Patient
Time frame: (1-14); (15-26) weeks after initial practice orientation
Total Number of Participant Phone Appointments
Time frame: (1-14); (1-26) weeks after initial practice orientation
Total Number of Participant In-person Appointments
Time frame: (1-14); (1-26) weeks after initial practice orientation
Count of Participants With Changes to Active Medication List
Time frame: (1-14); (1-26) weeks after initial practice orientation
Prescription Orders
Time frame: (1-14); (1-26) weeks after initial practice orientation
Flowsheet Entry Values (Descriptive)
Time frame: 2; 4; 6; 8; 10; 12; 14; 18; 22; 26 weeks after initial orientation meeting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Allyson B Root, MS principal investigator
General Services Administration, UC Berkeley
Season Majors, MSN,RN principal investigator
Inova Health Care Services
Mary Ann Friesen, PhD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Orientation, Standard Reminder and Gift Card Reminder in people with Diabetes Mellitus, run by Inova Health Care Services 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 2 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 19 Sep 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Participants Entering Flowsheet Data During Measurement Period, Extensive Margin (time frame: (1-14) weeks after initial practice orientation). The study lists 2 primary outcomes in all. 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 19 Sep 2024.