DiabetesNCT05463705
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
A study testing Intervention to address diffusion of responsibility and Intervention to address diffusion of responsibility + simplification of prescribing in people with Diabetes and SGLT-2i and GLP-1RA Therapies, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will test the impact of addressing diffusion of responsibility with and without additional reduction of prescribing burden on SGLT-2i and GLP-1RAs prescribing compared to usual care. Population: MGH primary care physicians caring for at least 2 eligible patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, SGLT-2i and GLP-1RA Therapies, Diffusion of Responsibility
- What is being tested?
- Intervention to address diffusion of responsibility and Intervention to address diffusion of responsibility + simplification of prescribing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,580 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 22 Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- We will use EHR data to identify patients
- 18-84 years of age
- Diagnosed with type 2 diabetes
- Has poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84)
- Have a compelling indication for an SGLT-2i or GLP-1RA who are not already prescribed one of these therapies. A compelling indication includes individuals with cardiovascular disease, kidney disease, heart failure, or obesity.
Show all 10Show fewer
- Physicians:
- Physicians will be included if they are
- Practicing in primary care at Massachusetts General Hospital
- Caring for at least 1 patient: (1) age 18-84, (2) diagnosed with type 2 diabetes, (3) has poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84) (4) has a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies.
Who cannot join
- Patients:
- We will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care.
- We will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans.
- Physicians:
- Providers will be excluded if they are involved in the design or conduct of this study (e.g. Drs. Haff and Horn, and the peer PCPs delivering the study intervention).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02120
About this study
This study will test the impact of addressing diffusion of responsibility with and without additional reduction of prescribing burden on SGLT-2i and GLP-1RAs prescribing compared to usual care.
Population: MGH primary care physicians caring for at least 2 eligible patients. Eligible patients are individuals age18 years or older with type 2 diabetes and HbA1c >7.5% and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies.
Intervention: PCPs will be randomized to one of three arms: 1) intervention to address diffusion of responsibility, 2) Intervention to address diffusion of responsibility with additional simplification of prescribing, 3) usual care.
Read the detailed description
This study will be conducted within MGH primary care. As with prior work, the investigators will use the hospital's EHR database, the Epic Enterprise Data Warehouse, to identify patients. Patients will be eligible if they are: adults 18-84 years of age with poorly controlled type 2 diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84) and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies. The investigators will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care. The investigators will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans. PCPs caring for at least one eligible patient will be included in the trial. Eligible PCPs will be randomized to one of three arms: (1) intervention to address diffusion of responsibility, (2) intervention to address diffusion of responsibility plus additional simplification of the prescribing process, and (3) usual care. Providers randomized to arm 1, the intervention to address diffusion of responsibility will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. Providers randomized to arm 2, the intervention addressing diffusion of responsibility and simplifying the prescribing process will receive the same contact addressing diffusion of responsibility as in arm 1, but they will additionally have access to an experienced administrative team for diabetes medication insurance authorization support. The primary outcome will be the rate of prescriptions for SGLT-2is and GLP-1RAs among eligible patients.
- Being tested
- Intervention to address diffusion of responsibility, Intervention to address diffusion of responsibility + simplification of prescribing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to address diffusion of responsibilityBehavioural
PCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer.
Intervention to address diffusion of responsibility + simplification of prescribingBehavioural
PCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress.
| Study group | Role | What they receive |
|---|---|---|
| Intervention to address diffusion of responsibility | Experimental | PCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. Receives: Behavioral: Intervention to address diffusion of responsibility |
| Intervention to address diffusion of responsibility + simplification of prescribing | Experimental | PCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress. Receives: Behavioral: Intervention to address diffusion of responsibility + simplification of prescribing |
| Usual care | No intervention | PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm
Electronic health record (EHR) prescribing data was used to identify the number of patients with prescriptions for SGLT-2i and GLP-1RA medications beginning 3 business days before the targeted patient visit and continuing through 28 days after the visit. The primary outcome only includes patients who attended the targeted visit.
Measured: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Secondary outcomes (2)
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms
Electronic health record (EHR) prescribing data was used to identify patients with prescriptions for SGLT-2i and GLP-1RA medications beginning 3 business days before the targeted patient visit and continuing through 28 days after the visit. This outcome includes all study-eligible patients, regardless of whether they attended the targeted visit.
Measured: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms
EHR data was used to identify Hemoglobin A1c values. The baseline A1c was the last A1c measured within the 6-months prior to the targeted visit, and the follow-up A1c was the A1c measured between 3 and 9 months after the targeted visit and closest to 6 months after the targeted visit. The change in A1c was calculated and compared across study arms. This analysis includes all patients who had an A1c in follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start4 May 2023
- Primary completion22 Nov 2023
- Study completion22 Aug 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nancy Haff, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463705
- Sponsor's protocol ID
- 2022P001663
- Other IDs
- 5P30AG064199-02
- Status last verified
- Oct 2024
- First submitted
- 7 Jul 2022
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haff N, Horn DM, Bhatkhande G, Sung M, Colling C, Wood W, Robertson T, Gaposchkin D, Simmons L, Yang J, Yeh J, Crum KL, Hanken KE, Lauffenburger JC, Choudhry NK. Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial. Am Heart J. 2025 Jul;285:39-51. doi: 10.1016/j.ahj.2025.02.007. Epub 2025 Feb 20.
PubMed 39986337
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
- ClinicalTrials.gov ID
- NCT05463705
- Acronym / sponsor ID
- 2022P001663
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,580 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the impact of addressing diffusion of responsibility with and without additional reduction of prescribing burden on SGLT-2i and GLP-1RAs prescribing compared to usual care.
Population: MGH primary care physicians caring for at least 2 eligible patients. Eligible patients are individuals age18 years or older with type 2 diabetes and HbA1c >7.5% and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies.
Intervention: PCPs will be randomized to one of three arms: 1) intervention to address diffusion of responsibility, 2) Intervention to address diffusion of responsibility with additional simplification of prescribing, 3) usual care.
Detailed description
This study will be conducted within MGH primary care. As with prior work, the investigators will use the hospital's EHR database, the Epic Enterprise Data Warehouse, to identify patients. Patients will be eligible if they are: adults 18-84 years of age with poorly controlled type 2 diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84) and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies. The investigators will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care. The investigators will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans. PCPs caring for at least one eligible patient will be included in the trial. Eligible PCPs will be randomized to one of three arms: (1) intervention to address diffusion of responsibility, (2) intervention to address diffusion of responsibility plus additional simplification of the prescribing process, and (3) usual care. Providers randomized to arm 1, the intervention to address diffusion of responsibility will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. Providers randomized to arm 2, the intervention addressing diffusion of responsibility and simplifying the prescribing process will receive the same contact addressing diffusion of responsibility as in arm 1, but they will additionally have access to an experienced administrative team for diabetes medication insurance authorization support. The primary outcome will be the rate of prescriptions for SGLT-2is and GLP-1RAs among eligible patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention to address diffusion of responsibility | Experimental | Behavioral: Intervention to address diffusion of responsibilityPCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. |
| Intervention to address diffusion of responsibility + simplification of prescribing | Experimental | Behavioral: Intervention to address diffusion of responsibility + simplification of prescribingPCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress. |
| Usual care | No intervention | –PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- We will use EHR data to identify patients
- 18-84 years of age
- Diagnosed with type 2 diabetes
- Has poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84)
- Have a compelling indication for an SGLT-2i or GLP-1RA who are not already prescribed one of these therapies. A compelling indication includes individuals with cardiovascular disease, kidney disease, heart failure, or obesity.
Key exclusion criteria (5 listed)
- We will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care.
- We will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans.
- Providers will be excluded if they are involved in the design or conduct of this study (e.g. Drs. Haff and Horn, and the peer PCPs delivering the study intervention).
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 |
|---|---|---|
| Intervention to address diffusion of responsibilityPCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. | Behavioural | Intervention to address diffusion of responsibility |
| Intervention to address diffusion of responsibility + simplification of prescribingPCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress. | Behavioural | Intervention to address diffusion of responsibility + simplification of prescribing |
Primary outcome
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm
Time frame: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Electronic health record (EHR) prescribing data was used to identify the number of patients with prescriptions for SGLT-2i and GLP-1RA medications beginning 3 business days before the targeted patient visit and continuing through 28 days after the visit. The primary outcome only includes patients who attended the targeted visit.
2 secondary outcomes
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms
Time frame: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39986337Haff N, Horn DM, Bhatkhande G, Sung M, Colling C, Wood W, Robertson T, Gaposchkin D, Simmons L, Yang J, Yeh J, Crum KL, Hanken KE, Lauffenburger JC, Choudhry NK. Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial. Am Heart J. 2025 Jul;285:39-51. doi: 10.1016/j.ahj.2025.02.007. Epub 2025 Feb 20.
- 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?
A study testing Intervention to address diffusion of responsibility and Intervention to address diffusion of responsibility + simplification of prescribing in people with Diabetes and SGLT-2i and GLP-1RA Therapies, run by Brigham and Women's Hospital 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 10 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 19 Nov 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 Nov 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?
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm (time frame: Beginning 3 days before the targeted visit and continuing through 28 days after the visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463705, which also lists 1 linked publication.
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 Nov 2024.