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Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications

Primary Purpose

Diabetes, SGLT-2i and GLP-1RA Therapies, Diffusion of Responsibility

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention to address diffusion of responsibility
Intervention to address diffusion of responsibility + simplification of prescribing
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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).

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention to address diffusion of responsibility

Intervention to address diffusion of responsibility + simplification of prescribing

Usual care

Arm Description

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.

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.

PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice.

Outcomes

Primary Outcome Measures

Rate of prescriptions for SGLT-2i or GLP-1RA among eligible patients in each arm, compared across study arms
The study team will use electronic health record (EHR) prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among eligible patients. Rates of prescribing of these medications will be compared across study arms.

Secondary Outcome Measures

Rate of prescriptions for SGLT-2i or GLP-1RA medications among all patients with diabetes, compared across study arms
The study team will use EHR prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among all patients with diabetes cared for by study PCPs. Rates of prescribing of these medications will be compared across study arms.
Change in Hemoglobin A1c (A1c) over the 6-month intervention period among eligible patients, compared across study arms
The study team will use EHR data to calculate a change in A1c among eligible patients. The baseline A1c will be the last A1c measured within the 6-months prior to intervention start, and the follow-up A1c will be the last A1c measured in the 6-month intervention period. This change in A1c will be compared across study arms.

Full Information

First Posted
July 7, 2022
Last Updated
May 4, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05463705
Brief Title
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Official Title
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, SGLT-2i and GLP-1RA Therapies, Diffusion of Responsibility, Prescribing Burden

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
191 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention to address diffusion of responsibility
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention to address diffusion of responsibility + simplification of prescribing
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice.
Intervention Type
Behavioral
Intervention Name(s)
Intervention to address diffusion of responsibility
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Intervention to address diffusion of responsibility + simplification of prescribing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of prescriptions for SGLT-2i or GLP-1RA among eligible patients in each arm, compared across study arms
Description
The study team will use electronic health record (EHR) prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among eligible patients. Rates of prescribing of these medications will be compared across study arms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of prescriptions for SGLT-2i or GLP-1RA medications among all patients with diabetes, compared across study arms
Description
The study team will use EHR prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among all patients with diabetes cared for by study PCPs. Rates of prescribing of these medications will be compared across study arms.
Time Frame
6 months
Title
Change in Hemoglobin A1c (A1c) over the 6-month intervention period among eligible patients, compared across study arms
Description
The study team will use EHR data to calculate a change in A1c among eligible patients. The baseline A1c will be the last A1c measured within the 6-months prior to intervention start, and the follow-up A1c will be the last A1c measured in the 6-month intervention period. This change in A1c will be compared across study arms.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications

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