Diabetes, Diffusion of Responsibility, Prescribing Burden, SGLT-2i and GLP-1RA Therapies
Conditions
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.
Interventions
BEHAVIORALIntervention to address diffusion of responsibility
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.
BEHAVIORALIntervention to address diffusion of responsibility + simplification of prescribing
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.
Sponsors
National Institute on Aging (NIA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms | 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 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. |
| Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
All primary care physicians at Mass General Hospital who were not participating in the delivery of the study and whose clinics agreed to participation were randomized to study arms.
Pre-assignment details
All primary care physicians at Mass General Hospital who were not participating in the delivery of the study and whose clinics agreed to participation were randomized to study arms. Eligible patients were identified using routinely-collected electronic health record data and were included in the study if they met inclusion criteria and had an upcoming visit scheduled with their PCP during the intervention period.
Participants by arm
| Arm | Count |
|---|---|
| Intervention to Address Diffusion of Responsibility - Patients Patients were not intervened upon directly. In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing, electronic health record (EHR) messages containing prescribing tips sent before visits with eligible patients, and a hand-signed note with a prescribing tips sheet from the peer champion. | 484 |
| Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Patients Patients were not intervened upon directly. In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing and a hand-signed note with a prescribing tips sheet from the peer champion. In this arm, electronic health record (EHR) messages sent before visits with eligible patients contained information on insurance coverage for SGLT2i and GLP-1RA medications specific to each patient. | 446 |
| Usual Care - Patients Patients were not intervened upon directly. PCPs in this arm received no additional outreach or resources. | 459 |
| Intervention to Address Diffusion of Responsibility - Providers In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing, electronic health record (EHR) messages containing prescribing tips sent before visits with eligible patients, and a hand-signed note with a prescribing tips sheet from the peer champion | 66 |
| Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Providers In this arm, PCPs received support for SGLT2i and GLP-1RA prescribing from the peer champions including a welcome email offering encouragement and support in prescribing and a hand-signed note with a prescribing tips sheet from the peer champion. In this arm, electronic health record (EHR) messages sent before visits with eligible patients contained information on insurance coverage for SGLT2i and GLP-1RA medications specific to the patient. | 63 |
| Usual Care - Providers PCPs in this arm received no additional outreach or resources. | 62 |
| Total | 1,580 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Did not complete a visit during study intervention period | 103 | 107 | 100 | 4 | 8 | 4 |
Baseline characteristics
| Characteristic | Usual Care - Patients | Total | Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Patients | Intervention to Address Diffusion of Responsibility - Patients | Usual Care - Providers | Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Providers | Intervention to Address Diffusion of Responsibility - Providers |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 11.9 | 66.0 years STANDARD_DEVIATION 12.1 | 65.0 years STANDARD_DEVIATION 12.6 | 66.4 years STANDARD_DEVIATION 11.8 | — | — | — |
| Baseline HbA1c (%) | 8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.4 | 8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 | 8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 | 8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 | — | — | — |
| Baseline SGLT2 and GLP-1 Prescribing Rate | — | 25.5 percentage STANDARD_DEVIATION 11.6 | — | — | 26.0 percentage STANDARD_DEVIATION 11.8 | 25.1 percentage STANDARD_DEVIATION 12.4 | 25.4 percentage STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 79 Participants | 218 Participants | 61 Participants | 78 Participants | — | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 354 Participants | 1088 Participants | 352 Participants | 382 Participants | — | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants | 83 Participants | 33 Participants | 24 Participants | — | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 4 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Asian | 38 Participants | 127 Participants | 48 Participants | 41 Participants | — | — | — |
| Race (NIH/OMB) Black or African American | 67 Participants | 185 Participants | 55 Participants | 63 Participants | — | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 80 Participants | 223 Participants | 62 Participants | 81 Participants | — | — | — |
| Race (NIH/OMB) White | 270 Participants | 846 Participants | 277 Participants | 299 Participants | — | — | — |
| Sex: Female, Male Female | 191 Participants | 644 Participants | 218 Participants | 235 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 268 Participants | 745 Participants | 228 Participants | 249 Participants | 0 Participants | 0 Participants | 0 Participants |
| SGLT2 / GLP1 qualifying condition For both SGLT2i and GLP-1RA | 107 Participants | 352 Participants | 124 Participants | 121 Participants | — | — | — |
| SGLT2 / GLP1 qualifying condition For GLP-1RA (Obesity, ASCVD) ONLY | 323 Participants | 960 Participants | 292 Participants | 345 Participants | — | — | — |
| SGLT2 / GLP1 qualifying condition For SGLT2i (CKD, Heart Failure) ONLY | 29 Participants | 77 Participants | 30 Participants | 18 Participants | — | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 459 | 1 / 484 | 2 / 446 | 0 / 62 | 0 / 66 | 0 / 63 |
| other Total, other adverse events | 0 / 459 | 0 / 484 | 0 / 446 | 0 / 62 | 0 / 66 | 0 / 63 |
| serious Total, serious adverse events | 0 / 459 | 0 / 484 | 0 / 446 | 0 / 62 | 0 / 66 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Population: This analysis includes only patients who attended the targeted visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention to Address Diffusion of Responsibility | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm | 109 Participants |
| Intervention to Address Diffusion of Responsibility + Simplification of Prescribing | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm | 92 Participants |
| Usual Care | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm | 92 Participants |
95% CI: [0.88, 1.96]
95% CI: [0.66, 1.52]
Secondary
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.
Time frame: 6 months
Population: This analysis includes all patients who had an A1c between 3 and 9 months after the targeted visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention to Address Diffusion of Responsibility | Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms | -0.51 percentage of glycated hemoglobin | Standard Deviation 1.44 |
| Intervention to Address Diffusion of Responsibility + Simplification of Prescribing | Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms | -0.51 percentage of glycated hemoglobin | Standard Deviation 1.76 |
| Usual Care | Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms | -0.58 percentage of glycated hemoglobin | Standard Deviation 1.55 |
95% CI: [-0.07, 0.43]
95% CI: [-0.22, 0.34]
Secondary
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.
Time frame: Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Population: This outcome includes all study-eligible patients, regardless of whether they attended the targeted visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention to Address Diffusion of Responsibility | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms | 134 Participants |
| Intervention to Address Diffusion of Responsibility + Simplification of Prescribing | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms | 110 Participants |
| Usual Care | Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms | 117 Participants |
95% CI: [0.83, 1.61]
95% CI: [0.64, 1.3]