Trial Outcomes & Findings for Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications (NCT NCT05463705)

Last Updated: 2024-11-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1580 participants

Primary outcome timeframe

Beginning 3 days before the targeted visit and continuing through 28 days after the visit

Results posted on

2024-11-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Usual Care - Patients PCPs in this arm received no additional outreach or resources.	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.	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.	Usual Care - Providers PCPs in this arm received no additional outreach or resources.	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.	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 each patient.
Overall Study STARTED	459	484	446	62	66	63
Overall Study COMPLETED	356	377	346	58	58	59
Overall Study NOT COMPLETED	103	107	100	4	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care - Patients PCPs in this arm received no additional outreach or resources.	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.	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.	Usual Care - Providers PCPs in this arm received no additional outreach or resources.	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.	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 each patient.
Overall Study Did not complete a visit during study intervention period	103	107	100	4	8	4

Baseline Characteristics

Age variable only known and reported for patient subjects. Provider demographic characteristics were not measured.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention to Address Diffusion of Responsibility - Patients n=484 Participants 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.	Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Patients n=446 Participants 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.	Usual Care - Patients n=459 Participants Patients were not intervened upon directly. PCPs in this arm received no additional outreach or resources.	Intervention to Address Diffusion of Responsibility - Providers n=66 Participants 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	Intervention to Address Diffusion of Responsibility + Simplification of Prescribing - Providers n=63 Participants 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.	Usual Care - Providers n=62 Participants PCPs in this arm received no additional outreach or resources.	Total n=1580 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 11.8 • n=484 Participants • Age variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	65.0 years STANDARD_DEVIATION 12.6 • n=446 Participants • Age variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	66.4 years STANDARD_DEVIATION 11.9 • n=459 Participants • Age variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	66.0 years STANDARD_DEVIATION 12.1 • n=1389 Participants • Age variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Sex: Female, Male Female	235 Participants n=484 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	218 Participants n=446 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	191 Participants n=459 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	644 Participants n=1389 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Sex: Female, Male Male	249 Participants n=484 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	228 Participants n=446 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	268 Participants n=459 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	745 Participants n=1389 Participants • Sex variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Ethnicity (NIH/OMB) Hispanic or Latino	78 Participants n=484 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	61 Participants n=446 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	79 Participants n=459 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	218 Participants n=1389 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.
Ethnicity (NIH/OMB) Not Hispanic or Latino	382 Participants n=484 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	352 Participants n=446 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	354 Participants n=459 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	1088 Participants n=1389 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.
Ethnicity (NIH/OMB) Unknown or Not Reported	24 Participants n=484 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	33 Participants n=446 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	26 Participants n=459 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	83 Participants n=1389 Participants • Ethnicity was only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	4 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	3 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	7 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) Asian	41 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	48 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	38 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	127 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	1 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	1 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) Black or African American	63 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	55 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	67 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	185 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) White	299 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	277 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	270 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	846 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) More than one race	0 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	0 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	0 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
Race (NIH/OMB) Unknown or Not Reported	81 Participants n=484 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	62 Participants n=446 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	80 Participants n=459 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.	—	—	—	223 Participants n=1389 Participants • Race variable only known and reported for patient subjects. Provider demographic characteristics were not measured.
SGLT2 / GLP1 qualifying condition For SGLT2i (CKD, Heart Failure) ONLY	18 Participants n=484 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	30 Participants n=446 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	29 Participants n=459 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	—	—	—	77 Participants n=1389 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.
SGLT2 / GLP1 qualifying condition For GLP-1RA (Obesity, ASCVD) ONLY	345 Participants n=484 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	292 Participants n=446 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	323 Participants n=459 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	—	—	—	960 Participants n=1389 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.
SGLT2 / GLP1 qualifying condition For both SGLT2i and GLP-1RA	121 Participants n=484 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	124 Participants n=446 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	107 Participants n=459 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.	—	—	—	352 Participants n=1389 Participants • Qualifying condition was only known and reported for patient subjects. This was not applicable for providers.
Baseline HbA1c (%)	8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 • n=484 Participants • Baseline HbA1c is only known and reported for patient subjects. Provider clinical characteristics were not measured.	8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 • n=446 Participants • Baseline HbA1c is only known and reported for patient subjects. Provider clinical characteristics were not measured.	8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.4 • n=459 Participants • Baseline HbA1c is only known and reported for patient subjects. Provider clinical characteristics were not measured.	—	—	—	8.4 percentage of glycated hemoglobin STANDARD_DEVIATION 1.5 • n=1389 Participants • Baseline HbA1c is only known and reported for patient subjects. Provider clinical characteristics were not measured.
Baseline SGLT2 and GLP-1 Prescribing Rate	—	—	—	25.4 percentage STANDARD_DEVIATION 10.7 • n=66 Participants • Baseline prescribing rate was only measured for providers. This is the percentage of each providers' patients with diabetes that were already prescribed a SGLT2i or GLP1-RA at baseline.	25.1 percentage STANDARD_DEVIATION 12.4 • n=63 Participants • Baseline prescribing rate was only measured for providers. This is the percentage of each providers' patients with diabetes that were already prescribed a SGLT2i or GLP1-RA at baseline.	26.0 percentage STANDARD_DEVIATION 11.8 • n=62 Participants • Baseline prescribing rate was only measured for providers. This is the percentage of each providers' patients with diabetes that were already prescribed a SGLT2i or GLP1-RA at baseline.	25.5 percentage STANDARD_DEVIATION 11.6 • n=191 Participants • Baseline prescribing rate was only measured for providers. This is the percentage of each providers' patients with diabetes that were already prescribed a SGLT2i or GLP1-RA at baseline.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention to Address Diffusion of Responsibility n=377 Participants 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.	Intervention to Address Diffusion of Responsibility + Simplification of Prescribing n=346 Participants 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.	Usual Care n=356 Participants PCPs in this arm received no additional outreach or resources.
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm	109 Participants	92 Participants	92 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention to Address Diffusion of Responsibility n=484 Participants 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.	Intervention to Address Diffusion of Responsibility + Simplification of Prescribing n=446 Participants 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.	Usual Care n=459 Participants PCPs in this arm received no additional outreach or resources.
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms	134 Participants	110 Participants	117 Participants

SECONDARY outcome

Timeframe: 6 months

Population: This analysis includes all patients who had an A1c between 3 and 9 months after the targeted visit.

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.