Trial Outcomes & Findings for Comparative Effectiveness of Diabetes Shared Medical Appointment Models (NCT NCT03590041)

Last Updated: 2025-04-06

Results Overview

Comparison of change in patient-reported outcomes around diabetes distress for patients in either SMA group. Measured by the Diabetes Distress Scale (DDS-17). The DDS-17 measures the worries, concerns and fears among individuals with diabetes over time as they struggle with managing diabetes. The DDS is a 17-item self-report instrument. Each of the 17 items is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses for all items. Average score of \< 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress Average score \> 3.0 = reflects high distress A total score \> 2.0 (moderate distress) is considered clinically significant

Recruitment status

COMPLETED

Study phase

Target enrollment

1085 participants

Primary outcome timeframe

At end of 6 group visits (time differs by practice, up to 6 months)

Results posted on

2025-04-06

Participant Flow

Patients were recruited into shared medical appointments as part of their usual care for type 2 diabetes by participating practices from January 4, 2019 to September 30, 2021.

Randomization occurred at the practice level via Covariate Constrained Randomization. Patients seeking treatment in a practice assigned to the Standardized or the Patient-Driven condition received that treatment condition. Patients who were deemed ineligible for the study because they had type 1 diabetes or were pregnant during the study were removed from the analysis.

Participant milestones

Participant milestones
Measure	Standardized SMA The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.	Patient-driven SMA In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
Overall Study STARTED	576	509
Overall Study COMPLETED	558	504
Overall Study NOT COMPLETED	18	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Standardized SMA The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.	Patient-driven SMA In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
Overall Study Protocol Violation	4	3
Overall Study No session data recorded	14	2

Baseline Characteristics

Comparative Effectiveness of Diabetes Shared Medical Appointment Models

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standardized SMA n=558 Participants The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.	Patient-driven SMA n=504 Participants In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.	Total n=1062 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 11.2 • n=99 Participants	61.0 years STANDARD_DEVIATION 11.6 • n=107 Participants	60.3 years STANDARD_DEVIATION 11.4 • n=206 Participants
Sex: Female, Male Female	347 Participants n=99 Participants	278 Participants n=107 Participants	625 Participants n=206 Participants
Sex: Female, Male Male	211 Participants n=99 Participants	226 Participants n=107 Participants	437 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	137 Participants n=99 Participants	155 Participants n=107 Participants	292 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	414 Participants n=99 Participants	319 Participants n=107 Participants	733 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=99 Participants	30 Participants n=107 Participants	37 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	63 Participants n=99 Participants	3 Participants n=107 Participants	66 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	29 Participants n=99 Participants	51 Participants n=107 Participants	80 Participants n=206 Participants
Race (NIH/OMB) White	433 Participants n=99 Participants	353 Participants n=107 Participants	786 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=99 Participants	93 Participants n=107 Participants	122 Participants n=206 Participants
Diabetes Distress Scores	2.2 units on a scale STANDARD_DEVIATION 0.9 • n=99 Participants	2.1 units on a scale STANDARD_DEVIATION 1.0 • n=107 Participants	2.2 units on a scale STANDARD_DEVIATION 0.9 • n=206 Participants
Hemoglobin A1c	8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2.0 • n=99 Participants	8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2.1 • n=107 Participants	8.3 % of hemoglobin coated in glucose STANDARD_DEVIATION 2.1 • n=206 Participants

PRIMARY outcome

Timeframe: At end of 6 group visits (time differs by practice, up to 6 months)

Population: Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model

Outcome measures

Outcome measures
Measure	Standardized SMA n=558 Participants The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.	Patient-driven SMA n=504 Participants In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
Diabetes Distress - Change in Patient Reported Outcomes (PROs)	1.9 score on a scale Standard Deviation 0.8	1.9 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: At end of 6 group visits (time differs by practice, up to 6 months)

Population: Patients receiving SMAs as part of standard care at practices randomized to delivering either the Standardized or Patient-Driven model

Comparison of change in patient HbA1c levels for patients in either SMA group. Measured by Electronic Medical Record data. It evaluates the average amount of glucose in the blood by measuring the percentage of glycated (glycosylated) hemoglobin

Outcome measures

Outcome measures
Measure	Standardized SMA n=558 Participants The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Standardized SMA: Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.	Patient-driven SMA n=504 Participants In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Patient-driven SMA: Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
Change in Patient HbA1c	7.8 %HbA1c Standard Deviation 1.9	7.9 %HbA1c Standard Deviation 1.8

Adverse Events

Standardized SMA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient-driven SMA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bethany Kwan

University of Colorado Anschutz medical Campus

Phone: 303-724-5153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place