Trial Outcomes & Findings for MedStar Health Type 2 Diabetes Pathway to Control (NCT NCT02925312)

Results Overview

Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

419 participants

Primary outcome timeframe

3 months

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	Matched Controls patients receive standard of care
Overall Study STARTED	125	294
Overall Study COMPLETED	98	294
Overall Study NOT COMPLETED	27	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	Matched Controls patients receive standard of care
Overall Study Lost to Follow-up	25	0
Overall Study Adverse Event	2	0

Baseline Characteristics

MedStar Health Type 2 Diabetes Pathway to Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=121 Participants Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	Matched Controls n=294 Participants patients receive standard of care	Total n=415 Participants Total of all reporting groups
Age, Customized age between 21 and 75	121 Participants n=5 Participants	294 Participants n=7 Participants	415 Participants n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	162 Participants n=7 Participants	229 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	132 Participants n=7 Participants	186 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Boot camp completers during the study period were compared to concurrent, propensity-matched chart controls.

Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group

Outcome measures

Outcome measures
Measure	Intervention n=121 Participants Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	Matched Controls n=294 Participants patients receive standard of care
Percentage Change in Hemoglobin A1C From Baseline to 3 Months	3.08 percentage Standard Deviation 2.01	1.64 percentage Standard Deviation 1.97

SECONDARY outcome

Timeframe: 6 months

Population: Poisson Regression Models of all utilizations (ED + hospitalization) at 6-month visits by Study Groups: Incidence rate ratios (IRRs) reported. In the six months after enrollment, controls are expected to have 0.646 admissions on average, and cases are expected to have 56.8% of the number of admissions that the controls had, or a reduction of 43.2%

Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit.

Outcome measures

Outcome measures
Measure	Intervention n=98 Participants Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	Matched Controls n=294 Participants patients receive standard of care
Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls.	0.568 ratio of risk incidences Interval 0.398 to 0.812	0.646 ratio of risk incidences Interval 0.561 to 0.745

SECONDARY outcome

Timeframe: 90 days

Population: This outcome measure was eliminated during the course of the study and data was not collected

Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Technology to perform eye exams in primary care offices was not deployed as had been anticipated, therefore data was not collected for this outcome

Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Matched Controls

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 Michelle Magee

Medstar Health Research Institute

Phone: 2028772383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place