T2DMBC: MedStar Health Type 2 Diabetes Pathway to Control

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02925312
• Collaborator: (none)
• Enrollment: 419
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 16.1

Study Details

Study Description

Brief Summary

A Diabetes Institute (MDI), in partnership with key stakeholders-including Primary Care Providers- in a northeastern US regional, mixed-payer healthcare system), seeks to implement an evidence-based, technology-enabled, innovative, and integrated diabetes care management pathway (Boot Camp) for adult patients with uncontrolled type 2 diabetes (A1C>/=9%) which will demonstrate improvement in diabetes clinical and health resources utilization outcomes.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Hyperglycemia	Other: Diabetes Pathway	N/A

Detailed Description

• The program is designed to integrate type 2 diabetes specialty services into Primary Care practices to support PCPs and their patients in improving a spectrum of diabetes-related outcomes.

• High-risk patients from Primary Care practices who have uncontrolled type 2 diabetes and meet the target population inclusion and exclusion criteria will be invited to participate in an intensive and concise "BOOT CAMP" medication management and education intervention of ~4-8 weeks duration.

• The intervention will consist of three key components: (1) intensive, algorithm-based medication management (Appendix A), based on continuous review and management of blood sugars; (2) survival skills diabetes self-management education based on knowledge deficits identified on the KNOW Diabetes knowledge survey; (3) enhanced patient-provider communication, all provided by Endocrinologist supervised allied health professionals (in this instance CDEs).

• Survival skills DSME will focus on nutrition and meal plan basics, blood glucose targets, taking medications as prescribed, hyper- and hypoglycemia recognition and treatment, and when to seek medical help.

• The intervention is initiated with one to two face-to-face meetings with the CDE, at which the patient's readiness to change is assessed.

• These are followed by virtual meetings though a variety of media based on patient preference and health literacy (largely telephone and text messaging).

• Various technology tools are used to facilitate patient engagement, access and attainment of glycemic targets, including smart meters, virtual meeting platforms, web-based education content and surveys administration via tablets, etc.

• Near real-time transmission of blood glucose data using a cellular-enabled blood glucose monitoring system sends all glucose results to a web-based dashboard accessed daily by the Boot Camp educators.

• Concurrent matched charts of patients receiving standard care at the three MedStar locations will serve as a basis of comparison in assessing the impact of MDI on clinical and education outcomes and process of care.

• Based on patient progress towards improved glycemic control, the patient will 'graduate' from the program and the CDE will refer the patient back to their PCP in 8-12 weeks with a full report of medication changes, blood glucose readings and further diabetes management recommendations eg referrals; further DSME, etc.

Study Design

• Study Type: Interventional
• Actual Enrollment: 419 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jun 30, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients receive the full diabetes pathway intervention consisting of: individualized diabetes self-management education and support; T2DM meds management by clinician-supervised diabetes educators using an evidence-based algorithm and FDA approved anti-hyperglycemic agents; near, real-time blood glucose monitoring, delivered via a combination of two in-person and weekly remote (telephone/text) visits.	Other: Diabetes Pathway; Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring; Other Names: Diabetes Boot Camp
No Intervention: Matched controls Patients receive standard of care from their primary care provider. Usual care visits are typically conducted quarterly per national guidelines for management of T2DM in adults, or more frequently as needed.

Outcome Measures

Primary Outcome Measures

1. Percentage Change in Hemoglobin A1C From Baseline to 3 Months [3 months]

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

Secondary Outcome Measures

1. 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. [6 months]

   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.

2. Adherence to Prescribed Diabetes Medications [90 days]

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

3. Frequency of Eye Exams [90 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of type 2 diabetes for >=1 year

• Active practice patient

• A1C > 9.0% at their last visit to Medical Home, ED or hospital admission plus one more high risk factor (ED visit or hospitalization in past 12 mos)

• Primary Care Provider willing to have patient enter the program

• Patient is able and willing to participate in the program and exhibits readiness to change DM self-management

• Proficient in English

Exclusion Criteria:

• Known history of DKA

• No MedStar PCP visit within past 12 months

• Endocrine or Diabetes Education consult referral order in the past 6 months which resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by patient during initial screen

• Active additional medical issues which in the opinion of the care team would preclude concentrating on BG control and/or would predispose to ED visits and/or hospital admits independent of glycemic control, e.g.: severe CHF, severe COPD; severe mental illness.

• Resident of skilled nursing facility, nursing home or receiving home health care services.

• Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer

• Supraphysiologic doses of glucocorticoids (hydrocortisone > 30mg/day; prednisone > 5-6mg daily; dexamethasone > 2mg daily).

• Pregnant or anticipates attempting conception in the following year

• Patient and/or custodial caregiver unwilling and/or unable to participate in program-related activities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

• Principal Investigator: Michelle F Magee, MD, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Magee MF, Baker KM, Fernandez SJ, Huang CC, Mete M, Montero AR, Nassar CM, Sack PA, Smith K, Youssef GA, Evans SR. Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes. BMJ Open Diabetes Res Care. 2019 Nov 13;7(1):e000731. doi: 10.1136/bmjdrc-2019-000731. eCollection 2019.

• Responsible Party: Michelle Magee, Director, MedStar Diabetes Institute, Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT02925312
• Other Study ID Numbers: 2014-191
• First Posted: Oct 5, 2016
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Michelle Magee, Director, MedStar Diabetes Institute, Medstar Health Research Institute: Diabetes Care Management; Chronic Care Model; Resources Utilization; Hemoglobin A1C; Hospitalizations; Emergency Room Visits; Cost analysis; Return on Investment
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Intervention	Matched Controls	Total
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	patients receive standard of care	Total of all reporting groups
Overall Participants	121	294	415
Age, Customized (Count of Participants)
age between 21 and 75	121 100%	294 100%	415 100%
Sex: Female, Male (Count of Participants)
Female	67 55.4%	162 55.1%	229 55.2%
Male	54 44.6%	132 44.9%	186 44.8%

Outcome Measures

1. Primary Outcome

Title	Percentage Change in Hemoglobin A1C From Baseline to 3 Months
Description	Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention	Matched Controls
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	patients receive standard of care
Measure Participants	121	294
Mean (Standard Deviation) [percentage]	3.08 (2.01)	1.64 (1.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Matched Controls
	Comments	The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	McNemar
	Comments

2. Secondary Outcome

Title	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.
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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%

Arm/Group Title	Intervention	Matched Controls
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	patients receive standard of care
Measure Participants	98	294
Number (95% Confidence Interval) [ratio of risk incidences]	0.568	0.646

3. Secondary Outcome

Title	Adherence to Prescribed Diabetes Medications
Description	Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention	Matched Controls
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	patients receive standard of care
Measure Participants	0	0

4. Secondary Outcome

Title	Frequency of Eye Exams
Description	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
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention	Matched Controls
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication	patients receive standard of care
Measure Participants	0	0

Adverse Events

Arm/Group Title	Intervention		Matched Controls
Arm/Group Description	Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication		patients receive standard of care
All Cause Mortality
	Intervention		Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention		Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/294 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Matched Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/294 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.