ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

— ENGAGE-DM  

Official title:

ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM): A 12-month Study of the Impact of Combined Shared-decision Making and Brief Negotiated Interviewing on Disease Control and Medication Adherence in Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910089
• Other study ID #: D1843R00254
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: September 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.

Description:

The US is facing a growing epidemic of type 2 diabetes. Among patients with poorly controlled diabetes, it is often not clear whether the problem is attributable to failure to appropriately intensify therapy, poor adherence to prescribed medications, unwillingness to accept new treatments or a combination of these factors. Multi-component pharmacist-delivered interventions, particularly those rooted in patient engagement, have been shown to be some of the most effective at improving adherence to chronic disease medications. Even though shared decision making and brief negotiated interviewing are complementary patient engagement techniques, the effectiveness of combining these 2 intervention approaches, especially in the management of diabetes, is unknown.

In this study of patients using at least one oral hypoglycemic therapy with poorly controlled disease, the investigators examine the impact of a shared decision making and behavioral interviewing intervention delivered telephonically by pharmacists, compared with usual care. Briefly, all patients allocated to the intervention will be mailed a patient decision aid to prime them for encounters with pharmacists. After receiving the decision aid, these patients will be asked to engage in and provide informed consent for at least 4 telephonic discussions with pharmacists about their diabetes treatment options, goals, and preferences, medication adherence, strategies for reducing adherence barriers, and the benefits of maintaining blood glucose control. The study is being conducted within a large insurer and consists of 700 patients each allocated to the intervention group and the control group. Analyses will be performed on an intent-to-treat basis.

After study completion, the investigators will also use predictive analytics to examine whether treatment response could be predicted based on patient characteristics, such as sociodemographic, clinical, medication use, and other motivational characteristics, which will provide information about which patients are most likely to benefit from the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion:

• Commercially-insured beneficiaries

• Receive all medical/prescription drug benefits through Horizon

• On =1 one oral hypoglycemic agent

• Latest HbA1c measurement = 8% (within previous 6 months)

• Provided phone number to Horizon

Exclusion:

• Currently using any insulin

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Shared Decision Making
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Brigham Women's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin (HbA1c):	Pre- to post-intervention change in mean HbA1c levels	baseline and at the end of 12 months post index date
Secondary	Medication Adherence (PDC Measure)	Mean Adherence (PDC) in each study arm in the follow-up period	during follow-up period of 12 months post index date
Secondary	Percentage (Proportion x 100) of Patients Achieving Optimal Adherence	Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC =0.80) in the follow-up period	during follow-up period of 12 months post index date
Secondary	Patients Achieving HbA1c	Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period	baseline and at the end of 12 months post index date

External Links

•   D1843R00254_ENGAGE_Protocol_redactedPDFA
•   D1843R00254_ENGAGE_SAP_RedactedPDFA
•   D1843R00254_ENGAGE_SAP_RedactedPDFA