Clinical trial NCT02910089: ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Brigham Women's Health
First posted: 2016-09-21
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c):
timeFrame: baseline and at the end of 12 months post index date
Secondary outcomes:
measure: Medication Adherence (PDC Measure)
timeFrame: during follow-up period of 12 months post index date
measure: Percentage (Proportion x 100) of Patients Achieving Optimal Adherence
timeFrame: during follow-up period of 12 months post index date
measure: Patients Achieving HbA1c
timeFrame: baseline and at the end of 12 months post index date
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
Study officials:
affiliation: Brigham Women's Health
name: Niteesh K. Choudhry, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Eric Wittbrodt, PharmD, MPH
role: STUDY_DIRECTOR
References:
citation: Lauffenburger JC, Ghazinouri R, Jan S, Makanji S, Ferro CA, Lewey J, Wittbrodt E, Lee J, Haff N, Fontanet CP, Choudhry NK. Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic randomized trial. PLoS One. 2019 Apr 2;14(4):e0214754. doi: 10.1371/journal.pone.0214754. eCollection 2019.