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Completed

NCT Number: NCT02910089

ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus

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.

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Key information

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Boston, Massachusetts, 2115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared Decision Making

Behavioral

This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).

Primary outcomes

  1. Glycosylated Hemoglobin (HbA1c):

    Time frame: baseline and at the end of 12 months post index date

    Pre- to post-intervention change in mean HbA1c levels

Secondary outcomes

  1. Medication Adherence (PDC Measure)

    Time frame: during follow-up period of 12 months post index date

    Mean Adherence (PDC) in each study arm in the follow-up period

  2. Percentage (Proportion x 100) of Patients Achieving Optimal Adherence

    Time frame: during follow-up period of 12 months post index date

    Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period

  3. Patients Achieving HbA1c

    Time frame: baseline and at the end of 12 months post index date

    Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Brigham Women's Health

Registry information

Official study 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

Acronym: ENGAGE-DM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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