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ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02910089
Acronym
ENGAGE-DM
Enrollment
1400
Registered
2016-09-21
Start date
2016-10-20
Completion date
2017-12-20
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

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.

Interventions

BEHAVIORALShared Decision Making

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

Sponsors

Brigham Women's Health
CollaboratorUNKNOWN
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Glycosylated Hemoglobin (HbA1c):baseline and at the end of 12 months post index datePre- to post-intervention change in mean HbA1c levels

Secondary

MeasureTime frameDescription
Medication Adherence (PDC Measure)during follow-up period of 12 months post index dateMean Adherence (PDC) in each study arm in the follow-up period
Percentage (Proportion x 100) of Patients Achieving Optimal Adherenceduring follow-up period of 12 months post index datePercentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period
Patients Achieving HbA1cbaseline and at the end of 12 months post index datePercentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period

Countries

United States

Participant flow

Recruitment details

Potentially eligible patients for inclusion in this study were those who: (1) were ≥18 years of age, (2) had filled a prescription for 1 or more oral hypoglycemic agents within the prior 12 months, and (3) had evidence of poor glycemic control (A1C ≥8%) within the previous 6 months.

Pre-assignment details

Patients were excluded if, prior to identification, they had fewer than 3 months of continuous enrolment in the health plan, had recently filled insulin or had no available telephone contact information.

Participants by arm

ArmCount
Shared Decision Making/Brief Negotiated Interviewing
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
678
Control Arm
Seven hundred patients will also be identified by Horizon Analytics as a control group for analyses purposes only; these patients will not be contacted.
684
Total1,362

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost insurance eligibility2216

Baseline characteristics

CharacteristicControl ArmTotalShared Decision Making/Brief Negotiated Interviewing
Age, Continuous54.6 Years
STANDARD_DEVIATION 8.4
54.6 Years
STANDARD_DEVIATION 8.3
55.0 Years
STANDARD_DEVIATION 8.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
684 Participants1362 Participants678 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
273 Participants509 Participants236 Participants
Sex: Female, Male
Male
411 Participants853 Participants442 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6780 / 684
other
Total, other adverse events
1 / 6780 / 684
serious
Total, serious adverse events
5 / 6780 / 684

Outcome results

Primary

Glycosylated Hemoglobin (HbA1c):

Pre- to post-intervention change in mean HbA1c levels

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

Population: Full Analysis Set

ArmMeasureValue (MEAN)Dispersion
Shared Decision Making/Brief Negotiated InterviewingGlycosylated Hemoglobin (HbA1c):-0.75 Percentage of HbA1cStandard Deviation 1.96
Control ArmGlycosylated Hemoglobin (HbA1c):-0.79 Percentage of HbA1cStandard Deviation 2.01
95% CI: [-0.2, 0.32]GEE
Secondary

Medication Adherence (PDC Measure)

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

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

Population: Full Analysis Set

ArmMeasureValue (MEAN)Dispersion
Shared Decision Making/Brief Negotiated InterviewingMedication Adherence (PDC Measure)67.5 Percentage of DaysStandard Deviation 31.6
Control ArmMedication Adherence (PDC Measure)66.2 Percentage of DaysStandard Deviation 32.7
Comparison: Average of the percentage (proportion x 100) of days covered across all subjects.95% CI: [-2.42, 4.4]GEE
Secondary

Patients Achieving HbA1c

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

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

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
Shared Decision Making/Brief Negotiated InterviewingPatients Achieving HbA1c34.8 Percentage of Participants
Control ArmPatients Achieving HbA1c38.0 Percentage of Participants
95% CI: [0.71, 1.17]See comments
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

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

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
Shared Decision Making/Brief Negotiated InterviewingPercentage (Proportion x 100) of Patients Achieving Optimal Adherence46.2 Percentage of Participants
Control ArmPercentage (Proportion x 100) of Patients Achieving Optimal Adherence45.0 Percentage of Participants
95% CI: [0.83, 1.28]GEE

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026