ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 127 |
| Updated: | 1/6/2018 |
| Start Date: | October 27, 2016 |
| End Date: | December 20, 2017 |
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
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.
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.
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.
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.
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
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