Research Site
Boston, Massachusetts, 2115, United States
NCT Number: NCT02910089
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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Notify Me18 year–130 year
All sexes
Interventional
Phase 4
Boston, Massachusetts, 2115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
Time frame: baseline and at the end of 12 months post index date
Pre- to post-intervention change in mean HbA1c levels
Time frame: during follow-up period of 12 months post index date
Mean Adherence (PDC) in each study arm in the follow-up period
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
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
AstraZeneca
Industry
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
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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