Diabetes Mellitus Type 2
Conditions
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
This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c): | baseline and at the end of 12 months post index date | Pre- to post-intervention change in mean HbA1c levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (PDC Measure) | during follow-up period of 12 months post index date | Mean Adherence (PDC) in each study arm in the follow-up period |
| Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | 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 |
| Patients Achieving HbA1c | 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 |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,362 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost insurance eligibility | 22 | 16 |
Baseline characteristics
| Characteristic | Control Arm | Total | Shared Decision Making/Brief Negotiated Interviewing |
|---|---|---|---|
| Age, Continuous | 54.6 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 684 Participants | 1362 Participants | 678 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 273 Participants | 509 Participants | 236 Participants |
| Sex: Female, Male Male | 411 Participants | 853 Participants | 442 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 678 | 0 / 684 |
| other Total, other adverse events | 1 / 678 | 0 / 684 |
| serious Total, serious adverse events | 5 / 678 | 0 / 684 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Glycosylated Hemoglobin (HbA1c): | -0.75 Percentage of HbA1c | Standard Deviation 1.96 |
| Control Arm | Glycosylated Hemoglobin (HbA1c): | -0.79 Percentage of HbA1c | Standard Deviation 2.01 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Medication Adherence (PDC Measure) | 67.5 Percentage of Days | Standard Deviation 31.6 |
| Control Arm | Medication Adherence (PDC Measure) | 66.2 Percentage of Days | Standard Deviation 32.7 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Patients Achieving HbA1c | 34.8 Percentage of Participants |
| Control Arm | Patients Achieving HbA1c | 38.0 Percentage of Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shared Decision Making/Brief Negotiated Interviewing | Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | 46.2 Percentage of Participants |
| Control Arm | Percentage (Proportion x 100) of Patients Achieving Optimal Adherence | 45.0 Percentage of Participants |