Diabetes
Conditions
Keywords
medication adherence, motivational interviewing
Brief summary
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Detailed description
Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes. Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 3-arm randomized clinical trial to test the effectiveness of providing primary care physicians (PCPs) with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications. Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system plus physicians and patients will receive support from an adherence clinic. Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients' adherence and goal levels. The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.
Interventions
BEHAVIORALAdherence information
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
BEHAVIORALAdherence information plus motivational interviewing
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month. * At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months. * Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d * Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.
Exclusion criteria
* Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period. * Participation in a disease management program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin Levels | at 18 months post randomization |
| LDL-cholesterol Levels | at 18 months post randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Morbidity and Mortality (Exploratory) | at 24 months post randomization | — |
| Adherence to Oral Anti-diabetic Medications | at 6 months post randomization | Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date. |
| LDL Cholesterol Levels | at 6 months post randomization | — |
| Glycated Hemoglobin Levels | at 6 months post randomization | — |
| Adherence to Lipid-lowering Drugs | at 6 months post randomization | Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm | 567 |
| Adherence Information Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. | 569 |
| Adherence Information Plus Motivational Interviewing Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal. | 556 |
| Total | 1,692 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Died or disenrolled | 57 | 69 | 54 |
Baseline characteristics
| Characteristic | Usual Care | Adherence Information | Adherence Information Plus Motivational Interviewing | Total |
|---|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 11.5 | 63.3 years STANDARD_DEVIATION 10.9 | 64.5 years STANDARD_DEVIATION 10.5 | 64.3 years STANDARD_DEVIATION 11 |
| Alpha-glucosidase inhibitor use | 5 participants | 4 participants | 3 participants | 12 participants |
| Biguanide use | 335 participants | 364 participants | 347 participants | 1046 participants |
| Bile acid sequestrant use | 9 participants | 4 participants | 3 participants | 16 participants |
| Diastolic blood pressure | 74.8 mmHg STANDARD_DEVIATION 10 | 75.6 mmHg STANDARD_DEVIATION 9.3 | 75.0 mmHg STANDARD_DEVIATION 9.2 | 75.1 mmHg STANDARD_DEVIATION 9.5 |
| Ezetimibe use | 73 participants | 77 participants | 90 participants | 240 participants |
| Fibrate use | 59 participants | 51 participants | 50 participants | 160 participants |
| HbA1c | 8.0 % STANDARD_DEVIATION 1.4 | 8.2 % STANDARD_DEVIATION 1.4 | 8.0 % STANDARD_DEVIATION 1.3 | 8.0 % STANDARD_DEVIATION 1.4 |
| Insulin use | 187 participants | 191 participants | 192 participants | 570 participants |
| LDL-C | 99.9 mg/dL STANDARD_DEVIATION 31.4 | 98.5 mg/dL STANDARD_DEVIATION 33.8 | 97.1 mg/dL STANDARD_DEVIATION 31.5 | 98.5 mg/dL STANDARD_DEVIATION 32.2 |
| Lipid-lowering medication adherence | 0.71 Adherence - proportion STANDARD_DEVIATION 0.37 | 0.70 Adherence - proportion STANDARD_DEVIATION 0.37 | 0.69 Adherence - proportion STANDARD_DEVIATION 0.37 | 0.70 Adherence - proportion STANDARD_DEVIATION 0.37 |
| Meglitinide use | 8 participants | 3 participants | 2 participants | 13 participants |
| Niacin use | 7 participants | 6 participants | 5 participants | 18 participants |
| Oral diabetes medication adherence | 0.76 Adherence - proportion STANDARD_DEVIATION 0.35 | 0.76 Adherence - proportion STANDARD_DEVIATION 0.35 | 0.75 Adherence - proportion STANDARD_DEVIATION 0.36 | 0.75 Adherence - proportion STANDARD_DEVIATION 0.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 224 Participants | 237 Participants | 238 Participants | 699 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 46 Participants | 38 Participants | 37 Participants | 121 Participants |
| Race (NIH/OMB) White | 297 Participants | 294 Participants | 281 Participants | 872 Participants |
| Serum creatinine | 1.1 mg/dL STANDARD_DEVIATION 0.4 | 1.1 mg/dL STANDARD_DEVIATION 0.3 | 1.2 mg/dL STANDARD_DEVIATION 0.9 | 1.1 mg/dL STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 302 Participants | 270 Participants | 266 Participants | 838 Participants |
| Sex: Female, Male Male | 265 Participants | 299 Participants | 290 Participants | 854 Participants |
| Statin use | 446 participants | 452 participants | 443 participants | 1341 participants |
| Sulfonylurea use | 327 participants | 341 participants | 337 participants | 1005 participants |
| Systolic blood pressure | 133.6 mmHg STANDARD_DEVIATION 15.4 | 132.3 mmHg STANDARD_DEVIATION 15.3 | 133.2 mmHg STANDARD_DEVIATION 15.8 | 133.0 mmHg STANDARD_DEVIATION 15.5 |
| Thiazolidinedione use | 78 participants | 85 participants | 73 participants | 236 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 567 | 0 / 569 | 0 / 556 |
| serious Total, serious adverse events | 0 / 567 | 0 / 569 | 0 / 556 |
Outcome results
Primary
Glycated Hemoglobin Levels
Time frame: at 18 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Glycated Hemoglobin Levels | 7.88 Percent | Standard Deviation 1.53 |
| Adherence Information | Glycated Hemoglobin Levels | 7.91 Percent | Standard Deviation 1.53 |
| Adherence Information Plus Motivational Interviewing | Glycated Hemoglobin Levels | 7.79 Percent | Standard Deviation 1.34 |
p-value: 0.763ANOVA
p-value: 0.285ANOVA
Primary
LDL-cholesterol Levels
Time frame: at 18 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | LDL-cholesterol Levels | 89.02 mg/dL | Standard Deviation 32.11 |
| Adherence Information | LDL-cholesterol Levels | 87.27 mg/dL | Standard Deviation 35.67 |
| Adherence Information Plus Motivational Interviewing | LDL-cholesterol Levels | 85.56 mg/dL | Standard Deviation 32.86 |
p-value: 0.38ANOVA
p-value: 0.084ANOVA
Secondary
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 12 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Lipid-lowering Drugs | 0.70 Adherence - proportion | Standard Deviation 0.36 |
| Adherence Information | Adherence to Lipid-lowering Drugs | 0.69 Adherence - proportion | Standard Deviation 0.37 |
| Adherence Information Plus Motivational Interviewing | Adherence to Lipid-lowering Drugs | 0.69 Adherence - proportion | Standard Deviation 0.37 |
p-value: 0.779ANOVA
p-value: 0.733ANOVA
Secondary
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 6 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Lipid-lowering Drugs | 0.70 Adherence - proportion | Standard Deviation 0.37 |
| Adherence Information | Adherence to Lipid-lowering Drugs | 0.69 Adherence - proportion | Standard Deviation 0.36 |
| Adherence Information Plus Motivational Interviewing | Adherence to Lipid-lowering Drugs | 0.69 Adherence - proportion | Standard Deviation 0.36 |
p-value: 0.881ANOVA
p-value: 0.849ANOVA
Secondary
Adherence to Lipid-lowering Drugs
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 18 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Lipid-lowering Drugs | 0.70 Adherence - proportion | Standard Deviation 0.37 |
| Adherence Information | Adherence to Lipid-lowering Drugs | 0.70 Adherence - proportion | Standard Deviation 0.37 |
| Adherence Information Plus Motivational Interviewing | Adherence to Lipid-lowering Drugs | 0.70 Adherence - proportion | Standard Deviation 0.37 |
p-value: 0.952ANOVA
p-value: 0.856ANOVA
Secondary
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 12 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Oral Anti-diabetic Medications | 0.75 Adherence - proportion | Standard Deviation 0.35 |
| Adherence Information | Adherence to Oral Anti-diabetic Medications | 0.74 Adherence - proportion | Standard Deviation 0.36 |
| Adherence Information Plus Motivational Interviewing | Adherence to Oral Anti-diabetic Medications | 0.74 Adherence - proportion | Standard Deviation 0.38 |
p-value: 0.573ANOVA
p-value: 0.443ANOVA
Secondary
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 18 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Oral Anti-diabetic Medications | 0.75 Adherence - proportion | Standard Deviation 0.36 |
| Adherence Information | Adherence to Oral Anti-diabetic Medications | 0.73 Adherence - proportion | Standard Deviation 0.37 |
| Adherence Information Plus Motivational Interviewing | Adherence to Oral Anti-diabetic Medications | 0.73 Adherence - proportion | Standard Deviation 0.38 |
p-value: 0.469ANOVA
p-value: 0.369ANOVA
Secondary
Adherence to Oral Anti-diabetic Medications
Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.
Time frame: at 6 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adherence to Oral Anti-diabetic Medications | 0.75 Adherence - proportion | Standard Deviation 0.35 |
| Adherence Information | Adherence to Oral Anti-diabetic Medications | 0.74 Adherence - proportion | Standard Deviation 0.36 |
| Adherence Information Plus Motivational Interviewing | Adherence to Oral Anti-diabetic Medications | 0.74 Adherence - proportion | Standard Deviation 0.37 |
p-value: 0.667ANOVA
p-value: 0.53ANOVA
Secondary
Cardiovascular Morbidity and Mortality (Exploratory)
Time frame: at 36 months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Cardiovascular Morbidity and Mortality (Exploratory) | 101 participants |
| Adherence Information | Cardiovascular Morbidity and Mortality (Exploratory) | 112 participants |
| Adherence Information Plus Motivational Interviewing | Cardiovascular Morbidity and Mortality (Exploratory) | 99 participants |
p-value: 0.419Chi-squared
p-value: 0.998Chi-squared
Secondary
Cardiovascular Morbidity and Mortality (Exploratory)
Time frame: at 24 months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Cardiovascular Morbidity and Mortality (Exploratory) | 63 participants |
| Adherence Information | Cardiovascular Morbidity and Mortality (Exploratory) | 80 participants |
| Adherence Information Plus Motivational Interviewing | Cardiovascular Morbidity and Mortality (Exploratory) | 58 participants |
p-value: 0.134Chi-squared
p-value: 0.714Chi-squared
Secondary
Glycated Hemoglobin Levels
Time frame: at 12 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Glycated Hemoglobin Levels | 7.94 Percent | Standard Deviation 1.6 |
| Adherence Information | Glycated Hemoglobin Levels | 7.96 Percent | Standard Deviation 1.54 |
| Adherence Information Plus Motivational Interviewing | Glycated Hemoglobin Levels | 7.84 Percent | Standard Deviation 1.4 |
p-value: 0.829ANOVA
p-value: 0.283ANOVA
Secondary
Glycated Hemoglobin Levels
Time frame: at 6 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Glycated Hemoglobin Levels | 7.81 Percent | Standard Deviation 1.42 |
| Adherence Information | Glycated Hemoglobin Levels | 7.90 Percent | Standard Deviation 1.44 |
| Adherence Information Plus Motivational Interviewing | Glycated Hemoglobin Levels | 7.81 Percent | Standard Deviation 1.41 |
p-value: 0.291ANOVA
p-value: 0.968ANOVA
Secondary
LDL Cholesterol Levels
Time frame: at 12 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | LDL Cholesterol Levels | 90.63 mg/dL | Standard Deviation 32.41 |
| Adherence Information | LDL Cholesterol Levels | 90.70 mg/dL | Standard Deviation 36.9 |
| Adherence Information Plus Motivational Interviewing | LDL Cholesterol Levels | 87.43 mg/dL | Standard Deviation 32.43 |
p-value: 0.971ANOVA
p-value: 0.115ANOVA
Secondary
LDL Cholesterol Levels
Time frame: at 6 months post randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | LDL Cholesterol Levels | 92.92 mg/dL | Standard Deviation 32.33 |
| Adherence Information | LDL Cholesterol Levels | 92.07 mg/dL | Standard Deviation 36.68 |
| Adherence Information Plus Motivational Interviewing | LDL Cholesterol Levels | 91.23 mg/dL | Standard Deviation 31.17 |
p-value: 0.671ANOVA
p-value: 0.399ANOVA