Diabetes
Conditions
Keywords
Insulin persistence, Telepharmacy
Brief summary
The purpose of this study is to evaluate three pharmacist-outreach strategies for improving adherence to insulin among individuals with diabetes. The three approaches are equivalently-priced but vary by degree of targeting and intervention intensity.
Detailed description
In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin \[HbA1c\] control among patients with diabetes on insulin. The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care. The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.
Interventions
OTHERLow intensity
Low intensity telepharmacy outreach
OTHERModerate intensity
Moderate intensity telepharmacy outreach
OTHERHigh intensity
High intensity telepharmacy outreach
Sponsors
Horizon Blue Cross Blue Shield of New Jersey
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey * At least 3 months of continuous enrollment prior to randomization * At least 1 prescription for basal insulin, 6 months prior to randomization * Type 2 diabetes diagnosis
Exclusion criteria
* Patients with Medicaid or Medicare as primary insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Persistence | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin Level (HbA1c) | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available. |
| Health Care Spending | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period |
| Number of Physician Office Visits | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | Number of all-cause physician office visits over the entire follow-up period |
| Number of Emergency Room Visits | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | Number of all-cause emergency room visits over the entire follow-up period |
| Number of Hospitalizations | From 1 month (30 days) after randomization through 12 months (365 days) after randomization | Number of All-cause hospitalizations over the entire follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Intensity All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
Low intensity: Low intensity telepharmacy outreach | 1,861 |
| Moderate Intensity Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program. The pharmacist will also provide limited follow-up with the participant's provider. Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
Moderate intensity: Moderate intensity telepharmacy outreach | 1,873 |
| High Intensity Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up. The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist. Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
High intensity: High intensity telepharmacy outreach | 1,862 |
| Total | 5,596 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Less than 31 days of follow-up | 56 | 45 | 52 |
| Overall Study | Lost Enrollment | 83 | 82 | 86 |
Baseline characteristics
| Characteristic | High Intensity | Total | Low Intensity | Moderate Intensity |
|---|---|---|---|---|
| Acute Stress | 57 Participants | 187 Participants | 68 Participants | 62 Participants |
| Age, Continuous | 55.9 years STANDARD_DEVIATION 10.7 | 55.9 years STANDARD_DEVIATION 11 | 56.1 years STANDARD_DEVIATION 11 | 55.6 years STANDARD_DEVIATION 11.3 |
| Asthma/COPD | 226 Participants | 724 Participants | 254 Participants | 244 Participants |
| At least 1 HbA1c value available | 642 Participants | 1945 Participants | 663 Participants | 640 Participants |
| Cancer | 220 Participants | 676 Participants | 235 Participants | 221 Participants |
| Chronic Kidney Disease | 1204 Participants | 3653 Participants | 1227 Participants | 1222 Participants |
| Congestive heart failure | 136 Participants | 412 Participants | 129 Participants | 147 Participants |
| Coronary artery disease | 382 Participants | 1178 Participants | 391 Participants | 405 Participants |
| Days hospitalized | 2.0 Days STANDARD_DEVIATION 7.6 | 2.1 Days STANDARD_DEVIATION 11 | 2.17 Days STANDARD_DEVIATION 11.1 | 2.2 Days STANDARD_DEVIATION 10.1 |
| Dementia | 36 Participants | 110 Participants | 40 Participants | 34 Participants |
| Depression | 134 Participants | 412 Participants | 143 Participants | 135 Participants |
| Hemoglobin A1c | 8.6 % of glycated hemoglobin (A1c) STANDARD_DEVIATION 1.8 | 8.5 % of glycated hemoglobin (A1c) STANDARD_DEVIATION 1.9 | 8.5 % of glycated hemoglobin (A1c) STANDARD_DEVIATION 1.8 | 8.5 % of glycated hemoglobin (A1c) STANDARD_DEVIATION 1.8 |
| Hyperlipidemia | 1275 Participants | 3801 Participants | 1278 Participants | 1248 Participants |
| Hypertension | 1429 Participants | 4219 Participants | 1381 Participants | 1409 Participants |
| Hypoglycemia | 87 Participants | 261 Participants | 86 Participants | 88 Participants |
| Ketoacidosis | 41 Participants | 143 Participants | 48 Participants | 54 Participants |
| Liver Disease | 138 Participants | 410 Participants | 130 Participants | 142 Participants |
| Nephropathy | 28 Participants | 121 Participants | 46 Participants | 47 Participants |
| Neuropathy | 412 Participants | 1262 Participants | 431 Participants | 419 Participants |
| Number of basal insulin claims | 2.6 Basal insulin claims STANDARD_DEVIATION 1.9 | 2.6 Basal insulin claims STANDARD_DEVIATION 1.9 | 2.6 Basal insulin claims STANDARD_DEVIATION 1.9 | 2.6 Basal insulin claims STANDARD_DEVIATION 1.8 |
| Number of Hospitalizations | 0.3 Hospitalizations STANDARD_DEVIATION 0.8 | 0.3 Hospitalizations STANDARD_DEVIATION 1.4 | 0.3 Hospitalizations STANDARD_DEVIATION 0.9 | 0.3 Hospitalizations STANDARD_DEVIATION 1.3 |
| Number of Office visits | 9.3 Office Visits STANDARD_DEVIATION 7.7 | 9.3 Office Visits STANDARD_DEVIATION 7.7 | 9.5 Office Visits STANDARD_DEVIATION 8 | 9.3 Office Visits STANDARD_DEVIATION 7.6 |
| Obesity | 497 Participants | 1430 Participants | 461 Participants | 472 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | 1862 participants | 5596 participants | 1861 participants | 1873 participants |
| Retinopathy | 170 Participants | 510 Participants | 184 Participants | 156 Participants |
| Sex: Female, Male Female | 763 Participants | 2252 Participants | 751 Participants | 738 Participants |
| Sex: Female, Male Male | 1099 Participants | 3344 Participants | 1110 Participants | 1135 Participants |
| Short or rapid-acting insulin use | 965 Participants | 2849 Participants | 954 Participants | 930 Participants |
| Stroke/Transient ischemic attack | 103 Participants | 300 Participants | 95 Participants | 102 Participants |
| Use of adjunct oral hypoglycemic | 1227 Participants | 3689 Participants | 1220 Participants | 1242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Insulin Persistence
Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Intensity | Insulin Persistence | 5.4 Percentage of participants |
| Moderate Intensity | Insulin Persistence | 4.7 Percentage of participants |
| High Intensity | Insulin Persistence | 4.9 Percentage of participants |
95% CI: [0.75, 1.03]
95% CI: [0.77, 1.06]
Secondary
Change in Glycated Hemoglobin Level (HbA1c)
The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity | Change in Glycated Hemoglobin Level (HbA1c) | -0.06 Percent change | Standard Deviation 1.48 |
| Moderate Intensity | Change in Glycated Hemoglobin Level (HbA1c) | -0.21 Percent change | Standard Deviation 1.37 |
| High Intensity | Change in Glycated Hemoglobin Level (HbA1c) | -0.31 Percent change | Standard Deviation 1.48 |
95% CI: [-0.34, 0.05]
95% CI: [-0.43, -0.06]
Secondary
Health Care Spending
Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity | Health Care Spending | 22616 Dollars | Standard Deviation 49250 |
| Moderate Intensity | Health Care Spending | 23284 Dollars | Standard Deviation 49094 |
| High Intensity | Health Care Spending | 22545 Dollars | Standard Deviation 44448 |
95% CI: [0.95, 1.11]
95% CI: [0.92, 1.06]
Secondary
Number of Emergency Room Visits
Number of all-cause emergency room visits over the entire follow-up period
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity | Number of Emergency Room Visits | 0.31 ER visits | Standard Deviation 1 |
| Moderate Intensity | Number of Emergency Room Visits | 0.43 ER visits | Standard Deviation 4.4 |
| High Intensity | Number of Emergency Room Visits | 0.30 ER visits | Standard Deviation 0.87 |
95% CI: [1.24, 1.53]
95% CI: [0.85, 1.07]
Secondary
Number of Hospitalizations
Number of All-cause hospitalizations over the entire follow-up period
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity | Number of Hospitalizations | 0.19 Hospitalizations | Standard Deviation 0.63 |
| Moderate Intensity | Number of Hospitalizations | 0.23 Hospitalizations | Standard Deviation 0.72 |
| High Intensity | Number of Hospitalizations | 0.21 Hospitalizations | Standard Deviation 0.65 |
95% CI: [1.06, 1.41]
95% CI: [0.99, 1.32]
Secondary
Number of Physician Office Visits
Number of all-cause physician office visits over the entire follow-up period
Time frame: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Intensity | Number of Physician Office Visits | 7.66 Physician office visits | Standard Deviation 7.29 |
| Moderate Intensity | Number of Physician Office Visits | 7.62 Physician office visits | Standard Deviation 7.17 |
| High Intensity | Number of Physician Office Visits | 7.50 Physician office visits | Standard Deviation 7.27 |
95% CI: [0.97, 1.02]
95% CI: [0.96, 1]