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| Name | Class |
|---|---|
| Horizon Blue Cross Blue Shield of New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity | Active Comparator | 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. |
|
| Moderate intensity | Experimental | 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. |
|
| High intensity | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity | Other | Low intensity telepharmacy outreach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Health Care Spending |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niteesh K Choudhry, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Blue Cross Blue Shield of New Jersey | Newark | New Jersey | 07105-2200 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30874782 | Derived | Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657. | |
| 29084790 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Moderate Intensity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Percentage of participants | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
We did not collect adverse event data (no investigational drug studied). Adverse events were not a pre-specified outcome for the trial. We also did not measure or evaluate mortality.
We did not collect adverse event data (no investigational drug studied). Adverse events were not a pre-specified outcome for the trial. We also did not measure or evaluate mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niteesh K. Choudhry, MD, PhD | Brigham and Women's Hospital | 617-278-0930 | nkchoudhry@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2018 | Feb 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| ID | Term |
|---|---|
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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| Moderate intensity |
| Other |
Moderate intensity telepharmacy outreach |
|
| High intensity | Other | High intensity telepharmacy outreach |
|
Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period |
| From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Number of Physician Office Visits | Number of all-cause physician office visits over the entire follow-up period | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Number of Emergency Room Visits | Number of all-cause emergency room visits over the entire follow-up period | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Number of Hospitalizations | Number of All-cause hospitalizations over the entire follow-up period | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
| Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551. |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | % of glycated hemoglobin (A1c) |
|
| At least 1 HbA1c value available | Count of Participants | Participants |
|
| Short or rapid-acting insulin use | Count of Participants | Participants |
|
| Number of basal insulin claims | Mean | Standard Deviation | Basal insulin claims |
|
| Use of adjunct oral hypoglycemic | Count of Participants | Participants |
|
| Hypoglycemia | Count of Participants | Participants |
|
| Ketoacidosis | Count of Participants | Participants |
|
| Retinopathy | Count of Participants | Participants |
|
| Nephropathy | Count of Participants | Participants |
|
| Neuropathy | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Stroke/Transient ischemic attack | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
| Asthma/COPD | Count of Participants | Participants |
|
| Cancer | Count of Participants | Participants |
|
| Liver Disease | Count of Participants | Participants |
|
| Chronic Kidney Disease | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Dementia | Count of Participants | Participants |
|
| Acute Stress | Count of Participants | Participants |
|
| Days hospitalized | Mean | Standard Deviation | Days |
|
| Number of Hospitalizations | Mean | Standard Deviation | Hospitalizations |
|
| Number of Office visits | Mean | Standard Deviation | Office Visits |
|
| OG002 | 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 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Percent change | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | Dollars | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
|
|
|
| Secondary | Number of Physician Office Visits | Number of all-cause physician office visits over the entire follow-up period | Posted | Mean | Standard Deviation | Physician office visits | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
|
|
|
| Secondary | Number of Emergency Room Visits | Number of all-cause emergency room visits over the entire follow-up period | Posted | Mean | Standard Deviation | ER visits | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
|
|
|
| Secondary | Number of Hospitalizations | Number of All-cause hospitalizations over the entire follow-up period | Posted | Mean | Standard Deviation | Hospitalizations | From 1 month (30 days) after randomization through 12 months (365 days) after randomization |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Male |
|
| Risk Difference (RD) |
| -0.25 |
| 2-Sided |
| 95 |
| -0.43 |
| -0.06 |
| Superiority |
| Risk Ratio (RR) |
| 0.99 |
| 2-Sided |
| 95 |
| 0.92 |
| 1.06 |
| Superiority |
| Risk Ratio (RR) |
| 0.98 |
| 2-Sided |
| 95 |
| 0.96 |
| 1.00 |
| Superiority |
| Risk Ratio (RR) |
| 0.96 |
| 2-Sided |
| 95 |
| 0.85 |
| 1.07 |
| Superiority |
| Risk Ratio (RR) |
| 1.14 |
| 2-Sided |
| 95 |
| 0.99 |
| 1.32 |
| Superiority |