Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard Vanguard Medical Associates | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.
Long-term adherence to evidence-based medications remains exceptionally poor. Half of all patients become non-adherent within a year of treatment initiation. Interventions that improve medication adherence may have important clinical benefits across large populations, and may even be cost-saving by reducing rates of costly and morbid clinical outcomes such as myocardial infarction and stroke.
The Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC 2 IT) is a cluster randomized controlled trial (RCT) evaluating whether a novel tele-pharmacist-based intervention improves medication adherence and disease control among individuals with hyperlipidemia, hypertension, and diabetes who are nonadherent to their medications and who have poor or worsening disease control. The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. Potentially eligible patients will be identified using data from paid-prescription claims data and the electronic health record. The study is being conducted at 14 practice sites in a large multi-specialty group practice with approximately 250 primary care physicians. Practice sites will be randomized to intervention or control. In intervention sites, the primary care physicians of potentially eligible patients will be asked whether they would like patients to be enrolled in the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telepharmacist intervention | Experimental | Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. |
|
| Usual care | No Intervention | Patients randomized to this arm will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telepharmacist intervention | Behavioral | The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study. Medication adherence is often reported as percentage of days covered. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control - All Eligible Conditions | Percentage of patients achieving good disease control for all eligible conditions. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all of their eligible conditions, as opposed to at least 1 for Outcome Measure 3. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niteesh K Choudhry, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Vanguard Medical Associates | Newton | Massachusetts | 02466 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30083727 | Derived | Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telepharmacist Intervention | Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. |
| FG001 | Usual Care | Patients randomized to this arm will receive usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention to treat
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telepharmacist Intervention | Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. |
| 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 | Medication Adherence | Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study. Medication adherence is often reported as percentage of days covered. | Intention to treat | Posted | Mean | Standard Deviation | percentage of days covered | 12 months |
|
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-specific outcome for the trial. We also did not measure or evaluate mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telepharmacist Intervention | Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. Telepharmacist intervention: The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niteesh K. Choudhry, MD, PhD | Brigham and Women's Hospital | 617-278-0930 | nkchoudhry@bwh.harvard.edu |
Not provided
| 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 | Apr 27, 2017 | Feb 13, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12 months |
| Disease Control | Percentage of patients achieving good disease control for at least one eligible condition. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all at least 1 eligible condition, as opposed to all of their eligible conditions for Outcome Measure 2. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. | 12 months |
| Healthcare Utilization - ER Visits | Number of patients with at least 1 ER visit. | 12 months |
| Healthcare Utilization - Office Visits | Number of patients with at least 1 office visit. | 12 months |
| Healthcare Utilization - Hospitalizations | Number of patients with at least 1 hospitalization. | 12 months |
| BG001 | Usual Care | Patients randomized to this arm will receive usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care | Patients randomized to this arm will receive usual care. |
|
|
|
| Secondary | Disease Control - All Eligible Conditions | Percentage of patients achieving good disease control for all eligible conditions. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all of their eligible conditions, as opposed to at least 1 for Outcome Measure 3. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. | Intention to treat | Posted | Number | percentage of participants | 12 months |
|
|
|
|
| Secondary | Disease Control | Percentage of patients achieving good disease control for at least one eligible condition. Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia). This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all at least 1 eligible condition, as opposed to all of their eligible conditions for Outcome Measure 2. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. | Intention to treat | Posted | Number | percentage of participants | 12 months |
|
|
|
|
| Secondary | Healthcare Utilization - ER Visits | Number of patients with at least 1 ER visit. | Intention to treat | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Healthcare Utilization - Office Visits | Number of patients with at least 1 office visit. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Healthcare Utilization - Hospitalizations | Number of patients with at least 1 hospitalization. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Patients randomized to this arm will receive usual care. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |