Diabetes, Hyperlipidemia, Hypertension
Conditions
Keywords
Medication Non-adherence, Hyperlipidemia, Diabetes, Hypertension
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTelepharmacist 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.
Sponsors
Harvard Vanguard Medical Associates
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 85 Years
Healthy volunteers
No
Inclusion criteria
* Filled and poorly adherent (defined as a PDC \< 80%) to medication for hyperlipidemia, hypertension, or diabetes * Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC \< 80%) * For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)
Exclusion criteria
* Patients with \<6 months of continuous enrolment in the health plan * Patients with no available contact information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control - All Eligible Conditions | 12 months | 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. |
| Disease Control | 12 months | 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. |
| Healthcare Utilization - ER Visits | 12 months | Number of patients with at least 1 ER visit. |
| Healthcare Utilization - Office Visits | 12 months | Number of patients with at least 1 office visit. |
| Healthcare Utilization - Hospitalizations | 12 months | Number of patients with at least 1 hospitalization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,038 |
| Usual Care Patients randomized to this arm will receive usual care. | 2,040 |
| Total | 4,078 |
Baseline characteristics
| Characteristic | Usual Care | Total | Telepharmacist Intervention |
|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 11.5 | 59.8 years STANDARD_DEVIATION 11.6 | 60.4 years STANDARD_DEVIATION 11.7 |
| Race/Ethnicity, Customized American Indian or Alaska | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 95 Participants | 189 Participants | 94 Participants |
| Race/Ethnicity, Customized Black or African American | 448 Participants | 1027 Participants | 579 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 91 Participants | 204 Participants | 113 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 95 Participants | 163 Participants | 68 Participants |
| Race/Ethnicity, Customized Patient Declined/ Missing | 72 Participants | 156 Participants | 84 Participants |
| Race/Ethnicity, Customized White | 1236 Participants | 2329 Participants | 1093 Participants |
| Region of Enrollment United States | 2040 Participants | 4078 Participants | 2038 Participants |
| Sex: Female, Male Female | 917 Participants | 1841 Participants | 924 Participants |
| Sex: Female, Male Male | 1123 Participants | 2237 Participants | 1114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telepharmacist Intervention | Medication Adherence | 46.2 percentage of days covered | Standard Deviation 33.9 |
| Usual Care | Medication Adherence | 42.1 percentage of days covered | Standard Deviation 33.8 |
95% CI: [3, 6.4]
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.
Time frame: 12 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telepharmacist Intervention | Disease Control | 72.9 percentage of participants |
| Usual Care | Disease Control | 71.2 percentage of participants |
95% CI: [0.94, 1.28]
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.
Time frame: 12 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telepharmacist Intervention | Disease Control - All Eligible Conditions | 67.4 percentage of participants |
| Usual Care | Disease Control - All Eligible Conditions | 66.2 percentage of participants |
95% CI: [0.91, 1.22]
Secondary
Healthcare Utilization - ER Visits
Number of patients with at least 1 ER visit.
Time frame: 12 months
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telepharmacist Intervention | Healthcare Utilization - ER Visits | 90 Participants |
| Usual Care | Healthcare Utilization - ER Visits | 113 Participants |
95% CI: [0.45, 0.85]
Secondary
Healthcare Utilization - Hospitalizations
Number of patients with at least 1 hospitalization.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telepharmacist Intervention | Healthcare Utilization - Hospitalizations | 170 Participants |
| Usual Care | Healthcare Utilization - Hospitalizations | 156 Participants |
95% CI: [0.78, 1.34]
Secondary
Healthcare Utilization - Office Visits
Number of patients with at least 1 office visit.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telepharmacist Intervention | Healthcare Utilization - Office Visits | 641 Participants |
| Usual Care | Healthcare Utilization - Office Visits | 594 Participants |
95% CI: [0.91, 1.36]