Diabetes, Hyperlipidemia, Hypertension, Medication Nonadherence
Conditions
Keywords
Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence
Brief summary
More than 50% of adults treated for diabetes, hypertension, or lipid disorders have suboptimal medication adherence, a prominent barrier to continued improvement in chronic disease care in the United States. Primary care providers (PCPs) often fail to identify medication nonadherence and/or have insufficient time and training to address underlying reasons for it. In this project, we propose a patient-centered and technology-driven strategy to identify patients with adherence issues and apply a team approach to help them achieve evidence-based personalized goals for glucose, blood pressure, or lipids. This intervention extends the use of a widely available clinical decision support (CDS) infrastructure to support a model of care that, for the first time outside of a fully integrated care environment, will integrate pharmacists within the primary care team. The intervention relies on a continuous health informatics loop to do the following: (a) identify high-risk patients with adherence problems at the point of care by expanding the capability of an electronic medical record (EMR)-linked CDS to identify poor adherence to medications; (b) establish and maintain an auto-populating up-to-date registry of patients identified for proactive pharmacist outreach; (c) implement a pharmacist outreach strategy based on an information-motivation-behavioral (IMB) framework recommended by the World Health Organization (WHO) with demonstrated ability to influence adherence across a variety of clinical applications; and (d) coordinate care and adherence information by incorporating pharmacist assessment and action plans into CDS at subsequent office encounters.
Detailed description
Patients are randomly allocated 1:1 through a computer-generated program to either control or intervention. Control: All control patients will continue to receive the basic Electronic Medical Record (EMR)-linked Clinical Decision Support (CDS) tool for cardiovascular (CV) risk factor management. This CDS includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. The basic CDS does not include any information on medication adherence. Patients will receive basic CDS plus usual care. Intervention: For intervention patients, the basic CDS system for CV risk-factor control is enhanced to support a team-based care model that identifies risk of non-adherence, computes adherence information and incorporates it in the CDS, creates a registry to direct proactive pharmacist outreach, and coordinates action plans. To do this, the CDS Web service will combine EMR-identified medications with Epic Medication Adherence score (e-PDC) data. Algorithms will identify poor adherence using e-PDC scores available within the Epic EMR at patient encounters. When medication adherence issues are identified, alert messages will appear on the CDS tools for patients and providers. Patients with index visits will be followed-up for 6 months as they continue to receive CDS at subsequent encounters. At 6 months, patient e-PDC as well as clinical outcomes will be reevaluated. Patients with persistent adherence issues identified are added to a registry that is used by the pharmacists to conduct outreach. Pharmacist outreach will be conducted primarily by phone, but in-person arrangements are also an option. Pharmacists conducting outreach will identify themselves to patients as part of the care team working with the primary care provider (PCP). Examples of specific action plans that may be recommended includes education, recommending lower cost alternative medications or combination medications, addressing side effects, using pill boxes, modifying pill-taking schedules and/or using reminder systems, or referrals to medication therapy management (MTM) services or health educators. Pharmacists will be guided by a script template for the phone outreach that walks them through the IMB intervention and data collection. The pharmacists involved will have full read/write access to the EMR in full compliance with HIPAA regulations. They can make medication changes through established care protocols and/or communicate with the prescriber through secure messaging or phone consultation. The date of the pharmacist outreach and actions that result from the IMB intervention will be documented in the EMR and incorporated into subsequent CDS tools and registries to reflect the new patient state.
Interventions
The adherence enhanced intervention consists of clinical decision support related to cardiovascular risk factors enhanced with external medication adherence information and is delivered at the point of care to the healthcare provider and patient.
Sponsors
Study design
Eligibility
Inclusion criteria
* One or more of the following clinical criteria: A. In the 12 months prior to the index visit, most recent hemoglobin A1C ≥8% AND have one or more active non-insulin glycemic medications on their electronic health record (EHR) medication list AND a potential adherence issue for one or more of these medications based on the Epic Medication Adherence score (e-PDC \<80%, moderate or high confidence). B. Two consecutive encounters with BP values ≥140/90 mm Hg AND one or more BP medications on their EHR medication list AND a potential adherence issue identified (e-PDC \<80%, moderate/high confidence). C. Meet the American College of Cardiology/American Heart Association (ACC/AHA) criteria listed below for moderate or high-intensity statin use AND a statin medication on their EHR medication list AND a potential statin adherence issue identified (e-PDC \<80%, moderate/high confidence): 1. Age \>21 with atherosclerotic cardiovascular disease (ASCVD) identified by a cardiovascular disease (CVD) diagnosis on the problem list or two or more International Classification of Diseases (ICD)-10 diagnostic codes in the last 2 years 2. Age \>21 and LDL \>190 mg/dL 3. Aged 40 to 75 AND diabetes identified by the diagnosis on the problem list or two or more ICD-10 diagnostic codes in the last 2 years 4. Aged 40 to 75 with 10-year CV Risk Score \>7.5% based on the ACC/AHA 10-year ASCVD risk equation.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from the study analysis: 1. Patients enrolled in hospice, 2. Patients with active cancer or undergoing chemotherapy 3. Patients with pregnancy in the last year 4. Patients without HealthPartners insurance coverage for at least 11 of the 12 months before the index visit will be excluded from cost analysis. 5. For Statin cohort, ≥1 LDL result \<100 mg/dl within 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Medication Adherence | 12 months after an index visit | Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one antihypertensive medication in each currently prescribed blood pressure medication class at 12 months following the index office visit date. |
| Non-Insulin Glycemic Medication Adherence | 12 months after an index visit | Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one non-insulin glycemic medication in each currently prescribed glycemic medication class at 12 months following the index office visit date. |
| Statin Medication Adherence | 12 months after an index visit | Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for a statin medication if currently prescribed at 12 months following the index office visit date. |
| Mean Change in Systolic Blood Pressure | 12 months after an index visit | Mean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit. |
| Mean Change in A1c | 12 months after an index visit | Mean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic-based Medical Care Costs | 12 months after an index visit | Change in annual clinic-based medical care costs, defined from the health system perspective. |
Countries
United States
Participant flow
Recruitment details
Participants were identified as eligible using an automated algorithm designed to display the adherence enhanced decision support at the point of care at a primary care clinic visit. The first visit where a participant met eligibility criteria (and prior to applying exclusion criteria) was considered their index visit. There was no direct contact between study participants and the study team. The study was granted a waiver of informed consent from HealthPartners IRB.
Pre-assignment details
Patients were randomly allocated 1:1 through a computer generated program to either control or intervention. The number Completed reflects the number of participants included in the final analysis after exclusions were applied.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes. | 2,676 |
| Adherence Intervention Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes. | 2,745 |
| Total | 5,421 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 24 | 28 |
| Overall Study | Lost to Follow-up | 231 | 230 |
| Overall Study | No 12 month medication adherence data available | 0 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Adherence Intervention | Total |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 10.6 | 57.2 years STANDARD_DEVIATION 10.9 | 57.4 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 114 Participants | 116 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2045 Participants | 2119 Participants | 4164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 517 Participants | 510 Participants | 1027 Participants |
| Presence of cardiovascular disease (CVD) | 323 Participants | 353 Participants | 676 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 16 Participants | 26 Participants |
| Race (NIH/OMB) Asian | 207 Participants | 189 Participants | 396 Participants |
| Race (NIH/OMB) Black or African American | 700 Participants | 688 Participants | 1388 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 197 Participants | 216 Participants | 413 Participants |
| Race (NIH/OMB) White | 1559 Participants | 1630 Participants | 3189 Participants |
| Region of Enrollment United States | 2676 participants | 2745 participants | 5421 participants |
| Sex: Female, Male Female | 1196 Participants | 1235 Participants | 2431 Participants |
| Sex: Female, Male Male | 1480 Participants | 1510 Participants | 2990 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 2,808 | 28 / 2,879 |
| other Total, other adverse events | 127 / 2,808 | 127 / 2,879 |
| serious Total, serious adverse events | 557 / 2,808 | 559 / 2,879 |
Outcome results
Blood Pressure Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one antihypertensive medication in each currently prescribed blood pressure medication class at 12 months following the index office visit date.
Time frame: 12 months after an index visit
Population: Participants that were not at evidence-based goals for blood pressure (BP) and had PDC less than 80% with moderate to high confidence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Blood Pressure Medication Adherence | 396 Participants |
| Adherence Intervention | Blood Pressure Medication Adherence | 470 Participants |
Mean Change in A1c
Mean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit.
Time frame: 12 months after an index visit
Population: Participants that were not at evidence-based goals for hemoglobin A1c and had PDC less than 80% with moderate to high confidence.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Change in A1c | -1.1 percentage of glycated hemoglobin |
| Adherence Intervention | Mean Change in A1c | -1.2 percentage of glycated hemoglobin |
Mean Change in Systolic Blood Pressure
Mean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit.
Time frame: 12 months after an index visit
Population: Not at evidence-based clinical goals for SBP and had proportion of days covered (PDC) greater than or equal to 80%.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Change in Systolic Blood Pressure | -15.2 mm Hg |
| Adherence Intervention | Mean Change in Systolic Blood Pressure | -13.8 mm Hg |
Non-Insulin Glycemic Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one non-insulin glycemic medication in each currently prescribed glycemic medication class at 12 months following the index office visit date.
Time frame: 12 months after an index visit
Population: Participants that were not at evidence-based goals for glucose (A1c) and had PDC less than 80% with moderate to high confidence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Non-Insulin Glycemic Medication Adherence | 279 Participants |
| Adherence Intervention | Non-Insulin Glycemic Medication Adherence | 296 Participants |
Statin Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for a statin medication if currently prescribed at 12 months following the index office visit date.
Time frame: 12 months after an index visit
Population: Participants that had PDC less than 80% with moderate to high confidence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Statin Medication Adherence | 529 Participants |
| Adherence Intervention | Statin Medication Adherence | 586 Participants |
Clinic-based Medical Care Costs
Change in annual clinic-based medical care costs, defined from the health system perspective.
Time frame: 12 months after an index visit
Population: All enrolled participants that were not at evidence-based goals for blood pressure (BP) or glucose and had proportion of days covered (PDC) less than 80% with moderate to high confidence for blood pressure, glucose, or statin medications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Clinic-based Medical Care Costs | 1210.15 US dollars | Standard Error 40.59 |
| Adherence Intervention | Clinic-based Medical Care Costs | 1202.68 US dollars | Standard Error 44.13 |