Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

Study Overview
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Brief Summary
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The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.

Detailed Description
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The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.

Official Title
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Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)

Conditions
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Diabetes Mellitus, Cardiovascular Disease

Intervention / Treatment
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* Other: Interactive Voice Recognition (IVR) phone calls
* Other: Educational mailings and follow-up for nonadherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40 years or older as of time of randomization. Flagged in KP's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year. Suboptimal adherence ((MPR<0.9) to either statins or ACEI/ARBs during the baseline year Continuous membership in KP for the 12 months prior to randomization. Qualified for an intervention call at the time of randomization. Exclusion Criteria: Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs medical conditions that would contraindicate use of statins or ACEI/ARBs Absence of either a phone number or mailing address in the EMR for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies on Kaiser Permanente's do not contact list or in other research studies that could add undue burden

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care (UC)<br>Participants in this arm received their usual care with no restrictions. | |
| Active Comparator: Interactive Voice Recognition (IVR)<br>automated phone calls | Other: Interactive Voice Recognition (IVR) phone calls<br>* The IVR intervention consisted of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the electronic medical record (EMR). Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.<br>* Other names: automated phone calls;|
| Active Comparator: Enhanced IVR (IVR+)<br>automated phone calls & Educational mailings and follow-up for nonadherence | Other: Interactive Voice Recognition (IVR) phone calls<br>* The IVR intervention consisted of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the electronic medical record (EMR). Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population.<br>* Other names: automated phone calls;Other: Educational mailings and follow-up for nonadherence<br>* Participants received bimonthly educational materials by mail. In addition, patients received mailed refill reminder letters and their providers were notified electronically if the patients failed to refill in response to the automated calls. The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as frequently asked questions (FAQs) about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers.<br>* Other names: educational mailings;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Statins | We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications. | 12 months post randomization | 
| Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) | We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications. | 12 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage With Good (>80%) Statin Adherence | Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no. | 12 months post randomization | 
| Percentage With Good (>80%) ACEI/ARB Adherence | Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no. | 12 months post randomization | 
| Systolic Blood Pressure (SBP) | Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization. | 12-months post randomization | 
| Percentage With Good (<140/90 mmHg) Blood Pressure Control | Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP <140 mmHg and a mean diastolic BP < 90 mmHg. | 12 months post randomization | 
| Post Intervention Low Density Lipoprotein (LDL) Level | We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed. | 12 months post randomization | 
| Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control | Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level <= 100 mg/dL. | 12 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, cardiovascular disease, randomized clinical trial, medication adherence, health information technology, adult, telephone calls, IVR