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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
21,752
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.
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.
Center for Health Research, Kaiser Permanente Southeast
Atlanta, Georgia, United States
Center for Health Research, Kaiser Permanente Hawaii
Honolulu, Hawaii, United States
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, United States
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.
Time frame: 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.
Time frame: 12 months post randomization
Percentage With Good (>80%) Statin Adherence
Binary indicator of good statin adherence, defined as an mMPR\>0.80. 1=yes, 0=no.
Time frame: 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.
Time frame: 12 months post randomization
Systolic Blood Pressure (SBP)
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Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post randomization