Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

Not Applicable

Completed

Interventions: Other: Interactive Voice Recognition (IVR) phone calls
Other: Educational mailings and follow-up for nonadherence

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Interactive Voice Recognition (IVR)	Interactive Voice Recognition (IVR) phone calls	automated phone calls
Enhanced IVR (IVR+)	Interactive Voice Recognition (IVR) phone calls	automated phone calls \& Educational mailings and follow-up for nonadherence
Enhanced IVR (IVR+)	Educational mailings and follow-up for nonadherence	automated phone calls \& Educational mailings and follow-up for nonadherence

Primary Outcome Measures

Name	Time	Method
Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)	12 months post randomization	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.
Adherence to Statins	12 months post randomization	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.

Secondary Outcome Measures

Name	Time	Method
Percentage With Good (>80%) Statin Adherence	12 months post randomization	Binary indicator of good statin adherence, defined as an mMPR\>0.80. 1=yes, 0=no.
Percentage With Good (>80%) ACEI/ARB Adherence	12 months post randomization	Binary indicator of good ACEI/ARB adherence, defined as an mMPR\>0.80. 1=yes, 0=no.
Systolic Blood Pressure (SBP)	12-months post randomization	Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.
Percentage With Good (<140/90 mmHg) Blood Pressure Control	12 months post randomization	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.
Post Intervention Low Density Lipoprotein (LDL) Level	12 months post randomization	We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.
Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control	12 months post randomization	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.

Locations (3): Center for Health Research, Kaiser Permanente Southeast
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Atlanta, Georgia, United States
Center for Health Research, Kaiser Permanente Northwest
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Portland, Oregon, United States
Center for Health Research, Kaiser Permanente Hawaii
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Honolulu, Hawaii, United States