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Completed

NCT Number: NCT01251757

Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

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.

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Key information

Conditions

Diabetes Mellitus Behavior Cardiovascular Disease Cardiovascular Diseases Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Research, Kaiser Permanente Southeast, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Voice Recognition (IVR) phone calls

Other

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.

Other names: automated phone calls

Educational mailings and follow-up for nonadherence

Other

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.

Other names: mail follow-up for nonadherence, educational mailings

Primary outcomes

  1. Adherence to Statins

    Time frame: 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.

  2. Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)

    Time frame: 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.

Secondary outcomes

  1. Percentage With Good (>80%) Statin Adherence

    Time frame: 12 months post randomization

    Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.

  2. Percentage With Good (>80%) ACEI/ARB Adherence

    Time frame: 12 months post randomization

    Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.

  3. Systolic Blood Pressure (SBP)

    Time frame: 12-months post randomization

    Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.

  4. Percentage With Good (<140/90 mmHg) Blood Pressure Control

    Time frame: 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.

  5. Post Intervention Low Density Lipoprotein (LDL) Level

    Time frame: 12 months post randomization

    We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.

  6. Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Johns Hopkins University
  • Kaiser Foundation Hospitals, Center for Health Research

Registry information

Official study title

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

Acronym: PATIENT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2010
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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