Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating CVD Medication Adherence Program in Low SES

NCT02375737

Cardiovascular Disease Hypertension Diabetes

COMPLETED NA

Increasing Adherence to Treatment Recommendations Following a Cardiac Event

NCT02327260

Cardiovascular Disease

COMPLETED NA

A Randomized Controlled Trial to Improve Medication Compliance Among Patients With Coronary Heart Disease

NCT00208832

Coronary Disease

COMPLETED NA

An mHealth Intervention to Improve Medication Adherence and Health Outcomes

NCT04703439

Coronary Heart Disease

COMPLETED NA

Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

NCT01242319

Hypercholesterolemia Coronary Disease Primary Health Care +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care (UC)

Participants in this arm received their usual care with no restrictions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interactive Voice Recognition (IVR)

automated phone calls

Group Type ACTIVE_COMPARATOR

Interactive Voice Recognition (IVR) phone calls

Intervention Type 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.

Enhanced IVR (IVR+)

automated phone calls \& Educational mailings and follow-up for nonadherence

Group Type ACTIVE_COMPARATOR

Interactive Voice Recognition (IVR) phone calls

Intervention Type 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.

Educational mailings and follow-up for nonadherence

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interactive Voice Recognition (IVR) phone calls

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.

Intervention Type OTHER

Educational mailings and follow-up for nonadherence

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

automated phone calls mail follow-up for nonadherence educational mailings

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No