Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Cardiovascular Disease	Other: Interactive Voice Recognition (IVR) phone calls Other: Educational mailings and follow-up for nonadherence	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

adherence to statins, ACE inhibitors, and angiotensinogen receptor blockers (ARBs). [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
We will use medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio for these three classes of medications. Nominally these measures will provide 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:

global physical and mental health status [ Time Frame: assessed at baseline and end-of-study ] [ Designated as safety issue: No ]
We plan to administer the SF-36 via mailed questionnaire to a random subset of study participants
acute health care utilization [ Time Frame: assessed over the 12 months post randomization ] [ Designated as safety issue: No ]
We will use data from the electronic medical record to measure the rate and costs of emergency department visits and hospitalizations for complications of diabetes and/or atherosclerotic cardiovascular disease.
depression [ Time Frame: assessed at baseline and end-of-study ] [ Designated as safety issue: No ]
We will assess probable depression via the PHQ-8, which will be mailed to a random subset of study participants

Estimated Enrollment:	19845
Study Start Date:	August 2011
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Usual Care (UC)
Active Comparator: Interactive Voice Recognition (IVR) In addition to their usual care, participants in the IVR arm will receive automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.	Other: Interactive Voice Recognition (IVR) phone calls The IVR intervention consists of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls will fall into two basic types: simple refill reminders and "tardy" calls for those who are overdue for a refill. Calls occur monthly and are triggered by dispensing information in the EMR. Call features include the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls are triggered by and focus on use of ACE inhibitors, ARBs and statins, they will also include reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population. Other Name: automated phone calls
Active Comparator: Enhanced IVR (IVR+) In addition to their usual care and the automated phone calls, participants in the IVR+ arm will receive mailed educational materials at the outset of the intervention and in addition both the participants and their primary care providers will receive mailed notifications when they do not fill their medications in response to the automated calls.	Other: Interactive Voice Recognition (IVR) phone calls The IVR intervention consists of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls will fall into two basic types: simple refill reminders and "tardy" calls for those who are overdue for a refill. Calls occur monthly and are triggered by dispensing information in the EMR. Call features include the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls are triggered by and focus on use of ACE inhibitors, ARBs and statins, they will also include reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population. Other Name: automated phone calls Other: Educational mailings and follow-up for nonadherence The mailed educational materials, mailed refill reminder letter and linkage to the PCP enhance the IVR intervention. Participant notification for overdue refills will be via regular mail, while providers will be notified electronically via the EMR. The educational mailing will include personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as 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

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 40-80 years as of time of randomization.
Two or more medication dispensings for any prescription medication from a KP outpatient pharmacy during the baseline year.
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)
Continuous membership in KP for the 12 months prior to randomization.
Willing to participate in the study.

Exclusion Criteria:

Evidence in the EMR of allergy or intolerance to statins, ACE inhibitors/ARBs,or aspirin
Use of warfarin or other antiplatelet agents for which aspirin use is contraindicated
End-stage renal disease or other conditions for which ACE inhibitor or ARB use is contraindicated
Use of medications for which use of statins is contraindicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251757

Locations

United States, Georgia
Center for Health Research, Kaiser Permanente Southeast
Atlanta, Georgia, United States, 30305
United States, Hawaii
Center for Health Research, Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96817
United States, Oregon
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, United States, 97227

Sponsors and Collaborators

Kaiser Permanente

Kaiser Foundation Hospitals, Center for Health Research

Johns Hopkins University

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:

William M Vollmer, PhD

Center for Health Research, Kaiser Permanente Northwest

More Information

No publications provided

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01251757 History of Changes
Other Study ID Numbers:	R01 HS19341-01
Study First Received:	November 30, 2010
Last Updated:	May 16, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

diabetes
cardiovascular disease
randomized clinical trial
medication adherence

health information technology
adult
telephone calls
IVR

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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