NCT01251757

Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21,752 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-12-02
• Last updated: 2017-03-13
• Results posted: 2017-02-01

Locations

3 sites across 1 country: United States