Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

Diabetes Mellitus Clinical Trial

— PATIENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251757
• Other study ID #: R01HS019341-01
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2010
• Last updated: August 7, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2012
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19845
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Health Research, Kaiser Permanente Southeast	Atlanta	Georgia
United States	Center for Health Research, Kaiser Permanente Hawaii	Honolulu	Hawaii
United States	Center for Health Research, Kaiser Permanente Northwest	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ), Johns Hopkins University, Kaiser Foundation Hospitals, Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to statins, ACE inhibitors, and angiotensinogen receptor blockers (ARBs).	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.	12 months post randomization	No
Secondary	global physical and mental health status	We plan to administer the SF-36 via mailed questionnaire to a random subset of study participants	assessed at baseline and end-of-study	No
Secondary	acute health care utilization	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.	assessed over the 12 months post randomization	No
Secondary	depression	We will assess probable depression via the PHQ-8, which will be mailed to a random subset of study participants	assessed at baseline and end-of-study	No