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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Diabetes Mellitus
• Intervention / Treatment: Other: Interactive Voice Recognition (IVR) phone calls; Other: Educational mailings and follow-up for nonadherence

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.

• Study Type: Interventional
• Enrollment (Actual): 21752
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (UC); Participants in this arm received their usual care with no restrictions.
Active Comparator: Interactive Voice Recognition (IVR); automated phone calls	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 Names: automated phone calls
Active Comparator: Enhanced IVR (IVR+); automated phone calls & Educational mailings and follow-up for nonadherence	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 Names: automated phone calls; 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.; Other Names: mail follow-up for nonadherence; educational mailings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Statins	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.	12 months post randomization
Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)	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.	12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage With Good (>80%) Statin Adherence	Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.	12 months post randomization
Percentage With Good (>80%) ACEI/ARB Adherence	Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.	12 months post randomization
Systolic Blood Pressure (SBP)	Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.	12-months post randomization
Percentage With Good (<140/90 mmHg) Blood Pressure Control	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.	12 months post randomization
Post Intervention Low Density Lipoprotein (LDL) Level	We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.	12 months post randomization
Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control	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.	12 months post randomization

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Johns Hopkins University; Agency for Healthcare Research and Quality (AHRQ); Kaiser Foundation Hospitals, Center for Health Research
• Investigators: Principal Investigator: William M Vollmer, PhD, Center for Health Research, Kaiser Permanente Northwest

Publications and helpful links

General Publications

• Vollmer WM, Owen-Smith AA, Tom JO, Laws R, Ditmer DG, Smith DH, Waterbury AC, Schneider JL, Yonehara CH, Williams A, Vupputuri S, Rand CS. Improving adherence to cardiovascular disease medications with information technology. Am J Manag Care. 2014 Nov;20(11 Spec No. 17):SP502-10.
• Smith DH, O'Keeffe-Rosetti M, Owen-Smith AA, Rand C, Tom J, Vupputuri S, Laws R, Waterbury A, Hankerson-Dyson DD, Yonehara C, Williams A, Schneider J, Dickerson JF, Vollmer WM. Improving Adherence to Cardiovascular Therapies: An Economic Evaluation of a Randomized Pragmatic Trial. Value Health. 2016 Mar-Apr;19(2):176-84. doi: 10.1016/j.jval.2015.11.013. Epub 2016 Feb 12.
• Owen-Smith AA, Smith DH, Rand CS, Tom JO, Laws R, Waterbury A, Williams A, Vollmer WM. Difference in Effectiveness of Medication Adherence Intervention by Health Literacy Level. Perm J. 2016 Summer;20(3):15-200. doi: 10.7812/TPP/15-200. Epub 2016 Jun 29.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; adult; cardiovascular disease; medication adherence; randomized clinical trial; health information technology; IVR; telephone calls
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: R01HS019341-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the request of AHRQ we did not create a formal public data release.