Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

NCT01251757 | Completed Results DMC

• 1 other identifier: R01HS019341-01
• Study Type: interventional
• Target: 21,752
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus; Cardiovascular Disease

Keywords

diabetes; cardiovascular disease; randomized clinical trial; medication adherence; health information technology; adult; telephone calls; IVR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage With Good (>80%) Statin Adherence

  12 months post randomization

• Percentage With Good (>80%) ACEI/ARB Adherence

  12 months post randomization

• Systolic Blood Pressure (SBP)

  12-months post randomization

• Percentage With Good (<140/90 mmHg) Blood Pressure Control

  12 months post randomization

• Post Intervention Low Density Lipoprotein (LDL) Level

  12 months post randomization

Study Arms (3)

Usual Care (UC)

NO INTERVENTION

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

Interactive Voice Recognition (IVR)

ACTIVE COMPARATOR

automated phone calls

Other: Interactive Voice Recognition (IVR) phone calls

Enhanced IVR (IVR+)

ACTIVE COMPARATOR

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

Other: Interactive Voice Recognition (IVR) phone calls; Other: Educational mailings and follow-up for nonadherence

Interventions

Interactive Voice Recognition (IVR) phone calls 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.

Also known as: automated phone calls

Enhanced IVR (IVR+); Interactive Voice Recognition (IVR)

Educational mailings and follow-up for nonadherence 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.

Also known as: mail follow-up for nonadherence, educational mailings

Enhanced IVR (IVR+)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Kaiser Foundation Hospitals, Center for Health Research: collaborator
• Johns Hopkins University: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Center for Health Research, Kaiser Permanente Southeast

Atlanta, Georgia, 30305, United States

Location

Center for Health Research, Kaiser Permanente Hawaii

Honolulu, Hawaii, 96817, United States

Location

Center for Health Research, Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 25811824 RESULT

• 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.

  PMID: 27021751 RESULT

• 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.

  PMID: 27352409 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: William M Vollmer, PhD
• Organization: Kaiser Permanente Center for Health Research

william.vollmer@kpchr.org

503-335-2400

Study Officials

• William M Vollmer, PhD

  Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 13, 2017
• Results First Posted: February 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)