Clinical trial NCT01251757: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies
Official title: Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Cardiovascular Disease
Keywords: diabetes
cardiovascular disease
randomized clinical trial
medication adherence
health information technology
adult
telephone calls
IVR
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Hospitals, Center for Health Research
name: Johns Hopkins University
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-12-02
Enrollment: 21752
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 criteria: 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

Primary outcomes:
measure: Adherence to Statins
timeFrame: 12 months post randomization
measure: Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)
timeFrame: 12 months post randomization
Secondary outcomes:
measure: Percentage With Good (>80%) Statin Adherence
timeFrame: 12 months post randomization
measure: Percentage With Good (>80%) ACEI/ARB Adherence
timeFrame: 12 months post randomization
measure: Systolic Blood Pressure (SBP)
timeFrame: 12-months post randomization
measure: Percentage With Good (<140/90 mmHg) Blood Pressure Control
timeFrame: 12 months post randomization
measure: Post Intervention Low Density Lipoprotein (LDL) Level
timeFrame: 12 months post randomization
measure: Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control
timeFrame: 12 months post randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Health Research, Kaiser Permanente Southeast
state: Georgia
city: Honolulu
country: United States
facility: Center for Health Research, Kaiser Permanente Hawaii
state: Hawaii
city: Portland
country: United States
facility: Center for Health Research, Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: Center for Health Research, Kaiser Permanente Northwest
name: William M Vollmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.