Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization

NCT00903032 | Completed Results DMC

• 1 other identifier: IIR 08-302
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 4

Brief Summary

We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective. ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.

Conditions

Acute Coronary Syndrome

Keywords

compliance/adherence

Outcome Measures

Primary Outcomes (1)

• Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)

  The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.

  12-months

Study Arms (2)

Arm 1

EXPERIMENTAL

The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.

Behavioral: Intervention

Arm 2

ACTIVE COMPARATOR

Patients will receive usual care following ACS hospital discharge

Behavioral: Usual care

Interventions

Intervention BEHAVIORAL

The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.

Arm 1

Usual care BEHAVIORAL

Usual care following ACS hospital discharge.

Arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted with acute coronary syndrome (ACS) as the primary reason for hospital admission and use the VA for their usual source of care, defined as having 1 primary care visit within the 12 months prior to hospital admission will be screened for eligibility to participate. ACS is defined as acute myocardial infarction (both ST-elevation MI and non-ST elevation MI) or unstable angina. The presence of acute myocardial infarction will be defined using standard definitions from an international consensus statement, based on the following: a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following:
• symptoms of ischemia;
• ECG change indicative of new ischemia (new ST-T changes or new left bundle branch block);
• development of pathological Q waves in the ECG; or
• imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.42 Unstable angina will be defined by presence of ischemic symptoms and ECG changes indicative of new ischemia but without biomarker evidence of myonecrosis (i.e., biomarker elevation) and no evidence of new pathological Q waves, loss of viable myocardium or regional wall motion abnormality.

You may not qualify if:

• Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g. perioperative MI);
• planned discharge to nursing home or skilled nursing facility;
• irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
• lack of telephone/cell phone;
• VA is not primary source of care;
• regularly fill medications at non-VA pharmacy.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (4)

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (3)

• Lambert-Kerzner A, Del Giacco EJ, Fahdi IE, Bryson CL, Melnyk SD, Bosworth HB, Davis R, Mun H, Weaver J, Barnett C, Radcliff T, Hubbard A, Bosket KD, Carey E, Virchow A, Mihalko-Corbitt R, Kaufman A, Marchant-Miros K, Ho PM; Multifaceted Intervention to Improve Cardiac Medication Adherence and Secondary Prevention Measures (Medication) Study Investigators. Patient-centered adherence intervention after acute coronary syndrome hospitalization. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):571-6. doi: 10.1161/CIRCOUTCOMES.111.962290.

  PMID: 22811499 BACKGROUND

• Ho PM, Lambert-Kerzner A, Carey EP, Fahdi IE, Bryson CL, Melnyk SD, Bosworth HB, Radcliff T, Davis R, Mun H, Weaver J, Barnett C, Baron A, Del Giacco EJ. Multifaceted intervention to improve medication adherence and secondary prevention measures after acute coronary syndrome hospital discharge: a randomized clinical trial. JAMA Intern Med. 2014 Feb 1;174(2):186-93. doi: 10.1001/jamainternmed.2013.12944.

  PMID: 24247275 RESULT

• Valle JA, Ho PM. Medication adherence in secondary prevention post-myocardial infarction. Curr Treat Options Cardiovasc Med. 2014 Dec;16(12):349. doi: 10.1007/s11936-014-0349-7.

  PMID: 25341689 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Patient Compliance

Interventions

Methods

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: P. Michael Ho
• Organization: VA ECHCS

Michael.Ho@va.gov

720-857-5115

Study Officials

• Michael Ho, MD PhD

  VA Eastern Colorado Health Care System, Denver, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 27, 2015
• Results First Posted: January 9, 2015

Record last verified: 2014-09

Locations

US (4)