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

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00903032
• Collaborator: (none)
• Enrollment: 253
• Locations: 4
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 63.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Behavioral: Intervention; Behavioral: Usual care	N/A

Detailed Description

RATIONALE: Acute coronary syndrome, including acute myocardial infarction (MI) is one of the leading causes of hospitalization for veterans. Recent advances in the treatment of acute MI have led to declines in hospital mortality. Despite this, the risk of recurrent events and mortality after the index MI hospitalization remains substantial in the following year. Non-adherence to proven cardioprotective medications is a potentially modifiable risk factor that contributes to the persistently high risk of adverse outcomes following MI hospitalization. Prior interventions to improve medication adherence in cardiovascular populations have produced mixed results and have not specifically targeted patients after acute coronary syndrome (ACS) hospital discharge. It is currently unknown if interventions targeting medication non-adherence in the year after ACS discharge will improve medication adherence and intermediate outcomes or will be cost-effective

OBJECTIVE(S): 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 LDL-cholesterol goals, reduces cardiac endpoints (MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

METHODS: We propose a 3-year, multi-site patient-level randomized controlled trial to evaluate, relative to usual care, a multi-faceted patient-centered intervention to improve adherence to cardioprotective medication among veterans following ACS hospital discharge. The study will enroll 280 patients to intervention versus usual care for 12-months at 3 VA Medical Centers (Eastern Colorado, Pudget Sound, and Central Arkansas). The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and tele-monitoring. The primary analyses will be a comparison of adherence to cardioprotective medications using pharmacy refill records based on the ReCOMP adherence measure developed in the VA. Secondary analyses will compare achievement of secondary prevention BP and LDL goals and cardiac events. In addition, cost-effectiveness analysis will be performed. All analyses will be intention to treat

Study Design

• Study Type: Interventional
• Actual Enrollment: 253 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Patient-Centered Adherence Intervention After ACS Hospitalization
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 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; 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.
Active Comparator: Arm 2 Patients will receive usual care following ACS hospital discharge	Behavioral: Usual care; Usual care following ACS hospital discharge.

Outcome Measures

Primary Outcome Measures

1. Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) [12-months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR	Little Rock	Arkansas	United States	72205-5484
2	VA Eastern Colorado Health Care System, Denver, CO	Denver	Colorado	United States	80220
3	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705
4	VA Puget Sound Health Care System, Seattle	Seattle	Washington	United States	98108

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Michael Ho, MD PhD, VA Eastern Colorado Health Care System, Denver, CO

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00903032
• Other Study ID Numbers: IIR 08-302
• First Posted: May 15, 2009
• Last Update Posted: Apr 27, 2015
• Last Verified: Sep 1, 2014

• Keywords provided by US Department of Veterans Affairs: compliance/adherence
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

Participant Flow

Arm/Group Title	Patient Centered Intervention	Usual Care
Arm/Group Description	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. Intervention: 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 re	Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
Period Title: Overall Study
STARTED	129	124
COMPLETED	122	119
NOT COMPLETED	7	5

Baseline Characteristics

Arm/Group Title	Patient Centered Intervention	Usual Care	Total
Arm/Group Description	The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, 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.	Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.	Total of all reporting groups
Overall Participants	122	119	241
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	77 63.1%	73 61.3%	150 62.2%
>=65 years	45 36.9%	46 38.7%	91 37.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (8.57)	63.8 (9.25)	64 (9)
Sex: Female, Male (Count of Participants)
Female	2 1.6%	3 2.5%	5 2.1%
Male	120 98.4%	116 97.5%	236 97.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.5%	7 5.9%	10 4.1%
Not Hispanic or Latino	86 70.5%	84 70.6%	170 70.5%
Unknown or Not Reported	33 27%	28 23.5%	61 25.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	3 2.5%	3 1.2%
Asian	9 7.4%	12 10.1%	21 8.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	17 13.9%	12 10.1%	29 12%
White	92 75.4%	78 65.5%	170 70.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 3.3%	14 11.8%	18 7.5%
Region of Enrollment (participants) [Number]
United States	122 100%	119 100%	241 100%

Outcome Measures

1. Primary Outcome

Title	Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)
Description	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.
Time Frame	12-months

Outcome Measure Data

Analysis Population Description

Composite Adherence* (PDC>0.80) (%)

Arm/Group Title	Patient Centered Intervention	Usual Care
Arm/Group Description	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. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.	Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
Measure Participants	122	119
Number [percentage of participants]	89.3 73.2%	73.9 62.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Centered Intervention, Usual Care
	Comments	Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Previously provided
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Patient Centered Intervention		Usual Care
Arm/Group Description	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. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, 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.		Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
All Cause Mortality
	Patient Centered Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patient Centered Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/119 (0%)
Other (Not Including Serious) Adverse Events
	Patient Centered Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/119 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.