Trial Outcomes & Findings for Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization (NCT NCT00903032)

NCT ID: NCT00903032

Last Updated: 2015-04-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 253 participants
• Primary outcome timeframe: 12-months
• Results posted on: 2015-04-27

Participant Flow

Participant milestones

Measure	Patient Centered 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. 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	Usual Care Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
Overall Study STARTED	129	124
Overall Study COMPLETED	122	119
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Patient Centered 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. 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	Usual Care Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
Overall Study Withdrawal by Subject	5	3
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient Centered Intervention n=122 Participants 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.	Usual Care n=119 Participants Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.	Total n=241 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=5 Participants	73 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 8.57 • n=5 Participants	63.8 years STANDARD_DEVIATION 9.25 • n=7 Participants	64 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	116 Participants n=7 Participants	236 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	84 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	78 Participants n=7 Participants	170 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	119 participants n=7 Participants	241 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months

Population: Composite Adherence\* (PDC\>0.80) (%)

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.

Outcome measures

Measure	Patient Centered Intervention n=122 Participants 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.	Usual Care n=119 Participants Patients will receive usual care following ACS hospital discharge Usual care: Usual care following ACS hospital discharge.
Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)	89.3 percentage of participants	73.9 percentage of participants

Adverse Events

Patient Centered Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P. Michael Ho

VA ECHCS

Phone: 720-857-5115

Email: Michael.Ho@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place