Trial Outcomes & Findings for Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks (NCT NCT00426231)

Results Overview

Achieving the goal of an LDL cholesterol level of \< 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

6 months

Results posted on

2014-02-24

Participant Flow

This trial recruited lower income and lower educational level Black and white American patients identified at the time of hospitalization of the Johns Hopkins Medical Institutions for a myocardial infarction, coronary artery bypass graft, or percutaneous intervention.

Participants were enrolled during their hospitalization. Participants had their randomization visit at 1 month.

Participant milestones

Participant milestones
Measure	Patient Navigator Intervention Patient Navigator intervention Navigation by a health worker : Help provided by health worker to navigate medication access programs	Information Control Information control Information control : Information about medication access programs provided to the participant and their healthcare provider
Overall Study STARTED	36	37
Overall Study COMPLETED	27	25
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient Navigator Intervention Patient Navigator intervention Navigation by a health worker : Help provided by health worker to navigate medication access programs	Information Control Information control Information control : Information about medication access programs provided to the participant and their healthcare provider
Overall Study Withdrawal by Subject	9	12

Baseline Characteristics

Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Navigator Intervention n=36 Participants Patient Navigator intervention Navigation by a health worker : Help provided by health worker to navigate medication access programs	Information Control n=37 Participants Information control Information control : Information about medication access programs provided to the participant and their healthcare provider	Total n=73 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	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	55.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	55.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	55.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	37 participants n=7 Participants	73 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Achieving the goal of an LDL cholesterol level of \< 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.

Outcome measures

Outcome measures
Measure	Patient Navigator Intervention n=36 Participants Patient Navigator intervention Navigation by a health worker : Help provided by health worker to navigate medication access programs	Information Control n=37 Participants Information control Information control : Information about medication access programs provided to the participant and their healthcare provider
Achievement of LDL-cholesterol Goals	31 participants	29 participants

SECONDARY outcome

Timeframe: 6 months

Only individuals with 6-month follow-up data were included in this analysis

Outcome measures

Outcome measures
Measure	Patient Navigator Intervention n=36 Participants Patient Navigator intervention Navigation by a health worker : Help provided by health worker to navigate medication access programs	Information Control n=37 Participants Information control Information control : Information about medication access programs provided to the participant and their healthcare provider
Self-reported Medication Adherence	16 participants	19 participants

Adverse Events

Patient Navigator Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Information Control

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

Dhananjay Vaidya

Johns Hopkins University

Phone: 410-6142307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place