Clinical trial NCT00416026: Translating Research: Patient Decision Support/Coaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Quality improvement
Patient-centered care
Acute coronary syndrome
Telephone counseling
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 304
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study was to test a telephone counseling intervention for patients after leaving the hospital for a heart attack to use medication, exercise, healthy eating and smoking cessation to prevent further heart attacks.

Detailed description: BACKGROUND: Efficacy of brief individual telephone coaching for secondary prevention behavior has been shown. However, the independent contribution of personal counseling to system-level intervention is untested. We tested a multiple-risk factor brief counseling intervention in acute coronary syndrome (ACS) following hospital-based quality improvement (QI) program.

METHODS: Patient-level randomized trial of hospital quality improvement (QI-only) versus quality improvement plus brief telephone coaching in the first three months post-hospitalization (QI-plus) for patients hospitalized for ACS. Data collection: medical record review, state vital records, and post-hospital surveys (baseline, 3 and 8 months post hospitalization). Main outcomes: secondary prevention behaviors, physical functioning, and quality of life.

RESULTS: QI-plus patients reported statistically significant independent improvements in physical activity (OR = 1.62; p = .01) during the intervention, and were more likely to participate in formal cardiac rehabilitation (OR = 2.51; p = .02). Smoking cessation was not statistically different (OR = 1.31; p = .68); functional status and quality of life were not different at 8 months. Medication use was high in QI and QI-plus groups, and improved over prior cohorts in the same hospitals.

CONCLUSION: QI improved physician and patient adherence to guidelines and improved medical therapy in-hospital continued in the outpatient setting. Brief telephone coaching was modestly effective in accomplishing short-term, but not long-term life-style behavior change. Patient life-style behavior change appears to require sustained intervention. QI-based improvement in medication use improves survival and appears to be the most efficient route to improved outcomes for all patients.

Eligibility criteria: Inclusion Criteria:

1. age of 21 years or older,
2. a documented serum Troponin I level of greater than, or equal to the upper limits of normal in each hospital, and
3. a working diagnosis of ACS in the medical record.

Exclusion Criteria:

1. inability to speak English or to complete the enrollment interview, and
2. discharge to a non-home setting.

Primary outcomes:
measure: Secondary prevention behaviors (smoking, exercise)
measure: Physical functioning (Activity Status Index)
measure: Quality of life (Euroqol EQ5D)
Secondary outcomes:
measure: Medication use
Other outcomes:
Locations:
city: Flint
country: United States
facility: Genesys Health System
state: Michigan
city: Flint
country: United States
facility: Hurley Hospital
state: Michigan
city: Flint
country: United States
facility: McLaren Health Systems
state: Michigan
city: Saginaw
country: United States
facility: Covenant Health System
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's Hospital
state: Michigan
Study officials:
affiliation: Michigan State University
name: Margaret M Holmes-Rovner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang Z, Olomu A, Corser W, Rovner DR, Holmes-Rovner M. Outpatient medication use and health outcomes in post-acute coronary syndrome patients. Am J Manag Care. 2006 Oct;12(10):581-7.
citation: Stommel M, Olomu A, Holmes-Rovner M, Corser W, Gardiner JC. Changes in practice patterns affecting in-hospital and post-discharge survival among ACS patients. BMC Health Serv Res. 2006 Oct 24;6:140. doi: 10.1186/1472-6963-6-140.
citation: Dunn SL, Corser W, Stommel M, Holmes-Rovner M. Hopelessness and depression in the early recovery period after hospitalization for acute coronary syndrome. J Cardiopulm Rehabil. 2006 May-Jun;26(3):152-9. doi: 10.1097/00008483-200605000-00007.
citation: Holtrop JS, Corser W, Jones G, Brooks G, Holmes-Rovner M, Stommel M. Health behavior goals of cardiac patients after hospitalization. Am J Health Behav. 2006 Jul-Aug;30(4):387-99. doi: 10.5555/ajhb.2006.30.4.387.
citation: Olomu AB, Corser WD, Stommel M, Xie Y, Holmes-Rovner M. Do self-report and medical record comorbidity data predict longitudinal functional capacity and quality of life health outcomes similarly? BMC Health Serv Res. 2012 Nov 14;12:398. doi: 10.1186/1472-6963-12-398.
citation: Corser W, Sikorskii A, Olomu A, Stommel M, Proden C, Holmes-Rovner M. "Concordance between comorbidity data from patient self-report interviews and medical record documentation". BMC Health Serv Res. 2008 Apr 16;8:85. doi: 10.1186/1472-6963-8-85.