Translating Research: Patient Decision Support/Coaching

NCT ID: NCT00416026

Last Updated: 2006-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-10-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Keywords

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Quality improvement Patient-centered care Acute coronary syndrome Telephone counseling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Educational/Counseling/Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Principal Investigators

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Margaret M Holmes-Rovner, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Genesys Health System

Flint, Michigan, United States

Site Status

Hurley Hospital

Flint, Michigan, United States

Site Status

McLaren Health Systems

Flint, Michigan, United States

Site Status

Covenant Health System

Saginaw, Michigan, United States

Site Status

St. Mary's Hospital

Saginaw, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17026412 (View on PubMed)

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.

Reference Type RESULT
PMID: 17062154 (View on PubMed)

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.

Reference Type RESULT
PMID: 16738453 (View on PubMed)

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.

Reference Type RESULT
PMID: 16787129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23151237 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18416841 (View on PubMed)

Other Identifiers

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R01HS010531

Identifier Type: AHRQ

Identifier Source: org_study_id

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