Using IVR to Maintain ACS Patients on Best Practice Guidelines (IVR-ACS BPG)

This study has suspended participant recruitment.
(Recruitment has been suspended due to revised sample size and resource availability)
Sponsor:
Collaborator:
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Neville Suskin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01260207
First received: December 13, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).

The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.


Condition Intervention Phase
Acute Coronary Syndrome
Medication Adherence
Other: IVR group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Interactive Voice Response to Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Compliance with BPGs [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 654
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IVR group
Patients in this arm will receive IVR follow-up telephone calls at 1,3,6,9 and 12 months post-discharge consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Upon completion of the IVR follow-up, all patients will be called by a member of the clinical research staff and asked to complete a follow-up survey.
Other: IVR group
Patients in this arm will receive IVR follow-up telephone calls at 1,3,6,9 and 12 months post-discharge consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Upon completion of the IVR follow-up, all patients will be called by a member of the clinical research staff and asked to complete a follow-up survey.
Other Name: Assignment to Interactive Voice Response
No Intervention: Usual care
Patients in this arm will not receive IVR follow-up. One year after discharge, all patients will be called by a member of the clinical research staff and asked to complete a follow-up survey.

Detailed Description:

Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients discharged from LHSC with ACS (acute myocardial infarction, STEMI, NSTEMI or unstable angina)
  • Patients who have a land line telephone service at home
  • Patients who speak English

Exclusion Criteria:

  • Patients discharged to a care facility or transferred to another health care institution
  • Patients who cannot provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260207

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Neville G. Suskin, MBChB, MSc University of Western Ontario and London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Neville Suskin, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01260207     History of Changes
Other Study ID Numbers: R-07-391
Study First Received: December 13, 2010
Last Updated: March 26, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Acute Coronary Syndrome
Interactive Voice Response Technology
Best Practice Guidelines
Compliance
Health Care Utilization

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014