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

Primary Purpose

Acute Coronary Syndrome, Medication Adherence

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
IVR group
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Interactive Voice Response Technology, Best Practice Guidelines, Compliance, Health Care Utilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IVR group

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compliance with BPGs

Secondary Outcome Measures

Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction

Full Information

First Posted
December 13, 2010
Last Updated
August 25, 2017
Sponsor
Lawson Health Research Institute
Collaborators
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01260207
Brief Title
Using IVR to Maintain ACS Patients on Best Practice Guidelines
Acronym
IVR-ACS BPG
Official Title
Using Interactive Voice Response to Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to unachievable sample size and lack of resource availability
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 15, 2014 (Actual)
Study Completion Date
December 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Medication Adherence
Keywords
Acute Coronary Syndrome, Interactive Voice Response Technology, Best Practice Guidelines, Compliance, Health Care Utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IVR group
Other Intervention Name(s)
Assignment to Interactive Voice Response
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance with BPGs
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neville G. Suskin, MBChB, MSc
Organizational Affiliation
University of Western Ontario and London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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Using IVR to Maintain ACS Patients on Best Practice Guidelines

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