NCT01260207

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2014

Completed
Last Updated

August 28, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

December 13, 2010

Last Update Submit

August 25, 2017

Conditions

Keywords

Acute Coronary SyndromeInteractive Voice Response TechnologyBest Practice GuidelinesComplianceHealth Care Utilization

Outcome Measures

Primary Outcomes (1)

  • Compliance with BPGs

    1 Year

Secondary Outcomes (1)

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

    1 Year

Study Arms (2)

IVR group

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

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.

Also known as: Assignment to Interactive Voice Response
IVR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients discharged to a care facility or transferred to another health care institution
  • Patients who cannot provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Acute Coronary SyndromeMedication AdherencePatient CompliancePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Neville G. Suskin, MBChB, MSc

    University of Western Ontario and London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 15, 2010

Study Start

January 1, 2010

Primary Completion

December 15, 2014

Study Completion

December 15, 2014

Last Updated

August 28, 2017

Record last verified: 2017-03

Locations