Acute Coronary SyndromePhase 3IVR-ACS BPGNCT01260207
Using IVR to Maintain ACS Patients on Best Practice Guidelines
A Phase 3 study testing IVR group in people with Acute Coronary Syndrome and Medication Adherence, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Medication Adherence
- What is being tested?
- IVR group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to 15 Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients discharged to a care facility or transferred to another health care institution
- Patients who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Interactive Voice Response to Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Medication Adherence
- Being tested
- IVR group
- Keywords
- Acute Coronary Syndrome, Interactive Voice Response Technology, Best Practice Guidelines, Compliance, Health Care Utilization
- Medical subject headings
- Acute Coronary Syndrome, Medication Adherence, Patient Compliance, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR groupOther
Also called Assignment to Interactive Voice Response
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with BPGs
Measured: 1 Year
Secondary outcomes (1)
Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startJan 2010
- Primary completion15 Dec 2014
- Study completion15 Dec 2014
Why it stopped: Terminated due to unachievable sample size and lack of resource availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Responsible party
- Sponsor
- Investigators
- Neville G. Suskin, MBChB, MSc, Principal investigator, University of Western Ontario and London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260207
- Sponsor's protocol ID
- R-07-391
- Acronym
- IVR-ACS BPG
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2010
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Interactive Voice Response to Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
- ClinicalTrials.gov ID
- NCT01260207
- Acronym / sponsor ID
- IVR-ACS BPG / R-07-391
- Conditions
- Acute Coronary Syndrome, Medication Adherence
- Keywords
- Acute Coronary Syndrome, Interactive Voice Response Technology, Best Practice Guidelines, Compliance, Health Care Utilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to unachievable sample size and lack of resource availability
- Enrolment
- 654 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- Jan 2010 (actual)
- Primary completion
- 15 Dec 2014 (actual)
- Study completion
- 15 Dec 2014 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVR group | Experimental | Other: IVR groupPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients discharged to a care facility or transferred to another health care institution
- Patients who cannot provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVR groupAlso: Assignment to Interactive Voice ResponsePatients 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 |
Primary outcome
Compliance with BPGs
Time frame: 1 Year
1 secondary outcome
Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
Time frame: 1 Year
Results and safety
The study was stopped early (reason given: Terminated due to unachievable sample size and lack of resource availability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neville G. Suskin, MBChB, MSc principal investigator
University of Western Ontario and London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVR group in people with Acute Coronary Syndrome and Medication Adherence, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to unachievable sample size and lack of resource availability). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with BPGs (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.