Acute Coronary SyndromesNCT00952250
Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care
A study testing Targeted Feedback Reports and Targeted Feedback Report in people with Acute Coronary Syndromes, run by Duke University at 1 site in United States.
Trial summary
This project is designed to examine the impact of tailored feedback on site performance. The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Targeted Feedback Reports and Targeted Feedback Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitals participating in the ACTION Registry GWTG
Who cannot join
- sites with low volume of data submission (< 10 data forms in the past year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: Personalized and Targeted Feedback in the ACTION-Registry-GWTG
This project is designed to examine the impact of tailored feedback on site performance.
The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.
Read more
The investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.
Outcomes:
The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.
The secondary outcome is improvement in the composite of targeted metrics.
Outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).
- Conditions
- Acute Coronary Syndromes
- Being tested
- Targeted Feedback Reports, Targeted Feedback Report
- Keywords
- quality improvement
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Feedback ReportsBehavioural
Sites randomized to this arm will receive specialized feedback summarizing their adherence to the guidelines and suggestions on ways to improve performance.
Targeted Feedback ReportBehavioural
Report designed to target areas for local hospital-specific improvement
| Study group | Role | What they receive |
|---|---|---|
| Targeted Feedback Reports | Active comparator | Conventional feedback reports Receives: Behavioral: Targeted Feedback Reports |
| Targeted Feedback Report | Experimental | Report designed to target areas for local hospital-specific improvement. Receives: Behavioral: Targeted Feedback Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.
Measured: 12 months
Secondary outcomes (1)
The secondary outcome is improvement in the composite of targeted metrics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Karen P Alexander, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952250
- Sponsor's protocol ID
- Pro00010526
- Status last verified
- Dec 2011
- First submitted
- 4 Aug 2009
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexander KP, Wang TY, Li S, Lytle BL, Slattery LE, Calhoun S, Poteat J, Roe MT, Rumsfeld JS, Cannon CP, Peterson ED. Randomized trial of targeted performance feedback to facilitate quality improvement in acute myocardial infarction care. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):129-35. doi: 10.1161/CIRCOUTCOMES.110.958470.
PubMed 21245461
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized and Targeted Feedback in the ACTION-Registry-GWTG
- ClinicalTrials.gov ID
- NCT00952250
- Acronym / sponsor ID
- Pro00010526
- Conditions
- Acute Coronary Syndromes
- Keywords
- quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Aug 2009 (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.
This project is designed to examine the impact of tailored feedback on site performance.
The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.
The investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.
Outcomes:
The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.
The secondary outcome is improvement in the composite of targeted metrics.
Outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Feedback Reports | Active comparator | Behavioral: Targeted Feedback ReportsConventional feedback reports |
| Targeted Feedback Report | Experimental | Behavioral: Targeted Feedback ReportReport designed to target areas for local hospital-specific improvement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hospitals participating in the ACTION Registry GWTG
Key exclusion criteria (1 listed)
- sites with low volume of data submission (< 10 data forms in the past year)
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 |
|---|---|---|
| Targeted Feedback ReportsSites randomized to this arm will receive specialized feedback summarizing their adherence to the guidelines and suggestions on ways to improve performance. | Behavioural | Targeted Feedback Reports |
| Targeted Feedback ReportReport designed to target areas for local hospital-specific improvement | Behavioural | Targeted Feedback Report |
Primary outcome
The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.
Time frame: 12 months
1 secondary outcome
The secondary outcome is improvement in the composite of targeted metrics.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Derived from this study: PubMed 21245461Alexander KP, Wang TY, Li S, Lytle BL, Slattery LE, Calhoun S, Poteat J, Roe MT, Rumsfeld JS, Cannon CP, Peterson ED. Randomized trial of targeted performance feedback to facilitate quality improvement in acute myocardial infarction care. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):129-35. doi: 10.1161/CIRCOUTCOMES.110.958470.
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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.
Karen P Alexander, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Feedback Reports and Targeted Feedback Report in people with Acute Coronary Syndromes, run by Duke University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2011. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952250, which also lists 1 linked publication.
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 2 Dec 2011.