EchocardiographyNCT01792544
Clinical Reminders in Test Reports to Improve Guideline Compliance
A study testing Statement and No Statement in people with Echocardiography, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Echocardiography
- What is being tested?
- Statement and No Statement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,706 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.
- Conditions
- Echocardiography
- Being tested
- Statement, No Statement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatementOther
No StatementOther
| Study group | Role | What they receive |
|---|---|---|
| Statement | Experimental | A statement is added to the echocardiography report describing if and when a follow-up echocardiogram is recommended. The statement may be positive (e.g. follow-up recommended in 6 months) or negative (e.g. no follow-up recommended). Receives: Other: Statement |
| No Statement | Experimental | No statement is added to the echocardiography report Receives: Other: No Statement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate follow-up
Performance of a follow-up echocardiogram when it was not indicated or not performing for a follow-up echocardiogram when it was indicated.
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 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionNov 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,706 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Heidenreich, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792544
- Sponsor's protocol ID
- SUIRB-021780
- Status last verified
- Apr 2016
- First submitted
- 12 Feb 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Reminders in Test Reports to Improve Guideline Compliance
- ClinicalTrials.gov ID
- NCT01792544
- Acronym / sponsor ID
- SUIRB-021780
- Conditions
- Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Feb 2013 (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 study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statement | Experimental | Other: StatementA statement is added to the echocardiography report describing if and when a follow-up echocardiogram is recommended. The statement may be positive (e.g. follow-up recommended in 6 months) or negative (e.g. no follow-up recommended). |
| No Statement | Experimental | Other: No StatementNo statement is added to the echocardiography report |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Statement | Other | Statement |
| No Statement | Other | No Statement |
Primary outcome
Inappropriate follow-up
Time frame: 1 year
Performance of a follow-up echocardiogram when it was not indicated or not performing for a follow-up echocardiogram when it was indicated.
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 28 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statement and No Statement in people with Echocardiography, run by VA Palo Alto Health Care System 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 28 Apr 2016. 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?
Inappropriate follow-up (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 Apr 2016.