Management of Actionable Test Results (ATRs)Phase 3OutptATRNCT01385982
Improving Management of Outpatient Actionable Test Results
A Phase 3 study testing Actionable Test Result Management/Standardization in people with Management of Actionable Test Results (ATRs), run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Clinically significant test results require timely clinician follow-up including the non-urgent clinically significant, or actionable, test results that have received less standardized management and attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Management of Actionable Test Results (ATRs)
- What is being tested?
- Actionable Test Result Management/Standardization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2013
- 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
- Primary care physicians will be enrolled in the study by virtue of being an actively practicing clinician in an PHS ambulatory practice, and having at least one patient with a diagnostic test included in the PHS CCSTR intervention. The patient population will consist of adult patients >17 years of age with diagnostic tests in the affiliated ambulatory practices of PHS. Patients will be recruited into the study by a review of electronic medical record data to identify patients with a diagnostic test specified in the PHS CCSTR intervention.
Who cannot join
- Participants who do not meet the inclusion/eligibility requirements will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Clinically significant test results require timely clinician follow-up including the non-urgent clinically significant, or actionable, test results that have received less standardized management and attention. Unfortunately, failure to correctly manage actionable test results is not infrequent and may be associated with important delays in diagnosis and treatment and patient harm. The investigators have designed a safe practice intervention to improve the management of actionable test results for ambulatory patients in a large healthcare system.
- Being tested
- Actionable Test Result Management/Standardization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actionable Test Result Management/StandardizationOther
The intervention includes enterprise-wide standardization of actionable test result (ATR) definitions with stratification of significant results into alert levels, expected timeframes for clinician responses, a set of policies for ATR follow-up, metrics to measure ATR management and performance feedback.
| Study group | Role | What they receive |
|---|---|---|
| Actionable Test Results | Other | Creating standardized policies and procedures around actionable test results (ATR) management, and implementing them network-wide:
1. Defining the levels of severity and urgency for clinically significant test results
2. Network-wide policy for test result follow-up by the responsible providers, documentation and escalation processes to assure timely communication.
3. Standardized policies for the time frames and nature of communication of test result alerts.
4. Establish criteria for appropriate ATR management by the responsible provider.
5. Feedback performance including provider, practice and service report cards Receives: Other: Actionable Test Result Management/Standardization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acknowledged Sub-Critical/Abnormal ATRs
The primary outcome of interest is the proportion of sub-critical/abnormal (Level 3 Laboratory and Level 2 Cardiology) ATRs documented as acknowledged by the responsible clinician and having appropriate, follow-up action(s).
Measured: Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert
Secondary outcomes (2)
Diagnosis and/or Treatment Delays
The frequency of delays to diagnoses and/or treatment of conditions of interest
Measured: Minumum of 3 months post ATR
Undiagnosed/Untreated Condition Frequency and Severity
The frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.
Measured: Minumum of 3 months post ATR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Actionable Test Results (ATRs)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jeffrey Rothschild, MD, Brigham and Women's Hospital
- Investigators
- Jeffrey Rothschild, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385982
- Sponsor's protocol ID
- 2011P000035
- Other IDs
- 1R18HS019603-01
- Acronym
- OutptATR
- Status last verified
- Jan 2016
- First submitted
- 29 Jun 2011
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Management of Outpatient Actionable Test Results
- ClinicalTrials.gov ID
- NCT01385982
- Acronym / sponsor ID
- OutptATR / 2011P000035
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jun 2011 (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.
Clinically significant test results require timely clinician follow-up including the non-urgent clinically significant, or actionable, test results that have received less standardized management and attention. Unfortunately, failure to correctly manage actionable test results is not infrequent and may be associated with important delays in diagnosis and treatment and patient harm. The investigators have designed a safe practice intervention to improve the management of actionable test results for ambulatory patients in a large healthcare system.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actionable Test Results | Other | Other: Actionable Test Result Management/StandardizationCreating standardized policies and procedures around actionable test results (ATR) management, and implementing them network-wide: 1. Defining the levels of severity and urgency for clinically significant test results 2. Network-wide policy for test result follow-up by the responsible providers, documentation and escalation processes to assure timely communication. 3. Standardized policies for the time frames and nature of communication of test result alerts. 4. Establish criteria for appropriate ATR management by the responsible provider. 5. Feedback performance including provider, practice and service report cards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care physicians will be enrolled in the study by virtue of being an actively practicing clinician in an PHS ambulatory practice, and having at least one patient with a diagnostic test included in the PHS CCSTR intervention. The patient population will consist of adult patients >17 years of age with diagnostic tests in the affiliated ambulatory practices of PHS. Patients will be recruited into the study by a review of electronic medical record data to identify patients with a diagnostic test specified in the PHS CCSTR intervention.
Key exclusion criteria (1 listed)
- Participants who do not meet the inclusion/eligibility requirements will be excluded.
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 |
|---|---|---|
| Actionable Test Result Management/StandardizationThe intervention includes enterprise-wide standardization of actionable test result (ATR) definitions with stratification of significant results into alert levels, expected timeframes for clinician responses, a set of policies for ATR follow-up, metrics to measure ATR management and performance feedback. | Other | Actionable Test Results |
Primary outcome
Acknowledged Sub-Critical/Abnormal ATRs
Time frame: Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert
The primary outcome of interest is the proportion of sub-critical/abnormal (Level 3 Laboratory and Level 2 Cardiology) ATRs documented as acknowledged by the responsible clinician and having appropriate, follow-up action(s).
2 secondary outcomes
Diagnosis and/or Treatment Delays
Time frame: Minumum of 3 months post ATR
Undiagnosed/Untreated Condition Frequency and Severity
Time frame: Minumum of 3 months post ATR
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 18 Jan 2016.
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.
Jeffrey Rothschild, M.D. principal investigator
Brigham and Women's Hospital
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 Actionable Test Result Management/Standardization in people with Management of Actionable Test Results (ATRs), run by Brigham and Women's Hospital 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 18 Jan 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.
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 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?
Acknowledged Sub-Critical/Abnormal ATRs (time frame: Acknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alert). 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 18 Jan 2016.