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Improving Management of Outpatient Actionable Test Results (OutptATR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01385982
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : January 18, 2016
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jeffrey Rothschild, MD, Brigham and Women's Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Management of Actionable Test Results (ATRs) Other: Actionable Test Result Management/Standardization Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Management of Outpatient Actionable Test Results
Study Start Date : July 2011
Primary Completion Date : September 2012
Study Completion Date : January 2013

Arm Intervention/treatment
Actionable Test Results

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
Other: Actionable Test Result Management/Standardization
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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Diagnosis and/or Treatment Delays [ Time Frame: Minumum of 3 months post ATR ]
    The frequency of delays to diagnoses and/or treatment of conditions of interest

  2. Undiagnosed/Untreated Condition Frequency and Severity [ Time Frame: Minumum of 3 months post ATR ]
    The frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

Participants who do not meet the inclusion/eligibility requirements will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01385982

United States, Massachusetts
Partners Healthcare
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Jeffrey Rothschild, M.D. Brigham and Women's Hospital

Responsible Party: Jeffrey Rothschild, MD, Hospitalist, Brigham and Women's Hospital Identifier: NCT01385982     History of Changes
Other Study ID Numbers: 2011P000035
1R18HS019603-01 ( U.S. AHRQ Grant/Contract )
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016