Improving Management of Outpatient Actionable Test Results (OutptATR)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Rothschild, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01385982
First received: June 29, 2011
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Management of Outpatient Actionable Test Results

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Diagnosis and/or Treatment Delays [ Time Frame: Minumum of 3 months post ATR ] [ Designated as safety issue: No ]
    The frequency of delays to diagnoses and/or treatment of conditions of interest

  • Undiagnosed/Untreated Condition Frequency and Severity [ Time Frame: Minumum of 3 months post ATR ] [ Designated as safety issue: No ]
    The frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.


Estimated Enrollment: 6000
Study Start Date: July 2011
Estimated Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385982

Locations
United States, Massachusetts
Partners Healthcare
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jeffrey Rothschild, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jeffrey Rothschild, MD, Hospitalist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01385982     History of Changes
Other Study ID Numbers: 2011P000035, 1R18HS019603-01
Study First Received: June 29, 2011
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014