Improving Management of Outpatient Actionable Test Results

Phase 3

Completed

• Conditions: Management of Actionable Test Results (ATRs)
• Interventions: Other: Actionable Test Result Management/Standardization

• Registration Number: NCT01385982
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-07
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Actionable Test Results	Actionable Test Result Management/Standardization	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

Primary Outcome Measures

Name	Time	Method
Acknowledged Sub-Critical/Abnormal ATRs	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

Name	Time	Method
Undiagnosed/Untreated Condition Frequency and Severity	Minumum of 3 months post ATR	The frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.
Diagnosis and/or Treatment Delays	Minumum of 3 months post ATR	The frequency of delays to diagnoses and/or treatment of conditions of interest

Trial Locations

Locations (1)

Partners Healthcare; 🇺🇸 Boston, Massachusetts, United States