Improving Management of Outpatient Actionable Test Results (OutptATR)

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 Overview

• Status: Completed
• Conditions: Management of Actionable Test Results (ATRs)
• Intervention / Treatment: Other: Actionable Test Result Management/Standardization

• Study Type: Interventional
• Enrollment (Actual): 6000
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Partners HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Actionable Test Results; Creating standardized policies and procedures around actionable test results (ATR) management, and implementing them network-wide: Defining the levels of severity and urgency for clinically significant test results; Network-wide policy for test result follow-up by the responsible providers, documentation and escalation processes to assure timely communication.; Standardized policies for the time frames and nature of communication of test result alerts.; Establish criteria for appropriate ATR management by the responsible provider.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis and/or Treatment Delays	The frequency of delays to diagnoses and/or treatment of conditions of interest	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.	Minumum of 3 months post ATR

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Jeffrey Rothschild, M.D., Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2011P000035; 1R18HS019603-01 (U.S. AHRQ Grant/Contract)