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Improving Management of Outpatient Actionable Test Results

Improving Management of Outpatient Actionable Test Results

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01385982
Acronym
OutptATR
Enrollment
6000
Registered
2011-06-30
Start date
2011-07-31
Completion date
2013-01-31
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of Actionable Test Results (ATRs)

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.

Interventions

OTHERActionable 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.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Acknowledged Sub-Critical/Abnormal ATRsAcknowledgement within 15 business days from the Level 3 Laboratory ATR alert and acknowledgement within 8 business hours of the cardiology Level 2 ATR alertThe 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

MeasureTime frameDescription
Diagnosis and/or Treatment DelaysMinumum of 3 months post ATRThe frequency of delays to diagnoses and/or treatment of conditions of interest
Undiagnosed/Untreated Condition Frequency and SeverityMinumum of 3 months post ATRThe frequency and severity of undiagnosed or untreated conditions of interest that occur during the study period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026