Completed

NCT Number: NCT01385982

Improving Management of Outpatient Actionable Test Results

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.

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Key information

Conditions

Management of Actionable Test Results (ATRs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Partners Healthcare

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actionable Test Result Management/Standardization

Other

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 outcomes

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 outcomes

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
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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: OutptATR

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Jun 30, 2011
Registry last updated: Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.