NCT00789594

Brief Summary

The investigators propose a cluster-randomized controlled trial (RCT) of computerized point-of-care alerts in the EHR to prevent errors related to laboratory monitoring at the initiation and continuation of drug therapy and a results management system to prevent errors related to the delay in follow-up of abnormal laboratory testing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

November 11, 2008

Last Update Submit

September 19, 2012

Conditions

Healthy

Keywords

MonitoringTestingMedicationsPatients receiving medications and having laboratory tests

Outcome Measures

Primary Outcomes (1)

  • Laboratory Monitoring

    6-months

Secondary Outcomes (1)

  • Result management

    6-months

Study Arms (4)

Laboratory Monitoring

EXPERIMENTAL

Laboratory Monitoring

Behavioral: laboratory monitoring alerts

Result management

EXPERIMENTAL

Result management

Behavioral: Result management module

Both interventions

EXPERIMENTAL

Both laboratory monitoring and result management interventions

Behavioral: laboratory monitoring alertsBehavioral: Result management module

Usual care

NO INTERVENTION

Usual care

Interventions

laboratory monitoring alertsBEHAVIORAL

laboratory monitoring alerts

Both interventionsLaboratory Monitoring
Result management moduleBEHAVIORAL

Result management module

Both interventionsResult management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving care from clinicians at primary care and adult internal medicine specialty practices

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Study Officials

  • Steven R Simon, MD

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

March 1, 2013

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

US(1)