NCT01792544

Brief Summary

This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,706

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

February 12, 2013

Last Update Submit

April 26, 2016

Conditions

Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Inappropriate follow-up

    Performance of a follow-up echocardiogram when it was not indicated or not performing for a follow-up echocardiogram when it was indicated.

    1 year

Study Arms (2)

Statement

EXPERIMENTAL

A statement is added to the echocardiography report describing if and when a follow-up echocardiogram is recommended. The statement may be positive (e.g. follow-up recommended in 6 months) or negative (e.g. no follow-up recommended).

Other: Statement

No Statement

EXPERIMENTAL

No statement is added to the echocardiography report

Other: No Statement

Interventions

StatementOTHER
Statement
No StatementOTHER
No Statement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto HCS

Palo Alto, California, 94304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Study Completion

July 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(1)