NCT00918944

Brief Summary

To determine whether an innovative clinical decision support system embedded in an existing electronic health record (EHR) will improve provider adherence to the existing National Asthma Education and Prevention Program (NAEPP) guidelines. 12 primary care pediatric practices at The Children's Hospital of Philadelphia(both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable asthma

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

January 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

3.5 years

First QC Date

June 9, 2009

Last Update Submit

December 22, 2011

Conditions

Asthma

Keywords

clinical decision support toolelectronic health recordcontrol toolspirometryquality of life surveyprovider survey

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the proportion of persistent asthmatic patients with at least one prescription for a controller medication in each period. There are two periods of study: baseline and intervention.

    6 months

Secondary Outcomes (1)

  • Secondary outcomes include the proportion of persistent asthmatic patients with 1)an updated asthma action plan, 2)spirometry as needed 3)problem list with current asthma severity 4)asthma-related quality of life scores 5)absent school and work days.

    6 months

Study Arms (2)

Control arm

OTHER

Practices with the EHR implemented will be randomized have the asthma disease management tools available passively (the control group).

Other: Control

Intervention arm

OTHER

The intervention sites will have decision support alerts and reminders activated to guide providers toward these tools in the appropriate situations.

Other: Intervention

Interventions

ControlOTHER

The asthma disease management toolkit available to all practices in the EHR will consist of four elements: * A data entry tool for capturing asthma control data * Standardized documentation templates to facilitate severity classification * Order sets to facilitate ordering controller medications * An asthma care plan that can be supplied to families

Control arm
InterventionOTHER

Three alerts and two reminders will be programmed: * Alert providers to enter asthma severity classification if none is on file * Alert providers to prescribe controller medications for persistent asthma if none on file * Alert providers to complete an asthma care plan if none on file * Remind providers to review the asthma care plan if it is already on file by providing a link to the form * Remind providers that educational content is available on-line by providing a web link

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • Known patients with asthma

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Methods

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Louis M Bell, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

January 1, 2006

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

US(1)