Electronic Health Record (EHR) Decision Support to Improve Outpatient Asthma Care

NCT ID: NCT00918944

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After receiving a standardized education module based on NAEPP guidelines, 12 primary care pediatric practices (both urban and suburban sites) will be randomized to receive either a passive EHR (control sites) or an interactive decision support system (intervention sites).

The primary outcome of interest will be the proportion of patients on appropriate asthma controller medication compared over time. Secondary outcomes include the proportion of asthma patients with: 1) an updated asthma action plan 2) documentation of spirometry performed (6 to 17 yrs) and 3) an updated problem list reflecting current asthma severity. After hours calls to providers and types of office visits related to asthma will be tracked. 4) In addition, measurement of asthma-related quality of life and missed school and work in a sample of 200 subjects from each group will be performed. Contextual factors at the clinic and patient level will be examined to assess their association with outcomes of interest.

If shown to be successful, this type of clinical decision support, embedded within the EHR, has the potential to be a powerful tool to improve the implementation of asthma guidelines and clinical practice guidelines for other conditions and illnesses in the primary setting.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

clinical decision support tool electronic health record control tool spirometry quality of life survey provider survey

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control arm

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

Group Type OTHER

Control

Intervention Type OTHER

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

Intervention arm

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

Group Type OTHER

Intervention

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control

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

Intervention Type OTHER

Intervention

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 Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Known patients with asthma

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis M Bell, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-11-4596

Identifier Type: -

Identifier Source: org_study_id