NCT02915068

Brief Summary

The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

September 20, 2016

Last Update Submit

September 13, 2017

Conditions

Keywords

patient-provider communicationElectronic Health RecordsProvider education

Outcome Measures

Primary Outcomes (1)

  • Change from baseline patient report of physician performance at 3 and 6 months

    The patient's report of physician performance will be used as the key measure in this study. They will use a validated instrument previously developed by the research group in the PACE trials, focusing on clinical practices of the clinician, especially, use of National Asthma Education and Prevention Program recommended therapies, communication and counseling behaviors specially related to EHR use.

    baseline, 3 months, 6 months

Secondary Outcomes (3)

  • Change from baseline patient satisfaction at 3 and 6 months

    baseline, 3 months, 6 months

  • Change from baseline asthma control at 3 and 6 months

    baseline, 3 months, 6 months

  • Change from baseline asthma-related quality of life at 3 and 6 months

    baseline, 3 months, 6 months

Study Arms (2)

Control

NO INTERVENTION

Physicians do not receive focused education and training on patient-centered communication with the EHR

EHR-PACE

EXPERIMENTAL

participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).

Behavioral: EHR-Physician Asthma Care Education Program

Interventions

participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).

EHR-PACE

Eligibility Criteria

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

You may qualify if:

  • Physicians:
  • Licensed physician in practice and board certified in primary care or family medicine
  • Treating adults with asthma
  • Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year
  • Consent to participate
  • Patients:
  • Treated by the participating physician during the study intake period
  • years of age or older
  • Have a diagnosis of asthma made by a physician using the National Asthma Education and Prevention Program Guidelines
  • Have at least one urgent medical care visit for asthma in the previous year
  • Have access to a telephone
  • Consent to participate

You may not qualify if:

  • Patients:
  • \. Have other chronic disorders that have pulmonary complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Health Associates ClinSite Research

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Minal R Patel, PhD, MPH

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 26, 2016

Study Start

June 1, 2015

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations