Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room

September 13, 2017 updated by: Minal Patel, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Failure in clinician-patient communication, lack of clarity regarding clinical treatment priorities, and more recently, ineffective use of health IT systems in exam rooms are associated with deficits in achieving chronic disease management goals, and increased healthcare utilization and costs. Strategies for communicating with patients in exam rooms in the presence of electronic health records (EHR) have been described in the literature. Whether such strategies are reaching clinicians and demonstrating positive health outcomes is unclear. The investigators propose to develop and test the feasibility on patient outcomes of an interactive training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). They 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 PACE program is based on concepts and skills for strengthening communication and patient-clinician relationships through behavior change principles that are highly applicable to patients with asthma and has potential for specific application to EHR use in clinical practice. 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.

EHR-PACE developed in this study is expected to have a high degree of relevance for improving the patient-provider communication skills of clinicians who see a wide range of patients in a variety of practice settings that have now integrated EHRs. Given that PACE can achieve dramatic outcomes within only two, 2-hour sessions, EHR-PACE has the potential to become an invaluable training tool to busy clinicians if proven feasible and effective. Ultimately, this work has potential for a high degree of impact.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Integrated Health Associates ClinSite Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Physicians:

  1. Licensed physician in practice and board certified in primary care or family medicine
  2. Treating adults with asthma
  3. Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year
  4. Consent to participate
  5. Will generate a roster of adult asthma patients for inclusion in the study

Patients:

  1. Treated by the participating physician during the study intake period
  2. 18 years of age or older
  3. Have a diagnosis of asthma made by a physician using the National Asthma Education and Prevention Program Guidelines
  4. Have at least one urgent medical care visit for asthma in the previous year
  5. Have access to a telephone
  6. Consent to participate

Exclusion Criteria:

Patients:

1. Have other chronic disorders that have pulmonary complications

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Physicians do not receive focused education and training on patient-centered communication with the EHR
Experimental: EHR-PACE
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline patient report of physician performance at 3 and 6 months
Time Frame: baseline, 3 months, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline patient satisfaction at 3 and 6 months
Time Frame: baseline, 3 months, 6 months
specific facets of satisfaction with care adapted from the widely used Patient Satisfaction Questionnaire, especially as it relates to interactions with clinicians in the presence of EHRs in the exam room
baseline, 3 months, 6 months
Change from baseline asthma control at 3 and 6 months
Time Frame: baseline, 3 months, 6 months
the Asthma Control Test (ACT), a valid measure responsive to changes in asthma control over time
baseline, 3 months, 6 months
Change from baseline asthma-related quality of life at 3 and 6 months
Time Frame: baseline, 3 months, 6 months
Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), a 15-item validated instrument that assesses physical, emotional, and social well-being of adults with asthma through four domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli).
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Minal R Patel, PhD, MPH, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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