Educational Intervention to Increase Physician Satisfaction and Effectiveness With a New Electronic Health Record

May 27, 2021 updated by: The Reading Hospital and Medical Center

Interventions to Increase Physician Effectiveness and Acceptance of a Electronic Health Record System

This study was intended to test the effects of adding a one-on-one educational intervention taught by a physician to a physician during their clinical work to improve their acceptance and satisfaction with a new inpatient electronic health record and ordering system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was a randomized, parallel , non- blinded controlled trial of real-time, focused educational interventions in an intervention arm compared with usual training and support in the control arm. Improvement in performance, defined as the time between opening and closing a progress note, and number of notes completed after shift , were the primary outcomes. Physician satisfaction was a secondary outcome. Participants from one 550-bed Academic Independent Medical Center were invited to participate if they were full-time hospitalists or residents in internal medicine with no prior experience with the EPIC electronic health record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19612
        • Reading Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Internal Medicine physicians and resident physicians with inpatient clinical duties at the time of the EPIC electronic health record go-live (Feb 4, 2013)

Exclusion Criteria:

  • Physicians whose duties did not include regular admissions and discharge of patients
  • Physicians whose work was limited to teaching
  • Physicians with prior experience in using EPIC systems for inpatient care .
  • Physician assistants and nurse practitioners

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One-on-one physician training
One-on-one physician training Physicians in the experimental arm were visited by a instructing physician at a computer while performing clinical duties who had observed others to identify best practices. Instructors watched subjects' work, looking for a specific tip that could be applied to the current work, then demonstrated the tip, and answered any questions the subject had about using or applying this new technique .
Other: One-on-one physician training
Physicians in the experimental arm were visited by a instructing physician at a computer while performing clinical duties who had observed others to identify best practices. Instructors watched subjects' work, looking for a specific tip that could be applied to the current work, then demonstrated the tip, and answered any questions the subject had about using or applying this new technique .
Other: Usual training
Usual training included online e-modules, 12 hours of classroom time, practice in the EPIC Playground, user acceptability training classes,non-physician technical support on all of the floors, and a physician-only help line.
Active Comparator: Usual training
Usual training. This group will get the usual specified training for learning to use our electronic health record. Both groups received 12 hours of EPIC classroom training, exposure to the EPIC e-learning modules, user acceptability testing classes, and unlimited time on the EPIC 'playground', a site to practice on virtual patients. All had 90 days of elbow support with an EPIC-training non-physician technician, who were visible and available on all inpatient wards, as well as access to a physician-only support line available at all hours.
Other: Usual training
Usual training included online e-modules, 12 hours of classroom time, practice in the EPIC Playground, user acceptability training classes,non-physician technical support on all of the floors, and a physician-only help line.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to complete a progress note
Time Frame: within 1 week of note completion
the primary outcome measure will be time to complete a progress note. this is defined as the difference between the recorded time of opening the note and the recorded time the note was signed in the EPIC electronic health record system.
within 1 week of note completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of notes completed after shift
Time Frame: within 1 week of posting note
Shifts are 7 a.m. - 7 p.m for doctors assigned to daytime work. We defined a note completed after shift as any note with a signed time that is after 7 p.m. on the day of a shift worked.
within 1 week of posting note
Physician Satisfaction with EPIC Electronic Health Record
Time Frame: at baseline, 15-20 shifts, and 35-40 shifts

We asked the participants this question:

How comfortable are you specifically using the EPIC program for inpatient practice?" at baseline, midpoint (after working 15-20 shifts), and end of the study (after working 35-40 shifts).
at baseline, 15-20 shifts, and 35-40 shifts

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Reading Hospital and Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leena Jalota, MBBS, Reading Health System
  • Study Director: Anthony A Donato, MD MHPE, Reading Health System

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ReadingHMC-IRB-045-12

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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