Notation Optimization Through Template Engineering (NOTE)

March 15, 2023 updated by: Johns Hopkins University
This is a randomized non-blinded controlled trial of a standard note template versus a redesigned note template using a simulated patient encounter and the electronic medical record.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Residents documented the simulated patient encounter using one of two templates. The standard template was based on the usual outpatient progress note. The new template placed the assessment and plan section in the beginning, grouped subjective data into the assessment section, and deemphasized elements not related to the current presentation.

Study Type

Interventional

Enrollment (Actual)

36

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Outpatient Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents who had open visit slots during their outpatient clinic time

Exclusion Criteria:

  • None

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
Intervention / Treatment
Active Comparator: Standard template
Usual outpatient progress note with standard Subjective Objective Assessment Plan (SOAP) format
Other: Standard progress note template
Residents assigned to document with standard progress note template
Experimental: New template
The assessment and plan section is placed in the beginning, subjective data grouped into the assessment section, and elements not related to the current presentation were deemphasized
Other: New progress note template
Residents assigned to document with new progress note template

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Note length
Time Frame: Duration of note entry, up to 2 hours
Note length in line count.
Duration of note entry, up to 2 hours
Time to note completion
Time Frame: Duration of note entry, up to 2 hours
Time to note completion in minutes.
Duration of note entry, up to 2 hours
Note evaluation by authors using a likert scale
Time Frame: Immediately after note entry, up to 1 hour
Likert-scale survey instrument evaluating perceived organization, structure, and efficiency of note.
Immediately after note entry, up to 1 hour
Note evaluation by reviewers using the Physician Documentation Quality Instrument
Time Frame: Within 1 year
Physician Documentation Quality Instrument (PDQI-9) - validated note quality scale composed of 9 metrics. 1 is not at all. 5 is extremely.
Within 1 year

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Jeremy A Epstein, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 20, 2017

Primary Completion (Actual)

April 26, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00117171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is no sensitive or protected information. I am able to share any aspect of this trial to whomever would like to know more.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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