NCT04333238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

January 20, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
Last Updated

March 17, 2023

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

March 29, 2020

Last Update Submit

March 15, 2023

Conditions

Keywords

Progress noteNote templateElectronic medical recordNote quality

Outcome Measures

Primary Outcomes (4)

  • Note length

    Note length in line count.

    Duration of note entry, up to 2 hours

  • Time to note completion

    Time to note completion in minutes.

    Duration of note entry, up to 2 hours

  • Note evaluation by authors using a likert scale

    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

    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

Study Arms (2)

Standard template

ACTIVE COMPARATOR

Usual outpatient progress note with standard Subjective Objective Assessment Plan (SOAP) format

Other: Standard progress note template

New template

EXPERIMENTAL

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

Interventions

Residents assigned to document with new progress note template

New template

Residents assigned to document with standard progress note template

Standard template

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Epstein JA, Cofrancesco J Jr, Beach MC, Bertram A, Hedian HF, Mixter S, Yeh HC, Berkenblit G. Effect of Outpatient Note Templates on Note Quality: NOTE (Notation Optimization through Template Engineering) Randomized Clinical Trial. J Gen Intern Med. 2021 Mar;36(3):580-584. doi: 10.1007/s11606-020-06188-0. Epub 2020 Sep 8.

Study Officials

  • Jeremy A Epstein, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 3, 2020

Study Start

January 20, 2017

Primary Completion

April 26, 2017

Study Completion

December 1, 2018

Last Updated

March 17, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL

Locations