Clinical DocumentationNOTENCT04333238
Notation Optimization Through Template Engineering
A study testing New progress note template and Standard progress note template in people with Clinical Documentation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinical Documentation
- What is being tested?
- New progress note template and Standard progress note template
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents who had open visit slots during their outpatient clinic time
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Clinical Documentation
- Being tested
- New progress note template, Standard progress note template
- Keywords
- Progress note, Note template, Electronic medical record, Note quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New progress note templateOther
Residents assigned to document with new progress note template
Standard progress note templateOther
Residents assigned to document with standard progress note template
| Study group | Role | What they receive |
|---|---|---|
| Standard template | Active comparator | Usual outpatient progress note with standard Subjective Objective Assessment Plan (SOAP) format Receives: 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 Receives: Other: New progress note template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Note length
Note length in line count.
Measured: Duration of note entry, up to 2 hours
Time to note completion
Time to note completion in minutes.
Measured: 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.
Measured: 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.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start20 Jan 2017
- Primary completion26 Apr 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical DocumentationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy A Epstein, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333238
- Sponsor's protocol ID
- IRB00117171
- Acronym
- NOTE
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is no sensitive or protected information. I am able to share any aspect of this trial to whomever would like to know more.
Publications
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.
PubMed 32901441
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Notation Optimization Through Template Engineering
- ClinicalTrials.gov ID
- NCT04333238
- Acronym / sponsor ID
- NOTE / IRB00117171
- Conditions
- Clinical Documentation
- Keywords
- Progress note, Note template, Electronic medical record, Note quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard template | Active comparator | Other: Standard progress note templateUsual outpatient progress note with standard Subjective Objective Assessment Plan (SOAP) format |
| New template | Experimental | Other: New progress note templateThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents who had open visit slots during their outpatient clinic time
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New progress note templateResidents assigned to document with new progress note template | Other | New template |
| Standard progress note templateResidents assigned to document with standard progress note template | Other | Standard template |
Primary outcome
Note length
Time frame: Duration of note entry, up to 2 hours
Note length in line count.
Time to note completion
Time frame: Duration of note entry, up to 2 hours
Time to note completion in minutes.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 32901441Epstein 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.
- Individual participant dataSharing planned: Yes. There is no sensitive or protected information. I am able to share any aspect of this trial to whomever would like to know more.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy A Epstein, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New progress note template and Standard progress note template in people with Clinical Documentation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Note length (time frame: Duration of note entry, up to 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.