Quality/Accuracy of Physician DocumentationNCT01958723
Problem Specific Templates for Electronic Hospital Documentation
An observational study of Quality/Accuracy of Physician Documentation and Efficiency of Physician Documentation, run by University of Florida at 1 site in United States.
Trial summary
The emergence of electronic documentation has led to multiple new challenges for physicians. Despite positive expectations, many physicians have received electronic health systems with mixed results. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality/Accuracy of Physician Documentation, Efficiency of Physician Documentation
- What is being tested?
- Hospitalists
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2014
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians of the Hospital Medicine Service
Who may be able to join
- Physicians: All physicians of the Hospital Medicine Service will be invited to participate
Who cannot join
- Any invited physicians who refuse to consent
Trial locations and contacts
1 site in 1 country.
About this study
The emergence of electronic documentation has led to multiple new challenges for physicians. Despite positive expectations, many physicians have received electronic health systems with mixed results. Review of current literature has identified the following reasons for concern: increased time required for documentation, deteriorating quality of notes, mindless use of copy-and-paste functions, and fragmentation of clinical work from poorly designed computing workflows. The study of template use has not been done in a large scale or with clear outcome measurements. The purpose of this study is to examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices.
Read the detailed description
This is a prospective cohort study, which will examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices. The Hospitalist physicians will be the subjects. All physicians of the Hospital Medicine Service will be invited to participate. For the intervention, participating Hospitalists will be trained on the use of templates for 20 common hospital problems. Once trained, the Hospitalists will be asked to use these templates for a one-month period. Pre-intervention and post-intervention medical records will be compared using chart reviews, validated document assessment instruments, physician surveys, and electronic medical record time auditing.
- Being tested
- Hospitalists
- Keywords
- Problem Specific Template, Physician Documentation, Electronic Medical Record Documentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalistsOther
Introduction of Problem Specific Templates
| Study group | Role | What they receive |
|---|---|---|
| Hospitalists | Introduction of Problem Specific Templates Receives: Other: Hospitalists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and Accuracy of Physician Documentation Practices (as measured through chart review)
Measured: 1 year
Efficiency of Physician Documentation Practices (as measured through the electronic medical record auditing function)
Measured: 1 year
Secondary outcomes (2)
Frequency of Physician Use of Problem Specific Templates (as measured through chart review)
Measured: 1 year
Physician Assessment of Note-Documenting and Electronic Medical Record (as measured through Physician Questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality/Accuracy of Physician DocumentationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raj Mehta, M.D., Principal investigator, University of FloridaRobert Leverence, M.D., Study chair, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958723
- Sponsor's protocol ID
- 201300232
- Status last verified
- Apr 2015
- First submitted
- 7 Oct 2013
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Specific Templates for Electronic Hospital Documentation
- ClinicalTrials.gov ID
- NCT01958723
- Acronym / sponsor ID
- 201300232
- Keywords
- Problem Specific Template, Physician Documentation, Electronic Medical Record Documentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- 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.
The emergence of electronic documentation has led to multiple new challenges for physicians. Despite positive expectations, many physicians have received electronic health systems with mixed results. Review of current literature has identified the following reasons for concern: increased time required for documentation, deteriorating quality of notes, mindless use of copy-and-paste functions, and fragmentation of clinical work from poorly designed computing workflows. The study of template use has not been done in a large scale or with clear outcome measurements. The purpose of this study is to examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices.
Detailed description
This is a prospective cohort study, which will examine the effects of Problem Specific Templates on quality, accuracy, and efficiency of physician documentation practices. The Hospitalist physicians will be the subjects. All physicians of the Hospital Medicine Service will be invited to participate. For the intervention, participating Hospitalists will be trained on the use of templates for 20 common hospital problems. Once trained, the Hospitalists will be asked to use these templates for a one-month period. Pre-intervention and post-intervention medical records will be compared using chart reviews, validated document assessment instruments, physician surveys, and electronic medical record time auditing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalists | – | Other: HospitalistsIntroduction of Problem Specific Templates |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians of the Hospital Medicine Service
Key inclusion criteria (1 listed)
- Physicians: All physicians of the Hospital Medicine Service will be invited to participate
Key exclusion criteria (1 listed)
- Any invited physicians who refuse to consent
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 |
|---|---|---|
| HospitalistsIntroduction of Problem Specific Templates | Other | Hospitalists |
Primary outcome
Quality and Accuracy of Physician Documentation Practices (as measured through chart review)
Time frame: 1 year
Efficiency of Physician Documentation Practices (as measured through the electronic medical record auditing function)
Time frame: 1 year
2 secondary outcomes
Frequency of Physician Use of Problem Specific Templates (as measured through chart review)
Time frame: 1 year
Physician Assessment of Note-Documenting and Electronic Medical Record (as measured through Physician Questionnaire)
Time frame: 1 year
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 13 Apr 2015.
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.
Raj Mehta, M.D. principal investigator
University of Florida
Robert Leverence, M.D. study chair
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality/Accuracy of Physician Documentation and Efficiency of Physician Documentation, run by University of Florida 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 13 Apr 2015. 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?
Quality and Accuracy of Physician Documentation Practices (as measured through chart review) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2015.