ObstetricsNCT06641063
Impact of a Standardized Obstetrics Note Template
An observational study of Obstetrics, run by MediSys Health Network at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a new standardized obstetrics note template on the quality, efficiency, and provider-perceived comprehensiveness of clinical documentation in a healthcare setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstetrics
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 20 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare providers (physicians, nurse practitioners, physician assistants) at Flushing Hospital Medical Center
Who may be able to join
- Healthcare providers (physicians, nurse practitioners, physician assistants) at Flushing Hospital Medical Center
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Flushing Hospital Medical Center
Flushing, New York, 11355
Paul-Ann Green, MD, 718-670-5000, pgreen@jhmc.org
About this study
Official title: Examining the Impact of a Standardized Obstetrics Note Template on Provider Satisfaction, Efficiency, and Perceived Comprehensiveness
The purpose of this study is to evaluate the effectiveness of a new standardized obstetrics note template on the quality, efficiency, and provider-perceived comprehensiveness of clinical documentation in a healthcare setting. The investigators aim to determine whether implementing standardized templates improves the completeness, clarity, and accuracy of clinical notes while reducing the time required for healthcare providers to review and document patient encounters.
Read the detailed description
Clinical documentation is a critical component of patient care, influencing communication among healthcare providers, continuity of care, and overall patient outcomes. Variability in note writing can lead to incomplete or unclear documentation, which may compromise patient safety. Standardized note writing templates have the potential to enhance the quality and efficiency of clinical documentation as well as improve overall provider satisfaction. Research has shown that structured documentation can improve provider efficiency and decrease documentation time. However, little is studied about the implementation of standardized prenatal care visit notes and provider perception of the comprehensiveness of prenatal care and provider satisfaction.
The investigators' study aims to evaluate pre- and post-intervention comparison of questionnaire responses to evaluate changes in the perceived quality and efficiency of clinical documentation. Questionnaires are good for gathering data about abstract ideas or concepts that are otherwise difficult to quantify, such as opinions, attitudes and beliefs. A baseline survey on the current feelings in regards to documentation practices will be collected, followed by the implementation of standardized note writing templates. Post-intervention surveys of the residents will then be gathered to assess the impact of the templates. To ensure an accurate assessment of stakeholders, a response rate of at least 60% (at least 7) is recommended.
This is a pilot longitudinal 4-timepoint panel design monthly survey of Post Graduate Year (PGY)1-4 Obstetrics and Gynecology (OBGYN) residents. The goal of this project is to provide a quality improvement evaluation of the benefits of a new standardized note template for prenatal care visits. Online surveys will be delivered via the Qualtrics survey platform to all residents in the Flushing Hospital Medical Center (FHMC) OBGYN residency program over the course of a 3 month quality improvement initiative. Data will be collected at baseline (immediately prior to the implementation of the note template), 1-month, 2-months, and 3-months.
Primary Outcomes:
- Reduce provider effort in reviewing and documenting prenatal records
- Improve standardization of the documentation and review of prenatal records
- Decrease the time to review patient charts for patient encounters.
Secondary Outcomes:
- Increase confidence in the comprehensiveness of prenatal records
- Increase confidence in the accuracy of prenatal records
- Increase provider satisfaction with the process of reviewing and documenting prenatal records
Procedures:
- Baseline Data Collection:
- The baseline survey will be administered to all residents prior to implementation of the standardized note template.
- Intervention:
- A training session for all healthcare providers on how to use the standardized templates will be provided during noon conference following baseline survey administration and prior to day one of implementation.
- The template will be implemented for a predefined period of 3 months, during which the template will be used by all residents for all prenatal encounters.
- Intervention Evaluation Data Collection:
- Monthly survey administration will occur during noon-conference during the implementation period at 1-month, 2-months, and 3-months post implementation. The survey will be delivered online via Qualtrics and made accessible to residents during noon-conference via Quick Response (QR) codes and survey links.
- Data Management and Analysis:
- After data collection, all survey responses will be immediately de-identified and assigned a unique subject identifier. Subjects will be identified only based on this number and not based on any other personal information or demographic characteristic.
- To test our primary hypotheses, the investigators will conduct a series of unadjusted and adjusted (i.e., controlling for training year) repeated measures Analysis of Variances (ANOVAs) to evaluate change over time in provider effort, time, confidence, and satisfaction.
- All analyses will be conducted using Statistical Analysis System (SAS) 9.4 and an alpha level of < .05 will denote statistical significance.
Potential Risks and Benefits:
- Risks: There are minimal risks associated with this study. Participants may experience a learning curve while adapting to the new templates, which could temporarily affect their documentation time.
- Benefits: The study may demonstrate improvements in clinical documentation quality and efficiency, ultimately enhancing patient care and provider satisfaction.
Confidentiality: All data collected will be de-identified to protect participant confidentiality. Data will be stored securely and only accessible to the research team.
Informed Consent: Informed consent will be obtained from all participants prior to their inclusion in the study. Participants will be informed about the study's purpose, procedures, risks, and benefits.
- Conditions
- Obstetrics
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-reported effort taken to review and document prenatal notes
Measured: From baseline to 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Sep 2024
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricsStudies of the same condition, open and under way.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediSys Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641063
- Sponsor's protocol ID
- 2223670
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of a Standardized Obstetrics Note Template on Provider Satisfaction, Efficiency, and Perceived Comprehensiveness
- ClinicalTrials.gov ID
- NCT06641063
- Acronym / sponsor ID
- 2223670
- Conditions
- Obstetrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MediSys Health NetworkUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
The purpose of this study is to evaluate the effectiveness of a new standardized obstetrics note template on the quality, efficiency, and provider-perceived comprehensiveness of clinical documentation in a healthcare setting. The investigators aim to determine whether implementing standardized templates improves the completeness, clarity, and accuracy of clinical notes while reducing the time required for healthcare providers to review and document patient encounters.
Detailed description
Clinical documentation is a critical component of patient care, influencing communication among healthcare providers, continuity of care, and overall patient outcomes. Variability in note writing can lead to incomplete or unclear documentation, which may compromise patient safety. Standardized note writing templates have the potential to enhance the quality and efficiency of clinical documentation as well as improve overall provider satisfaction. Research has shown that structured documentation can improve provider efficiency and decrease documentation time. However, little is studied about the implementation of standardized prenatal care visit notes and provider perception of the comprehensiveness of prenatal care and provider satisfaction.
The investigators' study aims to evaluate pre- and post-intervention comparison of questionnaire responses to evaluate changes in the perceived quality and efficiency of clinical documentation. Questionnaires are good for gathering data about abstract ideas or concepts that are otherwise difficult to quantify, such as opinions, attitudes and beliefs. A baseline survey on the current feelings in regards to documentation practices will be collected, followed by the implementation of standardized note writing templates. Post-intervention surveys of the residents will then be gathered to assess the impact of the templates. To ensure an accurate assessment of stakeholders, a response rate of at least 60% (at least 7) is recommended.
This is a pilot longitudinal 4-timepoint panel design monthly survey of Post Graduate Year (PGY)1-4 Obstetrics and Gynecology (OBGYN) residents. The goal of this project is to provide a quality improvement evaluation of the benefits of a new standardized note template for prenatal care visits. Online surveys will be delivered via the Qualtrics survey platform to all residents in the Flushing Hospital Medical Center (FHMC) OBGYN residency program over the course of a 3 month quality improvement initiative. Data will be collected at baseline (immediately prior to the implementation of the note template), 1-month, 2-months, and 3-months.
Primary Outcomes:
- Reduce provider effort in reviewing and documenting prenatal records
- Improve standardization of the documentation and review of prenatal records
- Decrease the time to review patient charts for patient encounters.
Secondary Outcomes:
- Increase confidence in the comprehensiveness of prenatal records
- Increase confidence in the accuracy of prenatal records
- Increase provider satisfaction with the process of reviewing and documenting prenatal records
Procedures:
- Baseline Data Collection:
- The baseline survey will be administered to all residents prior to implementation of the standardized note template.
- Intervention:
- A training session for all healthcare providers on how to use the standardized templates will be provided during noon conference following baseline survey administration and prior to day one of implementation.
- The template will be implemented for a predefined period of 3 months, during which the template will be used by all residents for all prenatal encounters.
- Intervention Evaluation Data Collection:
- Monthly survey administration will occur during noon-conference during the implementation period at 1-month, 2-months, and 3-months post implementation. The survey will be delivered online via Qualtrics and made accessible to residents during noon-conference via Quick Response (QR) codes and survey links.
- Data Management and Analysis:
- After data collection, all survey responses will be immediately de-identified and assigned a unique subject identifier. Subjects will be identified only based on this number and not based on any other personal information or demographic characteristic.
- To test our primary hypotheses, the investigators will conduct a series of unadjusted and adjusted (i.e., controlling for training year) repeated measures Analysis of Variances (ANOVAs) to evaluate change over time in provider effort, time, confidence, and satisfaction.
- All analyses will be conducted using Statistical Analysis System (SAS) 9.4 and an alpha level of < .05 will denote statistical significance.
Potential Risks and Benefits:
- Risks: There are minimal risks associated with this study. Participants may experience a learning curve while adapting to the new templates, which could temporarily affect their documentation time.
- Benefits: The study may demonstrate improvements in clinical documentation quality and efficiency, ultimately enhancing patient care and provider satisfaction.
Confidentiality: All data collected will be de-identified to protect participant confidentiality. Data will be stored securely and only accessible to the research team.
Informed Consent: Informed consent will be obtained from all participants prior to their inclusion in the study. Participants will be informed about the study's purpose, procedures, risks, and benefits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare providers (physicians, nurse practitioners, physician assistants) at Flushing Hospital Medical Center
Key inclusion criteria (1 listed)
- Healthcare providers (physicians, nurse practitioners, physician assistants) at Flushing Hospital Medical Center
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in self-reported effort taken to review and document prenatal notes
Time frame: From baseline to 3-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Obstetrics, run by MediSys Health Network 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in self-reported effort taken to review and document prenatal notes (time frame: From baseline to 3-months). 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 17 Oct 2024.