- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06641063
Impact of a Standardized Obstetrics Note Template
Examining the Impact of a Standardized Obstetrics Note Template on Provider Satisfaction, Efficiency, and Perceived Comprehensiveness
Study Overview
Status
Conditions
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:
o 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:
o 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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New York
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Flushing, New York, United States, 11355
- Recruiting
- Flushing Hospital Medical Center
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Contact:
- Paul-Ann Green, MD
- Phone Number: 718-670-5000
- Email: pgreen@jhmc.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare providers (physicians, nurse practitioners, physician assistants) at Flushing Hospital Medical Center
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in self-reported effort taken to review and document prenatal notes
Time Frame: From baseline to 3-months
|
From baseline to 3-months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2223670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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