Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615843
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GYNAB
Brief Summary:
The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up Conducted by Drs Laëtitia CAMPIN and Louis MARCELLIN at Hôpital Cochin it is sponsored by Assistance Publique - Hôpitaux de Paris The main objective is to assess patient satisfaction at day 7 on a scale from 0 to 10 considering symptom management follow-up quality and task performance Secondary objectives include comparing satisfaction at day 28 PROM-ED scores for symptom relief understanding reassurance and care planning at days 7 and 28 hospitalization rates unscheduled consultations surgical interventions total hospital time by day 28 and physician satisfaction at 28 days This randomized trial involves women aged 18-60 needing follow-up for conditions like genital infections non-complicated ectopic pregnancies unlocated pregnancy first trimester metrorrhagia miscarriages and severe vomiting before 12 weeks Inclusion criteria are women aged 18-60 needing specified follow-up Exclusion criteria are severe clinical intolerance severe criteria ultrasound findings non-French speakers and inability to use digital applications The intervention group uses a connected health app for data collection and communication logging symptoms and test results with medical team notifications for urgent updates The control group receives traditional in-person follow-up with scheduled consultations and emergency contact information The study hypothesizes that digital follow-up will improve patient experience reduce hospital visits and provide comparable or superior satisfaction and clinical outcomes The results could promote broader digital health adoption in various medical fields
Detailed Description:
Scientific Justification
Emergency gynecological consultations are frequent reasons for hospital visits Some clinical situations require scheduled follow-up to assess the progression of the initial condition through targeted questioning and additional tests such as blood work or pelvic ultrasounds Digital health platforms utilizing AI algorithms have proven valuable in telehealth appointment scheduling personalized care and prevention These platforms allow secure asynchronous follow-up potentially enhancing patient experience and reducing unnecessary hospital visits
Platform Capabilities The secure platforms offer features like messaging video consultations document scanning smart medical note-taking shared medical records structured questionnaires and automatic extraction of standardized medical information from consultations lab results and other medical documents Using machine learning these platforms assist in structuring medical decisions while enabling patients to be active participants in their care
Evaluation Criteria
Post-emergency gynecological follow-up is not standardized Iterative unscheduled emergency visits can indicate poor care quality though repeated scheduled visits are sometimes necessary for follow-up and not indicative of poor quality Patient satisfaction measured using validated tools like PROMs Patient-Reported Outcome Measures is a useful criterion for evaluating care quality PROMs are increasingly used to assess healthcare quality and patient management and their digitized secure and easily accessible formats allow efficient and standardized data collection
PROM-ED Questionnaire
A validated Canadian PROM-ED questionnaire evaluates patient experiences and satisfaction with emergency care focusing on symptom relief understanding reassurance and care planning This standardized tool is appropriate for evaluating satisfaction with emergency gynecological care
Hypothesis
We hypothesize that dematerialized follow-up using a connected health app will improve patient experience reduce hospital visits and lower hospitalization rates compared to traditional follow-up
Primary Objective
Compare overall patient satisfaction between dematerialized post-emergency follow-up at home using a health app and traditional in-person follow-up at the hospital seven days after the initial consultation Satisfaction will be assessed on a scale from 0 to 10 considering symptom management follow-up quality and task performance
Secondary Objectives
1 Compare satisfaction at 28 days
2 Evaluate PROM-ED scores for symptom relief understanding reassurance and care planning at days 7 and 28
3 Assess hospitalization rates by day 28
4 Assess unscheduled emergency consultations during the study
5 Assess surgical intervention rates by day 28
6 Assess total hospital time by day 28
7 Evaluate physician satisfaction at 28 days
Design Randomized superiority trial involving women aged 18-60 consulting for specific gynecological conditions requiring post-emergency follow-up Inclusion criteria are women aged 18-60 needing specified follow-up Exclusion criteria are severe clinical intolerance significant ultrasound findings non-French speakers and inability to use digital applications
Intervention Group Uses a connected health app for data collection and communication logging symptoms and test results with medical team notifications for urgent updates Patients will record vital signs at nearby pharmacies and log symptoms like pain bleeding and vomiting
Control Group Receives traditional in-person follow-up with scheduled consultations and emergency contact information
Data Collection and Randomization Patients will be randomized into either the intervention or control group Data will be collected via secure digital platforms with follow-up evaluations at days 7 and 28 Clinical data will be pseudonymized and securely stored
Expected Benefits Improved patient coordination and care efficiency reduced hospital visits enhanced access to care and reduced healthcare costs The study aims to validate the feasibility and effectiveness of digital health solutions in post-emergency gynecological care If successful this could lead to broader adoption of such technologies in various medical fields
Risks The study poses minimal risks as it includes patients with stable conditions and ensures continuous monitoring through digital platforms with emergency response capabilities
Participants 200 women 100 per group will be included based on previous satisfaction scores Inclusion criteria ensure patient stability and ability to use the digital platform
Duration Inclusion will last 24 months with a 28-day follow-up period for each patient
Statistical Analysis Conducted by the statistical team led by Prof Pierre-Yves Ancel at Université de Paris
Funding Private funding by NABLA 40 and public funding by BPI 60
Emergency gynecological consultations are frequent reasons for hospital visits Some clinical situations require scheduled follow-up to assess the progression of the initial condition through targeted questioning and additional tests such as blood work or pelvic ultrasounds Digital health platforms utilizing AI algorithms have proven valuable in telehealth appointment scheduling personalized care and prevention These platforms allow secure asynchronous follow-up potentially enhancing patient experience and reducing unnecessary hospital visits
Platform Capabilities The secure platforms offer features like messaging video consultations document scanning smart medical note-taking shared medical records structured questionnaires and automatic extraction of standardized medical information from consultations lab results and other medical documents Using machine learning these platforms assist in structuring medical decisions while enabling patients to be active participants in their care
Evaluation Criteria
Post-emergency gynecological follow-up is not standardized Iterative unscheduled emergency visits can indicate poor care quality though repeated scheduled visits are sometimes necessary for follow-up and not indicative of poor quality Patient satisfaction measured using validated tools like PROMs Patient-Reported Outcome Measures is a useful criterion for evaluating care quality PROMs are increasingly used to assess healthcare quality and patient management and their digitized secure and easily accessible formats allow efficient and standardized data collection
PROM-ED Questionnaire
A validated Canadian PROM-ED questionnaire evaluates patient experiences and satisfaction with emergency care focusing on symptom relief understanding reassurance and care planning This standardized tool is appropriate for evaluating satisfaction with emergency gynecological care
Hypothesis
We hypothesize that dematerialized follow-up using a connected health app will improve patient experience reduce hospital visits and lower hospitalization rates compared to traditional follow-up
Primary Objective
Compare overall patient satisfaction between dematerialized post-emergency follow-up at home using a health app and traditional in-person follow-up at the hospital seven days after the initial consultation Satisfaction will be assessed on a scale from 0 to 10 considering symptom management follow-up quality and task performance
Secondary Objectives
1 Compare satisfaction at 28 days
2 Evaluate PROM-ED scores for symptom relief understanding reassurance and care planning at days 7 and 28
3 Assess hospitalization rates by day 28
4 Assess unscheduled emergency consultations during the study
5 Assess surgical intervention rates by day 28
6 Assess total hospital time by day 28
7 Evaluate physician satisfaction at 28 days
Design Randomized superiority trial involving women aged 18-60 consulting for specific gynecological conditions requiring post-emergency follow-up Inclusion criteria are women aged 18-60 needing specified follow-up Exclusion criteria are severe clinical intolerance significant ultrasound findings non-French speakers and inability to use digital applications
Intervention Group Uses a connected health app for data collection and communication logging symptoms and test results with medical team notifications for urgent updates Patients will record vital signs at nearby pharmacies and log symptoms like pain bleeding and vomiting
Control Group Receives traditional in-person follow-up with scheduled consultations and emergency contact information
Data Collection and Randomization Patients will be randomized into either the intervention or control group Data will be collected via secure digital platforms with follow-up evaluations at days 7 and 28 Clinical data will be pseudonymized and securely stored
Expected Benefits Improved patient coordination and care efficiency reduced hospital visits enhanced access to care and reduced healthcare costs The study aims to validate the feasibility and effectiveness of digital health solutions in post-emergency gynecological care If successful this could lead to broader adoption of such technologies in various medical fields
Risks The study poses minimal risks as it includes patients with stable conditions and ensures continuous monitoring through digital platforms with emergency response capabilities
Participants 200 women 100 per group will be included based on previous satisfaction scores Inclusion criteria ensure patient stability and ability to use the digital platform
Duration Inclusion will last 24 months with a 28-day follow-up period for each patient
Statistical Analysis Conducted by the statistical team led by Prof Pierre-Yves Ancel at Université de Paris
Funding Private funding by NABLA 40 and public funding by BPI 60
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None