Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Patient Satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 and 60 years
- •No consultation at the gynecological emergency department in the previous month and/or for the same pregnancy.
- •Requires post-emergency follow-up for one of the following clinical conditions:
- •Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment
- •Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU < 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG < 5000, compliant patient, no contraindications for Methotrexate
- •Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG < 1500 IU
- •Missed Miscarriage (GAM): Confirmed by an intrauterine gestational sac ≥ 25mm without an embryo or an intrauterine gestational sac with an embryo ≥ 7mm without visible cardiac activity, treated with Misoprostol
- •First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability
- •Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up
排除标准
- •Severe clinical intolerance, defined by:
- •Signs of severe sepsis with unstable hemodynamics (TA with SBP < 90 mmHg and FC ≥ 105 bpm)
- •Abdominal defense or contracture
- •Pain not controlled by level 1 analgesics (EVA <7)
- •Severe dehydration defined by a body weight loss of more than 10%
- •Total food intolerance due to vomiting necessitating hospitalization
- •Uncontrolled active hemorrhage
- •Significant ultrasound findings:
- •Tubo-ovarian abscess ≥ 3 cm
- •Significant intra-abdominal effusion
- •Non-French speaking patients
- •Inability to download or use the digital application due to precarious or isolated digital circumstances
- •Refusal to sign consent form
- •Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship)
- •Patients not affiliated with a social security system
研究组 & 干预措施
Traditional In-Person Follow-Up
Participants in this arm will receive traditional in-person follow-up at the hospital. They will have scheduled consultations at the emergency department where they will undergo necessary evaluations and receive instructions for follow-up visits. Contact information for urgent needs will also be provided, allowing patients to reach medical services 24/7 if required
Dematerialized Follow-Up
Participants in this arm will receive post-emergency gynecological follow-up at home using a connected health app.
干预措施: Participants will receive post-emergency gynecological follow-up at home using a connected health app (Device)
结局指标
主要结局
Overall Patient Satisfaction
时间窗: 7 days after initial emergency gynecological consultation
Measure of overall patient satisfaction with post-emergency gynecological follow-up, assessed on a scale from 0 to 10. This includes symptom management, follow-up quality, and the ability to perform requested tasks.
次要结局
- Overall Patient Satisfaction at 28 Days(28 days after initial emergency gynecological consultation)
- PROM-ED Score for Symptom Relief(7 days after initial emergency gynecological consultation)
- PROM-ED Score for Symptom Relief at 28 Days(28 days after initial emergency gynecological consultation)
- PROM-ED Score for Understanding(7 days after initial emergency gynecological consultation)
- PROM-ED Score for Understanding at 28 days(28 days after initial emergency gynecological consultation)
- PROM-ED Score for Reassurance(7 days after initial emergency gynecological consultation)
- PROM-ED Score for Reassurance at 28 days(28 days after initial emergency gynecological consultation)
- PROM-ED Score for Care Planning(7 days after initial emergency gynecological consultation)
- PROM-ED Score for Care Planning at 28 days(28 days after initial emergency gynecological consultation)
- Hospitalization rate(28 days after initial emergency gynecological consultation)
- Unscheduled Emergency Consultations(28 days after initial emergency gynecological consultation)
- Surgical Intervention Rate(28 days after initial emergency gynecological consultation)
- Total Hospital Time(28 days after initial emergency gynecological consultation)
- Physician Satisfaction(28 days after initial emergency gynecological consultation)