Incorporating Mobile Technology Into Postoperative Care: A Randomized-Control Trial on Ambulatory Surgery With Recover@Home Approach Compared to Traditional Postoperative Inpatient Stay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- Occurrence of any postoperative complication within 30 days
研究概览
简要总结
This proposal describes a human subjects research study evaluating mHealth Ambulatory Surgery with Follow-up Nurse (Recovery@Home), as an alternative postoperative care pathway for selected low-acuity surgical procedures in Uganda. The Recovery@Home model discharges eligible patients home on the day of surgery and provides structured postoperative follow-up through nurse telephone calls, home visits, mobile-app documentation, escalation algorithms, and surgeon teleconsultation when clinically indicated. The proposed research includes a design to evaluate Recovery@Home against traditional postoperative inpatient care in a randomized controlled trial across three participating Ugandan surgical facilities.
详细描述
Surgeries in high-income countries have progressively transitioned to ambulatory settings, but in low- and middle-income countries, even patients who have low-acuity surgeries still typically stay in the hospital after their surgeries, and these postoperative inpatient stays are costly and inefficient, for both patients and the surgical facilities. We propose an innovative approach of Recover@Home in Uganda, incorporating mobile technology into postoperative care, to ensure safe, cost-effective and efficient care with same-day discharge and reliable follow-up after surgery. Using a multicenter, randomized controlled trial, we will provide the evidence necessary to shift practice towards ambulatory surgery for low-acuity surgical procedures, resulting in more efficient and effective allocation of healthcare resources in LMICs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Undergoing one of the eligible surgical procedures: inguinal/femoral hernia repair; umbilical/epigastric hernia repair; excision of soft tissue tumors; thyroidectomy; or appendectomy; varicocelectomy, hydrocelectomy.
- •Able to provide informed consent, with consent read aloud and/or fingerprint signature permitted where approved by local ethics authorities.
- •Available for inpatient interviews, postoperative clinic visit interviews, and postoperative telephone and/or home follow-up during the 30-day postoperative period.
排除标准
- •Clinical determination by the surgeon or anesthesia team that same-day discharge is unsafe or inappropriate.
- •Inability to provide informed consent or lack of an approved surrogate/alternative consent process if required by the IRB.
- •Any other exclusion required by the final approved protocol or local regulatory authority.
- •ASA 3 or higher
结局指标
主要结局
Occurrence of any postoperative complication within 30 days
时间窗: postoperative day 1, postoperative day 3, postoperative day 7, postoperative day 10, postoperative day 14, postoperative day 30
Occurrence of any postoperative complication within 30 days-will be treated as a binary variable (1 = complication, 0 = no complication).
次要结局
- Financial cost to the patient(end of study, at one month)
- Facility cost(end of study, at one month)
研究者
Linda P Zhang
Professor, Department of Surgery
Icahn School of Medicine at Mount Sinai