About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Recovery@home
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of any postoperative complication within 30 days
Occurrence of any postoperative complication within 30 days-will be treated as a binary variable (1 = complication, 0 = no complication).
Secondary outcomes
Financial cost to the patient
Indirect and direct costs to the patient
Facility cost
facility costs includes building maintenance cost, personnel cost, material/equipment cost
Sponsors and contacts
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Icahn School of Medicine at Mount Sinai
Lead sponsor
University of Pittsburgh
Collaborator
Global Surgical Initiatives Kyabirwa Surgical Center
Collaborator
Fogarty International Center of the National Institute of Health
Collaborator
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