Recover@Home Postoperative Follow-up Study | NCT07714343

NCT07714343

Overview

NCT ID: NCT07714343
Lead Sponsor: Icahn School of Medicine at Mount SinaiOTHER
Official Title: Incorporating Mobile Technology Into Postoperative Care: A Randomized-Control Trial on Ambulatory Surgery With Recover@Home Approach Compared to Traditional Postoperative Inpatient Stay
Brief Summary: 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion criteria:

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.

Exclusion criteria:

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

Central Contacts: Linda P Zhang, MDContact
linda.zhang@mountsinai.org(212) 241-0134