Recover@Home Postoperative Follow-up Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Recovery@home

    Other intervention

    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.

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: Intervention arm: Recovery@Home pathwayExperimental treatment 1 intervention
Group B: Traditional inpatient postoperative careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
postoperative day 1, postoperative day 3, postoperative day 7, postoperative day 10, postoperative day 14, postoperative day 30

Secondary outcomes

1

Financial cost to the patient

Indirect and direct costs to the patient

Time frame
end of study, at one month
2

Facility cost

facility costs includes building maintenance cost, personnel cost, material/equipment cost

Time frame
end of study, at one month

Other outcomes

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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