Clinical trial NCT06980402: Post-discharge Monitoring Initiative on Outcomes of Post-surgical Patients
Official title: Pragmatic Pilot Study of SKH@Home Post-discharge Monitoring Initiative on Outcomes of Surgical Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopy
Discharge Planning
Keywords: Bariatric surgery
Laparoscopic surgery
Abdominal abscesses
Liver abscesses
Discharge planning
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a prospective study to evaluate the SKH@Home programme, a post-discharge monitoring initiative for surgical patients. The aim of this study is to conduct a pragmatic, non-randomized pilot study to compare the SKH@Home programme with standard post-surgical care on patient outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patient is keen for home management
2. Hemodynamically stable
3. Able and willing to self-care and monitor / Good social support
4. Lives in Singapore's Northeast region

   EITHER
5. Diagnosed with intra-abdominal abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary OR Diagnosed with liver abscess requiring ongoing IV antibiotics as recommended by Infectious Diseases Specialist where necessary AND Has undergone initial treatment (e.g., drainage if required) and is clinically improving

   OR
6. Underwent an uneventful straightforward bariatric surgical procedure, and has been monitored overnight without any immediate postoperative issues OR Underwent uneventful straightforward laparoscopic/ endoscopic/ minimally invasive surgery, and has been monitored for at least 6 hours without any immediate postoperative issues AND has no significant intraprocedural concerns by the operating surgeon

Exclusion Criteria:

1. Unable to self-care / no caregiver
2. Requires daily review by the surgical team
3. Suspicion of surgical complications requiring surgical intervention
4. Requires post-discharge monitoring care for \> 2 weeks
5. Unregulated psychiatric disorders
6. Daily flushing of drains required

Primary outcomes:
measure: Bed days saved
timeFrame: From enrollment to 30 days after patient is discharged from the hospital/ post-discharge monitoring programme
measure: Return to hospital
timeFrame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care
measure: Length of stay
timeFrame: From enrollment until patient is discharged from the hospital/ from post-discharge monitoring care (up to around 2 weeks), whichever is longer
measure: Hospitalisation bill
timeFrame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care
measure: Postoperative complications
timeFrame: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sengkang General Hospital
name: Koy Min Chue
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209.
citation: Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.
citation: Jonker LT, Lahr MMH, Oonk MHM, de Bock GH, van Leeuwen BL. Post-discharge Telemonitoring of Physical Activity, Vital Signs, and Patient-Reported Symptoms in Older Patients Undergoing Cancer Surgery. Ann Surg Oncol. 2021 Oct;28(11):6512-6522. doi: 10.1245/s10434-021-09707-3. Epub 2021 Feb 27.
citation: van Ede ES, Scheerhoorn J, Buise MP, Bouwman RA, Nienhuijs SW. Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial. PLoS One. 2023 Feb 22;18(2):e0281992. doi: 10.1371/journal.pone.0281992. eCollection 2023.
citation: Cooper S, Patel S, Wynn M, Provost D, Hassan M. Outcomes of same-day discharge in bariatric surgery. Surg Endosc. 2024 Sep;38(9):5122-5129. doi: 10.1007/s00464-024-11053-w. Epub 2024 Jul 19.