Post-discharge Monitoring Initiative on Outcomes of Post-surgical Patients

Официальное название

Pragmatic Pilot Study of SKH@Home Post-discharge Monitoring Initiative on Outcomes of Surgical Patients

Обзор

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.

Вмешательства

• Процедура Early post-surgical discharge with post-surgical home based monitoring
  The SKH@home program, is a post-discharge monitoring program, which allows stable post-surgical patients to be discharged earlier from hospital while providing regular post-discharge monitoring at the patient's own home, either through home visits and patient assessment, or telemonitoring of patients.
• Процедура Standard inpatient care until deemed suitable for discharge
  Patients will receive standard postoperative management in the acute hospital until they are deemed fit for discharge by their primary surgeon

Первичные конечные точки

• Bed days saved [Срок оценки: From enrollment to 30 days after patient is discharged from the hospital/ post-discharge monitoring programme]
• Return to hospital [Срок оценки: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]
• Length of stay [Срок оценки: From enrollment until patient is discharged from the hospital/ from post-discharge monitoring care (up to around 2 weeks), whichever is longer]
• Hospitalisation bill [Срок оценки: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]
• Postoperative complications [Срок оценки: From enrollment until 30-days after patient is discharged from the hospital/ from post-discharge monitoring care]

Критерии участия

Критерии включения

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

EITHER

• 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

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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, S PMID 34593374
• 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. PMID 27016900
• 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. PMID 33641013
• 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. PMID 36812167
• 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. PMID 39028346

Идентификаторы

NCT: NCT06980402 · 2024-4580

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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