UPTAKE - Virtual Care: Virtual Home Hospital With Remote Monitoring to Reduce Acute Care Hospitalization

NCT06537453 | Recruiting

• 1 other identifier: REB23-0762
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 2

Brief Summary

Method: Randomized Controlled Trial Study Duration: 3 Years Study Centre(s) University of Calgary and University of Alberta Objectives: To fill care gaps by implementing strategies to reduce length of hospital stay, readmission rates, and improve long-term outcomes after Acute Kidney Injury (AKI). Number of Participants: Three Hundred and fifty four (n=354) Diagnosis and Main Inclusion Criteria: Hospitalized adults with AKI at high risk of hospital readmission or death Study Intervention: Multi-component Digital Health Solutions, including:

1. 1.Computerized Clinical Decision Support (CDS) and
2. 2.Virtual Care Delivered through Hospital at Home (VC) Duration of administration: Determined by the Patient's clinical team Reference therapy: Usual Care Statistical Analyses: Descriptive Analysis, Regression

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• the number of days alive out of hospital

  the number of days alive out of hospital

  Up to 45 days from the date of randomization

Secondary Outcomes (12)

• the time as inpatient in hospital

  Up to 45 days from the date of randomization

• death

  from the date of randomization up to 45 days, or date of death from any cause, whichever came first,

• hospital readmission

  Up to 45 days from the date of randomization

• Emergency Department visits

  Up to 45 days from the date of randomization

• Estimated Glomerular Filtration (eGFR)

  At 90 days after the date of randomization

Study Arms (2)

Virtual Care

EXPERIMENTAL

Participants will receive virtual care through Virtual Home Hospital programs in Alberta for their hospital to home transition of care.

Other: Virtual Care

Usual Care

NO INTERVENTION

Participants will be discharged as per usual care practices from hospital to their home.

Interventions

Virtual Care OTHER

Participants will go through Virtual hospital programs following the processes established by these programs in Alberta.

Virtual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• AKI identified in hospital using Kidney Disease Improving Global Outcomes (KDIGO) criteria17.
• Hospitalization \> 48 hours.
• LACE (L= Length patient Stay in the hospital, A= Acuity of Admission of patient in the hospital, C= Comorbidity and E= Emergency Visit.) Score 12 or higher.

You may not qualify if:

• Non-Alberta residents.
• Resides outside the catchment areas for the Calgary and Edmonton Virtual Home Hospital programs.
• C1 or C2 goals of care.
• Hospitalization \> 30 days.
• Will be discharged to long-term care.
• Kidney failure receiving dialysis.
• Already admitted in Virtual Home Hospital Program

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

NOT YET RECRUITING

Related Publications (9)

• Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005 Apr 2;330(7494):765. doi: 10.1136/bmj.38398.500764.8F. Epub 2005 Mar 14.

  PMID: 15767266 BACKGROUND

• Roshanov PS, Fernandes N, Wilczynski JM, Hemens BJ, You JJ, Handler SM, Nieuwlaat R, Souza NM, Beyene J, Van Spall HG, Garg AX, Haynes RB. Features of effective computerised clinical decision support systems: meta-regression of 162 randomised trials. BMJ. 2013 Feb 14;346:f657. doi: 10.1136/bmj.f657.

  PMID: 23412440 BACKGROUND

• James MT, Har BJ, Tyrrell BD, Faris PD, Tan Z, Spertus JA, Wilton SB, Ghali WA, Knudtson ML, Sajobi TT, Pannu NI, Klarenbach SW, Graham MM. Effect of Clinical Decision Support With Audit and Feedback on Prevention of Acute Kidney Injury in Patients Undergoing Coronary Angiography: A Randomized Clinical Trial. JAMA. 2022 Sep 6;328(9):839-849. doi: 10.1001/jama.2022.13382.

  PMID: 36066520 BACKGROUND

• James MT, Har BJ, Tyrrell BD, Ma B, Faris P, Sajobi TT, Allen DW, Spertus JA, Wilton SB, Pannu N, Klarenbach SW, Graham MM. Clinical Decision Support to Reduce Contrast-Induced Kidney Injury During Cardiac Catheterization: Design of a Randomized Stepped-Wedge Trial. Can J Cardiol. 2019 Sep;35(9):1124-1133. doi: 10.1016/j.cjca.2019.06.002. Epub 2019 Jun 7.

  PMID: 31472811 BACKGROUND

• Caplan GA, Sulaiman NS, Mangin DA, Aimonino Ricauda N, Wilson AD, Barclay L. A meta-analysis of "hospital in the home". Med J Aust. 2012 Nov 5;197(9):512-9. doi: 10.5694/mja12.10480.

  PMID: 23121588 BACKGROUND

• Goncalves-Bradley DC, Iliffe S, Doll HA, Broad J, Gladman J, Langhorne P, Richards SH, Shepperd S. Early discharge hospital at home. Cochrane Database Syst Rev. 2017 Jun 26;6(6):CD000356. doi: 10.1002/14651858.CD000356.pub4.

  PMID: 28651296 BACKGROUND

• Grinman, M., Kozicky, R. & Smith, M. Bringing Acute General Internal Medicine Outside of Hospital Walls. Canadian Journal of General Internal Medicine 17, 548 (2022

  BACKGROUND

• Gibbons-Reid, V., Wodinski, L. & Reynolds, C. Early Adoption & Implementation of Digital Remote Patient Monitoring in Virtual Hospital Care: Evaluation Report. Health Systems Evaluation and Evidence. (2021).

  BACKGROUND

• 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.

  PMID: 34593374 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Matthew James, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director

CONTACT

+1 (403) 210. 6730; cccr@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized in either arm, will be coded such that the outcome assessor is blinded to the arm assignment of the participant.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive the Virtual Care Intervention through Virtual Home Hospitals and other group will receive Usual Care.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CA (2)