Hospital-at-Home Education as Implementation Tool - RCT

Official title

Nordic Digital Health Education as an Implementation Tool for Hospital-at-home - Protocol for a Multicenter Randomized Controlled Trial

Overview

To enhance implementation of Hospital-at-home (HaH) in Scandinavia, the Nordic Digital Health \& Education (NorDigHE) project has developed a comprehensive virtual education on HaH for clinical staff. The goal of this clinical trial is to evaluate whether an online education for clinical staff can enhance the implementation of HaH services in hospitals across Denmark, Norway, and Sweden. The primary outcome of the RCT is HaH implementation measured at organization level, understood as a change in clinical practice by increased HaH activity. Secondary outcomes are HaH knowledge and motivation among clinical staff as well as patient days in hospital, days hospitalized at home, 30-day readmission, and mortality. Researchers will compare hospitals receiving the NorDigHE education (intervention group) to hospitals continuing treatment as usual (control group) to see if the education leads to greater adoption of HaH and changes in service delivery. Participants will: * Complete baseline, 3-month, and 6-month surveys assessing HaH activity, staff knowledge, and motivation. * Participate in a 12-month follow-up assessment (intervention group only). * Be invited (patients, staff, and management) to take part in semi-structured interviews to share experiences and preferences related to HaH. * (For staff in the intervention group) Complete the NorDigHE virtual education program embedded in the WHO Fast-IM. After the study, the control group will be offered access to the NorDigHE education as a participant retention measure.

Detailed description

Background: In response to increasing pressures on healthcare systems due to aging populations, and increasing shortages of clinical staff, increased use of digital service designs has been recommended by most governments in Scandinavian and European countries. Virtually supported Hospital-at-Home (HaH) models, delivering acute hospital services in-home have been shown to be both feasible and beneficial. Nevertheless, implementation and scaling barriers are major challenges. To enhance implementation of HaH in Scandinavia, the Nordic Digital Health \& Education (NorDigHE) project has developed a compre-hensive virtual education on HaH for clinical staff. The present study aims to evaluate the implementation impact of the NorDigHE education embedded in the WHO Fast-track Implementation Model (WHO Fast-IM).

Methods and analysis: We use a randomized design and nested qualitative studies to meet the aim. Via open-call, hospitals will be recruited in Denmark, Norway, and Sweden and randomized to either receive the education embedded in the WHO Fast-IM or to continue treatment as usual. The primary outcome of the RCT is HaH implementation measured at organization level, understood as a change in clinical practice by increased HaH activity. Secondary outcomes are HaH knowledge and motivation among clinical staff as well as patient days in hospital, days hospitalized at home, 30-day readmission, and mortality. Data are collected at baseline, after 3, and 6 months. A 12-month maintenance measurement is performed in the intervention group. Post-study, the control group is offered the NorDigHE education as a participant re-tention measure. In addition, the attitudes, experiences, and preferences of HaH among patients, clinical staff, and management are collected via nested semi-structured interviews.

Interventions

• Behavioral HaH education
  The intervention consists of the online NorDigHE HaH education with tailored implementation tools em-bedded in the WHO Fast-IM. The education is delivered online and asynchronously, combining e-learning, simulations, reflection exercises, and practical task training. The trial has adopted the evidence-based WHO Fast-track Implementation Model (WHO Fast-IM) as a framework to support the effectiveness and reporting of the implementation, and the tailored implementation tools embedded in the model

Primary outcome measures

• HaH implementation [Time frame: From enrollment until 6 months follow-up measurement]

Secondary outcome measures (5)

• Staff's motivation [Time frame: From enrollment until 6 months follow-up]
• Staff's knowledge [Time frame: From enrollment until 6 months follow-up]
• Days hospitalized at home [Time frame: From enrollment until 6 months follow-up]
• 30-day readmission [Time frame: From enrollment until 6 months follow-up]
• Mortality [Time frame: From enrollment until 6 months follow-up]

Eligibility criteria

Inclusion criteria

Hospitals with clinical departments treating acutely ill in-patients that have, or are ready to establish, the prerequisites and infrastructure for HaH - regardless of the specific approach, envisioned HaH model, primary sector collaborations, or local sector collaboration agreements and frameworks. Each hospital must have or be ready to establish:

• a governance structure to organize and oversee HaH-services.
• an IT-platform capable of managing data from and to HaH patients.
• a safe communication pathway between HaH-patient and the hospital.
• clear agreements on types of data to be exchanged between HaH-patient and hospital.
• agreements on roles, responsibilities, and capacity (incl. possibly primary sector entities).
• clinical guidelines, standard operating procedures, and action plans to support the HaH work.

Exclusion criteria

• Hospitals that do not have or are not ready to secure relevant pre-requisites listed above (a to f).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Denmark · 1 center

• Nordsjællands Hospital — Hillerød

Norway · 1 center

• University College of Østfold — Fredrikstad

Sweden · 1 center

• Sahlgrenska University hospital — Göteborg

Publications

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
• Foy R, Ivers NM, Grimshaw JM, Wilson PM. What is the role of randomised trials in implementation science? Trials. 2023 Aug 16;24(1):537. doi: 10.1186/s13063-023-07578-5. PMID 37587521
• Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180. PMID 22179294
• Jakobsen AS, Laursen LC, Rydahl-Hansen S, Ostergaard B, Gerds TA, Emme C, Schou L, Phanareth K. Home-based telehealth hospitalization for exacerbation of chronic obstructive pulmonary disease: findings from "the virtual hospital" trial. Telemed J E Health. 2015 May;21(5):364-73. doi: 10.1089/tmj.2014.0098. Epub 2015 Feb 5. PMID 25654366
• Sandreva T, Larsen MN, Rasmussen MK, Nielsen TL, von Sydow C, Schmidt TA, Fischer TK. Transforming health care: Investigating Influenzer, a novel telemedicine-supported early discharge program for patients with lower respiratory tract infection: A non-randomized feasibility study. J Telemed Telecare. 2025 Sep;31(8):1138-1151. doi: 10.1177/1357633X241254572. Epub 2024 May 23. PMID 38780386
• Pietersen PI, Bhatnagar R, Rahman NM, Maskell N, Wrightson JM, Annema J, Crombag L, Farr A, Tabin N, Slavicky M, Skaarup SH, Konge L, Laursen CB. Evidence-based training and certification: the ERS thoracic ultrasound training programme. Breathe (Sheff). 2023 Jun;19(2):230053. doi: 10.1183/20734735.0053-2023. Epub 2023 Jul 11. PMID 37492346
• Vindrola-Padros C, Singh KE, Sidhu MS, Georghiou T, Sherlaw-Johnson C, Tomini SM, Inada-Kim M, Kirkham K, Streetly A, Cohen N, Fulop NJ. Remote home monitoring (virtual wards) for confirmed or suspected COVID-19 patients: a rapid systematic review. EClinicalMedicine. 2021 Jul;37:100965. doi: 10.1016/j.eclinm.2021.100965. Epub 2021 Jun 23. PMID 34179736
• Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6. PMID 29411238

Identifiers

NCT: NCT07166653 · NorDigHE HaH RCT Protocol

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗