Hospital-at-Home Education as Implementation Tool - RCT

NCT07166653 | Recruiting DMC

• 1 other identifier: NorDigHE HaH RCT Protocol
• Study Type: interventional
• Target: 14
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Hospital

Keywords

clinical competence; digital health; education; hospital at home; hospital in the home; implementation; telemedicine

Outcome Measures

Primary Outcomes (1)

• HaH implementation

  The primary outcome, HaH implementation at the organizational level, is defined as a change in clinical practice, measured by the proportion of eligible patients who receive HaH.

  From enrollment until 6 months follow-up measurement

Secondary Outcomes (5)

• Staff's motivation

  From enrollment until 6 months follow-up

• Staff's knowledge

  From enrollment until 6 months follow-up

• Days hospitalized at home

  From enrollment until 6 months follow-up

• 30-day readmission

  From enrollment until 6 months follow-up

• Mortality

  From enrollment until 6 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group receives the NorDigHE HaH education embedded in the WHO Fast-IM.

Behavioral: HaH education

Control group

NO INTERVENTION

The control group continues treatment as usual over a 6-month period. To enhance participant retention, the control group will be offered the education after study completion and as a quality initiative.

Interventions

HaH education BEHAVIORAL

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 will be provided as part of the intervention to support in-tegration into daily clinical routines. The tailored toolbox consists of workshops, introductory meetings, written guides, and access to a hotline staffed by project specialists to facilitate implementation.

Also known as: NorDigHE education

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Sahlgrenska University Hospital: collaborator
• Lund University: collaborator
• University College Copenhagen: collaborator
• Ostfold University College: collaborator
• Region Capital Denmark: collaborator

Study Sites (3)

Nordsjællands Hospital

Hillerød, Capitol Region of Denmark, 3400, Denmark

RECRUITING

University College of Østfold

Fredrikstad, Østfold fylke, Norway

RECRUITING

Sahlgrenska University hospital

Göteborg, Skåne County, Sweden

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Leong MQ, Lim CW, Lai YF. Comparison of Hospital-at-Home models: a systematic review of reviews. BMJ Open. 2021 Jan 29;11(1):e043285. doi: 10.1136/bmjopen-2020-043285.

  PMID: 33514582 BACKGROUND

• Ankersen DV, Noack S, Munkholm P, Sparrow MP. E-Health and remote management of patients with inflammatory bowel disease: lessons from Denmark in a time of need. Intern Med J. 2021 Aug;51(8):1207-1211. doi: 10.1111/imj.15132. Epub 2021 Aug 3.

  PMID: 34346152 BACKGROUND

• Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.

  PMID: 11392867 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• J.K. Svane, L. Konge, and H. Tønnesen, "Fast and Well-reported Implementation: Fast-IM and RE-AIM", Clin. Health Promot. - Res. Best Pract. Patients Staff Community, bd. 10., no. 1, p. 10-14, dec. 2020, doi: 10.29102/clinhp.20003.

  BACKGROUND

• Svane JK, Chiou ST, Groene O, Kalvachova M, Brkic MZ, Fukuba I, Harm T, Farkas J, Ang Y, Andersen MO, Tonnesen H. A WHO-HPH operational program versus usual routines for implementing clinical health promotion: an RCT in health promoting hospitals (HPH). Implement Sci. 2018 Dec 22;13(1):153. doi: 10.1186/s13012-018-0848-0.

  PMID: 30577871 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

• Wallis JA, Shepperd S, Makela P, Han JX, Tripp EM, Gearon E, Disher G, Buchbinder R, O'Connor D. Factors influencing the implementation of early discharge hospital at home and admission avoidance hospital at home: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2024 Mar 5;3(3):CD014765. doi: 10.1002/14651858.CD014765.pub2.

  PMID: 38438114 BACKGROUND

• Edgar K, Iliffe S, Doll HA, Clarke MJ, Goncalves-Bradley DC, Wong E, Shepperd S. Admission avoidance hospital at home. Cochrane Database Syst Rev. 2024 Mar 5;3(3):CD007491. doi: 10.1002/14651858.CD007491.pub3.

  PMID: 38438116 BACKGROUND

Related Links

• World Health Organization, Global strategy on human resources for health: workforce 2030. Geneva: World Health Organization, 2016. Seen: 6. juni 2024.
• European Commission, "CORDIS programne: Societal Challenges - Health, demographic change and well-being", EU, H2020-EU.3.1., 2014. \[Online\].
• NOU: Norges offentlige utredninger, "Tid for handling: Personellet i en bærekraftig helse- og omsorgstjeneste", Departementenes sikkerhets- og serviceorganisasjon Teknisk redaksjon, 2023:4, 2023. \[Online\].
• Kommissionen for robusthed i sundhedsvæsenet, "Robusthedskommissionens anbefalinger", sep. 2023. \[Online\].
• Socialdepartementet SE, "Effektiv och behovsbaserad digital vård", Ds 2023:27, 2023. \[Online\].
• M. Monalto, "Definition: What is Hospital at Home? \| WHAHC", WHAHC-community. Seen: 4. februar 2025. \[Online\].
• "NorDigHE.org", Nordighe. Seen: 4. februar 2025. \[Online\]
• "Skillhabit". Set: 3. februar 2025. \[Online\].
• D. L. Kirkpatrick, "The Kirkpatrick Model", Kirkpatrick Partners, LLC.
• Better use of home monitoring. Experience from five departments of cardiology in the Capital Region of Denmark.
• "The Hospital moves into the living room during the pandemic". A.G. Poulsen, 2024
• "WARD Home Pilot - WARD Project"
• "Projects - DEFACTUM - Social, sundhed og arbejdsmarked"
• Erfaringer med Fremskudt akutfunktion på kommunale sengepladser i eHospitalet, Region Sjælland

Study Officials

• Thea K Fischer

  Forskningsafdelingen, Nordsjællands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mie H Martinussen

CONTACT

+45 20529362; mie.hjort.martinussen@regionh.dk

Jeff K Svane

CONTACT

+45 20544105; mie.hjort.martinussen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a two-armed, multicenter, superiority, cluster-randomized clinical trial with the hospital as the unit of randomization. The participating hospitals will autonomously select the relevant clinical departments and related staff to undergo the education tested. Data are collected at baseline, after 3, and 6 months. The intervention group also collects a 12-month maintenance assessment.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); NO (1); SE (1)