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HospitalHAH-EDUCATIONNCT07166653

Hospital-at-Home Education as Implementation Tool - RCT

A study testing HaH education in people with Hospital, run by Nordsjaellands Hospital at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Hospital
What is being tested?
HaH education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesin 3 countries
Study dates
1 Sep 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

3 sites in 3 countries

Denmark1 site, 1 recruiting
  • Nordsjællands Hospital

    Hillerød, Capitol Region of Denmark, 3400

    Mie H Martinussen, +45 20529362, mie.hjort.martinussen@regionh.dk

    Recruiting

Other trials in Denmark

Norway1 site, 1 recruiting
  • University College of Østfold

    Fredrikstad, Østfold fylke

    Vigdis Abrahamsen Grøndahl, Professor, +47 930 52 634, vigdis.a.grondahl@hiof.no

    Recruiting

Other trials in Norway

Sweden1 site, 1 recruiting
  • Sahlgrenska University hospital

    Göteborg, Skåne County

    Malin Portillo, +46 (0)766974418, malin.portillo@vgregion.se

    Recruiting

Other trials in Sweden

About this study

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

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.

Read more

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.

Read the 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.

Conditions
Hospital
Being tested
HaH education
Keywords
clinical competence, digital health, education, hospital at home, hospital in the home, implementation, telemedicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HaH educationBehavioural

    Also called NorDigHE 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 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.

Study groups in NCT07166653
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group receives the NorDigHE HaH education embedded in the WHO Fast-IM.
Receives: Behavioral: HaH education
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment until 6 months follow-up measurement

Secondary outcomes (5)
  1. Staff's motivation

    Staff's motivation to work with HaH. Staff HaH motivation is measured by Intrinsic Motivation Inventory (IMI) Scale questionnaires. Participants will be presented with a series of statements and asked to indicate how true each statement is for them on a 7-point scale, where 1 represents 'not true at all' and 7 represents 'very true'.

    Measured: From enrollment until 6 months follow-up

  2. Staff's knowledge

    Staff members' knowledge on HaH. Staff's knowledge is collected as pre- and post-education questionnaires at baseline and at 6 months follow-up. The knowledge questionnaires have been developed prior to the study and has undergone pilot-validation with healthcare students, clinical staff, and education sector experts as part of the NorDigHE project.

    Measured: From enrollment until 6 months follow-up

  3. Days hospitalized at home

    Length of stay while hospitalized at home versus in the hospital. Measured using registry data for patients admitted to the department during trial.

    Measured: From enrollment until 6 months follow-up

  4. 30-day readmission

    The percentage of patients that readmit to the hospital within 30 days with the same illness they were previously discharged. Measured using registry data for patients admitted to the department during the trial.

    Measured: From enrollment until 6 months follow-up

  5. Mortality

    Tthe number of deaths in participating hospitals (and their departments) during the trial (death rate)

    Measured: From enrollment until 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166653
Sponsor's protocol ID
NorDigHE HaH RCT Protocol
Acronym
HAH-EDUCATION
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29411238
  • 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.

    PubMed 33514582
  • 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.

    PubMed 34346152
  • 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.

    PubMed 11392867
  • 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.

    PubMed 10474547
  • 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.

  • 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.

    PubMed 30577871
  • 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.

    PubMed 28651296

Questions about this trial

What is this clinical trial studying?

A study testing HaH education in people with Hospital, run by Nordsjaellands Hospital at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mie H Martinussen (+45 20529362, mie.hjort.martinussen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HaH implementation (time frame: From enrollment until 6 months follow-up measurement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166653, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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