Hospital-at-Home Education as Implementation Tool - RCT
NCT ID: NCT07166653
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
14 participants
INTERVENTIONAL
2025-09-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuing Education in Nursing Home Dementia Care
NCT01715506
Randomized Controlled Trial of Health Care to Elderly Patients.
NCT00235404
Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial
NCT05950373
Developing and Evaluating a Digital Intervention Aiming to Support Informal Caregivers of People With Dementia
NCT07248241
[email protected]: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families
NCT04043364
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
The intervention group receives the NorDigHE HaH education embedded in the WHO Fast-IM.
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 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.
Control group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. a governance structure to organize and oversee HaH-services.
2. an IT-platform capable of managing data from and to HaH patients.
3. a safe communication pathway between HaH-patient and the hospital.
4. clear agreements on types of data to be exchanged between HaH-patient and hospital.
5. agreements on roles, responsibilities, and capacity (incl. possibly primary sector entities).
6. clinical guidelines, standard operating procedures, and action plans to support the HaH work.
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sahlgrenska University Hospital
OTHER
Lund University
OTHER
University College Copenhagen
OTHER
Ostfold University College
OTHER
Region Capital Denmark
OTHER
Nordsjaellands Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thea K Fischer
Role: PRINCIPAL_INVESTIGATOR
Forskningsafdelingen, Nordsjællands Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nordsjællands Hospital
Hillerød, Capitol Region of Denmark, Denmark
University College of Østfold
Fredrikstad, Østfold fylke, Norway
Sahlgrenska University hospital
Göteborg, Skåne County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NorDigHE HaH RCT Protocol
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.