DisasterOrAKELNCT06913010
DV 100 as a Framework for the Hospital Incident Command System
An observational study of Disaster and Crisis Response Plan, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
There is limited scientific research on the organizational structure of the Hospital Incident Command System. The Hospital Alarm and Emergency Planning manual by the German Federal Office of Civil Protection and Disaster Assistance (BBK) recommends a continental staff system-based organization, as outlined in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disaster, Crisis Response Plan, Emergency
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2025to 31 Oct 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises all Heidelberg University Hospital staff potentially involved in the hospital incident command system
Who may be able to join
- Participation in at least one hospital incident command system (ICS) training and, if applicable, in a ICS exercise.
- Written informed consent from the employee for participation in the second part of the study (semi-structured interview)
Who cannot join
- Decline of study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg
Maik von der Forst, MD MHBA DESAIC, 49 6221 56264-60, Maik.Forst@med.uni-heidelberg.de
About this study
Official title: The Service Regulation DV 100 as an Organizational Structure for Establishing the Hospital Incident Command System
There is limited scientific research on the organizational structure of the Hospital Incident Command System. The Hospital Alarm and Emergency Planning manual by the German Federal Office of Civil Protection and Disaster Assistance (BBK) recommends a continental staff system-based organization, as outlined in the Service Regulation DV 100, similar to military, fire, and police structures. This approach is frequently discussed at professional conferences, but evidence on its functionality in hospitals is lacking. This study aims to generate new insights into the use of a continental staff system-based Hospital Incident Command System and qualitatively analyze transition and communication processes within the command structure.
- Conditions
- Disaster, Crisis Response Plan, Emergency, Communication
- Being tested
- No interventions.
- Keywords
- Hospital Incident Command System, Continental Staff System, Service Regulation DV 100, Disaster Management, Emergency Planning, Hospital Alarm and Emergency Planning, Organizational Structure, Crisis Management, Communication Processes, Transition Processes, Healthcare Emergency Response, Civil Protection, Disaster Assistance, Incident Command Structure, Emergency Management Systems
- Medical subject headings
- Emergencies, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions.Other
This is an observational study with no interventions.
| Study group | Role | What they receive |
|---|---|---|
| University Hospital Heidelberg staff eligible for deployment in the hospital incident command system | Only adult employees capable of giving informed consent are included. The study population comprises all University Hospital Heidelberg staff potentially involved in the hospital incident command system. Receives: Other: No interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploration of leadership communication and dynamics during the transition from routine clinical operations to an emergency situation
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Assessment of training and exercise effects within a structured (according to DV-100) hospital incident command system, including challenges, resistance, benefits, subjective participant experiences, potential improvements, and alternatives
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Secondary outcomes (4)
Examination of the applicability of the traditional incident command concept in hospitals, considering a workforce largely inexperienced in continental staff system-based work.
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Evaluation of participants' operational confidence
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Analysis of communication behaviors within the command functions
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Assessment of the advantages and disadvantages of a structured hospital incident command system
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Measured: During the table-top exercise on May 26 and May 27, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start29 Apr 2025
- Primary completion29 Apr 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisasterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Erik Popp, MD, Prof. Markus Ries, MD, PhD, MHSc, MA, FCP, FIBODM, Janna Küllenberg, PhD, Kirsten Bikowski, Hanne Schäfer, RN, BS, MS
- Responsible party
- Principal investigator, Maik von der Forst, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913010
- Sponsor's protocol ID
- OrAKEL
- Acronym
- OrAKEL
- Status last verified
- Jul 2025
- First submitted
- 25 Mar 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Service Regulation DV 100 as an Organizational Structure for Establishing the Hospital Incident Command System
- ClinicalTrials.gov ID
- NCT06913010
- Acronym / sponsor ID
- OrAKEL / OrAKEL
- Conditions
- Disaster, Crisis Response Plan, Emergency, Communication
- Keywords
- Hospital Incident Command System, Continental Staff System, Service Regulation DV 100, Disaster Management, Emergency Planning, Hospital Alarm and Emergency Planning, Organizational Structure, Crisis Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Prof. Erik Popp, MD, Prof. Markus Ries, MD, PhD, MHSc, MA, FCP, FIBODM, Janna Küllenberg, PhD, Kirsten Bikowski, Hanne Schäfer, RN, BS, MS
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited scientific research on the organizational structure of the Hospital Incident Command System. The Hospital Alarm and Emergency Planning manual by the German Federal Office of Civil Protection and Disaster Assistance (BBK) recommends a continental staff system-based organization, as outlined in the Service Regulation DV 100, similar to military, fire, and police structures. This approach is frequently discussed at professional conferences, but evidence on its functionality in hospitals is lacking. This study aims to generate new insights into the use of a continental staff system-based Hospital Incident Command System and qualitatively analyze transition and communication processes within the command structure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University Hospital Heidelberg staff eligible for deployment in the hospital incident command system | – | Other: No interventions.Only adult employees capable of giving informed consent are included. The study population comprises all University Hospital Heidelberg staff potentially involved in the hospital incident command system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises all Heidelberg University Hospital staff potentially involved in the hospital incident command system
Key inclusion criteria (2 listed)
- Participation in at least one hospital incident command system (ICS) training and, if applicable, in a ICS exercise.
- Written informed consent from the employee for participation in the second part of the study (semi-structured interview)
Key exclusion criteria (1 listed)
- Decline of study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions.This is an observational study with no interventions. | Other | University Hospital Heidelberg staff eligible for deployment in the hospital incident command system |
Primary outcome
Exploration of leadership communication and dynamics during the transition from routine clinical operations to an emergency situation
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
Assessment of training and exercise effects within a structured (according to DV-100) hospital incident command system, including challenges, resistance, benefits, subjective participant experiences, potential improvements, and alternatives
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Assessed through semi-structured interviews based on Grounded Theory, a systematic method for developing theories through the analysis of qualitative data
4 secondary outcomes
Examination of the applicability of the traditional incident command concept in hospitals, considering a workforce largely inexperienced in continental staff system-based work.
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Evaluation of participants' operational confidence
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Analysis of communication behaviors within the command functions
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Assessment of the advantages and disadvantages of a structured hospital incident command system
Time frame: During the table-top exercise on May 26 and May 27, 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disaster and Crisis Response Plan, run by University Hospital Heidelberg at 1 site in Germany.
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 2 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Maik von der Forst, MD, MHBA, DESAIC (+49 6221 56264-60, Maik.Forst@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploration of leadership communication and dynamics during the transition from routine clinical operations to an emergency situation (time frame: During the table-top exercise on May 26 and May 27, 2025.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.