Delphi ProcessNCT06936826
Protocol of an International Delphi Process
An observational study of Delphi Process and Psychiatric Emergency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to develop a consensus-based protocol for medical screening in patients presenting with acute psychiatric symptoms. Using the Delphi method, the study seeks to identify which medical evaluations should be performed routinely in this patient population and under what circumstances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delphi Process, Psychiatric Emergency, Medical Screening
- What is being tested?
- Delphi Consensus Process
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2025to Apr 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
- Adult, Older adult
Study population: interdisciplinary group from national and international societies in emergency medicine and psychiatry on 5 continents and patient representatives * Patient representatives: at least 6 in total; can include patients, patient relatives, caregivers, organizations, experts, or advocates * society representatives: national and international societies for emergency medicine and psychiatry from North America, South America, Europe, and Australasia, 3 representatives per region, at least 12 in total; strong interest in medical screening with a proven track record in emergency psychiatry and/or current employment in an emergency psychiatry setting
Who may be able to join
- proficient in English
- possess prior experience with medical screening processes in the Emergency Department
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Luca Ünlü, +41 61 556 53 24, Luca.Uenlue@usb.ch
About this study
Official title: Development of a Medical Screening Process for Patients With Acute Psychiatric Symptoms Presenting to the Emergency Department - Protocol for a Modified International Delphi Process
The aim of this study is to develop a consensus-based protocol for medical screening in patients presenting with acute psychiatric symptoms. Using the Delphi method, the study seeks to identify which medical evaluations should be performed routinely in this patient population and under what circumstances. By engaging a panel of experts, the study aims to reduce variability in current practice and support the development of a standardized, evidence-informed approach.
Read the detailed description
Background
Patients presenting with acute psychiatric symptoms often require urgent assessment and care. While these symptoms are sometimes the result of a primary psychiatric disorder, they can also stem from or be complicated by underlying medical conditions. Timely and accurate medical screening is therefore essential to rule out or address such conditions before initiating or continuing psychiatric treatment.
Currently, there is no universally accepted standard for how and when to perform medical screening in this context. Practices vary widely between institutions, clinicians, and healthcare systems. Some patients may undergo extensive laboratory testing and physical examinations, while others may receive minimal screening. This lack of standardization can lead to both over- and under-investigation, resulting in unnecessary costs, missed diagnoses, or delays in psychiatric care.
Given these challenges, developing a consensus among experts is a necessary step toward ensuring consistent, safe, and effective care. The Delphi method offers a structured, transparent way to gather and refine expert opinion where strong evidence is lacking or practice is inconsistent.
Study Design
The study uses a modified Delphi approach, involving a structured, multi-round survey process with a panel of experts in psychiatry, emergency medicine, and patient representatives. The goal is to develop a consensus on key elements of medical screening for patients with acute psychiatric symptoms. The process includes four rounds:
Round 1: Exploratory Open-Ended Survey Experts are invited to provide free-text responses on which medical evaluations they consider essential in different clinical scenarios. This round is designed to gather a wide range of ideas and perspectives without imposing predefined categories.
Round 2: Structured Rating of Statements Based on the input from Round 1, the research team compiles a set of statements describing specific medical screening procedures or criteria. Experts are then asked to rate their agreement with each statement on a Likert scale. This helps to identify areas of preliminary consensus and disagreement.
Round 3: Re-evaluation and Feedback Statements that did not reach consensus in Round 2 are re-presented, along with anonymous summary statistics and comments from the previous round. Experts are asked to reconsider their ratings in light of this feedback. This round is intended to move the group closer to consensus.
Round 4: Final Prioritization In the final round, the remaining statements are ranked or rated for priority, clarity, and clinical utility. The goal is to finalize a core set of recommendations that reflect expert consensus and are suitable for implementation in clinical practice.
Throughout the process, responses are collected anonymously to minimize bias and ensure that all participants can express their views freely. The results will inform the development of a standardized protocol that can improve medical screening practices and patient outcomes in acute psychiatric care.
- Conditions
- Delphi Process, Psychiatric Emergency, Medical Screening
- Being tested
- Delphi Consensus Process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi Consensus ProcessOther
Round 1: Evaluation of current Medical Screening Tools and Scoping Review Results Round 2: Rating previous Statements from Round 1 Round 3: Consensus Round 4: Testing Content and Construct Validity of the new Medical Screening Tool with Clinical Vignettes
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus regarding items for the new medical screening tool
Consensus is define as agreement over a pre-set benchmark of ≥80% agreement. If ≥80% of the responses of all participants to a variable indicate "agree", "strongly agree" or "very strongly agree" in the final round of this Delphi study, it is considered consensus that the variable will be kept.
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start3 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delphi ProcessStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian H Nickel, Prof. MD, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936826
- Sponsor's protocol ID
- 2024-01162;am24Nickel
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Unlu L, Carpenter CR, Sterzer P, Griese JA, Chrobok L, Minotti B, Christ M, Nordstrom K, Skinner C, Lunardi C, Alsma J, Bingisser R, Wilson MP, Nickel CH. Development of a medical screening process for patients with acute psychiatric symptoms presenting to the emergency department: protocol for a modified international Delphi study. BMJ Open. 2025 Oct 20;15(10):e105062. doi: 10.1136/bmjopen-2025-105062.
PubMed 41120177
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Medical Screening Process for Patients With Acute Psychiatric Symptoms Presenting to the Emergency Department - Protocol for a Modified International Delphi Process
- ClinicalTrials.gov ID
- NCT06936826
- Acronym / sponsor ID
- 2024-01162;am24Nickel
- Conditions
- Delphi Process, Psychiatric Emergency, Medical Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 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.
The aim of this study is to develop a consensus-based protocol for medical screening in patients presenting with acute psychiatric symptoms. Using the Delphi method, the study seeks to identify which medical evaluations should be performed routinely in this patient population and under what circumstances. By engaging a panel of experts, the study aims to reduce variability in current practice and support the development of a standardized, evidence-informed approach.
Detailed description
Background
Patients presenting with acute psychiatric symptoms often require urgent assessment and care. While these symptoms are sometimes the result of a primary psychiatric disorder, they can also stem from or be complicated by underlying medical conditions. Timely and accurate medical screening is therefore essential to rule out or address such conditions before initiating or continuing psychiatric treatment.
Currently, there is no universally accepted standard for how and when to perform medical screening in this context. Practices vary widely between institutions, clinicians, and healthcare systems. Some patients may undergo extensive laboratory testing and physical examinations, while others may receive minimal screening. This lack of standardization can lead to both over- and under-investigation, resulting in unnecessary costs, missed diagnoses, or delays in psychiatric care.
Given these challenges, developing a consensus among experts is a necessary step toward ensuring consistent, safe, and effective care. The Delphi method offers a structured, transparent way to gather and refine expert opinion where strong evidence is lacking or practice is inconsistent.
Study Design
The study uses a modified Delphi approach, involving a structured, multi-round survey process with a panel of experts in psychiatry, emergency medicine, and patient representatives. The goal is to develop a consensus on key elements of medical screening for patients with acute psychiatric symptoms. The process includes four rounds:
Round 1: Exploratory Open-Ended Survey Experts are invited to provide free-text responses on which medical evaluations they consider essential in different clinical scenarios. This round is designed to gather a wide range of ideas and perspectives without imposing predefined categories.
Round 2: Structured Rating of Statements Based on the input from Round 1, the research team compiles a set of statements describing specific medical screening procedures or criteria. Experts are then asked to rate their agreement with each statement on a Likert scale. This helps to identify areas of preliminary consensus and disagreement.
Round 3: Re-evaluation and Feedback Statements that did not reach consensus in Round 2 are re-presented, along with anonymous summary statistics and comments from the previous round. Experts are asked to reconsider their ratings in light of this feedback. This round is intended to move the group closer to consensus.
Round 4: Final Prioritization In the final round, the remaining statements are ranked or rated for priority, clarity, and clinical utility. The goal is to finalize a core set of recommendations that reflect expert consensus and are suitable for implementation in clinical practice.
Throughout the process, responses are collected anonymously to minimize bias and ensure that all participants can express their views freely. The results will inform the development of a standardized protocol that can improve medical screening practices and patient outcomes in acute psychiatric care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- interdisciplinary group from national and international societies in emergency medicine and psychiatry on 5 continents and patient representatives * Patient representatives: at least 6 in total; can include patients, patient relatives, caregivers, organizations, experts, or advocates * society representatives: national and international societies for emergency medicine and psychiatry from North America, South America, Europe, and Australasia, 3 representatives per region, at least 12 in total; strong interest in medical screening with a proven track record in emergency psychiatry and/or current employment in an emergency psychiatry setting
Key inclusion criteria (2 listed)
- proficient in English
- possess prior experience with medical screening processes in the Emergency Department
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Delphi Consensus ProcessRound 1: Evaluation of current Medical Screening Tools and Scoping Review Results Round 2: Rating previous Statements from Round 1 Round 3: Consensus Round 4: Testing Content and Construct Validity of the new Medical Screening Tool with Clinical Vignettes | Other | – |
Primary outcome
Consensus regarding items for the new medical screening tool
Time frame: through study completion, an average of 7 months
Consensus is define as agreement over a pre-set benchmark of ≥80% agreement. If ≥80% of the responses of all participants to a variable indicate "agree", "strongly agree" or "very strongly agree" in the final round of this Delphi study, it is considered consensus that the variable will be kept.
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 20 Apr 2025.
- Derived from this study: PubMed 41120177Unlu L, Carpenter CR, Sterzer P, Griese JA, Chrobok L, Minotti B, Christ M, Nordstrom K, Skinner C, Lunardi C, Alsma J, Bingisser R, Wilson MP, Nickel CH. Development of a medical screening process for patients with acute psychiatric symptoms presenting to the emergency department: protocol for a modified international Delphi study. BMJ Open. 2025 Oct 20;15(10):e105062. doi: 10.1136/bmjopen-2025-105062.
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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.
Christian H Nickel, Prof. MD study chair
University Hospital, Basel, Switzerland
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 Delphi Process and Psychiatric Emergency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 20 Apr 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 Switzerland. 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 Luca Ünlü, MD (+41 61 556 53 24, Luca.Uenlue@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus regarding items for the new medical screening tool (time frame: through study completion, an average of 7 months). 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 NCT06936826, which also lists 1 linked publication.
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 20 Apr 2025.