NCT06936826

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

April 8, 2025

Last Update Submit

April 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 7 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • proficient in English
  • possess prior experience with medical screening processes in the Emergency Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Christian H Nickel, Prof. MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Central Study Contacts

Christian H Nickel, Prof. MD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 20, 2025

Study Start

April 3, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations