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NCT Number: NCT06936826

Protocol of an 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Delphi Consensus Process

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian H Nickel, Prof. MD

CONTACT

[email protected]

+ 41 61 556 5315

Luca Ünlü, MD

CONTACT

[email protected]

+41 61 556 53 24

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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