Protocol of an International Delphi Process

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.

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Emergency; Delphi Process; Medical Screening
• Intervention / Treatment: Other: Delphi Consensus Process

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 Type: Observational
• Enrollment (Estimated): 23

Contacts and Locations

• Study Contact: Name: Luca Ünlü, MD; Phone Number: +41 61 556 53 24; Email: Luca.Uenlue@usb.ch
• Study Contact Backup: Name: Christian H Nickel, Prof. MD; Phone Number: + 41 61 556 5315; Email: Christian.Nickel@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Luca Ünlü; Phone Number: +41 61 556 53 24; Email: Luca.Uenlue@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Christian H Nickel, Prof. MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2024-01162;am24Nickel

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No