Shared Decision Making to Improve Goals of Care in the ED

Not Applicable

Recruiting

• Conditions: Goals
• Interventions: Other: Shared Decision Aid Assessment

• Registration Number: NCT03833622
• Lead Sponsor: Mayo Clinic

Brief Summary

This project will develop and refine a shared decision making (SDM) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the Emergency Department (ED) setting.

Detailed Description

Develop a shared decision making (SDM) intervention informed by insights elicited from patients and clinicians to improve goals of care discussions.

The process of decision aid design involves: (1) review and synthesis of the evidence; (2) an analysis of usual practice through observation of clinical encounters; (3) development of an initial decision aid prototype; (4) field testing in the context of clinical care to gain insights on both intended and unintended effects of its use in practice to facilitate patient centered goals of care discussions; and (5) successive iterations of the decision aid until thematic saturation is reached and it is ready for testing in a clinical trial.

Study Timeline

• Study First Submitted: 2018-01-03
• Study Start: 2018-03-28
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shared decision aid assessment	Shared Decision Aid Assessment	Patients will be selected to have a goals of care discussion with an emergency physician utilizing a pilot decision aid and will be asked for feedback to assist with refinement of the decision aid.

Primary Outcome Measures

Name	Time	Method
Patient and physician feedback survey for tool development and iterative refinement	1 year	A debrief survey/open-ended questionnaire is filled out by the patient and his/her provider to collect feedback. This is used to refine this shared decision making (SDM) intervention in the Emergency Department (ED) setting.

Secondary Outcome Measures

Name	Time	Method
Patient and physician satisfaction questionnaire	1 year	A satisfaction questionnaire is filled out by the patient and his/her provider following conversation on goals of care either with or without the SDM intervention.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States