Shared Decision Making to Improve Goals of Care in the ED

Shared Decision Making to Improve Goals of Care Discussions in the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: Goals
• Intervention / Treatment: Other: Shared Decision Aid Assessment

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 Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Walker; Phone Number: 507-775-5607; Email: walker.laura@mayo.edu
• Study Contact Backup: Name: Derek VanMeter; Phone Number: 507-775-4732; Email: vameter.derek@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Not yet recruiting
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Derek VanMeter; Phone Number: 5072554016; Email: vanmeter.derek@mayo.edu
      • Contact: Michelle Berning; Phone Number: 5072555056; Email: Berning.Michelle1@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

1. Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department,
2. Patients at high risk for critical illness as determined by an Elderly Risk Assessment (ERA) score ≥ 16 or as determined by provider discretion,
3. ≥ 60 years of age,
4. Ability to provide informed consent,
5. Medically stable at the time of enrollment,
6. Able to participate without causing a delay in care.

Exclusion:

1. GCS scores < 15,
2. Signs of altered mental status,
3. Known to be pregnant,
4. Incarcerated or in Police Custody,
5. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Shared Decision Aid Assessment; Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and physician feedback survey for tool development and iterative refinement	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and physician satisfaction questionnaire	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.	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Laura E Walker, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials (best in chrome)

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 17-000128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No