Shared Decision Making to Improve Goals of Care in the ED

Goals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03833622
• Other study ID #: 17-000128
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Goals

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials