Shared Decision Making to Improve Goals of Care in the ED

Study Overview
=================
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.

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

Conditions
-----------------
Goals

Intervention / Treatment
-----------------
* Other: Shared Decision Aid Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department, Patients at high risk for critical illness as determined by an Elderly Risk Assessment (ERA) score ≥ 16 or as determined by provider discretion, ≥ 60 years of age, Ability to provide informed consent, Medically stable at the time of enrollment, Able to participate without causing a delay in care. Exclusion: GCS scores < 15, Signs of altered mental status, Known to be pregnant, Incarcerated or in Police Custody, Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared decision aid assessment<br>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<br>* Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department<br>|

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 |