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Clinical Trials/NCT03833622
NCT03833622
Recruiting
N/A

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

Mayo Clinic3 sites in 1 country230 target enrollmentMarch 28, 2018

Overview

Phase
N/A
Intervention
Shared Decision Aid Assessment
Conditions
Goals
Sponsor
Mayo Clinic
Enrollment
230
Locations
3
Primary Endpoint
Patient and physician feedback survey for tool development and iterative refinement
Status
Recruiting
Last Updated
2 months ago

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2018
End Date
December 1, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura E. Walker

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Arms & Interventions

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.

Intervention: Shared Decision Aid Assessment

Outcomes

Primary Outcomes

Patient and physician feedback survey for tool development and iterative refinement

Time Frame: 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 Outcomes

  • Patient and physician satisfaction questionnaire(1 year)

Study Sites (3)

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