NCT03833622

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2018Dec 2026

First Submitted

Initial submission to the registry

January 3, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

8.7 years

First QC Date

January 3, 2018

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient and physician satisfaction questionnaire

    1 year

Study Arms (1)

Shared decision aid assessment

EXPERIMENTAL

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

Interventions

Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department

Shared decision aid assessment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Study Officials

  • Laura E Walker

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2018

First Posted

February 7, 2019

Study Start

March 28, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations