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Recruiting NCT03833622

Shared Decision Making to Improve Goals of Care in the ED

No phase Interventional Goals

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shared Decision Aid Assessment.
Who it may be relevant to
Registry conditions: Goals. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Patient and physician feedback survey for tool development and iterative refinement [Time frame: 1 year]
Secondary outcome measures (1)
  • Patient and physician satisfaction questionnaire [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT03833622 · 17-000128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗