Shared Decision Making to Improve Goals of Care in the ED

Mayo Clinic

Status: Enrolling

Conditions: Goals

Treatments: Other: Shared Decision Aid Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03833622

17-000128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Shared decision aid assessment

Experimental group

Description:

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.

Treatment:

Other: Shared Decision Aid Assessment