GoalsNCT03833622
Shared Decision Making to Improve Goals of Care in the ED
A study testing Shared Decision Aid Assessment in people with Goals, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Goals
- What is being tested?
- Shared Decision Aid Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Michelle Berning, 5072555056, Berning.Michelle1@mayo.edu
Derek VanMeter, 5072554016, vanmeter.derek@mayo.edu
- Not yet recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Shared Decision Making to Improve Goals of Care Discussions in the Emergency Department
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.
Read the 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.
- Conditions
- Goals
- Being tested
- Shared Decision Aid Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Aid AssessmentOther
Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shared Decision Aid Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start28 Mar 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoalsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E. Walker, Mayo Clinic
- Investigators
- Laura E Walker, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833622
- Sponsor's protocol ID
- 17-000128
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2018
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making to Improve Goals of Care Discussions in the Emergency Department
- ClinicalTrials.gov ID
- NCT03833622
- Acronym / sponsor ID
- 17-000128
- Conditions
- Goals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shared decision aid assessment | Experimental | Other: Shared Decision Aid AssessmentPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision Aid AssessmentProvide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department | Other | Shared decision aid assessment |
Primary outcome
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.
1 secondary outcome
Patient and physician satisfaction questionnaire
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Mayo Clinic Clinical Trials (best in chrome)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura E Walker principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Aid Assessment in people with Goals, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Walker (507-775-5607, walker.laura@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and physician feedback survey for tool development and iterative refinement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.