~42 spots leftby Dec 2026

Shared Decision Aid for Goals of Care

Recruiting at 2 trial locations
LE
Overseen byLaura E Walker
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: GCS < 15, Altered mental status, Pregnancy, Incarceration, Communication barriers
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Shared Decision Aid Assessment treatment?

Research shows that shared decision-making tools, like decision aids, help patients feel more involved and satisfied with their healthcare choices. These tools have been shown to improve patient engagement and adherence to treatment plans, especially in managing conditions like diabetes.12345

How does the Shared Decision Aid for Goals of Care treatment differ from other treatments?

The Shared Decision Aid for Goals of Care is unique because it focuses on integrating goal setting into the shared decision-making process, which is particularly important for individuals with multiple long-term conditions. This approach emphasizes collaboration between patients and healthcare providers to align treatment decisions with the patient's personal goals and preferences, rather than solely focusing on medical outcomes.678910

Research Team

LE

Laura E Walker

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients 60 years or older visiting Mayo Clinic Rochester, Saint Marys' ED who are at high risk of becoming critically ill. They must be mentally stable with a GCS score of 15, able to consent, and not in police custody. Those with severe mental impairment or communication barriers cannot join.

Inclusion Criteria

Medically stable at the time of enrollment
I am 60 years old or older.
Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department
See 3 more

Exclusion Criteria

I have experienced changes in my mental state.
Incarcerated or in Police Custody
GCS scores < 15
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and refinement of a shared decision making (SDM) intervention informed by insights from patients and clinicians

6 months

Field Testing

Field testing of the decision aid in clinical care to gain insights and facilitate patient-centered goals of care discussions

6 months

Follow-up

Participants are monitored for satisfaction and feedback on the decision aid intervention

1 year

Treatment Details

Interventions

  • Shared Decision Aid Assessment (Behavioural Intervention)
Trial OverviewThe study is testing a new tool designed to help doctors and patients make better decisions together about end-of-life care in the emergency room. It aims to facilitate quality conversations about patient goals when facing serious illness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Shared decision aid assessmentExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

In a study involving 186 patients in Dutch mental health care, Shared Decision-Making (SDM) using Routine Outcome Monitoring (ROM) significantly reduced Decisional Conflict (DC) among depressed patients, indicating improved engagement and satisfaction in their treatment decisions.
While overall differences in DC, working alliance, and treatment outcomes were not significant between the SDM and standard decision-making groups, effective application of SDM and ROM correlated with better treatment outcomes, suggesting the need for further investment in patient-oriented approaches.
Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial.Metz, MJ., Veerbeek, MA., Twisk, JWR., et al.[2020]
Three healthcare organizations in the USA routinely measured shared decision-making (SDM) from patients' perspectives, highlighting the importance of patient involvement in healthcare decisions.
Facilitators for effective SDM measurement included organizational commitment to SDM, flexibility in measurement methods, and existing programs, while barriers included competing priorities and a lack of perceived benefits from measuring SDM.
Routine patient-reported experience measurement of shared decision-making in the USA: a qualitative study of the current state according to frontrunners.Forcino, RC., Meinders, MJ., Engel, JA., et al.[2021]
Patients using the arriba-lib decision aid reported high satisfaction with the shared decision-making process, with two-thirds expressing a desire for future consultations using the tool.
The study found that 80.7% of patients implemented their decisions made with the aid, indicating that the decision aid effectively supports adherence to treatment choices across diverse patient demographics.
Acceptance of shared decision making with reference to an electronic library of decision aids (arriba-lib) and its association to decision making in patients: an evaluation study.Hirsch, O., Keller, H., Krones, T., et al.[2021]

References

Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial. [2020]
Routine patient-reported experience measurement of shared decision-making in the USA: a qualitative study of the current state according to frontrunners. [2021]
Acceptance of shared decision making with reference to an electronic library of decision aids (arriba-lib) and its association to decision making in patients: an evaluation study. [2021]
The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. [2021]
Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. [2022]
Goal-Based Shared Decision-Making: Developing an Integrated Model. [2022]
Interventions to support shared decision making for medication therapy in long term conditions: A systematic review. [2020]
Will older persons and their clinicians use a shared decision-making instrument? [2022]
Efficacy of a Peer-Led, Recovery-Oriented Shared Decision-Making System: A Pilot Randomized Controlled Trial. [2019]
The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. [2022]