Shared Decision Aid for Goals of Care

Recruiting at 2 trial locations

Overseen by Laura 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

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

Exclusion Criteria

I have experienced changes in my mental state.

Incarcerated or in Police Custody

GCS scores < 15

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 Overview The 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

Group I: Shared decision aid assessment Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

This study will evaluate the effectiveness of patient decision aids in improving patient involvement in diabetes medication choices, medication adherence, and overall diabetes care outcomes among 240 patients with type 2 diabetes across 8 primary care practices.

The research will also explore the barriers and facilitators to integrating decision aids into routine clinical practice, providing insights into how to enhance patient-centered care in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. LeBlanc, A., Ruud, KL., Branda, ME., et al.[2021]

The patient-oriented decision aid for diabetes did not significantly improve patient empowerment in setting and achieving treatment goals compared to usual care, with only a slight increase in empowerment scores.

While there was a trend towards more intensive lipid-regulating treatment in the intervention group, this did not reach statistical significance, although the printed version of the decision aid showed a significant effect in comparison to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. Denig, P., Schuling, J., Haaijer-Ruskamp, F., et al.[2022]

The proposed integrated model for shared decision-making (SDM) emphasizes the importance of goal setting, particularly for patients with multiple long-term conditions, by incorporating a visualization tool called a Goal Board.

This model aims to enhance person-centered decision-making by helping patients prioritize their goals and align them with appropriate treatment options, although further research is needed to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-Based Shared Decision-Making: Developing an Integrated Model. Elwyn, G., Vermunt, NPCA.[2022]

A systematic review of 23 studies found that shared decision-making (SDM) interventions positively impacted patient involvement in decision-making and risk estimation, but had limited effects on other outcomes like medication adherence.

Electronically delivered SDM interventions and those that included value clarification exercises were more likely to lead to positive patient outcomes, highlighting the importance of intervention design in achieving effective patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to support shared decision making for medication therapy in long term conditions: A systematic review. Mathijssen, EGE., van den Bemt, BJF., van den Hoogen, FHJ., et al.[2020]

Older patients and clinicians expressed a strong interest in using a shared decision-making (SDM) instrument to enhance communication and ensure alignment on treatment goals during clinical encounters, as indicated by focus groups involving 41 older persons and 11 clinicians.

Participants viewed the SDM instrument as beneficial for customizing care and facilitating discussions, although some concerns were raised about time constraints and unfamiliarity with the SDM process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will older persons and their clinicians use a shared decision-making instrument? Naik, AD., Schulman-Green, D., McCorkle, R., et al.[2022]

The pilot study involving 56 outpatients with mental illness showed that a shared decision-making system improved patients' perceptions of their relationship with doctors compared to standard treatment.

However, this intervention did not significantly impact most clinical and recovery-related outcomes, indicating that while communication may improve, it does not necessarily lead to better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Peer-Led, Recovery-Oriented Shared Decision-Making System: A Pilot Randomized Controlled Trial. Yamaguchi, S., Taneda, A., Matsunaga, A., et al.[2019]

The SDM-Q-9, a 9-item questionnaire developed to measure Shared Decision Making (SDM) in clinical encounters, demonstrated high reliability with a Cronbach's alpha of 0.938 in a study involving 2351 patients in German primary care.

This instrument showed strong face validity and acceptance among patients, making it a useful tool for evaluating SDM in healthcare settings, although further testing in diverse populations is needed to confirm its generalizability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Kriston, L., Scholl, I., Hölzel, L., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Routine patient-reported experience measurement of shared decision-making in the USA: a qualitative study of the current state according to frontrunners. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Goal-Based Shared Decision-Making: Developing an Integrated Model. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Interventions to support shared decision making for medication therapy in long term conditions: A systematic review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Will older persons and their clinicians use a shared decision-making instrument? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Peer-Led, Recovery-Oriented Shared Decision-Making System: A Pilot Randomized Controlled Trial. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. [2022]