Shared Decision Aid for Goals of Care

Recruiting at 2 trial locations

Overseen By Derek VanMeter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: GCS < 15, Altered mental status, Pregnancy, Incarceration, Communication barriers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a tool to improve conversations between patients and doctors about end-of-life care in the emergency room. The goal is to make these important discussions more routine and beneficial. It includes a decision aid, which serves as a guide to help discuss care options. The trial seeks patients over 60 who visit the Mayo Clinic Rochester Emergency Department and are at high risk for serious illness. Participants must be stable and able to discuss their care without delay. As an unphased trial, this study offers a unique opportunity to contribute to enhancing communication tools that can benefit many patients in critical situations.

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 prior data suggests that this decision aid tool is safe for use in the Emergency Department?

Research has shown that tools like the decision aid in this trial are generally safe. These tools facilitate discussions between doctors and patients about care options. Because they do not involve drugs or medical procedures, they pose a low risk of harm.

Studies have found that decision aids in healthcare can enhance communication without known side effects. Doctors find these tools helpful for clear and effective conversations with patients. Overall, they are well-received and considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shared Decision Aid for Goals of Care because it focuses on improving communication between patients and emergency physicians. Unlike traditional approaches that often leave patients feeling uninformed or overwhelmed, this decision aid is designed to facilitate clear and effective discussions about care preferences. By actively involving patients in decision-making, the aid aims to ensure that treatment aligns more closely with their individual values and goals. This patient-centered approach could lead to more personalized care and better satisfaction with treatment decisions.

What evidence suggests that this decision aid is effective for improving end of life discussions?

Research has shown that when doctors and patients make decisions together, conversations about end-of-life care improve significantly. In this trial, participants will use a shared decision aid to facilitate goals of care discussions with an emergency physician. Studies have found that decision aids help patients learn more, with one review showing an average increase in knowledge by about 13.9 points on a 100-point scale. This improvement means patients better understand their choices and potential outcomes. Additionally, these tools often reduce uncertainty and increase patients' confidence and satisfaction with their care decisions. Overall, shared decision-making tools enhance communication and help ensure that care aligns with patients' values and preferences. ^{5 6 7 8 9}

Who Is on the Research Team?

Laura E Walker

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Shared Decision Aid Assessment

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10423463/

Shared decision-making as a method of care - PubMed Central Being able to cocreate and jointly revise plans of care may reduce the risk of a poor-quality decision, that is, one that does not respond ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9345077/

Effectiveness and implementation of SHared decision ... The aim of the SHared decision-making supported by OUTcome information (SHOUT) study is to assess the effectiveness of the intervention, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772628224000219

Measuring decision aid effectiveness for end-of-life care Outcome measures identified included decisional conflict, less aggressive care desired, knowledge improvements, communication improvements, tool satisfaction, ...

4. ebm.bmj.com ebm.bmj.com/content/28/4/213

Shared decision-making as a method of care Self-management logs, patient-reported outcome trends, results from ancillary laboratory and imaging tests can all support the problem-solving mode of SDM.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2790280

Shared Decision-Making Between Patients and Clinicians ... Eleven trials with 3619 participants showed an improvement in mean knowledge scores with pDAs (mean difference, 13.9 on a scale of 0-100 [95% CI, 9.0-18.8]).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5145730/

Development and testing of shared decision-making ... The goal was to determine a prioritized research agenda for the development and testing of shared decision-making interventions for use in emergency care.

7. annemergmed.com annemergmed.com/article/S0196-0644(18)30908-9/fulltext

Facilitating Shared Decisionmaking in Goals of Care ... To develop a decision aid to facilitate a shared decisionmaking conversation regarding goals of care in the emergency department.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224003205

Clinicians' perspectives on the implementation of patient ... The objective of this study was to explore barriers and facilitators identified by ECs regarding the implementation of DAs in the emergency department (ED).

9. bhm.scholasticahq.com bhm.scholasticahq.com/article/122787-shared-decision-making-in-patient-care-advantages-barriers-and-potential-solutions

Shared Decision-Making in Patient Care Shared Decision-Making (SDM) is an interactive, collaborative process where physicians focus on the best scientific evidence and patients' goals ...