Patient Priorities Care for Multiple Chronic Conditions

(PPC Trial)

No longer recruiting at 1 trial location

Overseen By Lilian N Dindo, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Nursing home, Dialysis, Psychosis, Dementia, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special care approach called Patient Priorities Care can better support Veterans with multiple ongoing health issues. The goal is to make treatment less overwhelming and align care with what matters most to them, compared to usual care. Participants will collaborate with a facilitator to identify health goals and preferences, which will guide the primary care doctor's treatment plan. Veterans who have had at least two recent medical visits and manage three or more health problems, or take ten or more medications, may be well-suited for this trial. As an unphased trial, this study offers Veterans a unique opportunity to shape their care according to personal health priorities.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves patients with multiple chronic conditions who are prescribed 10 medications, it seems likely that you can continue your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the trial focuses on aligning care with patient priorities.

What prior data suggests that the Patient Priorities Care protocol is safe for older Veterans with multiple chronic conditions?

Research shows that Patient Priorities Care (PPC) is generally well-received by older adults with multiple health issues. Studies have primarily highlighted the benefits of aligning care with patients' values, and they report no major safety concerns or negative effects. PPC focuses on understanding patients' health goals and adjusting care plans to match these priorities, which may feel less overwhelming than traditional methods.

The trial is labeled as "Not Applicable" for its phase, indicating it is non-invasive and centers on communication and coordinating care rather than using medication or surgery. This suggests a lower risk of negative effects. For those considering participation in a trial involving PPC, current research indicates it is a safe approach with no known harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Patient Priorities Care (PPC) for those with multiple chronic conditions because it shifts the focus from standard medical protocols to what truly matters to the patient. Unlike traditional approaches that may prioritize symptom management or disease metrics, PPC starts with understanding the patient's personal health goals and preferences. This method guides healthcare providers to tailor care plans that align closely with the individual’s priorities, potentially leading to greater patient satisfaction and improved adherence to treatment. By facilitating a structured conversation between patients and their primary care providers, PPC aims to create a more personalized healthcare experience.

What evidence suggests that Patient Priorities Care is effective for managing multiple chronic conditions?

Research has shown that Patient Priorities Care (PPC), one of the approaches studied in this trial, aligns medical treatments with what patients value most about their health. Some studies suggest this approach may improve important health outcomes for older adults with multiple chronic conditions. By focusing on patient desires and needs, PPC tailors healthcare decisions to what matters most to them. However, it has not shown benefits in every area, such as social roles. Overall, PPC aims to make treatment decisions that better reflect each patient's needs and priorities. ^{1 2 4 6 7}

Who Is on the Research Team?

Lilian N. Dindo, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for older veterans with multiple chronic conditions who have had at least two medical appointments in the past 18 months, are on ten or more medications, and have three active health issues. They must be able to give informed consent and not be expected to pass away within a year. Those with severe mental illness, dementia, substance abuse, complete hearing loss, frequent no-shows for appointments, nursing home residents or those needing a translator are excluded.

Inclusion Criteria

2 encounters in prior 18 months

I have 3 active health issues or am taking 10 medications.

Exclusion Criteria

Dementia

I need a translator to communicate in English.

I am on dialysis for end-stage kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Patient Priorities Care Facilitation

A facilitator conducts a structured assessment to establish patient priorities and goals before the PCP visit.

2-3 weeks

1 visit (in-person)

Treatment

PCPs align care with patients' priorities using established decisional strategies.

4 months

Regular visits as per usual care schedule

Follow-up

Participants are monitored for treatment burden, home and community services use, shared decision making, and goal setting.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Priorities Care
• Usual Care

Trial Overview The study compares Patient Priorities Care—a method focusing on patients' personal health priorities and reducing treatment burden—with usual care among veterans. Participants will be randomly assigned to either approach to see if it better aligns treatments with their life goals and reduces healthcare strain.

How Is the Trial Designed?

Group I: Patient Priorities Care Experimental Treatment 1 Intervention

A facilitator will schedule a PPC facilitation encounter 2-3 weeks before an upcoming PCP visit. The facilitator conducts a structured assessment using a written conversation guide that begins with general questions establishing what is most important to Veterans about their health and moves toward establishing specific goals (actionable outcomes), and what patients are willing/not willing to do to achieve these goals (care preferences). The result is a structured patient priorities report delivered to PCPs designed to facilitate changes in the patient's care plan to align it with his/her priorities. In the subsequent visit, the PCP will use one or more of the established PPC decisional strategies to align care with patients' priorities. Education for PCPs about the facilitation process, the patient priorities report, and the decisional strategies occurs prior to the PCP seeing any intervention patients. The PCP will document changes in care made to achieve the identified priorities.

Group II: Usual Care Placebo Group 1 Intervention

PCPs will not be alerted when an encounter involves a UC group participant. UC participant visits will appear the same as all other unenrolled patient encounters. UC participants will not receive any additional preparation

Patient Priorities Care is already approved in United States for the following indications:

Approved in United States as Patient Priorities Care for:

• Multiple Chronic Conditions
• Geriatric Care

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A qualitative study involving 10 primary care clinicians and 5 cardiologists identified key challenges in aligning healthcare decisions with the priorities of older patients with multiple chronic conditions, such as uncertainty and differing perspectives between patients and clinicians.

Strategies to improve decision-making included focusing on one priority that matters most to each patient, conducting trials of treatment options, and emphasizing functional outcomes over merely symptom elimination, suggesting that patient-centered care is achievable despite its complexities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and strategies in patients' health priorities-aligned decision-making for older adults with multiple chronic conditions. Tinetti, M., Dindo, L., Smith, CD., et al.[2023]

Patients are central to the patient safety agenda, benefiting from good care and suffering from unsafe practices, yet their preferences and needs are often overlooked in safety programs.

To improve patient safety, it is essential to actively engage patients in safety initiatives, ensuring that their experiences inform safety practices and that there is investment in strategies that enhance safety and align with patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety. Remember who it's really for. Brennan, PF., Safran, C.[2004]

A systematic review of 24 studies revealed a low level of agreement between the health priorities of patients with multimorbidity and those of clinicians, indicating a potential gap in understanding patient needs.

Patients prioritized preserving their functional ability based on their personal illness experiences, while clinicians tended to focus on long-term health risks, highlighting the importance of aligning treatment goals for better patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities of patients with multimorbidity and of clinicians regarding treatment and health outcomes: a systematic mixed studies review. Sathanapally, H., Sidhu, M., Fahami, R., et al.[2021]

In a study involving two general practices and five doctors, 31 adverse events were identified, with about half causing no health consequences, but a third leading to worsened symptoms and some resulting in unplanned hospital admissions.

The majority of adverse events (three-quarters) had potential negative health consequences, highlighting the need for patient safety programs in primary care to address both actual harm and the risk of harm from adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm caused by adverse events in primary care: a clinical observational study. Wetzels, R., Wolters, R., van Weel, C., et al.[2009]

A study involving interviews with 101 frontline clinicians and focus groups with 65 patients revealed that both groups view patient safety in primary care similarly, focusing on work functions and responsibilities rather than just expert-defined domains.

The findings suggest that understanding patient safety through the lens of frontline experiences may be more effective than traditional domain-based approaches, highlighting the importance of aligning safety concepts with actual care delivery practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Safety in Primary Care: Conceptual Meanings to the Health Care Team and Patients. Lai, AY., Yuan, CT., Marsteller, JA., et al.[2021]

The Patient Priorities Care (PPC) approach was implemented in a study involving 119 older adults with multiple chronic conditions, focusing on aligning care with patients' health outcome goals and preferences, which is crucial for improving their care experience.

After 10 months, 77% of participants returned to their primary care provider for follow-up discussions about their priorities, indicating that while implementing PPC is feasible, challenges remain in clinician time management and decision-making processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing Patient Priorities Care for Older Adults with Multiple Chronic Conditions. Blaum, CS., Rosen, J., Naik, AD., et al.[2020]

The study developed a natural language processing (NLP) model that accurately identifies when clinicians document patient priorities in electronic health records, achieving a high accuracy of 0.92 during validation.

Out of 778 patient notes analyzed, 75.7% contained patient priorities language, demonstrating the model's effectiveness in measuring the adoption of the Patient Priorities Care (PPC) model in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Adoption of Patient Priorities-Aligned Care Using Natural Language Processing of Electronic Health Records: Development and Validation of the Model. Razjouyan, J., Freytag, J., Dindo, L., et al.[2021]

The health priorities identification (HPI) process, implemented in VA Community Living Centers, was found to be feasible and effective in aligning care with patient priorities over an 8-month quality improvement program involving 20 encounters.

Facilitators reported that the HPI process was appropriate and not burdensome, enhancing person-centered care and improving documentation in electronic health records, indicating its potential for broader application in age-friendly health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding Post-Hospital Recovery by 'What Matters:' Implementation of Patient Priorities Identification in a VA Community Living Center. Ritchey, KC., Solberg, LM., Citty, SW., et al.[2023]

In a pilot study involving 70 older adults with multiple chronic conditions, identifying patient healthcare priorities during routine visits led to fewer medications being added for those in the Patient Priorities Care (PPC) group compared to usual care (UC) patients.

Patients in the PPC group received more referrals to community services and aligned self-management tasks, indicating that incorporating patient priorities can enhance care decisions and better meet individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Clinicians Aligning Health Care with Patient Priorities in Geriatrics Ambulatory Care. Freytag, J., Dindo, L., Catic, A., et al.[2021]

In a study involving 100 family practitioners and 888 patients with multiple chronic conditions, it was found that highly prevalent conditions were not always ranked as the top medical priority, with only 66% being the highest priority and 33% in the top three.

The research revealed no correlation between the prevalence of chronic conditions and their priority ranking, indicating that family practitioners prioritize conditions based on individual patient needs rather than their commonality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family practitioners' top medical priorities when managing patients with multimorbidity: a cross-sectional study. Herzig, L., Mueller, Y., Haller, DM., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38261319/

Patient Priorities-Aligned Care for Older Adults With Multiple ... This nonrandomized trial of priorities-aligned care showed no benefit for social roles or CollaboRATE.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814211

Patient Priorities–Aligned Care for Older Adults With ... These findings suggest that aligning care with health priorities may help improve some important health outcomes for older adults.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001964

A hybrid type 1 trial protocol of patient priorities care for ... In this clinical trial, we evaluate implementation and effectiveness outcomes of an innovative, structured, patient-centered care approach (Patient Priorities ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10807252/

Patient Priorities–Aligned Care for Older Adults With ... This nonrandomized controlled trial compares health care aligned with patient values, goals, and priorities with usual care to improve clinical outcomes for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04510948

Patient Priority Care for Older Adults With Multiple Chronic ... Patient Priorities Care (PPC) is an approach that aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each ...

6. medicine.yale.edu medicine.yale.edu/news-article/patient-priorities-care-shows-potential-improving-outcomes-older-adults-multiple-chronic-conditions/

Patient Priorities Care Shows Potential for Improving ... In a new JAMA Network Open study, researchers explored the impact of Patient Priorities Care (PPC) on older adults with multiple chronic conditions.

7. jamda.com jamda.com/article/S1525-8610(24)00002-1/fulltext

Patient Priorities Care Increases Long-Term Service and ... PPC results in higher LTSS use but not ED or urgent care in these veterans. LTSS use was higher for nonfrail veterans and those living longer.