Patient Priorities Care for Dementia

(IN-TX-PPC Trial)

No longer recruiting at 3 trial locations

Overseen By Jennifer L Carnahan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Nursing home, Hospice, Decline PPC, others

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

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Patient Priorities Care for individuals with dementia or mild cognitive impairment. It focuses on understanding what matters most to patients and their care partners, facilitating important conversations with healthcare professionals. The trial evaluates whether electronic health records effectively capture outcomes such as time spent at home, the number of medications, and referrals to specialists. It suits those diagnosed with dementia or mild cognitive impairment, who receive care from a participating doctor, and have an upcoming clinic visit. As an unphased trial, it offers a unique opportunity to contribute to research that prioritizes patient-centered care.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, the study will assess the total number of medications, so it's possible that medication management might be discussed during the trial.

What prior data suggests that this method is safe for patients with dementia or mild cognitive impairment?

Research has shown that Patient Priorities Care focuses on what matters most to patients with dementia or mild memory problems. This approach ensures healthcare decisions align with the patient’s goals and preferences. Studies have found that prioritizing care in this way can improve health outcomes for patients with long-term conditions. Since this care involves discussions and planning rather than medications or procedures, no side effects have been reported. This suggests that Patient Priorities Care is safe and well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Patient Priorities Care for dementia because it shifts the focus from a one-size-fits-all treatment approach to tailoring care based on what matters most to the patient. Unlike standard treatments that primarily address symptoms, this approach involves engaging patients and their care partners in meaningful conversations to align medical care with their personal goals and preferences. By documenting these priorities in the Electronic Health Record, it aims to ensure that all healthcare providers are on the same page, potentially leading to more satisfying and effective patient care.

What evidence suggests that Patient Priorities Care is effective for dementia?

Research has shown that focusing on what patients with dementia or mild cognitive impairment value most can lead to better health outcomes. In this trial, participants will receive Patient Priorities Care, which involves personalized conversations to identify and prioritize their health goals. Studies indicate that this approach benefits older adults, especially those with multiple chronic conditions, by addressing their specific needs and goals. Early findings suggest that centering care around a patient's priorities may reduce unnecessary treatments and lead to more meaningful health improvements. This method underscores the importance of personalized care in managing complex health issues. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer L Carnahan, MD

Principal Investigator

Regenstrief Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for English-speaking patients at Indiana sites or English/Spanish speakers in Texas, aged 40+, with mild cognitive impairment or dementia. They must be treated by a participating doctor and have an outpatient visit scheduled within two months.

Inclusion Criteria

Receiving care with a participating physician

Patients must meet all of the following criteria to participate in this study:

I am 40 years old or older.

Exclusion Criteria

Is enrolled in hospice

I choose not to participate in the PPC conversation.

Participants who meet any of the following criteria will be excluded from the study:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Priorities Care Conversation

Participants engage in a conversation about their priorities with trained facilitators at the clinic

Baseline and up to 2 months post baseline

1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes using the electronic health record

2 months pre and 2 months post baseline

What Are the Treatments Tested in This Trial?

Interventions

• Patient Priorities Care

Trial Overview

The study tests Patient Priorities Care (PPC) in primary care and geriatrics clinics. It involves identifying eligible patients using health records, engaging them in PPC conversations about their priorities, and measuring outcomes like days at home.

How Is the Trial Designed?

Group I: Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment Experimental Treatment 1 Intervention

Patients (and their care partners when available) will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient or patient care partner dyad. This conversation will be documented in the Electronic Health Record.

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?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Person-centered outcome measures (PCOMs) can enhance shared decision-making in dementia care by helping to understand individual needs, set care priorities, and evaluate treatment decisions, based on a review of 10 studies involving 1064 participants.

While PCOMs show potential for improving communication and care outcomes, the evidence for their effectiveness in enhancing physical function and daily activities remains weak, indicating a need for further research and training for family caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do person-centered outcome measures enable shared decision-making for people with dementia and family carers?-A systematic review. Aworinde, J., Ellis-Smith, C., Gillam, J., et al.[2023]

Person-centered care (PCC) is essential for delivering effective long-term services and supports (LTSS), and understanding meaningful outcomes is crucial for improving care processes.

To enhance the dementia care workforce's effectiveness, training in PCC and practical measures for assessing care quality are necessary, highlighting the need for policy changes and research in workforce development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations to Deliver Person-Centered Long-Term Care for Persons Living With Dementia. Wagner, LM., Van Haitsma, K., Kolanowski, A., et al.[2022]

This study aims to use the Analytic-Hierarchy-Process (AHP) to effectively gather and quantify the preferences of people living with dementia (PlwD) regarding their care, which is currently under-researched.

The research will also compare these patient preferences with physicians' judgments to identify any discrepancies, which is crucial for implementing truly person-centered care in dementia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elicitation of quantitative, choice-based preferences for Person-Centered Care among People living with Dementia in comparison to physicians' judgements in Germany: study protocol for the mixed-methods PreDemCare-study. Mohr, W., Rädke, A., Michalowsky, B., et al.[2022]

The review identified seven dementia-specific patient-reported outcome measures (PROMs) that capture patients' perspectives on quality of life and health impacts, but none are currently used in dementia registries.

Most PROMs are administered by researchers or clinicians and often completed by proxies rather than the patients themselves, highlighting a need for more direct patient involvement in reporting their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures to Inform Care of People With Dementia-A Systematic Scoping Review. Ayton, DR., Gardam, ML., Pritchard, EK., et al.[2021]

Nurses in an acute hospital dementia unit reported positive experiences with person-centred care (PCC), such as forming meaningful connections with patients, despite facing challenges like managing difficult behaviors.

The study highlighted that building confidence through training and teamwork is essential for nurses to effectively implement PCC, and that organizational support is crucial for overcoming initial challenges and enhancing care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-Centred Dementia Care in an Acute Hospital: Experiences from Nurses Working in a Specialized Dementia Unit. Cheong, CY., Tay, FHE., Choo, J., et al.[2023]

The study highlights that ensuring patient safety for individuals with advanced dementia in hospitals involves a collaborative approach among staff, emphasizing leadership, teamwork, and transparency to effectively manage risks.

Incorporating the voices of patients and their families is crucial for creating a safe care environment, suggesting that safety practices should be adaptable and responsive to the complexities of everyday clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety for people experiencing advanced dementia in hospital: A video reflexive ethnography. Dadich, A., Rodrigues, J., De Bellis, A., et al.[2023]

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]

A study involving 50 community-dwelling individuals with cognitive impairments and 25 physicians found that patient preferences for person-centered care closely aligned with physicians' judgments, indicating effective communication and understanding between the two groups.

The only significant difference noted was in the preference for Memory Exercises, where patients valued it more than physicians did, suggesting a need for further exploration of specific care elements in PCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do They Align? Congruence Between Patient Preferences of People Living with Cognitive Impairments and Physicians' Judgements for Person-Centered Care: An Analytic Hierarchy Process Study. Mohr, W., Rädke, A., Afi, A., et al.[2023]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

People living with dementia (PwD) prefer to be informed about their diagnosis early on to facilitate anticipatory care planning, highlighting the importance of communication in their treatment process.

The highest priority for PwD is the quality of life of their caregivers, indicating that they are concerned about not being a burden, and they desire to be involved in medical decisions, particularly regarding their daily routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities and Preferences of People Living with Dementia or Cognitive Impairment - A Systematic Review. Wehrmann, H., Michalowsky, B., Lepper, S., et al.[2022]

In a study of 710 older patients (aged over 70) admitted to a hospital, 8.6% experienced reported adverse events (RAEs), with patient-related incidents linked to factors like male gender, delirium, and cognitive impairment.

Despite the high incidence of RAEs, which occurred at a rate of 2.1 per person year, these events were not associated with increased mortality during the hospital stay, as 11.1% of patients died regardless of RAE occurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. Watkin, L., Blanchard, MR., Tookman, A., et al.[2021]

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]

Patients with dementia experience higher rates of adverse events in hospitals, leading to complications like falls, delirium, and increased mortality, highlighting the need for improved safety measures.

A multifactorial approach addressing various levels of care—such as patient assessment, staff training, and organizational support—is essential to enhance safety and quality of care for dementia patients in acute hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can we keep patients with dementia safe in our acute hospitals? A review of challenges and solutions. George, J., Long, S., Vincent, C.[2022]

Citations

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The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and ...

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Persons living with dementia frequently experience difficulty managing multiple chronic conditions (MCC) and have poorer outcomes.

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Patient Priorities Care- North Carolina (PPC-NC)

Patient priorities care (PPC) is an innovative solution to address the discrepancy between the care older adults with MCC receive and the outcomes they want.

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Priorities and Preferences of People Living with Dementia or ...

This study aimed to summarize preferences of PwD or people with mild cognitive impairment (MCI), considering all relevant aspects of health care and everyday ...

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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.

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agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.70136

A Qualitative Study of Health Priorities of People With ...

Hispanic people with dementia and their care partners prioritized maintaining social connection and independence when describing their health ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6784811/

Association of Patient Priorities–Aligned Decision-Making ...

This study's findings suggest that aligning care with patients' priorities may improve outcomes for patients with multiple chronic conditions.