Patient Priorities Care for Dementia

(IN-TX-PPC Trial)

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

173 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are: * demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patient and patient-care partner dyads who will engage in a Patient Priorities Care conversation with a trained facilitator. * demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians. * examine key feasibility measures across racial, ethnic, and socioeconomic subgroups. Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.

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 data supports the idea that Patient Priorities Care for Dementia is an effective treatment?

The available research shows that Patient Priorities Care (PPC) for dementia focuses on aligning healthcare with what matters most to patients. While specific data on its effectiveness for dementia isn't detailed, PPC is designed to improve care by considering patient preferences, which can lead to better satisfaction and outcomes. Compared to other treatments, PPC emphasizes understanding and incorporating patient choices, which is crucial for effective dementia care. This approach can potentially lead to more personalized and effective treatment plans, although more specific data on its direct impact on dementia outcomes would be beneficial. ^{1 2 3 4 5}

What safety data exists for Patient Priorities Care for Dementia?

The provided research does not specifically mention safety data for Patient Priorities Care for Dementia or its variants. The studies focus on general patient safety issues for individuals with dementia in hospital settings, highlighting challenges such as adverse events, increased length of stay, and the need for a multifactorial approach to improve safety. However, they do not provide specific safety data for the Patient Priorities Care treatment. ^{6 7 8 9 10}

Is Patient Priorities Care a promising treatment for dementia?

Yes, Patient Priorities Care is promising because it focuses on aligning healthcare with what patients with dementia find most important, which can lead to better care and outcomes. ^{2 5 11 12 13}

Research Team

Jennifer L Carnahan, MD

Principal Investigator

Regenstrief Institute, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Canada 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. [2021]

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

Recommendations to Deliver Person-Centered Long-Term Care for Persons Living With Dementia. [2022]

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

Patient-Reported Outcome Measures to Inform Care of People With Dementia-A Systematic Scoping Review. [2021]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Patient safety for people experiencing advanced dementia in hospital: A video reflexive ethnography. [2023]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

How can we keep patients with dementia safe in our acute hospitals? A review of challenges and solutions. [2022]

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

Patient safety. Remember who it's really for. [2004]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Person-Centred Dementia Care in an Acute Hospital: Experiences from Nurses Working in a Specialized Dementia Unit. [2023]

12. Netherlands 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. [2023]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Priorities and Preferences of People Living with Dementia or Cognitive Impairment - A Systematic Review. [2022]