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Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia (IN-TX-PPC)

Indiana University logo

Indiana University

Status

Completed

Conditions

Mild Cognitive Impairment
Dementia

Treatments

Behavioral: Patient Priorities Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06001775
U54AG063546 (U.S. NIH Grant/Contract)
FY22_Pilot1_Carnahan
15345
Pro00063400 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient Inclusion Criteria

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

  • 40 years or older

    • English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
    • Receiving care with a participating physician
    • Has a scheduled outpatient care visit within 1-2 months (60 days)
    • Individual has a diagnosis of MCI or dementia

Definition: To identify individuals with dementia and MCI, we will use two or more instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months. Typically, we would include instances of these billing codes within a year of each other but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical visits and less robust billing. Diagnostic codes include:

• F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.

Care Partner Inclusion Criteria

Care partners must meet all of the following criteria to participate in the study:

  • 18 years or older
  • English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site

A note about inclusion of care partners: Clinician determination of a patient's capacity to participate in a visit independently is part of a pragmatic approach. This means that clinic staff will determine when a care partner is needed. Generally, we act under the assumption that patients who require a care partner will have already included them in previous visits and/or provider communications (and we anticipate that this will be documented in the EHR), whereas patients who attend clinic visits independently and have no documentation indicating the involvement of a care partner in their medical decisions, or a need for one, will be determined to have the capacity to also participate in a PPC visit.

Exclusion criteria

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

  • Is not community-dwelling- e.g. lives in a nursing home

  • Is enrolled in hospice

  • Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC conversation) will be excluded from the study.

    • Note that declining to receive the PPC intervention will in no way impact the care that patients receive now or in the future.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

173 participants in 1 patient group

Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment
Experimental group
Description:
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.
Treatment:
Behavioral: Patient Priorities Care

Trial contacts and locations

3

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Central trial contact

Jennifer L Carnahan, MD; Emily Burke, BA

Data sourced from clinicaltrials.gov

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