Clinical trial NCT06001775: Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
Official title: Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Keywords: dementia
mild cognitive impairment
patient priorities care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2023-08-21
Enrollment: 173
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of a care partner
timeFrame: 2 months pre and 2 months post baseline
measure: Number of patients with documentation of Patient Priorities Care discussion in the electronic health record
timeFrame: Baseline
measure: Acceptability
timeFrame: Baseline and up to 2 months post baseline
measure: Appropriateness
timeFrame: Baseline and up to 2 months post baseline
measure: Feasibility of the intervention as described by Proctor et al
timeFrame: Baseline and up to 2 months post baseline
measure: Fidelity to the intervention
timeFrame: Baseline and up to 2 months post baseline
measure: Potential for future adoption of Patient Priorities Care intervention
timeFrame: Baseline and up to 2 months post baseline
Secondary outcomes:
measure: Number of patient days at home
timeFrame: 2 months pre and 2 months post baseline
measure: Number of total medications
timeFrame: 2 months pre and 2 months post baseline
measure: Number of new referrals to specialist physicians
timeFrame: 2 months pre and 2 months post baseline
measure: Number of Enrolled Eligible Dyads across racial, ethnic and socioeconomic subgroups
timeFrame: 2 months pre and 2 months post baseline
measure: Number of patients across racial, ethnic, and socioeconomic subgroups with documentation of Patient Priorities Care discussion in the electronic health record
timeFrame: 2 months pre and 2 months post baseline
measure: Clinical outcomes measures across racial, ethnic, and socioeconomic subgroups
timeFrame: 2 months pre and 2 months post baseline
measure: Acceptability across racial, ethnic, and socioeconomic subgroups.
timeFrame: Baseline and up to 2 months post baseline
measure: Appropriateness across racial, ethnic and socioeconomic subgroups
timeFrame: Baseline and up to 2 months post baseline
measure: Number of Patients with Social Factors Indicated in the Electronic Health Record
timeFrame: Baseline and up to 2 months post baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Connected Care
state: Indiana
city: Houston
country: United States
facility: University of Texas Health- Houston
state: Texas
Study officials:
affiliation: Regenstrief Institute, Inc.
name: Jennifer L Carnahan, MD
role: PRINCIPAL_INVESTIGATOR
References: