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

Primary Purpose

Dementia, Mild Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Patient Priorities Care

About this trial

This is an interventional supportive care trial for Dementia focused on measuring dementia, mild cognitive impairment, patient priorities care

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Regenstrief Institute, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment

Arm 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.

Outcomes

Primary Outcome Measures

Number of patients with documentation of Patient Priorities Care discussion in the electronic health record

We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded

Secondary Outcome Measures

Identification of a care partner

Identification of a care partner for 50% of eligible persons living with dementia and mild cognitive impairment. Care partners will be identified based on information provided by the patient, the electronic health record, and the clinical team.

Acceptability

We will utilize Sekhon et al's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.

Appropriateness

We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.

Feasibility of the intervention using Proctor et al as a guide

Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.

Fidelity to the intervention

Fidelity will be assessed when select charts are reviewed for adherence to the protocol.

Potential for future adoption of Patient Priorities Care intervention

We will assess potential for future adoption of the intervention via qualitative exit interviews with patients, care partners, and clinicians.

Number of patient days at home

We will use the electronic health record to assess for hospital visits, emergency room visits, or nursing home admissions.

Number of total medications

We will use the electronic health record to assess the medication list total at 2 months pre and post baseline.

Number of new referrals to specialist physicians

We will use the electronic health record to assess referrals to specialists at 2 months pre and post baseline

Full Information

NCT ID

NCT06001775

First Posted

August 7, 2023

Last Updated

September 6, 2023

Sponsor

Indiana University

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT06001775

Brief Title

Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia

Acronym

IN-TX-PPC

Official Title

Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 31, 2023 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia, Mild Cognitive Impairment

Keywords

dementia, mild cognitive impairment, patient priorities care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Patient Priorities Care

Intervention Description

According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.

Primary Outcome Measure Information:

Title

Number of patients with documentation of Patient Priorities Care discussion in the electronic health record

Description

We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Identification of a care partner

Description

Time Frame

2 months pre and 2 months post baseline

Title

Acceptability

Description

Time Frame