Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
- Conditions
- DementiaMild Cognitive Impairment
- Interventions
- Behavioral: Patient Priorities Care
- Registration Number
- NCT06001775
- Lead Sponsor
- Indiana University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 173
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment Patient Priorities Care 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.
- Primary Outcome Measures
Name Time Method Potential for future adoption of Patient Priorities Care intervention Baseline and up to 2 months post baseline We will assess potential for future adoption of the intervention via qualitative exit interviews with patients, care partners, and clinicians.
Identification of a care partner 2 months pre and 2 months post baseline 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 Baseline and up to 2 months post baseline 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 Baseline and up to 2 months post baseline We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.
Number of patients with documentation of Patient Priorities Care discussion in the electronic health record Baseline We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded
Feasibility of the intervention as described by Proctor et al Baseline and up to 2 months post baseline Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.
Fidelity to the intervention Baseline and up to 2 months post baseline Fidelity will be assessed when select charts are reviewed for adherence to the protocol.
- Secondary Outcome Measures
Name Time Method Number of Enrolled Eligible Dyads across racial, ethnic and socioeconomic subgroups 2 months pre and 2 months post baseline Number of eligible dyads enrolled across racial, ethnic and socioeconomic subgroups.
Number of patient days at home 2 months pre and 2 months post baseline We will use the electronic health record to assess for hospital visits, emergency room visits, or nursing home admissions.
Number of total medications 2 months pre and 2 months post baseline 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 2 months pre and 2 months post baseline We will use the electronic health record to assess referrals to specialists at 2 months pre and post baseline
Number of patients across racial, ethnic, and socioeconomic subgroups with documentation of Patient Priorities Care discussion in the electronic health record 2 months pre and 2 months post baseline We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded
Clinical outcomes measures across racial, ethnic, and socioeconomic subgroups 2 months pre and 2 months post baseline Days at home, total medications, and new referrals to specialist will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.
Acceptability across racial, ethnic, and socioeconomic subgroups. Baseline and up to 2 months post baseline Acceptability effects will be further evaluated across racial, ethnic, and socioeconomic subgroups. 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 across racial, ethnic and socioeconomic subgroups Baseline and up to 2 months post baseline Appropriateness will be further evaluated across racial, ethnic, and socioeconomic subgroups. We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.
Number of Patients with Social Factors Indicated in the Electronic Health Record Baseline and up to 2 months post baseline Established algorithms for detecting social factors that may influence patient care priorities, such as housing instability, financial insecurity, or transportation concerns will be deployed. These algorithms have been previously created and validated across the care spectrum and will be deployed at the primary site in current form on the established natural language processing platform at Regenstrief Institute. Similar data will be manually extracted using keywords from the primary site for the secondary site. All available clinical notes for the recruited cohort will be annotated by the software as either positive or negative for the social factors. This can then be incorporated into analyses.
Trial Locations
- Locations (3)
Indiana University Health Connected Care
🇺🇸Indianapolis, Indiana, United States
University of Texas Health- Houston
🇺🇸Houston, Texas, United States
Eskenazi Health
🇺🇸Indianapolis, Indiana, United States