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

Dementia Clinical Trial

— IN-TX-PPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001775
• Other study ID #: FY22_Pilot1_Carnahan
• Secondary ID: 15345Pro00063400
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: Emily Burke, BA
• Phone: 3172749047
• Email: esburke[@]regenstrief.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• Patient Priorities Care
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.

Locations

Country	Name	City	State
United States	Regenstrief Institute, Inc.	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Secondary	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.	2 months pre and 2 months post baseline
Secondary	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.	Baseline and up to 2 months post baseline
Secondary	Appropriateness	We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.	Baseline and up to 2 months post baseline
Secondary	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.	Baseline and up to 2 months post baseline
Secondary	Fidelity to the intervention	Fidelity will be assessed when select charts are reviewed for adherence to the protocol.	Baseline and up to 2 months post baseline
Secondary	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.	Baseline and up to 2 months post baseline
Secondary	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.	2 months pre and 2 months post baseline
Secondary	Number of total medications	We will use the electronic health record to assess the medication list total at 2 months pre and post baseline.	2 months pre and 2 months post baseline
Secondary	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	2 months pre and 2 months post baseline

External Links

•   Patient Priorities Care homepage