Dementia, Mild Cognitive Impairment
Conditions
Keywords
dementia, mild cognitive impairment, patient priorities 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 patients 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.
Interventions
BEHAVIORALPatient 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.
Sponsors
Indiana University
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of PPC Discussion | From enrollment to participating clinic visit | Review of the electronic health record will be used to assess for the presence of documentation of patient priorities care for each enrolled patient. Documentation can occur from enrollment through enrolled patient's visit with the participating physician in clinic. Enrollment (mailing of packet) occurred from two months prior to scheduled appointment with participating physician to clinic appointment. Documentation of discussion could occur from two months prior up to within 24 hours of clinic appointment with participating physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of a Care Partner | Baseline and up to 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 | Acceptability will be assessed using Sekhon'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 | Appropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians. |
| Feasibility of the Intervention | 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. |
| Potential for Future Adoption of Patient Priorities Care Intervention | Baseline and up to 2 months post baseline | Assessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians. |
| Number of Patient Days at Home | 2 months pre and 2 months post baseline | Review of the electronic health record will be used to assess for hospital visits, emergency room visits, or nursing home admissions. Number of patient days at home will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences. |
| Number of Total Medications | 2 months pre and 2 months post baseline | Review of the electronic health record will be used to assess the medication list total at 2 months pre and post baseline. Number of total medications will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences. |
| Number of New Referrals to Specialist Physicians | 2 months pre and 2 months post baseline | Review of the electronic health record to identify the number of referrals to specialists at 2 months pre and post baseline. Number of new referrals to specialist physicians will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences. |
| 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 | Evaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatie Allen, PhD
Regenstrief Institute, Inc.
Participant flow
Recruitment details
Recruitment from clinics and data collection between 08/31/2023 - 02/15/2025
Pre-assignment details
Participants enrolled when PPC packet mailed. Care partners were not enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68 year STANDARD_DEVIATION 23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Preferred language English | 150 Participants |
| Preferred language Spanish | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 178 |
| other Total, other adverse events | 0 / 178 |
| serious Total, serious adverse events | 0 / 178 |
Outcome results
None listed