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| ID | Type | Description | Link |
|---|---|---|---|
| 15345 | Other Identifier | Indiana University Institutional Review Board | |
| Pro00063400 | Other Identifier | Advarra (CIRBI) External Institutional Review Board | |
| U54AG063546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment | Experimental | Patients 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. This conversation will be documented in the Electronic Health Record. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Priorities Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Documentation of PPC Discussion | 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. | From enrollment to participating clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and up to 2 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Enrolled Eligible Patients Across Racial, Ethnic and Socioeconomic Subgroups | Number of eligible patients enrolled across racial, ethnic and socioeconomic subgroups. | 2 months pre and 2 months post baseline |
Inclusion Criteria:
Patient Inclusion Criteria
Patients must meet all of the following criteria to participate in this study:
40 years or older
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Katie Allen, PhD | Regenstrief Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Connected Care |
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| Label | URL |
|---|---|
| Patient Priorities Care homepage | View source |
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Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.
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Participants enrolled when PPC packet mailed. Care partners were not enrolled.
Recruitment from clinics and data collection between 08/31/2023 - 02/15/2025
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| ID | Title | Description |
|---|---|---|
| FG000 | PPC Packet Mailed | Patients were mailed a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) initiated a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record. Care partners were not considered enrolled in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PPC Packet Mailed | Patients were mailed a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) initiated a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record. All individuals receiving a packet in this single arm pilot are considered enrolled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Documentation of PPC Discussion | 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. | Posted | Count of Participants | Participants | From enrollment to participating clinic visit |
|
Two months after clinic visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PPC Packet Mailed | Patients were mailed a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) initiated a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record. All individuals receiving a packet in this single arm pilot are considered enrolled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Allen | Regenstrief Institute | 317-874-9202 | allenkat@regenstrief.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2023 | Jan 21, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2026 | Feb 12, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Acceptability |
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. |
| Baseline and up to 2 months post baseline |
| Appropriateness | Appropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians. | Baseline and up to 2 months post baseline |
| Feasibility of the Intervention | Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide. | Baseline and up to 2 months post baseline |
| 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 |
| Potential for Future Adoption of Patient Priorities Care Intervention | Assessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians. | Baseline and up to 2 months post baseline |
| Number of Patient Days at Home | 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. | 2 months pre and 2 months post baseline |
| Number of Total Medications | 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. | 2 months pre and 2 months post baseline |
| Number of New Referrals to Specialist Physicians | 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. | 2 months pre and 2 months post baseline |
| Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record | Evaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded. | 2 months pre and 2 months post baseline |
| Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups. | 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. | Baseline and up to 2 months post baseline |
| Number of Patients With Social Factors Indicated in the Electronic Health Record | 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. | Baseline and up to 2 months post baseline |
| Indianapolis |
| Indiana |
| 46219 |
| United States |
| University of Texas Health- Houston | Houston | Texas | 77030 | United States |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Preferred language | Electronic health record notes primary language participant prefers for medical visits | Count of Participants | Participants |
|
|
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| 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. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Acceptability | 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. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Appropriateness | Appropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Feasibility of the Intervention | Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Fidelity to the Intervention | Fidelity will be assessed when select charts are reviewed for adherence to the protocol. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Potential for Future Adoption of Patient Priorities Care Intervention | Assessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Number of Patient Days at Home | 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. | Not Posted | 2 months pre and 2 months post baseline | Participants |
| Secondary | Number of Total Medications | 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. | Not Posted | 2 months pre and 2 months post baseline | Participants |
| Secondary | Number of New Referrals to Specialist Physicians | 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. | Not Posted | 2 months pre and 2 months post baseline | Participants |
| Secondary | Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record | Evaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded. | Not Posted | 2 months pre and 2 months post baseline | Participants |
| Secondary | Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups. | 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. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Secondary | Number of Patients With Social Factors Indicated in the Electronic Health Record | 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. | Not Posted | Baseline and up to 2 months post baseline | Participants |
| Other Pre-specified | Number of Enrolled Eligible Patients Across Racial, Ethnic and Socioeconomic Subgroups | Number of eligible patients enrolled across racial, ethnic and socioeconomic subgroups. | Not Posted | Jun 2026 | 2 months pre and 2 months post baseline | Participants |
| 0 |
| 178 |
| 0 |
| 178 |
| 0 |
| 178 |
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| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |