Trial Outcomes & Findings for Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia (NCT NCT06001775)
NCT ID: NCT06001775
Last Updated: 2026-04-02
Results Overview
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.
COMPLETED
NA
178 participants
From enrollment to participating clinic visit
2026-04-02
Participant Flow
Recruitment from clinics and data collection between 08/31/2023 - 02/15/2025
Participants enrolled when PPC packet mailed. Care partners were not enrolled.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
178
|
|
Overall Study
50% intervention enrollment of participants
|
89
|
|
Overall Study
100% intervention enrollment of participants
|
89
|
|
Overall Study
COMPLETED
|
178
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
Baseline characteristics by cohort
| Measure |
PPC Packet Mailed
n=178 Participants
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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|---|---|
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Age, Continuous
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68 year
STANDARD_DEVIATION 23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Preferred language
Spanish
|
28 Participants
n=5 Participants
|
|
Preferred language
English
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to participating clinic visitReview 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.
Outcome measures
| Measure |
PPC Packet Mailed
n=178 Participants
Patients (and their care partners when available) 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 or patient care partner dyad. 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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|---|---|
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Documentation of PPC Discussion
PPC discussion documented
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72 Participants
|
|
Documentation of PPC Discussion
No PPC discussion documented
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106 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineIdentification 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineAcceptability 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineAppropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineFeasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineFidelity will be assessed when select charts are reviewed for adherence to the protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineAssessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 months pre and 2 months post baselineReview 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 months pre and 2 months post baselineReview 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 months pre and 2 months post baselineReview 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 months pre and 2 months post baselineEvaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineAcceptability 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 2 months post baselineEstablished 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months pre and 2 months post baselineNumber of eligible patients enrolled across racial, ethnic and socioeconomic subgroups.
Outcome measures
Outcome data not reported
Adverse Events
PPC Packet Mailed
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place