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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

178 participants

Primary outcome timeframe

From enrollment to participating clinic visit

Results posted on

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

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.
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

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.
Age, Continuous
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
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 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.

Outcome measures

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.
Documentation of PPC Discussion
PPC discussion documented
72 Participants
Documentation of PPC Discussion
No PPC discussion documented
106 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 months post baseline

Appropriateness 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 baseline

Feasibility 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 baseline

Fidelity 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 baseline

Assessment 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 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months pre and 2 months post baseline

Number of eligible patients enrolled across racial, ethnic and socioeconomic subgroups.

Outcome measures

Outcome data not reported

Adverse Events

PPC Packet Mailed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katie Allen

Regenstrief Institute

Phone: 317-874-9202

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place