Trial Outcomes & Findings for A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (NCT NCT04912245)
NCT ID: NCT04912245
Last Updated: 2023-03-07
Results Overview
Study will measure the amount of patient or patient-care partner dyads who agree to participate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
Baseline to Month 9
Results posted on
2023-03-07
Participant Flow
Participant milestones
| Measure |
Telehealth Visit-Patients
Patients with either Mild Cognitive Impairment (MCI) or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
Caregivers
Caregivers to Patients
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
45
|
|
Overall Study
COMPLETED
|
81
|
30
|
|
Overall Study
NOT COMPLETED
|
26
|
15
|
Reasons for withdrawal
| Measure |
Telehealth Visit-Patients
Patients with either Mild Cognitive Impairment (MCI) or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
Caregivers
Caregivers to Patients
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
Baseline Characteristics
25 Withdrew 16 Lost to Follow
Baseline characteristics by cohort
| Measure |
Telehealth Visit
n=152 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Age, Continuous
Patients
|
83.7 years
STANDARD_DEVIATION 6.5 • n=107 Participants • 25 Withdrew 16 Lost to Follow
|
|
Age, Continuous
Caregivers
|
70.5 years
STANDARD_DEVIATION 15.4 • n=45 Participants • 25 Withdrew 16 Lost to Follow
|
|
Sex: Female, Male
Patients · Female
|
73 Participants
n=107 Participants • 16 Lost to Follow 25 Withdrew
|
|
Sex: Female, Male
Patients · Male
|
34 Participants
n=107 Participants • 16 Lost to Follow 25 Withdrew
|
|
Sex: Female, Male
caregivers · Female
|
36 Participants
n=45 Participants • 16 Lost to Follow 25 Withdrew
|
|
Sex: Female, Male
caregivers · Male
|
9 Participants
n=45 Participants • 16 Lost to Follow 25 Withdrew
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
4 Participants
n=107 Participants • 25 Withdrew 16 Lost to Follow
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
103 Participants
n=107 Participants • 25 Withdrew 16 Lost to Follow
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to Follow
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
3 Participants
n=45 Participants • 25 Withdrew 16 Lost to Follow
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
42 Participants
n=45 Participants • 25 Withdrew 16 Lost to Follow
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=45 Participants • 25 Withdrew 16 Lost to Follow
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · Asian
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · Black or African American
|
18 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · White
|
89 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=107 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
7 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · White
|
37 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
1 Participants
n=45 Participants • 25 Withdrew 16 Lost to follow
|
PRIMARY outcome
Timeframe: Baseline to Month 9Population: 213 Screened - 168 Patients and 45 Caregivers - 152 enrolled (107 Patients and 45 Caregivers)
Study will measure the amount of patient or patient-care partner dyads who agree to participate.
Outcome measures
| Measure |
Telehealth Visit
n=213 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Number of Patient/Care Partner Agreeing to Participate
|
152 Participants
|
PRIMARY outcome
Timeframe: month 9Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.
Outcome measures
| Measure |
Telehealth Visit
n=152 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Number of Participants With Telehealth Advance Care Planning (ACP) Completed
|
111 Participants
|
SECONDARY outcome
Timeframe: month 9Population: 107 enrolled - 26 Withdrawals and Lost To Follows = 81 Participants
Study will measure the number of ACP discussions documented in the electronic health record.
Outcome measures
| Measure |
Telehealth Visit
n=81 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Number of Participants With One or More Advance Care Planning (ACP) Discussions
|
81 Participants
|
SECONDARY outcome
Timeframe: month 9Study will measure the usage of ACP billing codes (99497 and 99498).
Outcome measures
| Measure |
Telehealth Visit
n=81 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes
|
78 Participants
|
SECONDARY outcome
Timeframe: month 9Population: 107 enrolled - 26 Withdraws and Lost to Follows = 81 Participants
Discussion quality will be operationalized using a scoring system derived from the ACP Wise documentation program. Score range of 0 (indicating no advance care planning questions answered) to 9 (indicating nine advance care planning questions answered). High-quality ACP discussions will be defined as addressing ≥4 out of 9 core components in the ACP discussion, with 1 point assigned if the following factors were addressed as part of the ACP discussion: Disease understanding, health-related goals, what matters most in their life, important milestones, health-related worries, named surrogate decision-maker, unacceptable states at the end-of-life (e.g. being in a coma, etc.), goals if their health was to worsen, and documentation of code status.
Outcome measures
| Measure |
Telehealth Visit
n=81 Participants
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
|
|---|---|
|
Quality of Advance Care Planning (ACP) Discussion Scores
|
7.7 score on a scale
Standard Deviation 1.7
|
Adverse Events
Telehealth Visit
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Telehealth Visit
n=152 participants at risk
Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Telehealth visit: Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
Both Arms/Groups were combined since these were dyad visits - there we zero Adverse Events in the Care Partners Group and one AE in the Participant Group
|
|---|---|
|
Social circumstances
death
|
0.66%
1/152 • Number of events 1 • month 9
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place