Advance Care Planning, Dementia, Mild Cognitive Impairment, Telemedicine, Unrecognized Dementia
Conditions
Keywords
Dementia, telehealth, Advance Care Planning, Mild Cognitive Impairment
Brief summary
The purpose of this study is to pilot test a telehealth Advance Care Planning (ACP) intervention among those with either mild cognitive impairment (MCI) or unrecognized dementia. Our goal is to pilot-test and evaluate a pragmatic Telehealth ACP intervention among patients with either the diagnosis of mild cognitive impairment (MCI) or unrecognized dementia.
Detailed description
Telehealth has the potential to overcome barriers related to timing and travel restraints and to provide patients and their caregivers with an opportunity to discuss their goals, values, and priorities for their healthcare within their home setting. Recent studies have demonstrated patients' willingness to use telehealth and have shown that it can play an integral role in dementia care management.
Interventions
BEHAVIORALTelehealth 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.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a pragmatic pilot study where 300 patients with either mild cognitive impairment (MCI) or unrecognized dementia and their care partner (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of their primary care team in hopes of enrolling 94 patients. Patients are still eligible to participate in the study even if a care partner/loved one does not attend the ACP visit with them or if the patient does not have a care partner.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of recognized or probable Mild cognitive impairment (MCI) or mild dementia determined by either ICD10 diagnostic codes or electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) * Have decisional capacity according to their primary care physician (PCP) to complete ACP * Completed visit with their PCP within the past 12 months * Affiliated with an Accountable Care Organization. * English-speaking
Exclusion criteria
* Moderate to severe hearing loss that would preclude participating in a video or telephone intervention * No phone number available for patient. * Lives in a long-term care facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient/Care Partner Agreeing to Participate | Baseline to Month 9 | Study will measure the amount of patient or patient-care partner dyads who agree to participate. |
| Number of Participants With Telehealth Advance Care Planning (ACP) Completed | month 9 | Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Advance Care Planning (ACP) Discussions | month 9 | Study will measure the number of ACP discussions documented in the electronic health record. |
| Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes | month 9 | Study will measure the usage of ACP billing codes (99497 and 99498). |
| Quality of Advance Care Planning (ACP) Discussion Scores | month 9 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 11 |
| Overall Study | Withdrawal by Subject | 21 | 4 |
Baseline characteristics
| Characteristic | Telehealth Visit |
|---|---|
| Age, Continuous Caregivers | 70.5 years STANDARD_DEVIATION 15.4 |
| Age, Continuous Patients | 83.7 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 7 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Caregivers White | 37 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Patients Asian | 0 Participants |
| Race (NIH/OMB) Patients Black or African American | 18 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Patients White | 89 Participants |
| Sex: Female, Male caregivers Female | 36 Participants |
| Sex: Female, Male caregivers Male | 9 Participants |
| Sex: Female, Male Patients Female | 73 Participants |
| Sex: Female, Male Patients Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 152 |
| other Total, other adverse events | 0 / 152 |
| serious Total, serious adverse events | 1 / 152 |
Outcome results
Primary
Number of Participants With Telehealth Advance Care Planning (ACP) Completed
Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.
Time frame: month 9
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Visit | Number of Participants With Telehealth Advance Care Planning (ACP) Completed | 111 Participants |
Primary
Number of Patient/Care Partner Agreeing to Participate
Study will measure the amount of patient or patient-care partner dyads who agree to participate.
Time frame: Baseline to Month 9
Population: 213 Screened - 168 Patients and 45 Caregivers - 152 enrolled (107 Patients and 45 Caregivers)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Visit | Number of Patient/Care Partner Agreeing to Participate | 152 Participants |
Secondary
Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes
Study will measure the usage of ACP billing codes (99497 and 99498).
Time frame: month 9
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Visit | Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes | 78 Participants |
Secondary
Number of Participants With One or More Advance Care Planning (ACP) Discussions
Study will measure the number of ACP discussions documented in the electronic health record.
Time frame: month 9
Population: 107 enrolled - 26 Withdrawals and Lost To Follows = 81 Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Visit | Number of Participants With One or More Advance Care Planning (ACP) Discussions | 81 Participants |
Secondary
Quality of Advance Care Planning (ACP) Discussion Scores
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.
Time frame: month 9
Population: 107 enrolled - 26 Withdraws and Lost to Follows = 81 Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Visit | Quality of Advance Care Planning (ACP) Discussion Scores | 7.7 score on a scale | Standard Deviation 1.7 |