NCT04912245: ACP

A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia

Completed NA Results posted Last updated 7 March 2023

What this trial tests

NA trial testing Telehealth visit in Advance Care Planning in 152 participants. Completed in 9 May 2022.

Timeline

13 July 2021

Primary endpoint
9 May 2022

9 May 2022

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	152
Start date	13 July 2021
Primary completion	9 May 2022
Estimated completion	9 May 2022
Sites	7 locations across United States

Drugs / interventions tested

• Telehealth visit

Conditions studied

• Advance Care Planning — all drugs for Advance Care Planning →
• Telemedicine — all drugs for Telemedicine →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Unrecognized Dementia — all drugs for Unrecognized Dementia →

Sponsor

Wake Forest University Health Sciences

Who can join

65 and older, any sex, with Advance Care Planning or Telemedicine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patient/Care Partner Agreeing to Participate Primary · Baseline to Month 9

Study will measure the amount of patient or patient-care partner dyads who agree to participate.

Group	Value	95% CI
Telehealth Visit	152

Number of Participants With Telehealth Advance Care Planning (ACP) Completed Primary · month 9

Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.

Group	Value	95% CI
Telehealth Visit	111

Number of Participants With One or More Advance Care Planning (ACP) Discussions Secondary · month 9

Study will measure the number of ACP discussions documented in the electronic health record.

Group	Value	95% CI
Telehealth Visit	81

Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes Secondary · month 9

Study will measure the usage of ACP billing codes (99497 and 99498).

Group	Value	95% CI
Telehealth Visit	78

Quality of Advance Care Planning (ACP) Discussion Scores Secondary · 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 dec

Group	Value	95% CI
Telehealth Visit	7.7	± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: month 9. Reporting threshold: 0.0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Telehealth Visit

Serious: 1/152 (1%)

Deaths: 1/152

Serious adverse events (1 terms)

Reaction	System	Telehealth Visit
death	Social circumstances	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT04912245 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.