Online Advance Care Planning Tool for Cognitive Impairment

(Portal-Voice Trial)

Overseen By Erica Lawrence

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Long-term care, Blindness, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool called ACPVoice, designed to assist people with cognitive impairment, such as mild dementia, in discussing and documenting their future healthcare wishes with doctors. The researchers aim to determine if this tool facilitates these important conversations between patients and doctors. It suits individuals with mild cognitive issues who are connected with Atrium-Wake Forest Baptist Health and use an online patient portal to manage their care. Those who have recently visited their primary care doctor and have another visit planned soon may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance communication between patients and healthcare providers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ACP tool is safe for use in cognitive impairment?

Research has shown that the ACPVoice tool, designed for planning future medical care, was developed with input from individuals experiencing memory and thinking difficulties. This collaboration ensures the tool is easy and safe to use. Studies have not reported any negative effects or safety issues directly associated with the tool. The trial is labeled "Not Applicable" for phase, indicating a focus on testing the tool's practicality and user-friendliness rather than the safety concerns typically addressed in early trials. Overall, this suggests that ACPVoice is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACPVoice because it represents a novel approach to advance care planning for individuals with cognitive impairment. Unlike traditional methods that often rely on in-person consultations and paper documentation, ACPVoice leverages an online tool, making it more accessible and convenient for patients and caregivers. This digital platform allows for better communication and collaboration between patients, families, and healthcare providers, potentially enhancing decision-making and ensuring that care preferences are documented accurately and efficiently.

What evidence suggests that the ACPVoice tool is effective for improving advance care planning in cognitive impairment?

Research has shown that planning for future medical care, known as advance care planning (ACP), can greatly benefit people with memory or thinking problems. ACP involves discussing and recording the type of care a person would want at the end of life, ensuring their wishes are respected. However, few individuals with these challenges participate in ACP. To address this, researchers created the ACPVoice tool, which participants in this trial may use. This online system is designed to simplify planning. Early results suggest that digital tools like this can encourage more conversations and help document care preferences, making it easier for patients and families to make care decisions. ^{2 4 5 6 7}

Who Is on the Research Team?

Jennifer Gabbard, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for community-dwelling adults with cognitive impairment who are under outpatient primary care. The study aims to include those who may benefit from improved discussions and documentation of their future healthcare preferences.

Inclusion Criteria

I am 65 years old or older.

I've seen my primary care doctor in the last year and have another appointment scheduled within 6 months.

Diagnosis of recognized or probable mild cognitive impairment or mild dementia or elevated eRADAR score

Exclusion Criteria

Enrolled in hospice

Lives in a long-term care facility

Severe vision impairment/blindness (as they need to be able to read portal messages)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Participants receive the ACPVoice tool via the patient portal, paired with a motivational message, to improve advance care planning discussions and documentation.

6 months

Follow-up

Participants are monitored for the effectiveness of the ACPVoice tool in improving advance care planning documentation and discussions.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ACPVoice

Trial Overview

The study is testing ACPVoice, a tool designed for advance care planning (ACP), against the standard of care in ACP. It will evaluate how well ACPVoice facilitates conversations and decision-making about future healthcare needs.

How Is the Trial Designed?

Group I: ACPVoice Intervention Experimental Treatment 1 Intervention

Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.

Group II: Standard of Care Active Control 1 Intervention

Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 1672 dyads of persons with cognitive impairment and their care partners, discussing advance care planning (ACP) was associated with a 10% increase in the likelihood of completing advance directives (ADs).

Agreement between PwCIs and their care partners about having discussed ACP further increased the likelihood of completing ADs by 7%, highlighting the importance of effective communication in the decision-making process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making the Informal Formal: Discussing and Completing Advance Care Plans in Care Dyads with Cognitive Impairment. Shepherd-Banigan, M., Ford, CB., DePasquale, N., et al.[2022]

The MCI ENACT intervention, designed for advance care planning in individuals with mild cognitive impairment, was positively received by participants, who found group discussions helpful and expressed a strong desire for such discussions.

Although the intervention was deemed acceptable, challenges in recruiting participants highlighted the need for improved strategies to implement this program effectively in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human-Centered Design of an Advance Care Planning Group Visit for Mild Cognitive Impairment. Daddato, AE., Staton, EW., Bettcher, BM., et al.[2022]

The SHARE intervention, designed for adults aged 80 and older with possible cognitive impairment and their care partners, aims to improve advance care planning (ACP) communication in primary care settings through a structured approach that includes trained facilitators and personalized agenda-setting.

This randomized controlled trial will assess the effectiveness of the SHARE intervention on the quality of end-of-life care communication at 6 months, highlighting the importance of addressing caregiver burden and clinician barriers in ACP discussions for individuals with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial. Wolff, JL., Cagle, J., Echavarria, D., et al.[2023]

The study successfully validated shorter versions of the Advance Care Planning (ACP) Engagement Survey, reducing it from 82 items to as few as four items while maintaining high internal consistency and validity.

These shorter surveys can effectively measure a wide range of ACP behaviors in both English and Spanish speakers, making them useful tools for research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. Sudore, RL., Heyland, DK., Barnes, DE., et al.[2021]

The development of the ACPVoice tool involved cognitive interviews with 20 participants, including individuals with mild cognitive impairment and their care partners, to ensure the tool was understandable and user-friendly for older adults with cognitive challenges.

Revisions to the wording and format of the tool significantly enhanced comprehension and response accuracy, suggesting that such tailored approaches can effectively engage community-dwelling individuals with cognitive impairment in advance care planning discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Advance Care Planning Portal-Based Tool for Community-Dwelling Persons Living With Cognitive Impairment: The ACPVoice Tool. Gabbard, J., Strahley, AE., Pajewski, NM., et al.[2023]

The systematic review identified 30 interactive web-based advance care planning (ACP) tools, with varying formats and quality, highlighting that 80% of these tools had clear aims related to reflection, decision-making, and documentation support.

Quality scores for the tools ranged from 11 to 28, indicating that many tools lacked proper information sources, suggesting a need for better development processes involving users and scientific evidence to enhance content quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Publicly Available, Interactive Web-Based Tools to Support Advance Care Planning: Systematic Review. Dupont, C., Smets, T., Monnet, F., et al.[2022]

The PREPARE website aims to enhance advance care planning (ACP) for older Veterans by improving communication and informed decision-making, and is being tested in a randomized controlled trial with participants aged 60 and older who have multiple medical conditions.

The study will evaluate whether using the PREPARE website increases the completion rates of advance directives and engagement in the ACP process compared to a control group, potentially leading to better communication of medical wishes and improved decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. Sudore, R., Le, GM., McMahan, R., et al.[2018]

The PREPAREforYourCare.org advance care planning program was found to be feasible and user-friendly for 20 older adults with mild-to-moderate cognitive impairment and their caregivers, with high satisfaction ratings (mean of 8.6 for patients and 9.4 for caregivers on a 10-point scale).

After using the program for one week, 80% of participants showed increased engagement in advance care planning, with caregivers reporting significant improvements in knowledge and self-efficacy, indicating the program's potential to enhance decision-making support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Diverse Older Adults With Cognitive Impairment and Caregivers in Advance Care Planning: A Pilot Study of the Interactive PREPARE Website. Kotwal, AA., Barnes, DE., Volow, AM., et al.[2023]

The interactive web-based advance care planning (ACP) program significantly increased engagement in ACP among 147 participants with chronic diseases, with scores rising from 2.8 to 3.0 two months after completion (P<.001).

Participants found the program to be usable and understandable, with high satisfaction ratings, indicating it can effectively support initial discussions about treatment preferences and serve as a valuable tool for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Web-Based Advance Care Planning Program "Explore Your Preferences for Treatment and Care": Development, Pilot Study, and Before-and-After Evaluation. van der Smissen, D., Rietjens, JAC., van Dulmen, S., et al.[2022]

About 50% of patients with dementia had documented advance directives (ADs) or Do Not Resuscitate (DNR) status at the time of death, indicating that advance care planning (ACP) is not consistently utilized, with 30% lacking any documentation.

Younger patients and those who primarily spoke English were more likely to have ADs documented, while individuals from lower-income areas were significantly less likely to have POLST or DNR documentation, highlighting disparities in ACP access and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance Directive and POLST Documentation in Decedents With Dementia at a Memory Care Center: The Importance of Early Advance Care Planning. Naasan, G., Boyd, ND., Harrison, KL., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10102257/

Development of an Advance Care Planning Portal-Based ...

Our objective was to develop an ACP portal-based tool (ACPVoice) for community-dwelling persons living with cognitive impairment (PLCI) by engaging end-users ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06509373?cond=Cognitive%20planning&viewType=Table&rank=2

A Portal-based Advance Care Planning Intervention ...

The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and ...

3.

researchgate.net

researchgate.net/publication/364366979_Development_of_an_Advance_Care_Planning_Portal-Based_Tool_for_Community-Dwelling_Persons_Living_With_Cognitive_Impairment_The_ACPVoice_Tool

Development of an Advance Care Planning Portal-Based ...

ACP has been shown to improve important outcomes for individuals with cognitive impairment, but rates of ACP for these individuals are low ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0197457222000519

Feasibility and acceptability of a web-based advance care ...

Advance care planning (ACP) can help to elicit preferences for end-of-life care and is associated with improved end-of-life outcomes for persons living with ...

5.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14331

Advance care planning in adults ages 80 years and older with ...

We used thematic analysis to analyze transcripts of ACP conversations for 88 older adults with normal cognition (n = 15), mild cognitive ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36239407/

Development of an Advance Care Planning Portal-Based Tool ...

Our objective was to develop an ACP portal-based tool (ACPVoice) for community-dwelling persons living with cognitive impairment (PLCI) by engaging end-users ...

7.

acpjournals.org

acpjournals.org/doi/10.7326/ANNALS-24-00763

The Effect of the “Safety in Dementia” Online Tool to Assist ...

The online SiD decision aid increased preparation for decision making about firearm access in this sample of ADRD caregivers in the United States.