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

300 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment ACPVoice, ACP Portal-Based Tool, ACPVoice for cognitive impairment?

The development of the ACPVoice tool involved engaging users with cognitive impairment to improve their understanding and navigation of advance care planning, suggesting it could effectively help them engage in these discussions. ^{1 2 3 4 5}

Is the ACPVoice tool safe for use in humans?

The ACPVoice tool, designed for advance care planning in people with cognitive impairment, underwent testing with participants to improve understanding and ease of use. No safety concerns were reported during the development and testing process. ^{1 3 6 7 8}

How is the ACPVoice treatment different from other treatments for cognitive impairment?

ACPVoice is unique because it is an online tool specifically designed to help people with cognitive impairment engage in advance care planning (ACP) by using a patient portal. It focuses on improving understanding and communication about future medical decisions, which is different from traditional treatments that may not address these specific needs. ^{2 3 7 9 10}

What is the purpose of this trial?

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 documentation in persons living with cognitive impairment in outpatient primary care.

Research Team

Jennifer Gabbard, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Human-Centered Design of an Advance Care Planning Group Visit for Mild Cognitive Impairment. [2022]

2. Canada 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. [2022]

3. United States 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. [2023]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. [2021]

6. United States 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. [2023]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Making the Informal Formal: Discussing and Completing Advance Care Plans in Care Dyads with Cognitive Impairment. [2022]

9. England 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. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Publicly Available, Interactive Web-Based Tools to Support Advance Care Planning: Systematic Review. [2022]