SHARE Protocol for Cognitive Impairment

No longer recruiting at 9 trial locations

Overseen By Diane Echavarria, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 80, Non-English, No cognitive impairment, others

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a program called SHARE improves communication and planning for future medical care between patients with cognitive impairment and their caregivers. It involves two groups: one receives the SHARE program, which includes personalized guidance on discussing healthcare wishes, and the other receives standard educational materials (Minimally Enhanced Usual Care). The research examines the quality of conversations and planning, particularly for those managing or involved in care decisions for someone with cognitive difficulties. Ideal participants are patients aged 80 or older with some level of cognitive impairment, along with a family member or friend who regularly assists with their care. As an unphased trial, this study offers a unique opportunity to enhance care communication strategies for those with cognitive challenges.

Do I need to stop my current medications for the SHARE Protocol trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SHARE protocol is safe for cognitive impairment patients?

Research has shown that the SHARE protocol is a communication method designed to assist patients with memory or thinking problems and their caregivers in discussing healthcare preferences. This method employs tools like letters, trained helpers, and educational brochures to facilitate these important conversations.

In past studies, researchers tested the SHARE protocol with older adults and their families to evaluate its effectiveness. So far, no major safety issues have emerged. The protocol focuses on improving communication and planning, not on medical treatments or drugs, which typically results in a lower risk of physical side effects.

Overall, the SHARE protocol aids in conversation and planning, and it appears to be safe and well-accepted. Previous research has not reported any negative effects directly linked to using this protocol. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHARE Protocol because it goes beyond traditional cognitive impairment treatments by actively engaging both patients and their families in healthcare decision-making. This protocol includes a hands-on approach with trained facilitators guiding advance care planning discussions, helping align family and caregiver perspectives on care goals. Additionally, SHARE provides easy access to educational resources and tools, such as a detailed brochure and advance directive, ensuring participants are well-informed and can extend their engagement through a patient portal. This holistic approach aims to enhance communication and tailor care to individual needs, potentially improving outcomes for those with cognitive impairment.

What evidence suggests that the SHARE protocol is effective for improving communication and advance care planning in patients with cognitive impairment?

Research has shown that the SHARE program, one of the treatment arms in this trial, can enhance communication about healthcare wishes between patients with memory or thinking problems and their caregivers. In this trial, participants will be randomized to receive either the SHARE program or Minimally Enhanced Usual Care. Previous studies reported that people using SHARE experienced better communication. The program offers guidance from trained professionals and provides resources to clarify healthcare goals. Early results suggest these tools help patients and caregivers reach consensus on care decisions. Overall, the SHARE program aims to improve discussions about future healthcare needs. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Wolff, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for pairs ('dyads') where one person has mild to severe cognitive impairment, is 80 or older, and the other is a family member or friend over 18 who helps with their medical care. Both must speak English and not plan to move out of state within a year. The patient should be able to consent or have someone who can on their behalf.

Exclusion Criteria

I am under 80, can make my own health decisions, and plan to stay in-state.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SHARE protocol or minimally enhanced usual care, focusing on advance care planning and communication

24 months

Enrollment surveys conducted in-person or by telephone or video conference, followed by follow-up surveys at 6, 12, and 24 months

Follow-up

Participants are monitored for quality of communication and advance care planning processes, with additional assessments for bereaved family members if applicable

24 months

Follow-up telephone or web surveys at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Minimally Enhanced Usual Care
• Sharing Healthcare Wishes in Primary Care (SHARE)

Trial Overview The SHARE study compares two approaches in primary care: 'SHARE', which focuses on sharing healthcare wishes, versus minimally enhanced usual care. It looks at how well these methods work for improving communication about end-of-life decisions among patients with cognitive issues and their caregivers.

How Is the Trial Designed?

Group I: SHARE Experimental Treatment 1 Intervention

SHARE components include: 1) a letter from the practice introducing the initiative, 2) access to a designated person (medical assistant, social worker, nurse, or lay person) trained to lead advance care planning discussions, 3) person-family agenda-setting to align perspectives about the role of the caregiver and stimulate discussion about goals of care, and 4) education about communication and available resources, including a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor", a blank easy to complete advance directive, and facilitated registration to the patient portal (for patient and caregiver participants) to extend electronic interactions and information access to family.

Group II: Minimally Enhanced Usual Care Placebo Group 1 Intervention

Minimally enhanced usual care participants are provided with print educational materials that include a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor" and a blank easy-to-complete advance directive.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

MedStar Health

Collaborator

Trials

9

Recruited

76,100+

Johns Hopkins Community Physicians

Collaborator

Trials

5

Recruited

66,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485067/

Sharing health care wishes among older adults with ... We tested a remote multicomponent ACP model (SHARE) versus minimally enhanced usual care in 273 person–family dyads from eight primary care practices.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001313

Study protocol for a randomized controlled trial We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, “Sharing Healthcare Wishes in Primary Care” ( ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37116645/

Study protocol for a randomized controlled trial We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, "Sharing Healthcare Wishes in Primary Care" ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05033262

Study Details | NCT05033262 | Our Care Wishes - Dementia Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document ...

5. sciencedirect.com sciencedirect.com/science/article/am/pii/S1551714423001313

Sharing Health Care Wishes in Primary ... We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, “Sharing Healthcare Wishes in Primary Care” ( ...

6. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/sharing-health-care-wishes-in-primary-care-share-among-older-adul

Study protocol for a randomized controlled trial Sharing health care wishes in primary care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized ...

7. researchgate.net researchgate.net/publication/370306574_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

Study protocol for a randomized controlled trial We describe a randomized controlled trial to test the efficacy of a multicomponent communication intervention, "Sharing Healthcare Wishes in ...