SHARE Protocol for Cognitive Impairment

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

273 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the efficacy of Sharing Healthcare Wishes in Primary Care (SHARE), a two-group randomized trial at up to 9 primary care practices in which 124 dyads receive a control protocol of minimally enhanced usual care and 124 dyads receive the SHARE protocol. This study tests the efficacy of SHARE on quality of communication (primary outcome) and advance care planning processes (secondary outcomes) at 6 months among primary care patients with cognitive impairment (mild-severe) and family caregiver dyads. For patients who die while enrolled in the study by 24 months, this study examines the quality of end-of-life care and bereaved family caregiver experiences with medical decision-making (secondary outcomes).

Research Team

Jennifer Wolff, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+