273 Participants Needed

SHARE Protocol for Cognitive Impairment

Recruiting at 9 trial locations
DE
Overseen ByDiane Echavarria, MS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University

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

JW

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.

Inclusion Criteria

Family/Friend: 18 years and older, English speaking, hear well enough to communicate by telephone, not planning to move out of the state within the next year, do not report having a life-threatening illness and are a family member or unpaid friend who attends at least some medical visits of an eligible person with cognitive impairment, do not screen positive as having cognitive impairment on the basis of fewer than two incorrect answers on the 6-item telephone screening instrument.
I am 80 or older, speak English, can consent to treatment, have a supportive person, plan to stay in-state, and may have some memory issues.

Exclusion Criteria

I am under 80, can make my own health decisions, and plan to stay in-state.
I am over 18, speak English, help with care, attend medical visits, can hear well, don't plan to move, am not paid for my services, and passed a cognitive test.

Treatment Details

Interventions

  • Minimally Enhanced Usual Care
  • Sharing Healthcare Wishes in Primary Care (SHARE)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SHAREExperimental Treatment1 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 CarePlacebo Group1 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.

Find a Clinic Near You

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+