SHARE: Sharing Healthcare Wishes in Primary Care

NCT ID: NCT04593472

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2025-02-26

Brief Summary

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).

Detailed Description

SHARE is guided by the patient-provider communication, family caregiving, health services, and health informatics literatures in acknowledging the multiple pathways by which interpersonal relationships influence treatment decisions and end-of-life care. Each component of SHARE has been found to improve a range of communication outcomes in other care contexts, but have not previously been applied in this combination or examined with regard to advance care planning in persons with cognitive impairment. SHARE is designed to be broadly scalable and widely relevant to diverse primary care patients and stakeholders. The study goal is to engage family members or friends ("family" and/or "caregiver") in longitudinal interactions with primary care clinicians and stimulate and support advance care planning discussions in primary care. SHARE seeks to improve communication for persons with cognitive impairment by establishing a structured protocol to proactively engage family caregivers in ongoing interactions with primary care clinicians and stimulate and support advance care planning in primary care throughout the disease trajectory.

SHARE evaluates a multicomponent communication intervention to proactively engage family members or friends and support advance care planning in primary care. SHARE encompasses the following four therapeutic elements: 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) to extend electronic interactions and information access to family. The control group receives minimally enhanced usual care with print educational materials that include the 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. Participants in both groups are followed over a 24-month period. Outcomes are assessed from patient and caregiver enrollment surveys conducted in-person or by telephone or video conference at enrollment and follow-up telephone or web surveys at 6, 12, and 24 months; Electronic health record portal activity; information about advance directive completion from the electronic medical record; burdensome care at the end of life from family survey and Chesapeake Regional Information System for our Patients (CRISP).

Conditions

Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

SHARE

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 Type: EXPERIMENTAL

Sharing Healthcare Wishes in Primary Care (SHARE)

Intervention Type: BEHAVIORAL

SHARE is a multicomponent communication intervention to proactively engage family members or friends to support advance care planning in primary care.

Minimally Enhanced Usual Care

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.

Group Type: PLACEBO_COMPARATOR

Minimally Enhanced Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

Sharing Healthcare Wishes in Primary Care (SHARE)

SHARE is a multicomponent communication intervention to proactively engage family members or friends to support advance care planning in primary care.

Intervention Type: BEHAVIORAL

Minimally Enhanced Usual Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patient: 80 years or older, English speaking, able to provide informed consent themselves or through their legally authorized representative, identify a family member or friend who plays an active role in care coordination or accompanies them to primary care visits, not planning to move out of state within the next year, and cognitive impairment (mild-severe) on the basis of one or more incorrect answers or not being able to respond to a validated 6-item telephone screening instrument.
• 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.

Exclusion Criteria

• Patient: less than 80 years old, non-English speaking, do not help with care coordination or attend primary care visits with a family member/friend, no willing/able legal guardian or representative to provide written informed consent for those who do not have capacity, plan to move out of state within the next year, or do not have cognitive impairment on the basis of all correct answers on the 6-item telephone screening instrument.
• Family/Friend: less than 18 years old, non-English speaking, do not help with care coordination or attend at least some medical visits of an eligible patient, do not hear well enough to communicate by telephone, report having a life-threatening illness, plan to move out of state within the next year, are a non-family member who is paid for their services, or has cognitive impairment on the basis of two or more incorrect answers on the 6-item telephone screening instrument.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedStar Health

OTHER

Sponsor Role: collaborator

Johns Hopkins Community Physicians

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Wolff, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins Community Physicians - Remington

Baltimore, Maryland, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Beacham Center

Baltimore, Maryland, United States

Medstar Harbor Hospital

Baltimore, Maryland, United States

Johns Hopkins Community Physicians - Greater Dundalk

Dundalk, Maryland, United States

Medstar CSA Collington and House call Program

Mitchellville, Maryland, United States

Johns Hopkins Community Physicians - White Marsh

Nottingham, Maryland, United States

Medstar CSA Montgomery County

Olney, Maryland, United States

MedStar Health at Leisure World Boulevard

Silver Spring, Maryland, United States

Countries

United States

References

Wolff JL, Berger A, Clarke D, Green JA, Stametz R, Yule C, Darer JD. Patients, care partners, and shared access to the patient portal: online practices at an integrated health system. J Am Med Inform Assoc. 2016 Nov;23(6):1150-1158. doi: 10.1093/jamia/ocw025. Epub 2016 Mar 28.

Reference Type: BACKGROUND

PMID: 27026614 (View on PubMed)

Wolff JL, Aufill J, Echavarria D, Heughan JA, Lee KT, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Thorner E, Zafman N, Levy HP, Dy SM, Wolff AC. Sharing in care: engaging care partners in the care and communication of breast cancer patients. Breast Cancer Res Treat. 2019 Aug;177(1):127-136. doi: 10.1007/s10549-019-05306-9. Epub 2019 Jun 4.

Reference Type: BACKGROUND

PMID: 31165374 (View on PubMed)

Wolff JL, Roter DL, Boyd CM, Roth DL, Echavarria DM, Aufill J, Vick JB, Gitlin LN. Patient-Family Agenda Setting for Primary Care Patients with Cognitive Impairment: the SAME Page Trial. J Gen Intern Med. 2018 Sep;33(9):1478-1486. doi: 10.1007/s11606-018-4563-y. Epub 2018 Jul 18.

Reference Type: BACKGROUND

PMID: 30022409 (View on PubMed)

Wolff JL, Cagle J, Echavarria D, Dy SM, Giovannetti ER, Boyd CM, Hanna V, Hussain N, Reiff JS, Scerpella D, Zhang T, Roth DL. 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. Contemp Clin Trials. 2023 Jun;129:107208. doi: 10.1016/j.cct.2023.107208. Epub 2023 Apr 26.

Reference Type: BACKGROUND

PMID: 37116645 (View on PubMed)

Cagle JG, Reiff JS, Smith A, Echavarria D, Scerpella D, Zhang T, Roth DL, Hanna V, Boyd CM, Hussain NA, Wolff JL. Assessing Advance Care Planning Fidelity within the Context of Cognitive Impairment: The SHARE Trial. J Pain Symptom Manage. 2024 Aug;68(2):180-189. doi: 10.1016/j.jpainsymman.2024.05.002. Epub 2024 May 15.

Reference Type: BACKGROUND

PMID: 38754769 (View on PubMed)

Wolff JL, Cagle JG, Hanna V, Dy SM, Echavarria D, Giovannetti ER, Boyd CM, Saylor MA, Hussain N, Reiff JS, Scerpella D, Zhang T, Sekhon VK, Roth DL. Sharing health care wishes among older adults with cognitive impairment in primary care: Results from a randomized controlled trial. Alzheimers Dement. 2024 Oct;20(10):7263-7273. doi: 10.1002/alz.14210. Epub 2024 Aug 27.

Reference Type: BACKGROUND

PMID: 39189632 (View on PubMed)

Reiff JS, Cagle J, Zhang T, Roth DL, Wolff JL. Fielding the quality of communication questionnaire to persons with cognitive impairment and their family in primary care: A pilot study. J Am Geriatr Soc. 2023 Jan;71(1):221-226. doi: 10.1111/jgs.18034. Epub 2022 Sep 6.

Reference Type: DERIVED

PMID: 36069000 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AG058671

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00242431

Identifier Type: -

Identifier Source: org_study_id