SHARE: Sharing Healthcare Wishes in Primary Care

NCT04593472 | Completed Results DMC

• 2 other identifiers: IRB00242431R01AG058671
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 9

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).

Conditions

Cognitive Impairment

Keywords

Cognitive Impairment; Primary Care

Outcome Measures

Primary Outcomes (1)

• Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months

  The primary outcome assesses family-reported quality of communication with the primary care team using the 7-item end-of-life subscale of the validated Quality of Communication Scale. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'), with a range of 0-70 with higher scores indicating higher perceived quality of communication.

  6 months

Secondary Outcomes (7)

• Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months

  6 months

• Proportion of Patients With Documentation of Advance Directive Completion in the Electronic Health Record at 6-months

  6 months

• Average Scores for Bereaved Family-Reported Decisional Conflict

  24 months

• Average Scores for Bereaved Family-Reported Decisional Regret

  24 months

• Average Scores for Bereaved Family Symptoms of Anxiety

  24 months

Study Arms (2)

SHARE

EXPERIMENTAL

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.

Behavioral: Sharing Healthcare Wishes in Primary Care (SHARE)

Minimally Enhanced Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Minimally Enhanced Usual Care

Interventions

Sharing Healthcare Wishes in Primary Care (SHARE) BEHAVIORAL

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

SHARE

Minimally Enhanced Usual Care 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.

Minimally Enhanced Usual Care

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• MedStar Health: collaborator
• Johns Hopkins Community Physicians: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (9)

Johns Hopkins Community Physicians - Remington

Baltimore, Maryland, 21211, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Beacham Center

Baltimore, Maryland, 21224, United States

Location

Medstar Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

Johns Hopkins Community Physicians - Greater Dundalk

Dundalk, Maryland, 21222, United States

Location

Medstar CSA Collington and House call Program

Mitchellville, Maryland, 20721, United States

Location

Johns Hopkins Community Physicians - White Marsh

Nottingham, Maryland, 21236, United States

Location

Medstar CSA Montgomery County

Olney, Maryland, 20832, United States

Location

MedStar Health at Leisure World Boulevard

Silver Spring, Maryland, 20906, United States

Location

Related Publications (7)

• 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.

  PMID: 27026614 BACKGROUND

• 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.

  PMID: 31165374 BACKGROUND

• 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.

  PMID: 30022409 BACKGROUND

• 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.

  PMID: 37116645 BACKGROUND

• 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.

  PMID: 38754769 BACKGROUND

• 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.

  PMID: 39189632 BACKGROUND

• 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.

  PMID: 36069000 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Primary care practices in one geographic location inhibits generalizability. Study is subject to Methodological challenges in the field, like including a lack of established and reliable gold standard measures of clinically meaningful endpoints. Fielding quality of communication instrument has not been used primary care context to cognitively impairment patients and their care partners. Observed treatment effects were variable by outcome.

Results Point of Contact

• Title: Dr. Jennifer Wolff
• Organization: Johns Hopkins Bloomberg School of Public Heath

jwolff2@jhu.edu

4105020458

Study Officials

• Jennifer Wolff, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: October 21, 2020
• Primary Completion: October 24, 2023
• Study Completion: February 26, 2025
• Last Updated: March 13, 2025
• Results First Posted: January 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)