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Cognitive ImpairmentNCT04593472

SHARE: Sharing Healthcare Wishes in Primary Care

A study testing Sharing Healthcare Wishes in Primary Care (SHARE) in people with Cognitive Impairment, run by Johns Hopkins University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Cognitive Impairment
What is being tested?
Sharing Healthcare Wishes in Primary Care (SHARE)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
273 participants
Where
9 sitesUnited States
Study dates
21 Oct 2020to 26 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Johns Hopkins Community Physicians - Remington

    Baltimore, Maryland, 21211

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Beacham Center

    Baltimore, Maryland, 21224

  • Medstar Harbor Hospital

    Baltimore, Maryland, 21225

  • Johns Hopkins Community Physicians - Greater Dundalk

    Dundalk, Maryland, 21222

  • Medstar CSA Collington and House call Program

    Mitchellville, Maryland, 20721

  • Johns Hopkins Community Physicians - White Marsh

    Nottingham, Maryland, 21236

  • Medstar CSA Montgomery County

    Olney, Maryland, 20832

  • MedStar Health at Leisure World Boulevard

    Silver Spring, Maryland, 20906

Other trials in United States

About this study

Official title: Sharing Healthcare Wishes in Primary Care

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).

Read the 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).

Being tested
Sharing Healthcare Wishes in Primary Care (SHARE), Minimally Enhanced Usual Care
Keywords
Cognitive Impairment, Primary Care
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sharing Healthcare Wishes in Primary Care (SHARE)Behavioural

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

  • Minimally Enhanced Usual CareBehavioural

    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.

Study groups in NCT04593472
Study groupRoleWhat they receive
SHAREExperimentalSHARE 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.
Receives: Behavioral: Sharing Healthcare Wishes in Primary Care (SHARE)
Minimally Enhanced Usual CarePlacebo comparatorMinimally 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.
Receives: Behavioral: Minimally Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (7)

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

    The Advance Care Planning Engagement Survey is a validated patient-reported questionnaire that assesses advance care planning process measures on a 5-point Likert scale. The outcome assesses a 6-item subscale of the Advance Care Planning Engagement Survey that includes parallel items for patient and family participants. The scale for each item is from 1 ("I have never thought about it") to 5 ("I have already done it"), with a range of 6-30 with higher scores indicating higher perceived readiness to engage in advance care planning.

    Measured: 6 months

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

    Documentation of advance directive completion in the electronic health record is defined as having a durable power of attorney or a living will documented in the primary care electronic health record. The Medical Order for Life Sustaining Treatment (MOLST) will not be included for this outcome as the completion of a Maryland MOLST is mandatory in certain situations, such as on transfer between settings of care, and is not indicative of having had an advance care planning discussion or naming a durable power of attorney.

    Measured: 6 months

  3. Average Scores for Bereaved Family-Reported Decisional Conflict

    Caregivers of patients who die are asked to assess their Decisional Conflict 2-3 months after patient's death. The Decisional Conflict Scale is a 16-item instrument scored on a 5-point Likert scale ranging from 0 ("strongly agree") to 4 ("strongly disagree").The 16 items are summed, divided by 16, then multiplied by 25 to yield scores that range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Higher scores indicate higher decisional conflict.

    Measured: 24 months

  4. Average Scores for Bereaved Family-Reported Decisional Regret

    Caregivers of patients who die are asked to assess their Decisional Regret 2-3 months after patient's death. This outcome assesses bereaved family-reported decisional regret using a 5-item instrument that assesses the extent to which decision-makers experience regret about care. Response options are assessed using a 5-item Likert scale in which scores of 1 indicate the least regret and 5 the most regret. Scores are then reduced by 1 point and multiplied by 25 for a scale that ranges in value from 0 to 100. Prior studies have categorized scores of 0 as no regret, 1 to 25 as mild regret, and more than 25 as heightened regret. Higher scores indicate stronger feelings of regret.

    Measured: 24 months

  5. Average Scores for Bereaved Family Symptoms of Anxiety

    Caregivers of patients who die are asked to respond to questions about Symptoms of Anxiety 2-3 months after patient's death. This outcome assesses bereaved family symptoms of anxiety using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7). The GAD-7 is a validated instrument that asks about symptoms of anxiety using a two-week recall period with response categories that vary from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to construct composite scores. Higher scores indicate more symptoms of anxiety.

    Measured: 24 months

  6. Average Scores for Bereaved Family-Reported Satisfaction With Care at the End-of-Life in Dementia

    Caregivers of patients who die are asked to assess their Satisfaction with Care at the End-of-life in Dementia 2-3 months after patient's death using the Satisfaction with Care at the End-of-Life in Dementia (SWC-EOLD). This is a 10-item instrument measured on a 4-point Likert scale that ranges from 1 ("strongly disagree") to 4 ("strongly agree") with a summary score ranging from 10-40 in which higher values indicate higher satisfaction. Higher scores indicate better satisfaction with care at the end-of-life in dementia.

    Measured: 24 months

  7. Proportion of Patients Who Received Burdensome Care

    For patients who die while enrolled in the study by 24 months, this outcome assesses the proportion of patients who received burdensome care near the end of life. Burdensome care is defined as any intensive care unit use or life prolonging care (cardiopulmonary resuscitation, mechanical ventilation, tracheostomy, dialysis, artificial nutrition, chemotherapy) within 30 days of death using dates and services abstracted from medical records and the Chesapeake Regional Information System (CRISP), Maryland's Health Information Exchange, which includes all hospital encounters.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start21 Oct 2020
  3. Primary completion24 Oct 2023
  4. Study completion26 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04593472
Sponsor's protocol ID
IRB00242431
Other IDs
R01AG058671
Status last verified
Apr 2026
First submitted
13 Oct 2020
Last updated
14 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27026614

  • 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.

    PubMed 31165374

  • 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.

    PubMed 30022409

  • 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.

    PubMed 37116645

  • 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.

    PubMed 38754769

  • 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.

    PubMed 39189632

  • 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.

    PubMed 36069000

Questions about this trial

What is this clinical trial studying?

A study testing Sharing Healthcare Wishes in Primary Care (SHARE) in people with Cognitive Impairment, run by Johns Hopkins University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593472, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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