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Sharing Healthcare Wishes in Primary Care (SHARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593472
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Medstar Health Research Institute
Johns Hopkins Community Physicians
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study evaluates the efficacy of Sharing Healthcare Wishes in Primary Care (SHARE), a two-group randomized trial at 5 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).

Condition or disease Intervention/treatment Phase
Cognitive Impairment Behavioral: Sharing Healthcare Wishes in Primary Care (SHARE) Behavioral: Minimally Enhanced Usual Care Not Applicable

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; MyChart portal activity; information about advance directive completion from electronic medical record; burdensome care at the end of life from family survey and CRISP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Sharing Healthcare Wishes in Primary Care
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Between-Group Differences in Family-Reported Quality of Communication at 6-Months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Between-Group Differences in Family-Reported Readiness to Engage in Advance Care Planning at 6-months [ Time Frame: 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 4-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 4-20 with higher scores indicating higher perceived readiness to engage in advance care planning.

  2. Between-Group Differences in the Proportion of Patients with Documentation of Advance Directive Completion in the Electronic Health Record at 6-months [ Time Frame: 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.

  3. Between-Group Differences in Bereaved Family-Reported Decisional Conflict [ Time Frame: 2-3 months after patient death ]
    For patients who die while enrolled in the study by 24 months, this outcome assesses bereaved family-reported Decisional Conflict using 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).

  4. Between-Group Differences in Bereaved Family-Reported Decisional Regret [ Time Frame: 2-3 months after patient death ]
    For patients who die while enrolled in the study by 24 months, 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.

  5. Between-Group Differences in Bereaved Family Symptoms of Anxiety [ Time Frame: 2-3 months after patient death ]
    For patients who die while enrolled in the study by 24 months, 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.

  6. Between-Group Differences in Bereaved Family-Reported Satisfaction with Care at the End-of-Life in Dementia [ Time Frame: 2-3 months after patient death ]
    For patients who die while enrolled in the study by 24 months, this outcome assesses bereaved family-reported satisfaction with care. The Satisfaction with Care at the End-of-Life in Dementia (SWC-EOLD) 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.

  7. Between-Group Differences in Proportion of Patients Who Received Burdensome Care [ Time Frame: 2-3 months after patient death ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 accompanies them to primary care visits, 1 or more unplanned overnight hospitalization within previous 12 months, 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 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, no unplanned overnight hospitalization within previous 12 months, 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593472


Contacts
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Contact: Diane Echavarria, MS 410.614.7910 dechava1@jhu.edu

Locations
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United States, Maryland
MedStar Union Memorial Hospital Not yet recruiting
Baltimore, Maryland, United States, 21218
Contact: Erin Giovannetti, PhD         
Johns Hopkins Community Physicians - Greater Dundalk Recruiting
Dundalk, Maryland, United States, 21222
Contact: Diane Echavarria, MS         
Johns Hopkins Community Physicians - White Marsh Recruiting
Nottingham, Maryland, United States, 21236
Contact: Diane Echavarria, MS         
MedStar Health at Leisure World Boulevard Not yet recruiting
Silver Spring, Maryland, United States, 20906
Contact: Erin Giovannetti, PhD         
Sponsors and Collaborators
Johns Hopkins University
Medstar Health Research Institute
Johns Hopkins Community Physicians
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jennifer Wolff, PhD Johns Hopkins Bloomberg School of Public Health
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04593472    
Other Study ID Numbers: IRB00242431
R01AG058671 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Cognitive Impairment
Primary Care
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders