SHARE: Sharing Healthcare Wishes in Primary Care
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04593472 |
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Recruitment Status :
Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : February 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cognitive Impairment | Behavioral: Sharing Healthcare Wishes in Primary Care (SHARE) Behavioral: Minimally Enhanced Usual Care | Not Applicable |
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 CRISP.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 273 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 80 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| United States, Maryland | |
| Johns Hopkins Community Physicians - Remington | |
| Baltimore, Maryland, United States, 21211 | |
| MedStar Union Memorial Hospital | |
| Baltimore, Maryland, United States, 21218 | |
| Beacham Center | |
| Baltimore, Maryland, United States, 21224 | |
| Medstar Harbor Hospital | |
| Baltimore, Maryland, United States, 21225 | |
| Johns Hopkins Community Physicians - Greater Dundalk | |
| Dundalk, Maryland, United States, 21222 | |
| Medstar CSA Collington and House call Program | |
| Mitchellville, Maryland, United States, 20721 | |
| Johns Hopkins Community Physicians - White Marsh | |
| Nottingham, Maryland, United States, 21236 | |
| Medstar CSA Montgomery County | |
| Olney, Maryland, United States, 20832 | |
| MedStar Health at Leisure World Boulevard | |
| Silver Spring, Maryland, United States, 20906 | |
| Principal Investigator: | Jennifer Wolff, PhD | Johns Hopkins Bloomberg School of Public Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cognitive Impairment Primary Care |
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Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |