N/A
N=273
SHARE: Sharing Healthcare Wishes in Primary Care
Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04593472 ↗Enrolled (actual)
273
Serious AEs
2.2%
Results posted
Jan 2025
Primary outcome: Primary: Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months — 3.41; 3.09; 3.06; 1.93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sharing Healthcare Wishes in Primary Care (SHARE) (Behavioral); Minimally Enhanced Usual Care (Behavioral)
- Age
- Older Adult · 80+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months |
3.41; 3.09; 3.06; 1.93 | — |
| SECONDARY Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months |
27.01; 24.82; 17.25; 16.21 | — |
| SECONDARY Proportion of Patients With Documentation of Advance Directive Completion in the Electronic Health Record at 6-months |
— | — |
| SECONDARY Average Scores for Bereaved Family-Reported Decisional Conflict |
— | — |
| SECONDARY Average Scores for Bereaved Family-Reported Decisional Regret |
— | — |
| SECONDARY Average Scores for Bereaved Family Symptoms of Anxiety |
— | — |
| SECONDARY Average Scores for Bereaved Family-Reported Satisfaction With Care at the End-of-Life in Dementia |
— | — |
| SECONDARY Proportion of Patients Who Received Burdensome Care |
— | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04593472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.