Trial Outcomes & Findings for SHARE: Sharing Healthcare Wishes in Primary Care (NCT NCT04593472)
NCT ID: NCT04593472
Last Updated: 2025-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
273 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-13
Participant Flow
Participants were recruited from 8 primary care practices at two health systems from October 2020 to December 2022. Both patient and care partner must have been eligible to participate. Eligible patients were ≥80 years and screened positive for cognitive impairment (1+ incorrect answer or unable to respond to a 6-item screening survey). Eligible care partners were ≥18 years, English-speaking, no life-threatening illness, and did not screen positive for cognitive impairment.
Of 4,441 patient-family dyads who were outreached, 606 opted out of the study via opt-out card, and 3,835 were screened. Of 3,835 screened, 3,557 were ineligible (369 unreachable, 2,458 did not meet eligibility criteria, 730 refused, 5 consented not randomized due to lost to follow up). Patient and caregivers were enrolled as dyads. A total of 273 patient-family dyads were enrolled and randomized. The total number of individual participants is 546 (Participants started in Protocol Section).
Participant milestones
| Measure |
SHARE Group
Of 273 enrolled patient-family dyads, 145 were randomized to the SHARE intervention group and received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led advance care planning (ACP) conversation.
|
Control Group
Of 273 enrolled patient-family dyads, 128 were assigned to the control group and received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive.
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
128
|
|
Overall Study
Completed 6-Month Follow-Up Interview
|
108
|
97
|
|
Overall Study
Completed 12-Month Follow-Up Interview
|
86
|
77
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
98
|
79
|
Reasons for withdrawal
| Measure |
SHARE Group
Of 273 enrolled patient-family dyads, 145 were randomized to the SHARE intervention group and received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led advance care planning (ACP) conversation.
|
Control Group
Of 273 enrolled patient-family dyads, 128 were assigned to the control group and received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive.
|
|---|---|---|
|
Overall Study
Death
|
31
|
27
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
|
Overall Study
Dropped due to provider change between either 6, 12 or 24 months
|
33
|
22
|
|
Overall Study
Dropped due to caregiver change between either 6, 12 or 24 months
|
5
|
4
|
|
Overall Study
Dropped due to participants missing assessment at both 6 and 12-month
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Still collecting 24-month assessment
|
17
|
10
|
Baseline Characteristics
The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
Baseline characteristics by cohort
| Measure |
SHARE Group
n=290 Participants
Of 273 patient-family dyads enrolled, 145 patients and 145 caregivers were randomized to the SHARE intervention group and received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led ACP conversation. A total of 290 participants were randomized to the SHARE intervention group.
|
Control Group
n=256 Participants
Of 273 patient-family dyads enrolled, 128 patients and 128 caregivers were assigned to the control group and received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive. A total of 256 participants were randomized to the control group.
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Patient · <=18 years
|
0 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Categorical
Patient · Between 18 and 65 years
|
0 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Categorical
Patient · >=65 years
|
145 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
128 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
273 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Categorical
Caregiver · <=18 years
|
0 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Categorical
Caregiver · Between 18 and 65 years
|
81 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
67 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
148 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Categorical
Caregiver · >=65 years
|
64 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
61 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
125 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Continuous
Patient
|
88.0 years
STANDARD_DEVIATION 5.9 • n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
87.9 years
STANDARD_DEVIATION 5.8 • n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
88.0 years
STANDARD_DEVIATION 5.8 • n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Age, Continuous
Caregiver
|
65.7 years
STANDARD_DEVIATION 10.8 • n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
66.3 years
STANDARD_DEVIATION 13.6 • n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
66.0 years
STANDARD_DEVIATION 12.2 • n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Sex: Female, Male
Patient · Female
|
89 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
82 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
171 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Sex: Female, Male
Patient · Male
|
56 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
46 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
102 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Sex: Female, Male
Caregiver · Female
|
122 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
101 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
223 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Sex: Female, Male
Caregiver · Male
|
23 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
27 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
50 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Patient · Hispanic or Latino
|
6 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
3 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
9 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Patient · Not Hispanic or Latino
|
139 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
125 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
264 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Patient · Unknown or Not Reported
|
0 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
0 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
|
6 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
4 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
10 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
|
139 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
122 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
261 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
|
0 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
2 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
2 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Patient · Black
|
46 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
30 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
76 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Patient · Asian
|
6 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
7 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
13 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Patient · White
|
88 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
86 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
174 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Patient · Other race/missing
|
5 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
5 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
10 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Caregiver · Black
|
45 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
31 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
76 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Caregiver · Asian
|
5 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
5 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
10 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Caregiver · White
|
90 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
84 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
174 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Race/Ethnicity, Customized
Caregiver · Other race/missing
|
5 Participants
n=145 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
8 Participants
n=128 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
13 Participants
n=273 Participants • The row population for each row (patient and caregiver) differs from the overall number of baseline participants because each row specifies the number of participants analyzed separately by patient or caregiver.
|
|
Region of Enrollment
United States
|
290 Participants
n=290 Participants
|
256 Participants
n=256 Participants
|
546 Participants
n=546 Participants
|
|
Education >12th grade
Patient
|
72 Participants
n=145 Participants • Patients' and Caregivers' measures were assessed separately.
|
69 Participants
n=128 Participants • Patients' and Caregivers' measures were assessed separately.
|
141 Participants
n=273 Participants • Patients' and Caregivers' measures were assessed separately.
|
|
Education >12th grade
Caregiver
|
121 Participants
n=145 Participants • Patients' and Caregivers' measures were assessed separately.
|
96 Participants
n=128 Participants • Patients' and Caregivers' measures were assessed separately.
|
217 Participants
n=273 Participants • Patients' and Caregivers' measures were assessed separately.
|
|
Patient Diagnosis of Cognitive Impairment
|
71 Participants
n=145 Participants • Patients only
|
63 Participants
n=128 Participants • Patients only
|
134 Participants
n=273 Participants • Patients only
|
|
Patient - Moderate or Severe Cognitive Impairment (based on TICS-m score)
|
108 Participants
n=145 Participants • Patients only.
|
81 Participants
n=128 Participants • Patients only.
|
189 Participants
n=273 Participants • Patients only.
|
|
Patient - Live Alone
|
40 Participants
n=145 Participants • Patient only
|
41 Participants
n=128 Participants • Patient only
|
81 Participants
n=273 Participants • Patient only
|
|
Caregiver Relationship to Patient
Spouse/Partner
|
33 Participants
n=145 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
36 Participants
n=128 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
69 Participants
n=273 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
|
Caregiver Relationship to Patient
Adult Child
|
103 Participants
n=145 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
82 Participants
n=128 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
185 Participants
n=273 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
|
Caregiver Relationship to Patient
Other (friend, other relative)
|
9 Participants
n=145 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
10 Participants
n=128 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
19 Participants
n=273 Participants • The row population differs from the overall number of participants because this measure was only assessed for the caregiver population.
|
|
Patient Reported Quality of Life
|
34.5 score on a scale
STANDARD_DEVIATION 7.0 • n=145 Participants • Patient only
|
35.4 score on a scale
STANDARD_DEVIATION 6.5 • n=128 Participants • Patient only
|
34.9 score on a scale
STANDARD_DEVIATION 6.8 • n=273 Participants • Patient only
|
|
Caregiver Reported Fair or Poor Self-rated Health
|
22 Participants
n=145 Participants • Caregivers only
|
17 Participants
n=128 Participants • Caregivers only
|
39 Participants
n=273 Participants • Caregivers only
|
|
Caregiver Reported - Hours helping patient in a typical week
|
25.7 hours/week
STANDARD_DEVIATION 33.3 • n=145 Participants • Caregivers only
|
22.4 hours/week
STANDARD_DEVIATION 32.7 • n=128 Participants • Caregivers only
|
24.1 hours/week
STANDARD_DEVIATION 33.0 • n=273 Participants • Caregivers only
|
|
Caregiver Reported - Years accompanying patients to visits
|
8.3 years
STANDARD_DEVIATION 9.4 • n=145 Participants • Caregivers only
|
8.9 years
STANDARD_DEVIATION 9.0 • n=128 Participants • Caregivers only
|
8.6 years
STANDARD_DEVIATION 9.2 • n=273 Participants • Caregivers only
|
|
Caregiver - Symptoms of caregiving burden
|
15.1 score on a scale
STANDARD_DEVIATION 10.2 • n=145 Participants • Caregivers only
|
14.6 score on a scale
STANDARD_DEVIATION 8.4 • n=128 Participants • Caregivers only
|
14.9 score on a scale
STANDARD_DEVIATION 9.4 • n=273 Participants • Caregivers only
|
|
Caregiver - Symptoms of anxiety
|
3.4 score on a scale
STANDARD_DEVIATION 4.0 • n=145 Participants • Caregivers only
|
2.6 score on a scale
STANDARD_DEVIATION 2.9 • n=128 Participants • Caregivers only
|
3.0 score on a scale
STANDARD_DEVIATION 3.5 • n=273 Participants • Caregivers only
|
|
Caregiver - Shared decision-making
|
84.8 score on a scale
STANDARD_DEVIATION 23.2 • n=145 Participants • Caregivers only
|
82.9 score on a scale
STANDARD_DEVIATION 23.1 • n=128 Participants • Caregivers only
|
83.9 score on a scale
STANDARD_DEVIATION 23.1 • n=273 Participants • Caregivers only
|
|
Caregiver - Therapeutic Alliance
|
55.3 score on a scale
STANDARD_DEVIATION 9.4 • n=145 Participants • Caregivers only
|
53.3 score on a scale
STANDARD_DEVIATION 10.5 • n=128 Participants • Caregivers only
|
54.3 score on a scale
STANDARD_DEVIATION 10.0 • n=273 Participants • Caregivers only
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 216 represents the total number participants (patients, caregivers) assessed in the intervention group for this outcome at 6 months, and 194 represents the total number of participants (patients, caregivers) assessed in the control group for this outcome 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.
Outcome measures
| Measure |
SHARE
n=216 Participants
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.
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.
|
Minimally Enhanced Usual Care
n=194 Participants
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: 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.
|
|---|---|---|
|
Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months
Caregivers
|
3.41 score on a scale
Standard Deviation 2.4
|
3.09 score on a scale
Standard Deviation 2.4
|
|
Average Scores for Patient and Caregiver-Reported Quality of Communication at 6-Months
Patients
|
3.06 score on a scale
Standard Deviation 2.8
|
1.93 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 216 represents the total number participants (patients, caregivers) assessed in the intervention group for this outcome at 6 months, and 194 represents the total number of participants (patients, caregivers) assessed in the control group for this outcome 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.
Outcome measures
| Measure |
SHARE
n=216 Participants
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.
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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Minimally Enhanced Usual Care
n=194 Participants
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: 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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Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months
Caregivers
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27.01 score on a scale
Standard Deviation 4.2
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24.82 score on a scale
Standard Deviation 6.9
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Average Scores for Patient and Caregiver-Reported Readiness to Engage in Advance Care Planning at 6-months
Patients
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17.25 score on a scale
Standard Deviation 3.5
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16.21 score on a scale
Standard Deviation 4.6
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsCaregivers 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsCaregivers 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsCaregivers 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsCaregivers 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsFor 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.
Outcome measures
Outcome data not reported
Adverse Events
SHARE Group: Patients
Serious events: 8 serious events
Other events: 0 other events
Deaths: 34 deaths
Control Group: Patients
Serious events: 3 serious events
Other events: 0 other events
Deaths: 29 deaths
SHARE Group: Caregivers
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SHARE Group: Patients
n=145 participants at risk
The SHARE intervention group received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led ACP conversation.
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Control Group: Patients
n=128 participants at risk
The control group received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive.
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SHARE Group: Caregivers
n=145 participants at risk
The SHARE intervention group received a packet from the primary care practice including a person-family agenda setting checklist, blank advance directive, guide for communication with clinicians, instructions for completing proxy registration for the patient portal and an invitation to a facilitator led ACP conversation.
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Control Group: Caregivers
n=128 participants at risk
The control group received minimally enhanced usual care encompassing an introductory letter, the guide for communicating with clinicians and blank advance directive.
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General disorders
Patient Hospitalized, Rehabilitated or Placed in Hospice
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5.5%
8/145 • Up to 24 months
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2.3%
3/128 • Up to 24 months
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0.69%
1/145 • Up to 24 months
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0.00%
0/128 • Up to 24 months
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Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Wolff
Johns Hopkins Bloomberg School of Public Heath
Phone: 4105020458
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place