Trial Outcomes & Findings for Improving Communication About Serious Illness (NCT NCT01933789)

NCT ID: NCT01933789

Last Updated: 2019-03-20

Results Overview

Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

817 participants

Primary outcome timeframe

2 weeks after target visit

Results posted on

2019-03-20

Participant Flow

CLINICIANS and INTERPROFESSIONAL (IP) TEAM recruited from Feb 2014 to Nov 2015. PATIENTS and FAMILY recruited from Mar 2014 to Jun 2016. Potential subjects received introductory letters and phone calls to assess interest and eligibility. INTERVIEWEES were selected via purposive sampling from those who completed the intervention activities.

635 CLINICIANS assessed for eligibility; 503 excluded; 132 enrolled. Unit of randomization was clinician. 11 IP TEAM members identified; 4 enrolled. 1113 PATIENTS assessed for eligibility; 576 excluded; 537 enrolled. 142 FAMILY identified; 23 excluded; 119 enrolled. Subjects were enrolled if they completed a baseline survey prior to target visit.

Participant milestones

Participant milestones
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
Received "Jumpstart" feedback forms and education
Patient Control
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Overall Study
STARTED
65
67
2
2
249
288
58
61
25
Overall Study
Had Target Visit
61
65
2
2
228
266
0
0
0
Overall Study
Completed After-visit Survey
57
64
2
1
0
0
0
0
0
Overall Study
Completed 2-Week Survey
0
0
0
0
184
215
0
0
0
Overall Study
Completed 3-Month Survey
0
0
0
0
176
211
37
43
0
Overall Study
Completed 6-Month Survey
0
0
0
0
160
188
35
40
0
Overall Study
Qualitative Interviews
0
0
0
0
0
0
0
0
25
Overall Study
COMPLETED
59
66
2
1
190
221
43
47
25
Overall Study
NOT COMPLETED
6
1
0
1
59
67
15
14
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
Received "Jumpstart" feedback forms and education
Patient Control
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Overall Study
Death
0
0
0
0
21
32
0
0
0
Overall Study
Lost to Follow-up
0
0
0
1
8
9
1
4
0
Overall Study
Withdrawal by Subject
2
1
0
0
17
16
1
4
0
Overall Study
Became Ineligible
4
0
0
0
13
10
13
6
0

Baseline Characteristics

Reporting on Clinician subjects only.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clinician Intervention
n=65 Participants
Received "Jumpstart" feedback forms and education
Clinician Control
n=67 Participants
Received/Provided usual care, surveys only
IP Team Intervention
n=2 Participants
Received "Jumpstart" feedback forms and education
IP Team Control
n=2 Participants
Received/Provided usual care, surveys only
Patient Intervention
n=249 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=288 Participants
Received usual care, surveys only
Family Member Intervention
n=58 Participants
Received "Jumpstart" feedback forms and education
Family Member Control
n=61 Participants
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members. These subjects did not complete baseline measures.
Total
n=792 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=65 Participants
0 Participants
n=67 Participants
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=249 Participants
0 Participants
n=288 Participants
0 Participants
n=58 Participants
0 Participants
n=61 Participants
0 Participants
n=792 Participants
Age, Categorical
Between 18 and 65 years
65 Participants
n=65 Participants
65 Participants
n=67 Participants
2 Participants
n=2 Participants
2 Participants
n=2 Participants
60 Participants
n=249 Participants
76 Participants
n=288 Participants
28 Participants
n=58 Participants
27 Participants
n=61 Participants
325 Participants
n=792 Participants
Age, Categorical
>=65 years
0 Participants
n=65 Participants
2 Participants
n=67 Participants
0 Participants
n=2 Participants
0 Participants
n=2 Participants
189 Participants
n=249 Participants
212 Participants
n=288 Participants
30 Participants
n=58 Participants
34 Participants
n=61 Participants
467 Participants
n=792 Participants
Age, Continuous
46.9 years
STANDARD_DEVIATION 8.64 • n=65 Participants
47.2 years
STANDARD_DEVIATION 10.48 • n=67 Participants
41.0 years
STANDARD_DEVIATION 2.83 • n=2 Participants
59.0 years
STANDARD_DEVIATION 5.66 • n=2 Participants
73.6 years
STANDARD_DEVIATION 11.37 • n=249 Participants
73.3 years
STANDARD_DEVIATION 13.71 • n=288 Participants
65.4 years
STANDARD_DEVIATION 13.32 • n=58 Participants
65.3 years
STANDARD_DEVIATION 13.96 • n=61 Participants
67.7 years
STANDARD_DEVIATION 15.73 • n=792 Participants
Sex: Female, Male
Female
37 Participants
n=65 Participants
34 Participants
n=67 Participants
2 Participants
n=2 Participants
2 Participants
n=2 Participants
124 Participants
n=249 Participants
132 Participants
n=288 Participants
46 Participants
n=58 Participants
43 Participants
n=61 Participants
420 Participants
n=792 Participants
Sex: Female, Male
Male
28 Participants
n=65 Participants
33 Participants
n=67 Participants
0 Participants
n=2 Participants
0 Participants
n=2 Participants
125 Participants
n=249 Participants
156 Participants
n=288 Participants
12 Participants
n=58 Participants
18 Participants
n=61 Participants
372 Participants
n=792 Participants
Race/Ethnicity, Customized
White Non-Hispanic
49 Participants
n=65 Participants
51 Participants
n=67 Participants
2 Participants
n=2 Participants
2 Participants
n=2 Participants
206 Participants
n=249 Participants
219 Participants
n=288 Participants
49 Participants
n=58 Participants
51 Participants
n=61 Participants
629 Participants
n=792 Participants
Race/Ethnicity, Customized
Minority Race/Ethnicity
16 Participants
n=65 Participants
16 Participants
n=67 Participants
0 Participants
n=2 Participants
0 Participants
n=2 Participants
43 Participants
n=249 Participants
69 Participants
n=288 Participants
9 Participants
n=58 Participants
8 Participants
n=61 Participants
161 Participants
n=792 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
0 Participants
n=65 Participants
0 Participants
n=67 Participants
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=249 Participants
0 Participants
n=288 Participants
0 Participants
n=58 Participants
2 Participants
n=61 Participants
2 Participants
n=792 Participants
Clinician Type
Physician
60 Participants
n=65 Participants • Reporting on Clinician subjects only.
62 Participants
n=67 Participants • Reporting on Clinician subjects only.
122 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician Type
Nurse Practicioner
5 Participants
n=65 Participants • Reporting on Clinician subjects only.
5 Participants
n=67 Participants • Reporting on Clinician subjects only.
10 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Family Medicine
14 Participants
n=65 Participants • Reporting on Clinician subjects only.
17 Participants
n=67 Participants • Reporting on Clinician subjects only.
31 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Internal Medicine
18 Participants
n=65 Participants • Reporting on Clinician subjects only.
18 Participants
n=67 Participants • Reporting on Clinician subjects only.
36 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Oncology
8 Participants
n=65 Participants • Reporting on Clinician subjects only.
18 Participants
n=67 Participants • Reporting on Clinician subjects only.
26 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Pulmonology
3 Participants
n=65 Participants • Reporting on Clinician subjects only.
5 Participants
n=67 Participants • Reporting on Clinician subjects only.
8 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Cardiology
14 Participants
n=65 Participants • Reporting on Clinician subjects only.
3 Participants
n=67 Participants • Reporting on Clinician subjects only.
17 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Gastroenterology
3 Participants
n=65 Participants • Reporting on Clinician subjects only.
1 Participants
n=67 Participants • Reporting on Clinician subjects only.
4 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Nephrology
3 Participants
n=65 Participants • Reporting on Clinician subjects only.
4 Participants
n=67 Participants • Reporting on Clinician subjects only.
7 Participants
n=132 Participants • Reporting on Clinician subjects only.
Clinician's Specialty
Geriatrics
2 Participants
n=65 Participants • Reporting on Clinician subjects only.
1 Participants
n=67 Participants • Reporting on Clinician subjects only.
3 Participants
n=132 Participants • Reporting on Clinician subjects only.
Competence [Communication & End-of-Life (EOL) Care]
3.8 units on a scale
STANDARD_DEVIATION 0.55 • n=64 Participants • Questionnaire asked of clinicians at baseline. One intervention clinician did not return a baseline survey.
3.5 units on a scale
STANDARD_DEVIATION 0.57 • n=67 Participants • Questionnaire asked of clinicians at baseline. One intervention clinician did not return a baseline survey.
3.8 units on a scale
STANDARD_DEVIATION 0.56 • n=131 Participants • Questionnaire asked of clinicians at baseline. One intervention clinician did not return a baseline survey.
Patient Self-Assessed Health Status
2 units on a scale
n=247 Participants • Survey item asked of patients at baseline. Two intervention patients did not provide a valid response.
2 units on a scale
n=288 Participants • Survey item asked of patients at baseline. Two intervention patients did not provide a valid response.
2 units on a scale
n=535 Participants • Survey item asked of patients at baseline. Two intervention patients did not provide a valid response.
Patient Education Level
3 units on a scale
n=248 Participants • Survey item asked of patients at baseline. One intervention patient did not provide a valid response.
3 units on a scale
n=288 Participants • Survey item asked of patients at baseline. One intervention patient did not provide a valid response.
3 units on a scale
n=536 Participants • Survey item asked of patients at baseline. One intervention patient did not provide a valid response.
Patient Average Monthly Income
5 units on a scale
n=230 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide a valid response.
5 units on a scale
n=270 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide a valid response.
5 units on a scale
n=500 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide a valid response.
Preference Regarding Future Discussion with Clinician
No objection to future discussion stated
197 Participants
n=249 Participants • Based on survey items asked of patients at baseline.
212 Participants
n=288 Participants • Based on survey items asked of patients at baseline.
409 Participants
n=537 Participants • Based on survey items asked of patients at baseline.
Preference Regarding Future Discussion with Clinician
Objected to future discussion
52 Participants
n=249 Participants • Based on survey items asked of patients at baseline.
76 Participants
n=288 Participants • Based on survey items asked of patients at baseline.
128 Participants
n=537 Participants • Based on survey items asked of patients at baseline.
Quality of Communication (QOC): Four-Indicator Latent Construct
-0.695 scores on a scale
STANDARD_DEVIATION 7.089 • n=127 Participants • All 4 items answered at baseline \& 2 weeks: 127 valid intervention responses; 141 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
0.000 scores on a scale
STANDARD_DEVIATION 6.332 • n=141 Participants • All 4 items answered at baseline \& 2 weeks: 127 valid intervention responses; 141 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
-0.329 scores on a scale
STANDARD_DEVIATION 6.698 • n=268 Participants • All 4 items answered at baseline \& 2 weeks: 127 valid intervention responses; 141 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
Quality of Communication (QOC): Individual QOC Items
Discuss feelings about getting sicker
5.5 units on a scale
n=230 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
8 units on a scale
n=267 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
6 units on a scale
n=497 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Discuss details about getting sicker
7 units on a scale
n=235 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
8 units on a scale
n=266 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
7 units on a scale
n=501 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Discuss prognosis
0 units on a scale
n=235 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=273 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=508 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Discuss what dying might be like
0 units on a scale
n=239 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=278 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=517 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Involve in EOL treatment decisions
0 units on a scale
n=235 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=277 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=512 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Ask about important things in life
5 units on a scale
n=237 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
8 units on a scale
n=272 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
6 units on a scale
n=509 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Quality of Communication (QOC): Individual QOC Items
Ask about spiritual or religious beliefs
0 units on a scale
n=236 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=271 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
0 units on a scale
n=507 Participants • Survey item asked of patients at baseline. Some intervention and control patients did not provide valid responses on all items.
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
0.327 scores on a scale
STANDARD_DEVIATION 0.706 • n=117 Participants • Both items answered at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
0.000 scores on a scale
STANDARD_DEVIATION 0.743 • n=145 Participants • Both items answered at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
0.146 scores on a scale
STANDARD_DEVIATION 0.743 • n=262 Participants • Both items answered at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
5.859 scores on a scale
STANDARD_DEVIATION 4.796 • n=245 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.
5.152 scores on a scale
STANDARD_DEVIATION 4.744 • n=286 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.
5.478 scores on a scale
STANDARD_DEVIATION 4.777 • n=531 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
0.179 scores on a scale
STANDARD_DEVIATION 0.901 • n=127 Participants • Both items answered at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
0.000 scores on a scale
STANDARD_DEVIATION 0.899 • n=150 Participants • Both items answered at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
0.082 scores on a scale
STANDARD_DEVIATION 0.903 • n=277 Participants • Both items answered at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses. Unit of measure: continuous measure with control group mean fixed at zero.
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
2 scores on a scale
n=247 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 6+ items.
1 scores on a scale
n=287 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 6+ items.
2 scores on a scale
n=534 Participants • Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 6+ items.
Choosing Care
Extending life
46 Participants
n=249 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
43 Participants
n=286 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
12 Participants
n=58 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
11 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
112 Participants
n=652 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
Choosing Care
Quality of life (relieving pain and discomfort)
149 Participants
n=249 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
174 Participants
n=286 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
32 Participants
n=58 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
38 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
393 Participants
n=652 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
Choosing Care
I don't know/Not sure
54 Participants
n=249 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
69 Participants
n=286 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
14 Participants
n=58 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
10 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
147 Participants
n=652 Participants • Survey items asked of patients \& family members at baseline. Two control patients and two control family members did not answer this item.
Focus of Care
Extending life
84 Participants
n=244 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
113 Participants
n=284 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
19 Participants
n=57 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
20 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
236 Participants
n=644 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
Focus of Care
Quality of life (relieving pain and discomfort)
84 Participants
n=244 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
90 Participants
n=284 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
20 Participants
n=57 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
24 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
218 Participants
n=644 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
Focus of Care
I don't know/Not sure
76 Participants
n=244 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
81 Participants
n=284 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
18 Participants
n=57 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
15 Participants
n=59 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
190 Participants
n=644 Participants • Survey items asked of patients \& family members at baseline. Nine patients \[5 intervention and 4 control\] and three family members \[1 intervention and 2 control\] did not answer this item.
Barriers
I don't know what kind of care I would want
101 Participants
n=241 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
114 Participants
n=286 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
215 Participants
n=527 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I'm not ready to talk about care I would want
55 Participants
n=245 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
55 Participants
n=287 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
110 Participants
n=532 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I don't like to talk about getting very sick
69 Participants
n=243 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
79 Participants
n=288 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
148 Participants
n=531 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
My doctor never seems to have the time
18 Participants
n=237 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
25 Participants
n=282 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
43 Participants
n=519 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I'd rather concentrate on staying alive
145 Participants
n=242 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
169 Participants
n=285 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
314 Participants
n=527 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I feel that talking about death can bring it close
29 Participants
n=241 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
37 Participants
n=283 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
66 Participants
n=524 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I have a living will, so I don't need to talk
51 Participants
n=245 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
73 Participants
n=283 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
124 Participants
n=528 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
My ideas about the kind of care I want change
107 Participants
n=243 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
110 Participants
n=285 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
217 Participants
n=528 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I have not felt sick enough
132 Participants
n=244 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
146 Participants
n=284 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
278 Participants
n=528 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Barriers
I'm not sure which doctor would be caring for me
126 Participants
n=242 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
136 Participants
n=283 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
262 Participants
n=525 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of barrier item. Not all patients answered all items.
Facilitators
I have been very sick
130 Participants
n=243 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
145 Participants
n=284 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
275 Participants
n=527 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
Facilitators
I have had family or friends who have died
161 Participants
n=240 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
200 Participants
n=285 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
361 Participants
n=525 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
Facilitators
I worry about the quality of my life in the future
132 Participants
n=245 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
151 Participants
n=285 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
283 Participants
n=530 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
Facilitators
I worry that I could be a burden
171 Participants
n=245 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
190 Participants
n=285 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.
361 Participants
n=530 Participants • Survey items asked of patients at baseline. Row values indicate endorsement ("applies to me") of facilitator item. Not all patients answered all items.

PRIMARY outcome

Timeframe: 2 weeks after target visit

Population: Patients completing 2-week questionnaires. Not all patients provided data at this time point.

Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=184 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=215 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Occurrence of Discussion About Goals of Care at Target Visit
Yes
137 Participants
66 Participants
Occurrence of Discussion About Goals of Care at Target Visit
No or Don't Know
47 Participants
145 Participants
Occurrence of Discussion About Goals of Care at Target Visit
No response
0 Participants
4 Participants

SECONDARY outcome

Timeframe: Target visit

Population: Target visit abstracted from patient electronic health record (EHR); not all data were available for this time point.

Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Occurrence of Discussion About Goals of Care at Target Visit
Discussion documented
140 Participants
45 Participants
Occurrence of Discussion About Goals of Care at Target Visit
Discussion not documented
87 Participants
220 Participants

SECONDARY outcome

Timeframe: 2 weeks after target visit

Population: Patients who completed 2-week questionnaires and reported no objection at baseline.

Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=143 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=164 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
Yes
112 Participants
44 Participants
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
No or Don't know
31 Participants
116 Participants
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
No response
0 Participants
4 Participants

SECONDARY outcome

Timeframe: Target visit

Population: Patient EHR abstracted for target visit and had no objection at baseline.

Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=180 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=199 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
Discussion documented
114 Participants
34 Participants
Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline
Discussion not documented
66 Participants
165 Participants

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Survey items asked of patients at 3-months. Not all patients provided data at this time point.

Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=176 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=211 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Goal-Concordant Care
Discordant
74 Participants
116 Participants
Goal-Concordant Care
Concordant
93 Participants
84 Participants
Goal-Concordant Care
Unknown (no resp to preference &/or current care)
9 Participants
11 Participants

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Survey items asked of patients at 3-months. Not all patients provided data at this time point.

Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=104 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=103 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Goal-Concordant Care Among Patients With Stable Treatment Preference
Concordant
74 Participants
57 Participants
Goal-Concordant Care Among Patients With Stable Treatment Preference
Discordant
27 Participants
43 Participants
Goal-Concordant Care Among Patients With Stable Treatment Preference
Unknown (no resp to preference &/or current care)
3 Participants
3 Participants

SECONDARY outcome

Timeframe: 2 weeks from target visit

Population: All 4 items asked of patients at baseline \& 2 weeks. Not all patients provided data at these time points. Continuous measure with control group mean fixed at zero at baseline.

Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Measured with QOC items 1, 2, 5, \& 6 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable; Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=127 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=141 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Quality of Communication (QOC): Four-Indicator Latent Construct
4.585 scores on a scale
Standard Deviation 4.208
2.128 scores on a scale
Standard Deviation 5.570

SECONDARY outcome

Timeframe: 2 weeks from target visit

Population: Survey items asked of patients at 2-weeks. Not all patients provided data at this time point.

Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine'). Individual QOC Items. Theoretical range: 0-11 Actual range: 0-11 Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: units on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=249 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=288 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Quality of Communication (QOC): Individual QOC Items
Discuss feelings about getting sicker
10 units on a scale
Interval 6.5 to 11.0
8 units on a scale
Interval 0.0 to 11.0
Quality of Communication (QOC): Individual QOC Items
Discuss details about getting sicker
9 units on a scale
Interval 0.0 to 11.0
8 units on a scale
Interval 0.0 to 11.0
Quality of Communication (QOC): Individual QOC Items
Discuss prognosis
0 units on a scale
Interval 0.0 to 9.0
0 units on a scale
Interval 0.0 to 9.0
Quality of Communication (QOC): Individual QOC Items
Discuss what dying might be like
0 units on a scale
Interval 0.0 to 1.0
0 units on a scale
Interval 0.0 to 0.0
Quality of Communication (QOC): Individual QOC Items
Involve in EOL treatment decisions
9 units on a scale
Interval 0.0 to 11.0
0 units on a scale
Interval 0.0 to 10.0
Quality of Communication (QOC): Individual QOC Items
Ask about important things in life
9 units on a scale
Interval 0.0 to 11.0
8 units on a scale
Interval 0.0 to 11.0
Quality of Communication (QOC): Individual QOC Items
Ask about spiritual or religion beliefs
0 units on a scale
Interval 0.0 to 9.0
0 units on a scale
Interval 0.0 to 4.5

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses. Continuous measure with control group mean fixed at zero.

Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 \& 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=117 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=145 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
0.255 scores on a scale
Standard Deviation 0.804
0.199 scores on a scale
Standard Deviation 0.722

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.

Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=167 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=195 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
5.879 scores on a scale
Standard Deviation 4.776
4.908 scores on a scale
Standard Deviation 4.634

SECONDARY outcome

Timeframe: 6 months after target visit

Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 117 valid intervention responses; 145 valid control responses. Continuous measure with control group mean fixed at zero at baseline.

Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with PHQ items 1 \& 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=117 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=145 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct
0.399 scores on a scale
Standard Deviation 0.873
0.244 scores on a scale
Standard Deviation 0.737

SECONDARY outcome

Timeframe: 6 months after target visit

Population: Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 7+ items.

Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered). Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=146 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=171 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Patient Health Questionnaire (PHQ-8): Eight-Item Scale
5.853 scores on a scale
Standard Deviation 5.339
4.850 scores on a scale
Standard Deviation 4.410

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses. Continuous measure with control group mean fixed at zero at baseline.

Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 \& 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=127 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=150 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
0.281 scores on a scale
Standard Deviation 0.788
0.217 scores on a scale
Standard Deviation 0.807

SECONDARY outcome

Timeframe: 3 months after target visit

Population: Survey items asked of patients at 3-months. Some intervention and control patients did not provide valid responses on 6+ items.

Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=171 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=196 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
2 scores on a scale
Interval 0.0 to 5.0
2 scores on a scale
Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 6 months after target visit

Population: Both survey items answered by patients at baseline, 3-months \& 6-months: 127 valid intervention responses; 150 valid control responses. Continuous measure with control group mean fixed at zero at baseline.

Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Two-Indicator Latent Construct: Measured with GAD items 1 \& 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable. Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=127 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=150 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct
0.297 scores on a scale
Standard Deviation 0.847
0.209 scores on a scale
Standard Deviation 0.935

SECONDARY outcome

Timeframe: 6 months after target visit

Population: Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 6+ items.

Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'. Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.) Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=153 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=176 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Generalized Anxiety Disorder (GAD-7): Seven-Item Scale
1 scores on a scale
Interval 0.0 to 6.0
1 scores on a scale
Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Avoidance of Life-Sustaining Therapies, All Patients
Received LST
18 Participants
14 Participants
Avoidance of Life-Sustaining Therapies, All Patients
Avoided LST
209 Participants
251 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation for patients preferring "comfort" (quality of life over extending life) at the end-of-life

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=109 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=112 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
Received LST
7 Participants
10 Participants
Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference
Avoided LST
102 Participants
102 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation, Inpatient Stay - All Patients
No
221 Participants
260 Participants
Palliative Care Consultation, Inpatient Stay - All Patients
Yes
6 Participants
5 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=87 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=110 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
No
86 Participants
102 Participants
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
Yes
1 Participants
8 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation, Inpatient Stay - All Patients
No
218 Participants
257 Participants
Palliative Care Consultation, Inpatient Stay - All Patients
Yes
9 Participants
8 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=93 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=119 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
No
91 Participants
114 Participants
Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit
Yes
2 Participants
5 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Referral, Outpatient Visit - All Patients
No
217 Participants
250 Participants
Palliative Care Referral, Outpatient Visit - All Patients
Yes
10 Participants
15 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=87 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=110 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
No
84 Participants
103 Participants
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
Yes
3 Participants
7 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Referral, Outpatient Visit - All Patients
No
213 Participants
244 Participants
Palliative Care Referral, Outpatient Visit - All Patients
Yes
14 Participants
21 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=93 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=119 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
No
89 Participants
108 Participants
Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit
Yes
4 Participants
11 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation and/or Referral - All Patients
Yes
15 Participants
18 Participants
Palliative Care Consultation and/or Referral - All Patients
No
212 Participants
247 Participants

SECONDARY outcome

Timeframe: 3-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=87 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=110 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
No
83 Participants
102 Participants
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
Yes
4 Participants
8 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=227 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=265 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation and/or Referral - All Patients
No
206 Participants
240 Participants
Palliative Care Consultation and/or Referral - All Patients
Yes
21 Participants
25 Participants

SECONDARY outcome

Timeframe: 6-month period following the target visit

Population: Patients who had a target visit and a chart reviewed.

EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for "comfort care" (quality of life over extending life) and wanted a discussion.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=93 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=119 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
No
87 Participants
106 Participants
Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit
Yes
6 Participants
13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after target visit

Population: Patients completing 3-month questionnaires.

Binary variable indicating whether patient's current preference was for life-extension or comfort care

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=176 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=211 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
Life extension
33 Participants
31 Participants
Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
Comfort
104 Participants
121 Participants
Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
Unsure
34 Participants
52 Participants
Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)
No response
5 Participants
7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after target visit

Population: Patients completing 3-month questionnaires.

Binary variable indicating whether patient's treatment preference was stable between target visit (or baseline, if no 2-week questionnaire was returned) and 3 months.

Outcome measures

Outcome measures
Measure
Clinician Intervention
Received "Jumpstart" feedback forms and education
Clinician Control
Received/Provided usual care, surveys only
IP Team Intervention
Received "Jumpstart" feedback forms and education
IP Team Control
Received/Provided usual care, surveys only
Patient Intervention
n=176 Participants
Received "Jumpstart" feedback forms and education
Patient Control
n=211 Participants
Received usual care, surveys only
Family Member Intervention
Received "Jumpstart" feedback forms and education
Family Member Control
Received usual care, surveys only
Interviewees
Key informants: Clinicians, Patients and Family Members
Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)
Stable
104 Participants
103 Participants
Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)
Not stable
12 Participants
13 Participants
Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)
Unknown (pref not stated at one or both time pts)
60 Participants
95 Participants

Adverse Events

Clinician Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Clinician Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IP Team Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IP Team Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Patient Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Patient Control

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Family Member Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Family Member Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Interviewees

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Clinician Intervention
n=65 participants at risk
Received "Jumpstart" feedback forms and education
Clinician Control
n=67 participants at risk
Received/Provided usual care, surveys only
IP Team Intervention
n=2 participants at risk
Received "Jumpstart" feedback forms and education
IP Team Control
n=2 participants at risk
Received/Provided usual care, surveys only
Patient Intervention
n=249 participants at risk
Received "Jumpstart" feedback forms and education
Patient Control
n=288 participants at risk
Received usual care, surveys only
Family Member Intervention
n=58 participants at risk
Received "Jumpstart" feedback forms and education
Family Member Control
n=61 participants at risk
Received usual care, surveys only
Interviewees
n=25 participants at risk
Key informants: Clinicians, Patients and Family Members
Product Issues
Subject complaint
0.00%
0/65 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/67 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/2 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/2 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/249 • Adverse events were collected for the duration of the study activities: 42 months.
0.69%
2/288 • Number of events 2 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/58 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/61 • Adverse events were collected for the duration of the study activities: 42 months.
0.00%
0/25 • Adverse events were collected for the duration of the study activities: 42 months.

Additional Information

Dr. J. Randall Curtis

University of Washington

Phone: 206-744-3356

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place