Trial Outcomes & Findings for Integrated Multidisciplinary Patient and Family Advance Care Planning Trial (NCT NCT03609658)
NCT ID: NCT03609658
Last Updated: 2021-08-06
Results Overview
Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.
COMPLETED
NA
146 participants
End of Study (Month 13)
2021-08-06
Participant Flow
This protocol has Zelen's Design. Subjects were randomized to either the usual care arm or the nurse navigator arm prior to signing consent. And only those who were randomized to nurse navigator arm were consented. 379 subjects randomized to the nurse navigator arm, and of those, only 146 agreed to participate and signed consent. Subjects randomized to the usual care arm had a waiver of consent. The study team only did chart analysis for usual care subjects.
Participant milestones
| Measure |
Nurse Navigator Pathway Group
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Overall Study
STARTED
|
379
|
380
|
|
Overall Study
COMPLETED
|
379
|
380
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Multidisciplinary Patient and Family Advance Care Planning Trial
Baseline characteristics by cohort
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
Total
n=759 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
65 to <75 years
|
149 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Age, Customized
75 to <85 years
|
161 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Age, Customized
≥85 years
|
69 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
300 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
617 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
71 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
379 participants
n=5 Participants
|
380 participants
n=7 Participants
|
759 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 13)Population: This outcome includes all randomized subjects (Zelen's design).
Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator
|
134 Discussions
|
0 Discussions
|
PRIMARY outcome
Timeframe: End of Study (Month 13)Population: This outcome applies to randomized subjects.
Reported as the number of documentations completed in the newly created ACP note template for provider note templates.
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Number of Patient's Documented Advance Care Planning Discussions - Provider
|
160 discussions
|
14 discussions
|
PRIMARY outcome
Timeframe: End of Study (Month 13)Population: Data was not collected for this outcome measure.
Measured by the newly created ACP note template for both nurse navigator (score ranging from 0-8). Score of 5 or higher determines better outcome.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of Study (Month 13)Population: data was not collected for this outcome
Measured by the newly created ACP note template for provider note templates (score ranging from 0-15). Score of 8 or higher in the provider template determines better outcome.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of Study (Month 13)Population: This outcome does not apply to usual care group. Ten subjects were lost to follow up and 5 subjects withdrew consent from Nurse Navigator arm. Completion of the QOC was optional for the participants who had completed the provider visit.
Measured by the Quality about End of Life (EOL) Communication (QOC), The instrument is reported as 2 subscales: "general communication skills" and "communication about end-of-life care." Score range for the subscales is 1-11 Higher scores determine better outcomes.
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=87 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Quality of Advance Care Planning Discussion From the Patient's Perspective
General Communication
|
10.2 score on a scale
Standard Deviation 1.8
|
—
|
|
Quality of Advance Care Planning Discussion From the Patient's Perspective
End of Life
|
7.9 score on a scale
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: End of Study (Month 13)Population: This outcome uses all randomized subjects (Zelen's Design).
ACP billing codes: 99497 and 99498 usages will be recorded
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Advance Care Planning Billing Code Usage
|
96 code usages
|
5 code usages
|
SECONDARY outcome
Timeframe: End of Study (Month 13)Population: This outcome uses all randomized (Zelen's Design).
Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Number of Designated Surrogate Decision Makers
|
241 surrogate decision makers
|
132 surrogate decision makers
|
SECONDARY outcome
Timeframe: End of Study (Month 13)Population: Based on all randomized (Zelen's Design).
Reported as the number of scanned advance directive documents in the EHR.
Outcome measures
| Measure |
Nurse Navigator Pathway Group
n=379 Participants
Participants in this Nurse Navigator led ACP pathway group will participate in ACP discussions, surveys, and participant visit(s) for duration of the study (12 months)
Nurse Navigator Pathway: In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
|
Usual Care Group
n=380 Participants
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Usual Care: In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
|
|---|---|---|
|
Advance Directive Completion
|
92 scanned documents
|
38 scanned documents
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Month 13)Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 29The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Month 13)Frequency is measured by the number of healthcare events recorded in the EHR.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Month 13)Cost of patient healthcare utilization per group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 11This is a likert scale total score (0-78). Higher scores denotes better outcomes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Month 13)The number of protocol deviations will be reported to measure the fidelity of study implementation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of Study (Month 13)Measured by the System Usability Scale (SUS) survey. Likert Scale of strongly disagree, disagree, neutral, agree, and strongly agree. Score ranges from 1 to 5. Higher score equates higher usability.
Outcome measures
Outcome data not reported
Adverse Events
Nurse Navigator Pathway Group
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place