An interventional study of Nurse Navigator Pathway and Usual Care in Advance Care Planning, sponsored by Wake Forest University Health Sciences. Completed at 9 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
The purpose of this study is to compare ways to engage sick patients and their family members in Advance Care Planning (ACP) discussions. Two pathways will be tested, discussions using a Nurse Navigator led pathway versus usual care.
This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to engage multimorbid patients and their family members in Advance Care Planning through a Nurse Navigator led pathway versus usual care. Investigators propose to utilize Zelen's design (a more recent label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT), a pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Behavioral: Nurse Navigator Pathway
Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Behavioral: Usual Care
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.
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
Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.
Time frame: End of Study (Month 13)
Number of Patient's Documented Advance Care Planning Discussions - Provider
Reported as the number of documentations completed in the newly created ACP note template for provider note templates.
Time frame: End of Study (Month 13)
Quality of Advance Care Planning Discussion - Nurse Navigator
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.
Time frame: End of Study (Month 13)
Quality of Advance Care Planning Discussion - Provider
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.
Time frame: End of Study (Month 13)
Quality of Advance Care Planning Discussion From the Patient's Perspective
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.
Time frame: End of Study (Month 13)
Advance Care Planning Billing Code Usage
ACP billing codes: 99497 and 99498 usages will be recorded
Time frame: End of Study (Month 13)
Number of Designated Surrogate Decision Makers
Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).
Time frame: End of Study (Month 13)
Advance Directive Completion
Reported as the number of scanned advance directive documents in the EHR.
Time frame: End of Study (Month 13)
Number of Medical Scope of Treatment (MOST) Discussions
Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR
Time frame: End of Study (Month 13)
After-death Bereaved Family Member Interview
The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.
Time frame: Month 29
Frequency of Patient Healthcare Utilization
Frequency is measured by the number of healthcare events recorded in the EHR.
Time frame: End of Study (Month 13)
Cost of Patient Healthcare Utilization
Cost of patient healthcare utilization per group
Time frame: End of Study (Month 13)
Provider Satisfaction With the Intervention Scale
This is a likert scale total score (0-78). Higher scores denotes better outcomes
Time frame: Month 11
Number of Protocol Deviations
The number of protocol deviations will be reported to measure the fidelity of study implementation.
Time frame: End of Study (Month 13)
Usability of the ACP Documentation Tool (ACPWiseTool)
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.
Time frame: End of Study (Month 13)
| Milestone | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Started | 379 | 380 |
| Completed | 379 | 380 |
| Not completed | 0 | 0 |
Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates.
| Discussions | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator | 134 | 0 |
Reported as the number of documentations completed in the newly created ACP note template for provider note templates.
| discussions | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Number of Patient's Documented Advance Care Planning Discussions - Provider | 160 | 14 |
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.
No measurements were reported 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.
No measurements were reported for this outcome.
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.
| score on a scale | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| General Communication | 10.2 ± 1.8 | — |
| End of Life | 7.9 ± 3.1 | — |
ACP billing codes: 99497 and 99498 usages will be recorded
| code usages | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Advance Care Planning Billing Code Usage | 96 | 5 |
Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR).
| surrogate decision makers | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Number of Designated Surrogate Decision Makers | 241 | 132 |
Reported as the number of scanned advance directive documents in the EHR.
| scanned documents | Nurse Navigator Pathway Group | Usual Care Group |
|---|---|---|
| Advance Directive Completion | 92 | 38 |
Reported as the number of completed MOST discussion within the new ACP template and/or scanned form in the EHR
Results for this outcome have not been posted.
The After-death bereaved family member interview measures the quality of end of life care. Interview is analyzed utilizing Q-pro software for qualitative data.
Results for this outcome have not been posted.
Frequency is measured by the number of healthcare events recorded in the EHR.
Results for this outcome have not been posted.
Cost of patient healthcare utilization per group
Results for this outcome have not been posted.
This is a likert scale total score (0-78). Higher scores denotes better outcomes
Results for this outcome have not been posted.
The number of protocol deviations will be reported to measure the fidelity of study implementation.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Month 1 through Month 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nurse Navigator Pathway Group | 0/379 (0%) | 0/379 (0%) | 0/379 (0%) |
| Usual Care Group | — | — | — |
Baseline Analysis Population includes all randomized subjects prior to signing consent.
| Age, Customized(Participants) | Nurse Navigator Pathway Group | Usual Care Group | Total |
|---|---|---|---|
| 65 to <75 years | 149 | 156 | 305 |
| 75 to <85 years | 161 | 151 | 312 |
| ≥85 years | 69 | 73 | 142 |
| Sex: Female, Male(Participants) | Nurse Navigator Pathway Group | Usual Care Group | Total |
|---|---|---|---|
| Female | 226 | 229 | 455 |
| Male | 153 | 151 | 304 |
| Race/Ethnicity, Customized(Participants) | Nurse Navigator Pathway Group | Usual Care Group | Total |
|---|---|---|---|
| white | 300 | 317 | 617 |
| black | 71 | 59 | 130 |
| other | 8 | 4 | 12 |
| Region of Enrollment(participants) | Nurse Navigator Pathway Group | Usual Care Group | Total |
|---|---|---|---|
| United States | 379 | 380 | 759 |
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Wake Forest University Health Sciences