Advance Care Planning
Conditions
Keywords
Vulnerable Older Adults, Nurse Navigator, Usual Care, Family, Multimorbid patients
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALNurse 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.
BEHAVIORALUsual 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.
Sponsors
Duke University
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
There are two groups. 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. Note that patients that do not consent to the intervention are still counted as part of control group under an intent-to-treat paradigm, which necessitates passive ascertainment mechanisms for outcomes (i.e. administrative claims or the EHR).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 65 or older patient within the Wake Forest/Cornerstone ACO * Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 months * English speaking * No documented Advance Directive in the EHR * Impairments in either physical function, cognition, and/or frailty
Exclusion criteria
* No available proxy (e.g. in setting of cognitive impairment) * Severe/advanced dementia * Moderate to severe hearing loss * Non-English speaking * No phone number available for patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator | End of Study (Month 13) | Reported as the number of documentations completed in the newly created ACP note template for nurse navigator note templates. |
| Quality of Advance Care Planning Discussion From the Patient's Perspective | End of Study (Month 13) | 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. |
| Quality of Advance Care Planning Discussion - Provider | End of Study (Month 13) | 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. |
| Quality of Advance Care Planning Discussion - Nurse Navigator | End of Study (Month 13) | 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. |
| Number of Patient's Documented Advance Care Planning Discussions - Provider | End of Study (Month 13) | Reported as the number of documentations completed in the newly created ACP note template for provider note templates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advance Care Planning Billing Code Usage | End of Study (Month 13) | ACP billing codes: 99497 and 99498 usages will be recorded |
| Number of Designated Surrogate Decision Makers | End of Study (Month 13) | Reported as the number of designated surrogate decision makers documented in Electronic Health Record (EHR). |
| Advance Directive Completion | End of Study (Month 13) | Reported as the number of scanned advance directive documents in the EHR. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Patient Healthcare Utilization | End of Study (Month 13) | Frequency is measured by the number of healthcare events recorded in the EHR. |
| After-death Bereaved Family Member Interview | Month 29 | 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. |
| Number of Protocol Deviations | End of Study (Month 13) | The number of protocol deviations will be reported to measure the fidelity of study implementation. |
| Provider Satisfaction With the Intervention Scale | Month 11 | This is a likert scale total score (0-78). Higher scores denotes better outcomes |
| Cost of Patient Healthcare Utilization | End of Study (Month 13) | Cost of patient healthcare utilization per group |
| Usability of the ACP Documentation Tool (ACPWiseTool) | 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. |
| Number of Medical Scope of Treatment (MOST) Discussions | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 379 |
| 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. | 380 |
| Total | 759 |
Baseline characteristics
| Characteristic | Nurse Navigator Pathway Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Customized 65 to <75 years | 149 Participants | 156 Participants | 305 Participants |
| Age, Customized 75 to <85 years | 161 Participants | 151 Participants | 312 Participants |
| Age, Customized ≥85 years | 69 Participants | 73 Participants | 142 Participants |
| Race/Ethnicity, Customized black | 71 Participants | 59 Participants | 130 Participants |
| Race/Ethnicity, Customized other | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized white | 300 Participants | 317 Participants | 617 Participants |
| Region of Enrollment United States | 379 participants | 380 participants | 759 participants |
| Sex: Female, Male Female | 226 Participants | 229 Participants | 455 Participants |
| Sex: Female, Male Male | 153 Participants | 151 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 379 | 0 / 0 |
| other Total, other adverse events | 0 / 379 | 0 / 0 |
| serious Total, serious adverse events | 0 / 379 | 0 / 0 |
Outcome results
Primary
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)
Population: This outcome includes all randomized subjects (Zelen's design).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse Navigator Pathway Group | Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator | 134 Discussions |
| Usual Care Group | Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator | 0 Discussions |
Primary
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)
Population: This outcome applies to randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse Navigator Pathway Group | Number of Patient's Documented Advance Care Planning Discussions - Provider | 160 discussions |
| Usual Care Group | Number of Patient's Documented Advance Care Planning Discussions - Provider | 14 discussions |
Primary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nurse Navigator Pathway Group | Quality of Advance Care Planning Discussion From the Patient's Perspective | General Communication | 10.2 score on a scale | Standard Deviation 1.8 |
| Nurse Navigator Pathway Group | Quality of Advance Care Planning Discussion From the Patient's Perspective | End of Life | 7.9 score on a scale | Standard Deviation 3.1 |
Primary
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)
Population: Data was not collected for this outcome measure.
Primary
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)
Population: data was not collected for this outcome
Secondary
Advance Care Planning Billing Code Usage
ACP billing codes: 99497 and 99498 usages will be recorded
Time frame: End of Study (Month 13)
Population: This outcome uses all randomized subjects (Zelen's Design).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse Navigator Pathway Group | Advance Care Planning Billing Code Usage | 96 code usages |
| Usual Care Group | Advance Care Planning Billing Code Usage | 5 code usages |
Secondary
Advance Directive Completion
Reported as the number of scanned advance directive documents in the EHR.
Time frame: End of Study (Month 13)
Population: Based on all randomized (Zelen's Design).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse Navigator Pathway Group | Advance Directive Completion | 92 scanned documents |
| Usual Care Group | Advance Directive Completion | 38 scanned documents |
Secondary
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)
Population: This outcome uses all randomized (Zelen's Design).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse Navigator Pathway Group | Number of Designated Surrogate Decision Makers | 241 surrogate decision makers |
| Usual Care Group | Number of Designated Surrogate Decision Makers | 132 surrogate decision makers |
Other Pre-specified
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
Other Pre-specified
Cost of Patient Healthcare Utilization
Cost of patient healthcare utilization per group
Time frame: End of Study (Month 13)
Other Pre-specified
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)
Other Pre-specified
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)
Other Pre-specified
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)
Other Pre-specified
Provider Satisfaction With the Intervention Scale
This is a likert scale total score (0-78). Higher scores denotes better outcomes
Time frame: Month 11
Other Pre-specified
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)