Integrated Multidisciplinary Patient and Family Advance Care Planning Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)

Conditions
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Advance Care Planning

Intervention / Treatment
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* Behavioral: Nurse Navigator Pathway
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse Navigator Pathway Group<br>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<br>* 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.<br>|
| Sham Comparator: Usual Care Group<br>Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months). | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | End of Study (Month 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance Care Planning Billing Code Usage | ACP billing codes: 99497 and 99498 usages will be recorded | 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). | End of Study (Month 13) | 
| Advance Directive Completion | Reported as the number of scanned advance directive documents in the EHR. | End of Study (Month 13) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulnerable Older Adults, Nurse Navigator, Usual Care, Family, Multimorbid patients