Integrated Multidisciplinary Patient and Family Advance Care Planning Trial

Not Applicable

Completed

• Conditions: Advance Care Planning
• Interventions: Behavioral: Usual Care; Behavioral: Nurse Navigator Pathway

• Registration Number: NCT03609658
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Study Start: 2018-11-02
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2021-06
• Results First Submitted: 2021-06-10
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Usual Care	Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).
Nurse Navigator Pathway Group	Nurse Navigator Pathway	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)

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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 - 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.

Secondary Outcome Measures

Name	Time	Method
Advance Directive Completion	End of Study (Month 13)	Reported as the number of scanned advance directive documents in the EHR.
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).

Trial Locations

Locations (9)

Family & Community Medicine of Asheboro; 🇺🇸 Asheboro, North Carolina, United States

Chronic Complex Care; 🇺🇸 High Point, North Carolina, United States

Cornerstone Internal Medicine at Westchester; 🇺🇸 High Point, North Carolina, United States

Thomasville Family Practice; 🇺🇸 Thomasville, North Carolina, United States

Conover Family Practice; 🇺🇸 Conover, North Carolina, United States

Downtown Health Plaza; 🇺🇸 Winston-Salem, North Carolina, United States

Claremont Family Medicine; 🇺🇸 Claremont, North Carolina, United States

High Point Family Practice; 🇺🇸 High Point, North Carolina, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States