Clinical trial NCT03609658: Integrated Multidisciplinary Patient and Family Advance Care Planning Trial
Official title: Integrated Approach to Patient and Family Engagement for Advance Care Planning for Vulnerable Older Adult Within an Accountable Care Organization (ACO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Keywords: Vulnerable Older Adults
Nurse Navigator
Usual Care
Family
Multimorbid patients
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2018-08-01
Enrollment: 146
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patient's Documented Advance Care Planning Discussion- Nurse Navigator
timeFrame: End of Study (Month 13)
measure: Number of Patient's Documented Advance Care Planning Discussions - Provider
timeFrame: End of Study (Month 13)
measure: Quality of Advance Care Planning Discussion - Nurse Navigator
timeFrame: End of Study (Month 13)
measure: Quality of Advance Care Planning Discussion - Provider
timeFrame: End of Study (Month 13)
measure: Quality of Advance Care Planning Discussion From the Patient's Perspective
timeFrame: End of Study (Month 13)
Secondary outcomes:
measure: Advance Care Planning Billing Code Usage
timeFrame: End of Study (Month 13)
measure: Number of Designated Surrogate Decision Makers
timeFrame: End of Study (Month 13)
measure: Advance Directive Completion
timeFrame: End of Study (Month 13)
Other outcomes:
measure: Number of Medical Scope of Treatment (MOST) Discussions
timeFrame: End of Study (Month 13)
measure: After-death Bereaved Family Member Interview
timeFrame: Month 29
measure: Frequency of Patient Healthcare Utilization
timeFrame: End of Study (Month 13)
measure: Cost of Patient Healthcare Utilization
timeFrame: End of Study (Month 13)
measure: Provider Satisfaction With the Intervention Scale
timeFrame: Month 11
measure: Number of Protocol Deviations
timeFrame: End of Study (Month 13)
measure: Usability of the ACP Documentation Tool (ACPWiseTool)
timeFrame: End of Study (Month 13)
Locations:
city: Asheboro
country: United States
facility: Family & Community Medicine of Asheboro
state: North Carolina
city: Claremont
country: United States
facility: Claremont Family Medicine
state: North Carolina
city: Conover
country: United States
facility: Conover Family Practice
state: North Carolina
city: High Point
country: United States
facility: Chronic Complex Care
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Internal Medicine at Westchester
state: North Carolina
city: High Point
country: United States
facility: High Point Family Practice
state: North Carolina
city: Thomasville
country: United States
facility: Thomasville Family Practice
state: North Carolina
city: Winston-Salem
country: United States
facility: Downtown Health Plaza
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jennifer Gabbard, MD
role: PRINCIPAL_INVESTIGATOR
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