Integrated Multidisciplinary Patient and Family Advance Care Planning Trial (IMPACT)

Wake Forest University (WFU)

Status: Completed

Conditions: Advance Care Planning

Treatments: Behavioral: Nurse Navigator Pathway; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03609658

IRB00049370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Nurse Navigator Pathway Group

Experimental group

Description:

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)

Treatment:

Behavioral: Nurse Navigator Pathway

Usual Care Group

Sham Comparator group

Description:

Participants in the Usual Care group will follow usual daily living activities for the duration of the study (12 months).

Treatment:

Behavioral: Usual Care