NCT03609658

Integrated Multidisciplinary Patient and Family Advance Care Planning Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advance Care Planning

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2018-11-02
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2018-08-01
• Last updated: 2021-08-06
• Results posted: 2021-08-06

Locations

9 sites across 1 country: United States