Clinical trial NCT03904524: SET-to-Meet; Pilot Testing of a Nurse-led Intervention
Official title: SET-to-Meet; Pilot Testing of a Nurse-led Intervention to Ensure Routine Interdisciplinary Family Meetings in ICUs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Intensive Care Unit
Serious Illness Communication
Clinician-Family Communication
Family Support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cambia Health Foundation
First posted: 2019-04-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: While interdisciplinary family meetings are evidence-based and part of usual care, this study seeks to test a novel set of implementation strategies (the SET-to-Meet intervention) to improve adherence to best practice guidelines for interdisciplinary family meetings. SET stands for Screen-Engage-Track; SET-to Meet is a nurse-led, team based intervention to ensure routine interdisciplinary family meetings are held on behalf of incapacitated, critically-ill patients in ICUs. This study is a feasibility and acceptability pilot test of the intervention.

Detailed description: The intervention components are: a protocol for interdisciplinary family meetings that is tailored to the individual ICU unit and steps in the SET-to-Meet process: 1.) Screening of patients on admission to determine if patient meets criteria for a family meeting; 2.) proactively Engaging family members to inform them about the unit's protocol for family meetings and to find out who from the family might attend the meeting; and Tracking the progress of setting up the meeting (identifying the patient during ICU team rounds as a patient meeting criteria for a family meeting; discussing setting up the meeting with the ICU team; scheduling the meeting and communicating details to attendees.)

Implementation of the intervention includes: 1.) Working with the site ICU physician and nursing leadership to tailor the SET-to-meet protocol and tracking tool for family meetings, ensuring they are customized for the unit workflow and staffing model, and 2.) Providing on-line training and 2 weeks of on-site coaching to ICU nursing staff, care management/social work staff, and intensivists (MD and APP) in the use of the tailored protocol and tracking tool.

Feasibility and acceptability will be assessed by percentage of staff completing training, adherence to elements of the intervention, and number of patients meeting enrollment criteria. Acceptability will be assessed via focus groups and a survey testing satisfaction with the intervention.

Eligibility criteria: Inclusion Criteria:

* Patients: Individuals ≥18 year of age, admitted to the ICU for intensive care services at one of the 3 pilot sites during the pilot testing phase.
* Pilot site clinicians: nurses, care managers, social workers, and physicians who are employed/provide services in the pilot site.

Exclusion Criteria:

* Patient Exclusion Criteria : Those individuals \< 18 years of age, incarcerated, or admitted for reasons other than receipt of intensive care services (e.g. boarders).
* Pilot Site Clinicians Exclusion Criteria: none

Primary outcomes:
measure: Feasibility of training the staff for the intervention, as measured by percent of staff members completing on-line training
timeFrame: At the completion of the two week training phase which will occur immediately prior to initiating the 3-month pilot of the intervention
measure: Feasibility of patient recruitment at the site, as measured by the volume of eligible patients admitted to the pilot ICU during the pilot phase.
timeFrame: At the conclusion of the 3-month pilot
measure: Adherence to elements of intervention protocol
timeFrame: Throughout the 3 month pilot phase
measure: Acceptability of the intervention to clinicians assessed via focus groups
timeFrame: At the conclusion of the 3-month pilot
measure: Clinician Satisfaction with the intervention assessed via on-line survey
timeFrame: At the conclusion of the 3-month pilot
Secondary outcomes:
measure: Proportion of patients with a family meeting
timeFrame: At the conclusion of the 3-month pilot
measure: Time elapsed until the first family meeting
timeFrame: At the conclusion of the 3-month pilot
Other outcomes:
Locations:
city: Greensburg
country: United States
facility: Excela Westmoreland Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Nursing
name: Jennifer B Seaman, PhD,RN,CHPN
role: PRINCIPAL_INVESTIGATOR
References: