SET-to-Meet; Pilot Testing of a Nurse-led Intervention (SET-to-Meet)

SET-to-Meet; Pilot Testing of a Nurse-led Intervention to Ensure Routine Interdisciplinary Family Meetings in ICUs

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: SET-to-Meet

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • Excela Westmoreland Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SET-to-MEET; This is a single arm, open trial that will be conducted in parallel in 3 separate ICUs. Each site will receive the SET-to-MEET intervention.	Behavioral: SET-to-Meet; The overall objective of this study is to pilot test, in advance of a larger randomized trial, a scalable, nurse-led intervention to ensure timely interdisciplinary family meetings are held on behalf of critically-ill ICU patients who cannot participate in discussions about their care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of training the staff for the intervention, as measured by percent of staff members completing on-line training	Feasibility of using online training will be assessed by percent of staff members who complete the on-line training during the two week training phase.	At the completion of the two week training phase which will occur immediately prior to initiating the 3-month pilot of the intervention
Feasibility of patient recruitment at the site, as measured by the volume of eligible patients admitted to the pilot ICU during the pilot phase.	Feasibility of recruitment will be assessed by the volume of eligible patient admitted to the pilot ICU.	At the conclusion of the 3-month pilot
Adherence to elements of intervention protocol	Adherence to steps in the intervention protocol for eligible patients will be assessed by review of tracking forms, questions to staff about patient screening and about engagement with family members, and direct observation of staff during interdisciplinary team rounds.	Throughout the 3 month pilot phase
Acceptability of the intervention to clinicians assessed via focus groups	Acceptability of the intervention will be evaluated using focus group sessions with physicians, social workers, care managers, and nurses. Using a semi-structured interview guide, we will elicit detailed information about staff satisfaction with the intervention; the clinician experience of participating in the intervention; staff-perceived value of the intervention to patients and families; and suggestions for improvement.	At the conclusion of the 3-month pilot
Clinician Satisfaction with the intervention assessed via on-line survey	Satisfaction of staff with: 1.) the intervention training and 2.) on-site support, as well as perceived value to patients/families and perceived burden of carrying out the intervention will be evaluated using a multi-item, likert-scale scored online survey sent to physicians, social workers, care managers, and nurses.	At the conclusion of the 3-month pilot

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a family meeting	The impact of the intervention will be assessed via the proportion of eligible patients having an interdisciplinary family meeting.	At the conclusion of the 3-month pilot
Time elapsed until the first family meeting	The impact of the intervention will be assessed via the mean time from enrollment to the first interdisciplinary family meeting.	At the conclusion of the 3-month pilot

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Cambia Health Foundation
• Investigators: Principal Investigator: Jennifer B Seaman, PhD,RN,CHPN, University of Pittsburgh School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Family Support; Serious Illness Communication; Clinician-Family Communication
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: STUDY18090002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

This study will be conducted at sites within two different health systems, Allegheny Health Network and Excela Health, each with their own Institutional Review Board (IRB). The data use agreements with those respective organizations are pending, and we do not yet know the conditions and specifically, if and under what circumstances data sharing will be permitted.

Provided data sharing is permitted, and in accordance with those agreements, academic collaborators of the Principal Investigator outside of the University of Pittsburgh may have access to participant data collected during the trial, after de-identification. These outside collaborators will obtain their own IRB approval for their role.

• IPD Sharing Time Frame: These will be made available beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: We will make this data available to collaborators whose proposed use of the data has been approved by an independent review committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No