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

Critical Illness Clinical Trial

— SET-to-Meet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904524
• Other study ID #: STUDY18090002
• Status: Completed
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 31, 2023
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

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.

Locations

Country	Name	City	State
United States	Excela Westmoreland Hospital	Greensburg	Pennsylvania
United States	West Penn Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Cambia Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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