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

NCT03904524 | Completed

• 1 other identifier: STUDY18090002
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness

Keywords

Intensive Care Unit; Serious Illness Communication; Clinician-Family Communication; Family Support

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Proportion of patients with a family meeting

  At the conclusion of the 3-month pilot

• Time elapsed until the first family meeting

  At the conclusion of the 3-month pilot

Study Arms (1)

SET-to-MEET

EXPERIMENTAL

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

Interventions

SET-to-Meet BEHAVIORAL

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.

SET-to-MEET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Cambia Health Foundation: collaborator

Study Sites (2)

Excela Westmoreland Hospital

Greensburg, Pennsylvania, 15601, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer B Seaman, PhD,RN,CHPN

  University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Nursing

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 5, 2019
• Study Start: June 13, 2019
• Primary Completion: August 5, 2020
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These will be made available beginning 9 months and ending 36 months following article publication.
• Access Criteria: We will make this data available to collaborators whose proposed use of the data has been approved by an independent review committee.

Locations

US (2)