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

Primary Purpose

Critical Illness

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SET-to-Meet
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring Intensive Care Unit, Serious Illness Communication, Clinician-Family Communication, Family Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Excela Westmoreland Hospital
  • West Penn Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SET-to-MEET

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 27, 2019
Last Updated
August 31, 2023
Sponsor
University of Pittsburgh
Collaborators
Cambia Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03904524
Brief Title
SET-to-Meet; Pilot Testing of a Nurse-led Intervention
Acronym
SET-to-Meet
Official Title
SET-to-Meet; Pilot Testing of a Nurse-led Intervention to Ensure Routine Interdisciplinary Family Meetings in ICUs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Cambia Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Intensive Care Unit, Serious Illness Communication, Clinician-Family Communication, Family Support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SET-to-MEET
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SET-to-Meet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of training the staff for the intervention, as measured by percent of staff members completing on-line training
Description
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.
Time Frame
At the completion of the two week training phase which will occur immediately prior to initiating the 3-month pilot of the intervention
Title
Feasibility of patient recruitment at the site, as measured by the volume of eligible patients admitted to the pilot ICU during the pilot phase.
Description
Feasibility of recruitment will be assessed by the volume of eligible patient admitted to the pilot ICU.
Time Frame
At the conclusion of the 3-month pilot
Title
Adherence to elements of intervention protocol
Description
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.
Time Frame
Throughout the 3 month pilot phase
Title
Acceptability of the intervention to clinicians assessed via focus groups
Description
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.
Time Frame
At the conclusion of the 3-month pilot
Title
Clinician Satisfaction with the intervention assessed via on-line survey
Description
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.
Time Frame
At the conclusion of the 3-month pilot
Secondary Outcome Measure Information:
Title
Proportion of patients with a family meeting
Description
The impact of the intervention will be assessed via the proportion of eligible patients having an interdisciplinary family meeting.
Time Frame
At the conclusion of the 3-month pilot
Title
Time elapsed until the first family meeting
Description
The impact of the intervention will be assessed via the mean time from enrollment to the first interdisciplinary family meeting.
Time Frame
At the conclusion of the 3-month pilot

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer B Seaman, PhD,RN,CHPN
Organizational Affiliation
University of Pittsburgh School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Excela Westmoreland Hospital
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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