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Completed

NCT Number: NCT03904524

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Excela Westmoreland Hospital, Greensburg, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of training the staff for the intervention, as measured by percent of staff members completing on-line training

    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

    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.

  2. Feasibility of patient recruitment at the site, as measured by the volume of eligible patients admitted to the pilot ICU during the pilot phase.

    Time frame: At the conclusion of the 3-month pilot

    Feasibility of recruitment will be assessed by the volume of eligible patient admitted to the pilot ICU.

  3. Adherence to elements of intervention protocol

    Time frame: Throughout the 3 month pilot phase

    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.

  4. Acceptability of the intervention to clinicians assessed via focus groups

    Time frame: At the conclusion of the 3-month pilot

    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.

  5. Clinician Satisfaction with the intervention assessed via on-line survey

    Time frame: At the conclusion of the 3-month pilot

    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 outcomes

  1. Proportion of patients with a family meeting

    Time frame: At the conclusion of the 3-month pilot

    The impact of the intervention will be assessed via the proportion of eligible patients having an interdisciplinary family meeting.

  2. Time elapsed until the first family meeting

    Time frame: At the conclusion of the 3-month pilot

    The impact of the intervention will be assessed via the mean time from enrollment to the first interdisciplinary family meeting.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Cambia Health Foundation

Registry information

Official study title

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

Acronym: SET-to-Meet

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Apr 5, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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