Critical IllnessSET-to-MeetNCT03904524
SET-to-Meet; Pilot Testing of a Nurse-led Intervention
A study testing SET-to-Meet in people with Critical Illness, run by University of Pittsburgh at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- SET-to-Meet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Excela Westmoreland Hospital
Greensburg, Pennsylvania, 15601
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- SET-to-Meet
- Keywords
- Intensive Care Unit, Serious Illness Communication, Clinician-Family Communication, Family Support
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SET-to-MeetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SET-to-Meet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the conclusion of the 3-month pilot
Secondary outcomes (2)
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.
Measured: 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.
Measured: At the conclusion of the 3-month pilot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start13 Jun 2019
- Primary completion5 Aug 2020
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cambia Health Foundation
- Responsible party
- Principal investigator, Jennifer Seaman, University of Pittsburgh
- Investigators
- Jennifer B Seaman, PhD,RN,CHPN, Principal investigator, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904524
- Sponsor's protocol ID
- STUDY18090002
- Acronym
- SET-to-Meet
- Status last verified
- May 2024
- First submitted
- 27 Mar 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SET-to-Meet; Pilot Testing of a Nurse-led Intervention to Ensure Routine Interdisciplinary Family Meetings in ICUs
- ClinicalTrials.gov ID
- NCT03904524
- Acronym / sponsor ID
- SET-to-Meet / STUDY18090002
- Conditions
- Critical Illness
- Keywords
- Intensive Care Unit, Serious Illness Communication, Clinician-Family Communication, Family Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Cambia Health Foundation
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SET-to-MEET | Experimental | Behavioral: SET-to-MeetThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SET-to-MeetThe 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. | Behavioural | SET-to-MEET |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Proportion of patients with a family meeting
Time frame: At the conclusion of the 3-month pilot
Time elapsed until the first family meeting
Time frame: At the conclusion of the 3-month pilot
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer B Seaman, PhD,RN,CHPN principal investigator
University of Pittsburgh School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SET-to-Meet in people with Critical Illness, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.