CLINICAL TRIAL

SET-to-Meet for Critical Illness

Waitlist Available · 18+ · All Sexes · Greensburg, PA

This study is evaluating whether a nurse-led intervention can improve adherence to best practice guidelines for interdisciplinary family meetings.

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About the trial for Critical Illness

Treatment Groups

This trial involves 2 different treatments. SET-to-Meet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SET-to-Meet
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Throughout the 3 month pilot phase
Screening: ~3 weeks
Treatment: Varies
Reporting: Throughout the 3 month pilot phase
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Throughout the 3 month pilot phase.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SET-to-Meet will improve 5 primary outcomes and 2 secondary outcomes in patients with Critical Illness. Measurement will happen over the course of 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 training the staff for the intervention, as measured by percent of staff members completing on-line training
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.
AT THE COMPLETION OF THE TWO WEEK TRAINING PHASE WHICH WILL OCCUR IMMEDIATELY PRIOR TO INITIATING THE 3-MONTH PILOT OF THE INTERVENTION
Clinician Satisfaction with the intervention assessed via on-line survey
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.
AT THE CONCLUSION OF THE 3-MONTH PILOT
Proportion of patients with a family meeting
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.
AT THE CONCLUSION OF THE 3-MONTH PILOT
Feasibility of patient recruitment at the site, as measured by the volume of eligible patients admitted to the pilot ICU during the pilot phase.
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.
AT THE CONCLUSION OF THE 3-MONTH PILOT
Time elapsed until the first family meeting
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.
AT THE CONCLUSION OF THE 3-MONTH PILOT
Acceptability of the intervention to clinicians assessed via focus groups
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.
AT THE CONCLUSION OF THE 3-MONTH PILOT
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Who is running the study

Principal Investigator
J. S.
Prof. Jennifer Seaman, Assistant Professor, School of Nursing
University of Pittsburgh

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of critical illness?

Signs of critical illness include a reduced alertness, a reduced interest in everyday life for the patient, as well as problems with the body's physical functioning including a reduced ability to breathe, to eat, to keep warm. More specific signs of critical illness include a decreased breathing rate and decreased heart rate. These signs are not specific to the cause of critical illness. Patients' self-reported health is an important sign of critical illness.\n

Anonymous Patient Answer

How many people get critical illness a year in the United States?

It is important to recognize, appropriately and early, the illnesses that precipitate critical illness and in doing so, the potential need for organ replacement. The number of people who need critical illness is increasing and must be taken into account when caring for these patients.

Anonymous Patient Answer

Can critical illness be cured?

Almost a third of intensive care admissions can be reversed once critical illness has been treated without impacting on long-term outcomes. Future studies are needed to identify additional factors that predict a reversal of critical illness.

Anonymous Patient Answer

What causes critical illness?

This prospective cohort study shows the complex interactions between the host and the disease. It has implications for understanding the pathophysiology of critical illness, and supports the notion that the host is an important determinant in any understanding of the pathophysiology of critical illness.

Anonymous Patient Answer

What is critical illness?

Critical illness is a condition defined as a serious illness (defined below) that occurs in the acute, subacute, or chronic phase of an underlying medical condition, such that it can adversely affect the course, outcome, or even longevity of the patient.

Anonymous Patient Answer

What are common treatments for critical illness?

Treatment for critical illness may encompass a variety of treatment modalities, but the most common treatments include fluid replacement, vasopressors and antibiotics and, when possible, renal support.

Anonymous Patient Answer

Is set-to-meet typically used in combination with any other treatments?

A set-to-meet might hinder other treatments in some respects. Clinicians need to be trained in the set-to-meet in some respects so that patients are more actively involved in treatment planning for a number of problems that are difficult to manage under any other treatment circumstances.

Anonymous Patient Answer

How does set-to-meet work?

The set-to-meet agenda needs to evolve into an active and mutually beneficial collaboration among critical care professionals in an effort to improve quality and delivery of critical care.

Anonymous Patient Answer

How serious can critical illness be?

The magnitude of many of the morbidities associated with critical illness is not necessarily limited by the severity of physical or emotional stress, and some of the complications in critically ill patients can be expected to occur even without detectable level of stress.

Anonymous Patient Answer

Who should consider clinical trials for critical illness?

Although the majority of patients were willing to consider treatment in research, less than half of people with severe illness, and less than 16% of patients with moderate/no illness, thought their lives were worth saving in a clinical trial. Patients' perceptions of their illness-related issues could help decide whether they could benefit. Patients with severe illness should consider enrollment in clinical trials, especially if other patients could benefit.

Anonymous Patient Answer

What are the common side effects of set-to-meet?

In a recent study, findings found that only 5.3% of people in the general population were concerned about the side effects of set-to-meet. However, it remains important that the individual risks and benefits are thoroughly discussed and understood, so that everyone can make an informed decision about whether to take part in a given clinical trial. If participants feel that they are at higher risk of experiencing or experiencing severe side effects, they might want to think twice about taking part in a set-to-meet trial.

Anonymous Patient Answer

What is the primary cause of critical illness?

Critical illness is a highly complex condition with many unknown factors influencing outcomes. Recent findings, we identified that secondary infections occur early after intensive care. Recent findings also demonstrated that a simple algorithm of screening and empirical therapy could improve the clinical outcomes of critically ill patients. Recent findings warrant further prospective study including validation with other prospective cohorts to confirm this hypothesis.

Anonymous Patient Answer
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