CompletedNot Applicable

A Study to Evaluate the Introduction of New Staffing Models in Intensive Care: a Realist Evaluation (SEISMIC-R)

United Kingdom87 participantsStarted 2023-06-14

Plain-language summary

Background: Staffing in intensive care units (ICU) has been in the spotlight since the pandemic. Having enough nurses to deliver safe, quality care in ICU is important. However, what the skill mix should be (how many should be qualified nurses or have an ICU qualification) is unclear. Very little research has been done to look at which nursing staff combinations and mix of skills works best in ICU to support patients (described as 'staffing models').Research shows that there is a link between the quality of nurse staffing and poor patient outcomes, including deaths. Aim: Our research plans to look at different staffing models across the UK. This study aims to examine new staffing models in ICU across six very different Trusts. This study will use a research technique called Realist Evaluation that examines what works best in different situations and help to understand why some things work for some people and not others. The design of this approach will help to better understand the use of different staff ratios across different ICU settings. This study will examine what combinations of staff numbers and skills result in better patient care and improved survival rates. The aim is to produce a template that every ICU unit can use. To do this, this study will compare staffing levels with how well patients recover, and seek to understand the decisions behind staffing combinations. Methods: This study will: 1. carry out a national survey to understand the different staff models being used, comparing this against the current national standard (n=294 ICUs in the UK including Scotland) 2. observe how people at work in 6 hospitals (called ethnography), watching how they make decisions around staffing and the effect on patients. The investigators will also conduct interviews (30 interviews plus 30 ethnographic observations) to understand staffing decisions. 3. look at ICU staffing patterns and models, and linked patient outcomes (such as whether people survive ICU) over 3 years (2019-2023) in those hospitals, including with a very different combination of staffing). The investigators will then carry out some mathematical calculations to understand the best possible staffing combinations, and how this varies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Interviews with nursing staff * Registered Nurses who have worked in ICU for at least six months. Inclusion criteria: Interviews with nurse managers * Clinically-based nurse managers who have worked in ICU for at least one year. Inclusion criteria: Interviews with organisational leads * Organisational leads who have been working in their role and in the ICU field for at least one year. Inclusion criteria: Interviews with regional managers/commissioners • Regional managers/commissioners who have been working in their role and in the ICU field for at least one year. Inclusion criteria: Interviews with patients/families * Patient or family member over 18 years old. * Patients who have been in General ICU for at least 48 hours in the last 6 months. * Family members who have visited ICU for at least 20 mins on two days in the preceding 6 months. * Patient discharged from hospital at least 2 weeks prior to the interview. * Patient expected to be well enough, after hospital discharge, to attend the interview and to have capacity to consent. Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Death from all causes within 30 days of ICU admission

Timeframe: 2019-2023

Trial details

NCT IDNCT05917574

SponsorUniversity of Hertfordshire

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

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