Condition category
Not Applicable
Date applied
23/03/2015
Date assigned
24/03/2015
Last edited
24/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Most preventable hospital deaths are due to errors on general wards. We know that ward staff can tell us about major safety problems they see each day, but turning that knowledge into safer care has been difficult. We want to find out if a daily safety briefing for medical ward staff helps to improve the quality and safety of care for their patients.

Who can participate?
Staff in seven different clinical areas, in two hospitals, will be asked to use the HEADS-UP safety briefing.

What does the study involve?
Each working day, ward teams taking part will complete the HEADS-UP safety briefing. This is a short structured session each morning to find out what had happened the day before. For example, teams will ask if there were any equipment problems or communication mistakes. They will decide if they can do anything straight away to solve the problems they've discussed. If the problems can't be solved straight away, they are sent to more senior members of the team to decide how to put them right. HEADS-UP is designed to make sure that patients receive the best care already available, not to introduce new treatments, so patients on HEADS-UP wards may not notice any difference.

What are the possible risks and benefits of participating?
On a busy ward, it's easy to overlook important problems. Sometimes, the hospital may not even know there is a problem, even if it frustrates staff and is a risk to patients. HEADS-UP should help make sure that background problems are picked up, and corrected, before they lead to a patient being harmed. HEADS-UP teams should be more confident that they are providing safe care and working well as a team. Patients on HEADS-UP wards should receive more effective care and be discharged more quickly. We don't think there are major risks to a ward taking part in HEADS-UP. Senior doctors and managers want their teams to be more involved in delivering safe care. HEADS-UP shouldn't take doctors, nurses or therapists away from their ward jobs for more than a few minutes each day. Even if the hospital can't solve all of the problems that HEADS-UP points out, it's important that they know about them to plan for the future.

Where is the study run from?
The HEADS-UP study is run by the National Institute for Health Research Imperial Patient Safety Translational Research Centre (NIHR Imperial PSTRC), which is part of Imperial College London.

When is the study starting and how long is it expected to run for?
The study started in December 2013 and should run for 15 months.

Who is funding the study?
The NIHR Imperial PSTRC and West Middlesex University Hospital (UK).

Who is the main contact?
Dr Sam Pannick
s.pannick@imperial.ac.uk





Trial website

Contact information

Type

Scientific

Primary contact

Clinical Research Fellow Sam Pannick

ORCID ID

http://orcid.org/0000-0001-9381-5556

Contact details

Room 503
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)207 594 3425
s.pannick@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A stepped wedge, cluster-controlled trial to evaluate a structured team intervention on medical wards (Hospital Event Analysis Describing Significant Unanticipated Problems)

Acronym

HEADS-UP (Hospital Event Analysis Describing Significant Unanticipated Problems)

Study hypothesis

We hypothesised that:
1. Team use of the HEADS-UP briefing would empower junior clinicians to voice concerns, improving their teams’ situational awareness (an important factor in mitigating risks) and their units’ safety and teamwork climates
2. This would promote early team recognition of the deteriorating patient, and facilitate the process of escalation of care
3. Information generated by ward teams would both inform their own practice and prompt downstream service reorganisation
4. The combination of ward and support service improvement would improve clinical outcomes, with a dose-response relationship (i.e., the better the tool is used in practice, the greater the benefit seen)
5. An explicit focus on team-wide recognition of adverse events would improve engagement with existing incident reporting systems, thus leading to an increase in formally reported incidents within wards implementing HEADS-UP.

Ethics approval

Permission for the study was sought from the relevant Research & Development authority at each participating institution. Both authorities approved the study as a quality improvement and service development initiative not requiring formal ethical evaluation (Imperial College Academic Health Science Centre Joint Research Compliance Office/West Middlesex University Hospital Research & Development Department)

Study design

Interventional; multi-centre; stepped wedge, cluster controlled; additional mixed methods qualitative analysis

Primary study design

Interventional

Secondary study design

Non-randomised cluster controlled study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Quality and safety of inpatient medical care

Intervention

A prompt-led team briefing (HEADS-UP) to help multidisciplinary medical ward teams discuss clinical and administrative challenges, including adverse events, of the preceding 24 hours. Regular feedback to participating teams, managers and senior clinicians, allied to an organisational response.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Excess length of stay (a surplus stay of 24 hours or more, compared to peer institutions' Healthcare Resource Groups-predicted length of stay), measured in each cluster each month (according to the stepped wedge design) over the course of the 14-month study period

Secondary outcome measures

1. Excess length of stay or readmission within 30 days, measured in each cluster each month
2. In-hospital death or death/readmission within 30 days, measured in each cluster each month
3. Complications of care (hospital-acquired infections and pressure ulcers), measured in each cluster each month
4. Processes of escalation of care (use of the ICU outreach service, unplanned ICU admissions, and cardiac arrest calls), measured in each cluster each month
5. Staff engagement with incident reporting, measured in each cluster each month
6. Patient safety and teamwork subsections of the Safety Attitudes Questionnaire, at baseline and then 6 months later

Overall trial start date

01/12/2013

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health professionals on participating medical wards available to take part in the HEADS-UP briefings
2. All patients admitted to those wards during the study period, unless they meet one of the exclusion criteria

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

7 clusters; approximately 15 staff in each cluster; 7840 patients

Participant exclusion criteria

Patient exclusion criteria:
1. Time spent on the specified ward comprising less than 50% of the total inpatient stay
2. Discharge to a new skilled care facility or other hospital (i.e., not the patient’s address at the time of admission; discharge to a new facility typically incurs substantial delays, outside of the ward team’s control)
3. Multiple intra-hospital ward transfers. A single transfer from the initial admissions unit to a downstream medical ward is permitted. One further transfer to an escalation area to facilitate discharge (whereby the patient spends less than 24 hours in the escalation area immediately prior to their discharge home) is also permitted
4. Admission to the high dependency unit or ICU
5. Elective admission or direct admission from another hospital
6. Surgeon-directed care for more than 24 hours during the inpatient stay

Recruitment start date

01/12/2013

Recruitment end date

28/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Middlesex University Hospital NHS Trust
Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Trial participating centre

St Mary's Hospital (Imperial College Healthcare NHS Trust)
Praed Street
London
W2 1NY
United Kingdom

Sponsor information

Organisation

NIHR Imperial Patient Safety Translational Research Centre

Sponsor details

5th Floor Medical School Building
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom

Sponsor type

University/education

Website

http://www.cpssq.org

Funders

Funder type

Hospital/treatment centre

Funder name

West Middlesex University Hospital NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26100026

Publication citations

Additional files

Editorial Notes