Hospital Acquired PneumoniaNCT01769742
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
A study testing Early mobility bundle in people with Hospital Acquired Pneumonia, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hospital Acquired Pneumonia
- What is being tested?
- Early mobility bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Sep 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any medical inpatient
Who cannot join
- Nil for main study
- Immobile patients and those unable to consent will be excluded from the sub-study using activity reporting and monitoring by Actigraph
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England NHS Trust
Birmingham, West Midlands, B9 5SS
About this study
Official title: Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients
Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical inpatients.
The investigators propose a pilot study to assess the impact of introducing an early mobilisation strategy to general medical and respiratory wards at an acute Trust in the United Kingdom (UK). The investigators will recruit all new admissions to each of 2 respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual mobility, current mobility and actual activity levels will be studied by accelerometer and simple patient questionnaire in the first 48 hours of admission, and compared between groups. Incidence of HAP and total LOS will be recorded and compared between groups.
Read more
The investigators hypotheses are that the physiotherapy intervention will increase activity levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the National Health Service (NHS), which the investigators will model using local tariff data.
The investigators plan to use our data to power a larger randomised controlled study, or if the intervention is a marked success, such that a control group would be unethical, then a wider service development and evaluation programme.
- Conditions
- Hospital Acquired Pneumonia
- Being tested
- Early mobility bundle
- Keywords
- Pneumonia, promotion of activity
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobility bundleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Early mobility bundle | Experimental | Delivery of early targeted physiotherapy to patients on the interventional wards; to comprise assessment and communication of mobility to ward staff and patient, provision of mobility aids, guidance and encouragement to patient and staff to allow patient to dress and mobilise independently if clinically safe to do so Receives: Behavioral: Early mobility bundle |
| Usual care | No intervention | Usual physiotherapy service only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital acquired pneumonia
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care. This is the time period in which incidence of hospital acquired pneumonia will be measured, and expressed as incidence/week of stay. Patients whose length of stay is lower or higher than average will not be excluded.
Measured: Duration of hospital stay (up to 12 days)
Secondary outcomes (3)
Length of hospital stay in days
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care. This is the time period in which incidence of hospital acquired pneumonia will be measured. Patients whose length of stay is lower or higher than average will not be excluded
Measured: Duration of hospital stay (up to 12 days)
Incidence of falls
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care. This is the time period in which incidence of hospital acquired pneumonia will be measured. Patients whose length of stay is lower or higher than average will not be excluded
Measured: Duration of hospital stay (up to 12 days)
Incidence of pressure area problems
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care. This is the time period in which incidence of hospital acquired pneumonia will be measured. Patients whose length of stay is lower or higher than average will not be excluded
Measured: Duration of hospital stay (up to 12 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heart of England NHS Trust
- Responsible party
- Principal investigator, Alice Turner, University of Birmingham
- Investigators
- Alice Turner, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769742
- Sponsor's protocol ID
- RG-12-237
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Stolbrink M, McGowan L, Saman H, Nguyen T, Knightly R, Sharpe J, Reilly H, Jones S, Turner AM. The Early Mobility Bundle: a simple enhancement of therapy which may reduce incidence of hospital-acquired pneumonia and length of hospital stay. J Hosp Infect. 2014 Sep;88(1):34-9. doi: 10.1016/j.jhin.2014.05.006. Epub 2014 Jun 20.
PubMed 25063011
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients
- ClinicalTrials.gov ID
- NCT01769742
- Acronym / sponsor ID
- RG-12-237
- Conditions
- Hospital Acquired Pneumonia
- Keywords
- Pneumonia, promotion of activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Heart of England NHS Trust
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Jan 2013 (estimated)
- 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.
Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical inpatients.
The investigators propose a pilot study to assess the impact of introducing an early mobilisation strategy to general medical and respiratory wards at an acute Trust in the United Kingdom (UK). The investigators will recruit all new admissions to each of 2 respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual mobility, current mobility and actual activity levels will be studied by accelerometer and simple patient questionnaire in the first 48 hours of admission, and compared between groups. Incidence of HAP and total LOS will be recorded and compared between groups.
The investigators hypotheses are that the physiotherapy intervention will increase activity levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the National Health Service (NHS), which the investigators will model using local tariff data.
The investigators plan to use our data to power a larger randomised controlled study, or if the intervention is a marked success, such that a control group would be unethical, then a wider service development and evaluation programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobility bundle | Experimental | Behavioral: Early mobility bundleDelivery of early targeted physiotherapy to patients on the interventional wards; to comprise assessment and communication of mobility to ward staff and patient, provision of mobility aids, guidance and encouragement to patient and staff to allow patient to dress and mobilise independently if clinically safe to do so |
| Usual care | No intervention | –Usual physiotherapy service only |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any medical inpatient
Key exclusion criteria (2 listed)
- Nil for main study
- Immobile patients and those unable to consent will be excluded from the sub-study using activity reporting and monitoring by Actigraph
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 |
|---|---|---|
| Early mobility bundle | Behavioural | Early mobility bundle |
Primary outcome
Incidence of hospital acquired pneumonia
Time frame: Duration of hospital stay (up to 12 days)
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care. This is the time period in which incidence of hospital acquired pneumonia will be measured, and expressed as incidence/week of stay. Patients whose length of stay is lower or higher than average will not be excluded.
3 secondary outcomes
Length of hospital stay in days
Time frame: Duration of hospital stay (up to 12 days)
Incidence of falls
Time frame: Duration of hospital stay (up to 12 days)
Incidence of pressure area problems
Time frame: Duration of hospital stay (up to 12 days)
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 3 Dec 2014.
- Results publication: PubMed 25063011Stolbrink M, McGowan L, Saman H, Nguyen T, Knightly R, Sharpe J, Reilly H, Jones S, Turner AM. The Early Mobility Bundle: a simple enhancement of therapy which may reduce incidence of hospital-acquired pneumonia and length of hospital stay. J Hosp Infect. 2014 Sep;88(1):34-9. doi: 10.1016/j.jhin.2014.05.006. Epub 2014 Jun 20.
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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.
Alice Turner principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobility bundle in people with Hospital Acquired Pneumonia, run by University of Birmingham at 1 site in United Kingdom.
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 1 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Incidence of hospital acquired pneumonia (time frame: Duration of hospital stay (up to 12 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769742, which also lists 1 linked publication.
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 3 Dec 2014.