- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769742
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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West Midlands
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Birmingham, West Midlands, United Kingdom, B9 5SS
- Heart of England NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any medical inpatient
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early mobility bundle
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
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No Intervention: Usual care
Usual physiotherapy service only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration of hospital stay (up to 12 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay in days
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.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
Incidence of falls
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.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
Incidence of pressure area problems
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.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Activity levels as reported by patient
Time Frame: Days 1 and 2 of admission to ward
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Days 1 and 2 of admission to ward
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Activity levels as measured by Actigraph
Time Frame: Day 1 and 2 of admission to ward
|
Day 1 and 2 of admission to ward
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alice Turner, University of Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG-12-237
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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