Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
Primary Purpose
Hospital Acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Early mobility bundle
Sponsored by
About this trial
This is an interventional prevention trial for Hospital Acquired Pneumonia focused on measuring Pneumonia, promotion of activity
Eligibility Criteria
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
Sites / Locations
- Heart of England NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early mobility bundle
Usual care
Arm Description
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
Usual physiotherapy service only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT01769742
First Posted
November 27, 2012
Last Updated
December 1, 2014
Sponsor
University of Birmingham
Collaborators
Heart of England NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01769742
Brief Title
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
Official Title
Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
Heart of England NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Acquired Pneumonia
Keywords
Pneumonia, promotion of activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early mobility bundle
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual physiotherapy service only
Intervention Type
Behavioral
Intervention Name(s)
Early mobility bundle
Primary Outcome Measure Information:
Title
Incidence of hospital acquired pneumonia
Description
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.
Time Frame
Duration of hospital stay (up to 12 days)
Secondary Outcome Measure Information:
Title
Length of hospital stay in days
Description
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
Time Frame
Duration of hospital stay (up to 12 days)
Title
Incidence of falls
Description
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
Time Frame
Duration of hospital stay (up to 12 days)
Title
Incidence of pressure area problems
Description
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
Time Frame
Duration of hospital stay (up to 12 days)
Other Pre-specified Outcome Measures:
Title
Activity levels as reported by patient
Time Frame
Days 1 and 2 of admission to ward
Title
Activity levels as measured by Actigraph
Time Frame
Day 1 and 2 of admission to ward
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Turner
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart of England NHS Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25063011
Citation
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.
Results Reference
result
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Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
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