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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01769742
Other study ID # RG-12-237
Secondary ID
Status Completed
Phase N/A
First received November 27, 2012
Last updated December 1, 2014
Start date February 2013
Est. completion date September 2013

Study information

Verified date December 2014
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 1178
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Early mobility bundle


Locations

Country Name City State
United Kingdom Heart of England NHS Trust Birmingham West Midlands

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Activity levels as reported by patient Days 1 and 2 of admission to ward No
Other Activity levels as measured by Actigraph Day 1 and 2 of admission to ward No
Primary 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. Duration of hospital stay (up to 12 days) No
Secondary 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 Duration of hospital stay (up to 12 days) No
Secondary 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 Duration of hospital stay (up to 12 days) Yes
Secondary 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 Duration of hospital stay (up to 12 days) No
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