We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769742
First Posted: January 17, 2013
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart of England NHS Trust
Information provided by (Responsible Party):
Alice Turner, University of Birmingham
  Purpose

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.


Condition Intervention
Hospital Acquired Pneumonia Behavioral: Early mobility bundle

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients

Resource links provided by NLM:


Further study details as provided by Alice Turner, University of Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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

  • 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


Other Outcome Measures:
  • Activity levels as reported by patient [ Time Frame: Days 1 and 2 of admission to ward ]
  • Activity levels as measured by Actigraph [ Time Frame: Day 1 and 2 of admission to ward ]

Enrollment: 1178
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Early mobility bundle
No Intervention: Usual care
Usual physiotherapy service only

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769742


Locations
United Kingdom
Heart of England NHS Trust
Birmingham, West Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
University of Birmingham
Heart of England NHS Trust
Investigators
Principal Investigator: Alice Turner University of Birmingham
  More Information

Publications:
Responsible Party: Alice Turner, Clinician Scientist and Honorary Consultant Physician, University of Birmingham
ClinicalTrials.gov Identifier: NCT01769742     History of Changes
Other Study ID Numbers: RG-12-237
First Submitted: November 27, 2012
First Posted: January 17, 2013
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Alice Turner, University of Birmingham:
Pneumonia
promotion of activity

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections