NCT01769742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

November 27, 2012

Last Update Submit

December 1, 2014

Conditions

Keywords

Pneumoniapromotion of activity

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Length of hospital stay in days

    Duration of hospital stay (up to 12 days)

  • Incidence of falls

    Duration of hospital stay (up to 12 days)

  • Incidence of pressure area problems

    Duration of hospital stay (up to 12 days)

Other Outcomes (2)

  • Activity levels as reported by patient

    Days 1 and 2 of admission to ward

  • Activity levels as measured by Actigraph

    Day 1 and 2 of admission to ward

Study Arms (2)

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

Behavioral: Early mobility bundle

Usual care

NO INTERVENTION

Usual physiotherapy service only

Interventions

Early mobility bundle

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any medical inpatient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart of England NHS Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related 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. 2014 Sep;88(1):34-9. doi: 10.1016/j.jhin.2014.05.006. Epub 2014 Jun 20.

MeSH Terms

Conditions

Healthcare-Associated PneumoniaPneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alice Turner

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist and Honorary Consultant Physician

Study Record Dates

First Submitted

November 27, 2012

First Posted

January 17, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations