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

NCT ID: NCT01769742

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospital Acquired Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Early mobility bundle

Intervention Type BEHAVIORAL

Usual care

Usual physiotherapy service only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Early mobility bundle

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heart of England NHS Trust

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alice Turner

Clinician Scientist and Honorary Consultant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alice Turner

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heart of England NHS Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25063011 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RG-12-237

Identifier Type: -

Identifier Source: org_study_id