Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
29/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr J Rowles

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Department of Trauma & Orthopaedics
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077155742

Study information

Scientific title

Acronym

Study hypothesis

Does giving patients additional pre-operative information with regards to expected length and course of inpatient stay following total hip replacement shorten their actual length of stay?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Hip replacement

Intervention

Patients attending pre-operative assessment for their total hip replacement will be randomised into 2 groups. They will all be given the information booklet they have always been given which includes the statement that they will be in hospital 5-10 days. All patients will be managed identically to current practice. The pre-operative assessment clinic involves the patients meeting with a nurse, surgeon and anaesthetist to establish fitness for anaesthetic and operation. The patient also undergoes a fully informed consenting procedure to ensure they understand what the operation entails and risks of complications.

One subset of patients will be given some additional verbal information with regards to the details of their expected course. this will explain which days are targets for achieving sitting out of bed, mobilising with a zimmer and ultimately discharge date. The remaining patients will be managed as per current practice.

Management of the patients will then be identical and also no different from current management. They will undergo surgery and the same nursing and physiotherapy care on the ward. There will be no pressure for earlier discharge as the ward staff and physiotherapists will not be aware of which group is which.

Once the patients are discharged I will review their notesto document details such as age, sex, concurrent medical problems, type of prosthesis, day of surgery (if a patient is operated on Friday their discharge may be delayed as there is reduced physiotherapy over the weekend) and post-operative complications. It will be of course noted the actual length of stay. As a precaution the notes will also be reviewed 4 weeks following discharge to ensure the patients did not require readmission.

I will then compare the 2 groups against one another and statistically analyse to see if there is a significant difference in length of stay between them. A qualitative picture of whether length of stay has been shortened by increasing patients information about inpatient stay will be obtained by comparison of the groups.

Please note, this trial was superseded by the introduction of independent treatment centres with length of stay changing over night to a 5 day programme making this study null and void.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Length of inpatient stay following primary total hip replacement.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/02/2005

Overall trial end date

01/01/2007

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

All patients on the waiting list for a total hip replacement (under care of participating consultants) undergo pre-operative assessment 2-3 weeks prior to surgery. This is in order to check they are medically fit for surgery and also to make sure they understand the procedure and what to expect from the surgery.
The patients will be randomised into 2 groups and colour coded on the list of patients attending that day in pre-op assessment. The nurses and doctors in the pre-operative assessment unit will them know who is in which group. There will be no documentation on the patient notes stating which group they are in.
During the consultation with the doctor, half of the patients will be managed as per current practice. the other group will be verbally told additional information about their expected inpatient stay.
The patients will not be able to be informed of the study as this will obviously invalidate the results by heightening their awareness of the issue of inpatient stay (that is they may go and do further research themselves, including speaking to the other patients about what they have been told).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

500

Participant exclusion criteria

Any patients undergoing revision total hip replacement.

Recruitment start date

03/02/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes