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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list