Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000723088
Ethics application status
Approved
Date submitted
27/08/2010
Date registered
31/08/2010
Date last updated
19/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol initiated discharge in a 23-hour post surgical ward: a randomized controlled trial.
Scientific title
Among patients admitted to a 23-hour post surgical unit, will using a protocol for discharge affect the number of discharges by 0900 hours and patient satisfaction.
Secondary ID [1] 252582 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Minor surgery 258075 0
Condition category
Condition code
Surgery 258246 258246 0 0
Other surgery
Public Health 258265 258265 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protocol having clear criteria for admission to the unit; the completion of surgery summaries and discharge prescriptions at the end of the procedure; and using the Modified Post Anaesthetic Discharge Scoring System (MPADSS) to assess if the patient is ready for discharge.
The intervention covers the time from admission to the 23-hour unit to the time of discharge from the unit.
Intervention code [1] 257104 0
Other interventions
Comparator / control treatment
Usual care. No discharge protocol used. Patients are assessed as fit for discharge by their surgeon.
Control group
Active

Outcomes
Primary outcome [1] 259093 0
Proportion of patients discharged by 0900 hours. Assessed by time recorded in the patient's medical record.
Timepoint [1] 259093 0
At discharge from the 23-hour unit
Secondary outcome [1] 265386 0
Patient satisfaction is assessed by self-report questionnaire, which asks the patients to decribe positive aspects of the unit, negative aspects of the unit and suggestions for improvement. Participants are also asked to provide a score out of 100 for their care.
Timepoint [1] 265386 0
One week after hospital discharge
Secondary outcome [2] 265387 0
Hospital admission assesed using the patient's medical record.
Timepoint [2] 265387 0
At discharge from the 23-hour unit
Secondary outcome [3] 265388 0
Hospital re-admission assessed by asking the patient in a follow-up questionnaire or phone call.
Timepoint [3] 265388 0
One week after hospital discharge

Eligibility
Key inclusion criteria
Patients booked for surgery who were expected to be admitted to the 23-hour unit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No consent
< 18 years
Surgeon has not agreed to for patients to be included
patients undergoing eye surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting patients were allocated by telephone randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence was generated by computer. Randomisation was blocked and patients were randomised 1:1 to a ‘normal care discharge’ group or a ‘protocol initiated discharge’ group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2010
Actual
5/05/2010
Date of last participant enrolment
Anticipated
Actual
24/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
188
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257552 0
Other
Name [1] 257552 0
Queensland Nursing Council
Country [1] 257552 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 256773 0
None
Name [1] 256773 0
Address [1] 256773 0
Country [1] 256773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259576 0
Royal Brisbane and Womens Hospital (RBWH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 259576 0
Level 7, Block 7
RBWH
Butterfield St
Herston
QLD 4029
Ethics committee country [1] 259576 0
Australia
Date submitted for ethics approval [1] 259576 0
18/08/2009
Approval date [1] 259576 0
21/09/2009
Ethics approval number [1] 259576 0
HREC/09/QRBW/256

Summary
Brief summary
There is limited published literature about the effectiveness of protocol initiated discharge in short-stay post-surgical units. The current study enrolled 182 participants who were randomly allocated to intervention or control groups.
Trial website
Not applicable
Trial related presentations / publications
Webster J, Connolly A, Paton F, Corry J. The effectiveness of protocol driven, nurse-initiated discharge in a 23-h post surgical ward: A randomized controlled trial. International Journal of Nursing Studies 2011; 48:1173-1179
Public notes

Contacts
Principal investigator
Name 31579 0
Prof Joan Webster
Address 31579 0
Level 2, Centre for Clinical Nursing, RBWH, Butterfield St, Herston, QLD 4029
Country 31579 0
Australia
Phone 31579 0
+61 7 3646 8590
Fax 31579 0
Email 31579 0
[email protected]
Contact person for public queries
Name 14826 0
Joan Webster
Address 14826 0
Centre for Clinical Nursing
RBWH
Butterfield Street
Herston
QLD 4029
Country 14826 0
Australia
Phone 14826 0
+ 61 7 3636 8590
Fax 14826 0
N/A
Email 14826 0
[email protected]
Contact person for scientific queries
Name 5754 0
Joan Webster
Address 5754 0
Centre for Clinical Nursing
RBWH
Butterfield Street
Herston
QLD 4029
Country 5754 0
Australia
Phone 5754 0
+ 61 7 3636 8590
Fax 5754 0
N/A
Email 5754 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.