Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000528752
Ethics application status
Approved
Date submitted
2/05/2013
Date registered
13/05/2013
Date last updated
13/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a follow up service on health related quality of life in patients post sepsis syndromes.
Scientific title
The effect of a multidisciplinary follow up service on health related quality of life in patients post sepsis syndromes: a randomized controlled trial
Secondary ID [1] 282408 0
Nil
Universal Trial Number (UTN)
U1111-1142-4194
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Sepsis syndromes 288990 0
Condition category
Condition code
Infection 289331 289331 0 0
Other infectious diseases
Physical Medicine / Rehabilitation 289405 289405 0 0
Physiotherapy
Physical Medicine / Rehabilitation 289406 289406 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will attend a follow-up clinic monthly for 1.5 hours for up to six months after discharge from the hospital. Screening instruments will be utilized and appropriate management and referral provided. Examples of screening instruments are: overall medical review involving all systems assessment, medications, vital signs, assessment of mobility (modified Rivermead Mobility Index), balance assessment (Berg Balance measure) referrals to community for further rehabilitation, discussion with carer as to concerns (Zarit Burden interview), screening for chronic pain syndromes, nutritional review - referral to nutritionists and/or speech pathology if required, screening with UK-PTSS-14 (for post traumatic stress syndrome) and K-10 inventory for depression, referral to general practitioner or psychologists if needed, referral for occupational assessment re return to work or activities of daily living, liaison with general practitioners.
Intervention code [1] 287041 0
Rehabilitation
Comparator / control treatment
Patients in the control group will have usual care ie referred to specialist outpatient clinics and/or general practitioners on discharge
Control group
Active

Outcomes
Primary outcome [1] 289446 0
The Short Form (36) Health Survey (SF-36) which consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are:
1. vitality
2. physical functioning
3. bodily pain
4. general health perceptions
5. physical role functioning
6. emotional role functioning
7. social role functioning
8. mental health
Timepoint [1] 289446 0
Baseline (enrolment), six months and twelve months post baseline
Secondary outcome [1] 302489 0
Readmission to hospital
Timepoint [1] 302489 0
Total numbers readmitted to any hospital compared between groups at 12 months post enrolment
Secondary outcome [2] 302490 0
Mortality
Timepoint [2] 302490 0
Total numbers who die compared between groups at 12 months post enrolment
Secondary outcome [3] 302491 0
Health care resource use - will be monitored through examination of patient medical records, patient self-report and through Medicare / Pharmaceutical Benefits Scheme data extraction.
Timepoint [3] 302491 0
This will be compared between groups at 6 and 12 months post enrolment
Secondary outcome [4] 302492 0
Individual patient productivity - This will be measured using a work/activity impairment questionnaire, the Work Productivity and Activity Impairment Questionnaire (WPAI)
Timepoint [4] 302492 0
This will be compared between groups at 6 and 12 months post enrolment

Eligibility
Key inclusion criteria
1. Patients included will be male or female,
2. >18 years,
3. documented episode(s) of sepsis, severe sepsis or septic shock
4. Required intensive care admission
5. Required mechanical ventilation for longer than 48 hours
6. Discharged to community or low level facility
Minimum age
18 Years
Maximum age
96 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neurological injuries,
2. Spinal injuries
3. Burns injury
4. Non-English speaking
5. Mini-mental state examination<25/30

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clinical staff will screen daily for patients while in intensive care. If patients appear suitable for the study, on discharge to the ward they will ask the patient as to whether the investigators may approach them to discuss the study. The patient will then be approached and provided with information about the study and asked for informed consent. If consent is obtained, the patient will be randomized to one of two groups by the use of computer randomization by an independent perspn unaware of the patients current condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be via a computer generated randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size –
Power calculations are based on SF-36 using previously published Minimally Clinically Important Differences (MCIDs) for the SF36 physical domain scores of 7.8 points (sd 15). The sample size, based on a two sample comparison of means was calculated at 78 per group for the SF-36 at 90% power with a two-sided, alpha error level of 0.05. Allowing for an almost 30% loss to follow up (mortality, drop outs) a total of 204 participants will be required


A baseline comparison of demographics, severity of illness acute physiological and chronic health evaluation score (APACHE II), and baseline measures will be done between each group, using a combination of t-tests and Chi-square.
Primary outcome: SF-36 domain scores and the summary score (utility) derived from the SF-36) will be compared between groups using a mixed model effect to allow for missing data. Secondary outcomes: Mortality will be compared between groups using a Cox proportional hazards (time until death) analysis proportional hazards (time until death) analysis. Time to first readmission will be compared between groups by a survival analysis. Health care costs will be compared between groups using a GLM to account for the non normal distribution. Economic (health resource) evaluation will be an incremental cost utility analysis. Direct costs included will be: cost of care provided in hospitals, by GP’s, home nursing, complementary [allied] health providers, alternative health providers, opportunity cost of unpaid carers, cost of transportation to program and to other health services, and cost of pharmaceuticals. Indirect costs include loss of productivity due to disease, such as time lost from work or providing informal care to another individual. All costs will be valued using market costs where available and productivity costs will be valued using actual patient wage rates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 958 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 6813 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 287204 0
Charities/Societies/Foundations
Name [1] 287204 0
Royal Brisbane & Womens Hospital Research Foundation
Country [1] 287204 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Mayne Medical School
288 Herston Road, Herston
Brisbane, QLD, 4006
Country
Australia
Secondary sponsor category [1] 285967 0
Hospital
Name [1] 285967 0
Royal Brisbane & Womens Hospital
Address [1] 285967 0
100 Butterfield St,
Herston QLD 4029
Country [1] 285967 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289196 0
Royal Brisbane & Womens Hospital HREC
Ethics committee address [1] 289196 0
Floor 7, Block 7
Royal Brisbane & Womens Hospiral
Butterfield St,
Herston 4029, QLD
Ethics committee country [1] 289196 0
Australia
Date submitted for ethics approval [1] 289196 0
Approval date [1] 289196 0
24/04/2013
Ethics approval number [1] 289196 0
HREC/2013/QRBW/17
Ethics committee name [2] 289197 0
The University of Queensland HREC
Ethics committee address [2] 289197 0
Cumbrae Stewart Building,
The University of Queensland,
St Lucia, 4072, QLD
Ethics committee country [2] 289197 0
Australia
Date submitted for ethics approval [2] 289197 0
Approval date [2] 289197 0
02/05/2013
Ethics approval number [2] 289197 0
#2013000543

Summary
Brief summary
IMPROVING OUTCOME OF SEPSIS

Greater numbers of patients are surviving intensive care but have poor quality of life due to immobility, poor cognition, post traumatic stress disorder, depression and frequent readmissions to hospital. Patients with a severe infection “sepsis” are particularly affected.
This study aims to improve the overall outcome of critically ill patients with sepsis, through a follow up outpatient service. The intervention group will be screened by several instruments and appropriate referrals made.
This trial will investigate whether these interventions can prevent readmission to hospital; improve health related quality of life, decrease mortality, and decrease utilization of health resources thereby decreasing the burden on the Australian health system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39610 0
Dr Jennifer Paratz
Address 39610 0
Level 3, NHB,
Dept of Intensive Care Medicine,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston 4029 QLD
Country 39610 0
Australia
Phone 39610 0
61 7 36461980
Fax 39610 0
61 7 36463542
Email 39610 0
j.paratz@uq.edu.au
Contact person for public queries
Name 39611 0
Dr Jennifer Paratz
Address 39611 0
Level 3, NHB,
Dept of Intensive Care Medicine,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston 4029 QLD
Country 39611 0
Australia
Phone 39611 0
61 7 36461980
Fax 39611 0
61 7 36463542
Email 39611 0
j.paratz@uq.edu.au
Contact person for scientific queries
Name 39612 0
A/Prof Robert Boots
Address 39612 0
Level 3, NHB,
Dept of Intensive Care Medicine,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston 4029 QLD
Country 39612 0
Australia
Phone 39612 0
61 7 36461949
Fax 39612 0
61 7 36463542
Email 39612 0
Rob_Boots@health.qld.gov.au

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
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Documents added automatically
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