Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000055505
Ethics application status
Approved
Date submitted
8/01/2015
Date registered
22/01/2015
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhanced recovery for patients undergoing lung cancer surgery?
Scientific title
Does a quality improvement programme enhance recovery for patients undergoing lung cancer surgery
Secondary ID [1] 285925 0
Nil
Universal Trial Number (UTN)
U1111-1165-8003
Trial acronym
The ERATS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 293851 0
Condition category
Condition code
Surgery 294154 294154 0 0
Surgical techniques
Cancer 294244 294244 0 0
Lung - Non small cell
Cancer 294245 294245 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will utilise quality improvement methodologies to design and implement a multimodal, multidisciplinary programme for patients undergoing surgery for lung cancer at this hospital. We will assess the ability of this programme to improve the quality of recovery for these patients.
The study will involve five phases: study planning; assessment; alignment; application and measuring.
Study planning: This phase will involve finalisation of the study protocol; development of study tools and education of research staff around data collection methods. Ethics and local approvals will also be obtained in this period.
Assessment: This phase will involve data collection on all patients admitted following lung cancer surgery to the ICU over a six month period. The aims of this phase are to identify the target patient population; map current workflow and care practices; assess current morbidity rate; assess current intensive care and hospital length of stay for this group; estimate current clinical and economic impact and costs; and identify specific opportunities for improvement. Patients will be invited to participate in a follow-up interview with a research nurse which will assess quality of recovery via a web-based or telephone based interview using the postoperative quality recovery scale (PQRS scale).
Alignment:This phase will commence on completion of the assessment phase and will last three months. We will identify and engage core interdisciplinary team members; define Enhance Recovery Programme (ERP) triggers and build checklists; map and test ERP workflow and interventions and communicate the plan to key stakeholders in preparation for the application phase of study. All staff will be trained in the programme and how it will be implemented. During this period, data collected in the assessment phase will be analysed and used as the comparator for the data collected following the application phase to assess the success of the programme.
Application: This phase - lasting six months - involves establishing the ERP in this patient population and to complete recruitment and document compliance levels with the ER programme. Patients will be approached by an ERP nurse specialist following referral for surgery and introduced to the programme. All elements of the programme will be instituted and then patients will be invited to participate in a follow-up interview with a research nurse which will assess quality of recovery via a web-based or telephone based interview using the post-operative quality recovery scale.
Measuring: In this final phase we will gather morbidity, length of stay and compliance data for the group enrolled to experience ERP. Also, one year follow-up measures of quality of life and recovery will be completed. Measurement and analysis of clinical and economic outcome benefits will compare ER outcomes to programme goals; we will communicate results to the key stakeholders and identify opportunities for improvement, expansion and knowledge translation. Also in this time, a detailed assessment of adherence to the programme and its interventions will be undertaken, analysed and disseminated.
Intervention code [1] 290901 0
Treatment: Other
Comparator / control treatment
Current care provided to patients undergoing lung cancer surgery and admitted to the study ICU for a 6 month period from 1st March 2015 to 1st September 2015
Control group
Historical

Outcomes
Primary outcome [1] 293948 0
Quality of recovery as measured by the PQRS score
Timepoint [1] 293948 0
28 days post-operative
Secondary outcome [1] 312213 0
Adherence to the all elements of the enhanced recovery programme using audit of care received to that prescribed. Adherence will be calculated as the number of interventions received/total number of possible perioperative interventions recommended
Timepoint [1] 312213 0
28 days post-operative
Secondary outcome [2] 312214 0
Incidence of post-operative complications e.g. pulmonary and cardiac complications; nausea and vomiting; agitation and delirium; deep vein thrombosis.
These will be assessed using discharge coding for pulmonary and cardiac complications and DVT; use of antiemetics; and CAM-ICU score.
Timepoint [2] 312214 0
28 days post-operative
Secondary outcome [3] 312215 0
Quality of life measures - EQ5D questionnaire
Timepoint [3] 312215 0
28 days, 3 months, 6 months and 12 months post-operative
Secondary outcome [4] 312216 0
Quality of recovery using the PQRS online score www.pqrsonline.org
Timepoint [4] 312216 0
28 days, 3 months, 6 months and 12 months post-operative
Secondary outcome [5] 312217 0
Pain score using Faces Charts
Timepoint [5] 312217 0
ICU and Hospital discharge, 28 days, 3 months, 6 months and 12 months post-operative
Secondary outcome [6] 312218 0
Length of stay in ICU and hospital
Timepoint [6] 312218 0
ICU and hospital discharge

Eligibility
Key inclusion criteria
Patients scheduled for lung cancer surgery at one hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who meet eligibility criteria for a pre-determined 6 month period will be enrolled into the "before" study of routine and all patients who meet eligibility criteria for a pre-determined 6 month period will be enrolled into the "after" study period to compare.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a before and after study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation is not possible with this study design. We know that there are approximately 150 patients per year admitted for lung cancer surgery it is hoped that this study will be appealing to them and they will all agree to participate in the follow-up interviews regarding quality of life and recovery.
All patients admitted during the study period will have data collected.

For normally distirbuted data mean and standard deviation will be reported. Nonparametric tests will be used if data is shown to be not normally distirbuted. Baseline characteristics will be analysed to determine predictors of outcome variables such as postopertive complications, length of stay, morbidity and quality of life and recovery.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2015
Actual
16/03/2015
Date of last participant enrolment
Anticipated
31/05/2016
Actual
16/09/2015
Date of last data collection
Anticipated
Actual
16/09/2016
Sample size
Target
150
Accrual to date
Final
114
Recruitment outside Australia
Country [1] 6582 0
New Zealand
State/province [1] 6582 0
Auckland

Funding & Sponsors
Funding source category [1] 290513 0
Self funded/Unfunded
Name [1] 290513 0
Country [1] 290513 0
Primary sponsor type
Individual
Name
Rachael Parke
Address
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1124
Country
New Zealand
Secondary sponsor category [1] 289207 0
None
Name [1] 289207 0
Address [1] 289207 0
Country [1] 289207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292165 0
Northern A HDEC
Ethics committee address [1] 292165 0
Ethics committee country [1] 292165 0
New Zealand
Date submitted for ethics approval [1] 292165 0
11/12/2014
Approval date [1] 292165 0
10/02/2015
Ethics approval number [1] 292165 0
14/NTA/234

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53838 0
Dr Rachael Parke
Address 53838 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 53838 0
New Zealand
Phone 53838 0
+6421893176
Fax 53838 0
Email 53838 0
[email protected]
Contact person for public queries
Name 53839 0
Rachael Parke
Address 53839 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 53839 0
New Zealand
Phone 53839 0
+6421893176
Fax 53839 0
Email 53839 0
[email protected]
Contact person for scientific queries
Name 53840 0
Rachael Parke
Address 53840 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 53840 0
New Zealand
Phone 53840 0
+6421893176
Fax 53840 0
Email 53840 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.