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Trial registered on ANZCTR


Registration number
ACTRN12619000586112
Ethics application status
Approved
Date submitted
9/03/2019
Date registered
16/04/2019
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The ICU Feedback Study: comparing response rate of paper based questionnaires versus electronic questionnaires in patients with a recent intensive care stay.
Scientific title
The ICU Feedback Study: evaluating the effectiveness of using a multimodal platform compared to a paper-based platform in providing feedback for ICU survivors
Secondary ID [1] 297683 0
None
Universal Trial Number (UTN)
U1111-1229-8436
Trial acronym
TIFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ICU Survivors after >48hrs stay 311961 0
Condition category
Condition code
Public Health 310539 310539 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomised cohort study, we plan to contact groups of patients at one of three different time points (3, 6 and 12 months) following ICU discharge (we will not contact every patient at every time point but but rather every patient at one specific time point, depending on the date of ICU discharge and the date of enrollment). We will randomise patients into two groups, one group will be asked to complete a 30 minute online questionnaire with non-responders being provided with a paper questionnaire while the other group will be provided with the same questionnaire but only in paper form. This questionnaire will consist of the following outcome questionnaires: EQ-5D (descriptive system of five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression + VAS), HADS (detects features of depression and anxiety in the out-patient setting) and IES-R (self-rating scale that measures traumatic stress responses related to PTSD after a variety of traumatic events) together with a few questions to asses their preferred means of being contacted, their satisfaction about the way the study is conducted and a few open questions about their ICU experience.

We hope to assess the overall response rate, the response rate in relation to the time period following ICU discharge and the effect of questionnaire modality on response rate.
Patients in the multimodal group will be sent an email (if an email address was provided at consent) or letter that contains a web address 14 days prior to their 3, 6 or 12-month time point. For patients who have provided an email address and if no response has been received, a further email will be sent after 3 days, up to a total of 3 repeat requests. If no response has been obtained after a further 5 days (14 days post initial email) a letter with a paper questionnaire will be sent with a pre-paid envelope for its return. We will call all non-responders after a further 7 days. A final open disclosure and thank you letter will be sent 7 days after that.

Patients in the paper group will be contacted through:
- paper mail for the enrollment, questionnaire and repeat questionnaire
- by phone if the patients does not respond to the enrollment letter or paper questionnaire.

Adherence to the forms in the online questionnaires will be added to an online database (Redcap) directly, the form information from the paper questionnaires will be manually added to the online database (Redcap).
Intervention code [1] 313915 0
Behaviour
Comparator / control treatment
All patients will be contacted via paper mail for study enrollment.

Patients randomised to the paper only group will be sent a letter with the questionnaire. This will be followed by a repeat questionnaire at 14 days if no response is received. If still no response is received, a phone call will be made to enquire if they have received either letter. A final open disclosure and thank you letter will be send 7 days after that.
Control group
Active

Outcomes
Primary outcome [1] 319399 0
Response rate to the questionnaires
Timepoint [1] 319399 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [1] 368022 0
Contact preference.

This will be assessed as the patient has to provide the preferred contact means when filling in the questionnaire. This part of the questionnaire is designed specifically for this study and assesses through a 5 point scale how capable the patient is with completing questionnaires on paper, web-based or through a smartphone app (the latter which is not used in this study).
Timepoint [1] 368022 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [2] 368023 0
Cost effectiveness of both feedback modalities.

This will be assessed based on the actual cost of physical paperwork and postage costs versus the upkeep of the website. Both the paper and multi modal questionnaires will be sent and followed up by registrars. We will base the personnel cost on the average time spent on contacting the study patients through the various ways depending on the randomization group.
Timepoint [2] 368023 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [3] 368560 0
Quality of life assessed through the results of the EQ-5D questionnaire.
Timepoint [3] 368560 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [4] 368626 0
Features of depression and anxiety in the out-patient setting assessed through the HADS questionnaire.
Timepoint [4] 368626 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [5] 368627 0
Traumatic stress responses related to PTSD after a variety of traumatic events (ie. ICU stay in this study) through the IES-R questionnaire
Timepoint [5] 368627 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)
Secondary outcome [6] 368628 0
Patient experience of their ICU stay assessed through a series of open questions designed specifically for this study
Timepoint [6] 368628 0
28 days post T0 (T0 is either 3, 6 or 12 months after ICU discharge, depending on which group the patient falls under)

Eligibility
Key inclusion criteria
Aged > 18 years
Discharge home from hospital.
ICU length of stay > 48 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of consent
Readmitted to ICU
Remain in hospital
Death during ICU or following ICU discharge

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will receive a list of patients whom have been discharged alive from ICU and the hospital. All these patients will be eligible for enrollment. This list is provided by the ICU head of research whom is not aware of how the randomization will happen and does not participate in the study itself. The randomization will be done during the follow-up phase through database randomization in Excell.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients who consent to participate in the study will be randomised using a random number generator in excel to either the multimodal group or the paper only group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to enrol approximately 300 patients, 100 each at 3, 6 and 12 months following ICU discharge. Anticipating a 50% non-response/non-consent rate we will retrospectively approach 200 patients at each time period who were in ICU for >48 hours, were discharged home and are still alive. The sample is a convenience sample based on existing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,SA
Recruitment hospital [1] 13349 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25948 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 302208 0
Hospital
Name [1] 302208 0
Royal Adelaide Hospital
Country [1] 302208 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
RAH ICU, Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 302056 0
None
Name [1] 302056 0
Address [1] 302056 0
Country [1] 302056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302887 0
Central Adelaide Local Health Network Research Ethics Committee
Ethics committee address [1] 302887 0
Ethics committee country [1] 302887 0
Australia
Date submitted for ethics approval [1] 302887 0
03/09/2018
Approval date [1] 302887 0
11/10/2018
Ethics approval number [1] 302887 0
HREC/18/CALHN/549

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

Contacts
Principal investigator
Name 91742 0
Dr Hao Zheng Wong
Address 91742 0
RAH ICU, Port Road, Adelaide SA 5000
Country 91742 0
Australia
Phone 91742 0
+61 412383825
Fax 91742 0
Email 91742 0
wonghaozheng@gmail.com
Contact person for public queries
Name 91743 0
Maarten Brusseleers
Address 91743 0
RAH ICU, Port Road, Adelaide SA 5000
Country 91743 0
Australia
Phone 91743 0
+61467840666
Fax 91743 0
Email 91743 0
m.brusseleers@gmail.com
Contact person for scientific queries
Name 91744 0
Maarten Brusseleers
Address 91744 0
RAH ICU, Port Road, Adelaide SA 5000
Country 91744 0
Australia
Phone 91744 0
+61467840666
Fax 91744 0
Email 91744 0
m.brusseleers@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1559Ethical approval    377171-(Uploaded-09-03-2019-15-11-54)-Study-related document.docx
1560Study protocol    377171-(Uploaded-09-03-2019-15-12-32)-Study-related document.docx



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.