Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000389909
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
23/03/2020
Date last updated
5/06/2023
Date data sharing statement initially provided
23/03/2020
Date results provided
5/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving post-discharge recovery for general surgery patients (the PREVENT study)
Scientific title
Web-based postdischarge education to increase general surgical patients' knowledge and skills in self-managing postdischarge recovery.
Secondary ID [1] 300395 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The PREVENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative complications for general surgical patients following general surgery. 316024 0
Condition category
Condition code
Surgery 314301 314301 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be implemented is an adjunct to the standard care as participants randomised to the intervention group will be able to review the web content while in hospital and after hospital discharge. Participants randomomised to the intervention group will be asked to access the content of the intervention via a fixed URL address on their home computer, smartphones or tablets after hospital discharge. Reminders will be sent to patients every 3 days for 2 weeks via SMS and email with the web link to remind them to access the web-based education. The intervention will take approximately 10 minutes for participants to complete.

The PREVENT intervention is developed using responsive web design. Participants in the intervention group will be able to access it using a full range of devices and screen sizes (i.e. smartphones, desktop and laptops, and tablet devices.

PREVENT Content
The intervention has three main components: 1) post general surgery warning signs; 2) post general surgery everyday care; and 3) signs of wound complications using dynamic explanatory 3D video. The intervention was developed based on existing literature and CDC guidelines for wound care as well as from findings from interviews with patients and clinical staff (both nurses and doctors).

In the area post general surgery warning signs, there are 3 statuses- Green, Yellow and Red, with descriptions of warning signs and a timely set of actions required by the patients. The statuses are categorised in a coloured coded framework to help patients and carers make sense of the meaning of the different statuses. Discharge instructions to patients are distilled down to succinct warning signs using simple language and patients will be coached on how to recognise the warning signs and contact the healthcare system, using standardised language when communicating warning signs to healthcare providers.

In the area post general surgery everyday care, self-management information is provided to remind patients of the activities to undertake after going home. Patients are encouraged to be more proactive and to explore the next step in their care by attending the follow-up appointments.

In the signs and symptoms of wound infection video, patients will be guided through a 4 minute animated, interactive learning process about signs and symptoms of potential surgical wound complications and recognising when to seek professional help.
Intervention code [1] 316684 0
Prevention
Intervention code [2] 316685 0
Treatment: Other
Comparator / control treatment
Participants in the control group will not have access to the components of the intervention. All participants will receive usual care during their hospitalisation, including a predischarge teaching session by the bedside nurse and other HCP on resuming activities of daily living, dressing change post general surgery risk factors, and new medications. This may include the standard ward pamphlet on what patients can and cannot do after discharge following a general surgery procedure.
Control group
Active

Outcomes
Primary outcome [1] 322689 0
The primary outcome measures of feasibility will be tested against recruitment, protocol fidelity, retention and missing data.
Timepoint [1] 322689 0
Baselineline data at recruitment and two weeks postdischarge.
Primary outcome [2] 322945 0
Acceptability of of the intervention.
Timepoint [2] 322945 0
A the end of the program at two weeks postdischarge. A subsample of about 12 participants that have received the intervention will be purposively selected to be asked about their perceived acceptability of the intervention at four weeks postdischarge during a phone interview which will take approximately 20 minutes.
Secondary outcome [1] 379301 0
Patients' knowledge, skills and confidences in self-care after hospital discharge will be measured using the Patient Activation Measure (PAM)- 13 item and the therapeutic self-care scale (TSCS).

The PAM-13 survey is designed to elicit responses from a person about his or her attitudes toward knowledge, skills, and confidence for self-management.

The TSCS measure patients perceived ability for self-care, operationalized in behaviours related to taking medications, recognizing and managing symptoms, carrying out activities of daily living, and managing changes in condition.
Timepoint [1] 379301 0
Baselineline data at recruitment and two weeks postdischarge. Data collected at 2-week follow up will be via telephone interview. A data collection form will be used to collect information on patients' attitudes of engaging with their self-care during the telephone follow-up.
Secondary outcome [2] 379302 0
Hospital utilisations ( GP visits, unplanned emergency room presentations and unplanned hospital readmissions)
Timepoint [2] 379302 0
Two weeks after hospital discharge using telephone interviews and patients' medical charts on day 30 after hospital discharge.
Secondary outcome [3] 379303 0
Hospital length of stay
Timepoint [3] 379303 0
Patients medical chart at day 30 after hospital discharge
Secondary outcome [4] 379304 0
Postoperative complications (i.e. wound complications, respiratory complications, sepsis, gastrointestinal complications.)
Timepoint [4] 379304 0
Two weeks after hospital discharge using telephone interviews and patients' medical charts at day 30 after hospital discharge.

Eligibility
Key inclusion criteria
i. Age 18 years or older and had general surgery procedure
ii. Ability to access the intervention independently using the web link provided on their home computer or their smartphone or tablet device
iii. Contactable by telephone
iv. Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Ambulatory or day surgery procedures
ii. Colorectal surgery procedures
iii. Patients discharged as hospital in the home patients or discharged to residential care as the planned discharge destination

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)
At the time of recruitment (prior to patients’ discharge), the recruiter will access the centralised web-based service to determine group allocation. Participants randomised to the intervention group will be shown how to access the PREVENT intervention on a tablet and shown the components of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to the two study groups using simple random sampling in a 1:1 ratio. The randomisation will be blocked (using randomly varying blocks of sizes 4 and 6).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcomes to be assessed relate to recruitment, retention, intervention fidelity and missing data to assess the feasibility of conducting a full-scale efficacy study. Recruitment: 80% eligible participants or more will agree to participate; Protocol fidelity: 95% patients or more who are randomised to each group will receive the allocated intervention to which participants are randomized; Retention: less than 10% of patients will be lost to follow up; Missing data: less than 10% of data will be missing. Descriptive statistics will be computed to assess the pilot’s success in meeting feasibility criteria (recruitment, retention, missing data, protocol fidelity) using absolute and relative frequencies for categorical data.

The secondary outcomes related to the efficacy of the intervention include patient activation, self-care ability, postoperative complications, healthcare utilisations and length of hospital stay will be reported descriptively across the intervention and control groups using the approach described above. As this is a pilot study, hypotheses testing is not the focus; comparisons between the two groups will only be undertaken to obtain an indication of the general trends in the data as recommended in pilot study methodology.

To test for baseline differences between groups, independent samples t-tests will be used to test whether there are differences in outcome measures across study arms at baseline. When data is not normally distributed, Mann-Whitney U tests will be performed for non-normally distributed continuous variables and chi-square test for categorical variables. A p-value of <.05 will be considered statistically significant.

Qualitative data on intervention acceptability will be analysed using content analysis to highlight the individual points made as these will be grouped into key themes. Interview transcripts will be analysed in depth using indexing and charting methods inspired by Framework Method. Data analysis will include codes which will be compiled into a tentative coding frame with thematic headings. Narrative summaries will be created from each of the conceptual themes across all cases.








Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2020
Actual
1/10/2020
Date of last participant enrolment
Anticipated
30/10/2020
Actual
5/01/2021
Date of last data collection
Anticipated
30/11/2020
Actual
30/01/2021
Sample size
Target
90
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15718 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 29138 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 304820 0
Other
Name [1] 304820 0
Australian College of Perioperative Nurses Queensland
Country [1] 304820 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast campus
1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 305148 0
None
Name [1] 305148 0
NA
Address [1] 305148 0
NA
Country [1] 305148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305232 0
Gold Coast Health Research Ethics Committee
Ethics committee address [1] 305232 0
Ethics committee country [1] 305232 0
Australia
Date submitted for ethics approval [1] 305232 0
11/03/2020
Approval date [1] 305232 0
27/05/2020
Ethics approval number [1] 305232 0

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

Contacts
Principal investigator
Name 99698 0
Ms Evelyn Kang
Address 99698 0
Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222
Country 99698 0
Australia
Phone 99698 0
+61 7 5552 9737
Fax 99698 0
Email 99698 0
[email protected]
Contact person for public queries
Name 99699 0
Evelyn Kang
Address 99699 0
Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222
Country 99699 0
Australia
Phone 99699 0
+61 7 5552 9737
Fax 99699 0
Email 99699 0
[email protected]
Contact person for scientific queries
Name 99700 0
Evelyn Kang
Address 99700 0
Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222
Country 99700 0
Australia
Phone 99700 0
+61 7 5552 9737
Fax 99700 0
Email 99700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The sharing of patients' data has not been sought.


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the feasibility of a web-based discharge education programme to improve general surgical patients' postdischarge recovery: A pilot randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-054038
N.B. These documents automatically identified may not have been verified by the study sponsor.