ANZCTR - Registration

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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 information initially 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]

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.

Condition category

Condition code

Surgery

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]

Prevention

Intervention code [2]

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]

The primary outcome measures of feasibility will be tested against recruitment, protocol fidelity, retention and missing data.

Timepoint [1]

Baselineline data at recruitment and two weeks postdischarge.

Primary outcome [2]

Acceptability of of the intervention.

Timepoint [2]

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]

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]

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]

Hospital utilisations ( GP visits, unplanned emergency room presentations and unplanned hospital readmissions)

Timepoint [2]

Two weeks after hospital discharge using telephone interviews and patients' medical charts on day 30 after hospital discharge.

Secondary outcome [3]

Hospital length of stay

Timepoint [3]

Patients medical chart at day 30 after hospital discharge

Secondary outcome [4]

Postoperative complications (i.e. wound complications, respiratory complications, sepsis, gastrointestinal complications.)

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Australian College of Perioperative Nurses Queensland

Address [1]

GPO Box 2518 Brisbane QLD 4001

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Gold Coast campus
1 Parklands Dr, Southport QLD 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Health Research Ethics Committee

Ethics committee address [1]

Office for Research Governance and Development
Level 2 Block E – Pathology and Education
1 Hospital Boulevard
Southport, QLD, 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/03/2020

Approval date [1]

27/05/2020

Ethics approval number [1]

Summary

Brief summary

Management of self-care during the postdischarge period for general surgical patients is often challenging due to pain, fatigue and the presence of a surgical wound. Discharge education has been viewed as a critical part of meeting the patient’s continuing care needs and is crucial to enable patients to recognise when professional intervention is required. This transition period exposes patients to unnecessary risks related to inadequate preparation before leaving the hospital, potentially leading to postoperative complications and patient harm. With shorter hospitalisations, limited time and patients in a haste to leave the hospital, critical information may be poorly understood by patients or inadequately imparted by the health professionals facilitating the discharge process.

Advances in web-based technology have introduced approaches that support effective and affordable healthcare delivery and patient education. The PREVENT discharge education package was designed to guide patients in recognising and understanding the signs and symptoms that patients may face at home after general surgery Discharge instructions for patients can be simplified to warning signs in understandable language as patients can be taught how to recognise and identify the warning signs, and how to contact the healthcare system using a standardised language.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Evelyn Kang

Address

Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222

Country

Australia

Phone

+61 7 5552 9737

Fax

[email protected]

Contact person for public queries

Name

Ms Evelyn Kang

Address

Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222

Country

Australia

Phone

+61 7 5552 9737

Fax

[email protected]

Contact person for scientific queries

Name

Ms Evelyn Kang

Address

Griffith University,
Gold Coast Campus
Academic Building 1 Rm2.03
Southport
QLD 4222

Country

Australia

Phone

+61 7 5552 9737

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Kang E, Chaboyer W, Tobiano G, et alEvaluating the... [More Details]	379160-(Uploaded-13-04-2023-12-39-16)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluating the feasibility of a web-based discharge education programme to improve general surgical patients' postdischarge recovery: A pilot randomised controlled trial.	2022	https://dx.doi.org/10.1136/bmjopen-2021-054038

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically