ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001343796

Ethics application status

Approved

Date submitted

6/12/2013

Date registered

9/12/2013

Date last updated

10/07/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Introducing a care bundle to prevent pressure injury

Scientific title

In hospitalised patients at risk of developing pressure ulcers, will a pressure injury prevention care bundle, compared to usual care reduce the incidence of hospitalised acquired pressure ulcers?

Secondary ID [1]

NONE

Universal Trial Number (UTN)

Trial acronym

INTACT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pressure Injury

Condition category

Condition code

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Pressure Injury Prevention Care Bundle (PIPCB). Includes the delivery of a one on one education containing 3 key messages: 1) keep moving, 2) good skin care, and 3) good nutrition via a brochure, poster and a 5 min DVD.
Participants in the intervention group will receive the PIPCB in addition to usual care. After recruitment by a dedicated recruiting RA, an intervention RA will provide the training in a single session, expected to last approximately 30 minutes.

Intervention code [1]

Prevention

Comparator / control treatment

Standard Care: Participants will receive all of the hospital pressure injury prevention strategies such as: pressure injury risk assessment, regular repositioning, good skin care, patient education etc.

Control group

Active

Outcomes

Primary outcome [1]

The incidence of hospital acquired pressure injury (HAPI) in "at risk" hospitalised patients. The RA assessing the outcome will be different to the RA recruiting patient and the RA delivering the intervention in the intervention group. The outcome assessor will only know that the study is focusing on the development of new PI (i.e. HAPI) in patients who have consented to have their skin assessed daily.

Timepoint [1]

Development of a HAPI; Hospital Discharge (includes rehabilitation unit); or Day 28, whichever comes first.

Secondary outcome [1]

a) Pressure injury stage i.e depth of tissue damage. This outcomes will be assessed by a trained outcome assessor (dedicated to this activity only). The outcome assessor will visually inspect the skin of all participants daily and will refer to their training manual to determine if an area of skin abnormality meets the definition of a Stage of Pressure Injury (stage 1-4). The outcome assessor will be employed to assess patients in one site only and will be unaware of what the intervention and control arms of this study are. They will be aware that the study is focusing on measuring the development of a pressure injury on consenting patients.

Timepoint [1]

Development of a HAPI; Hospital Discharge (includes rehabilitation unit); or Day 28, whichever comes first.

Secondary outcome [2]

Patient participation in care. A 13-item patient participation in care scale, rigorously developed and tested in 2,025 patients will be used. Item stems will be modified to reflect participation in PIP. Patients will complete this scale on reaching one of the trial endpoints. The outcome assessor RA will administer the scale to participants.

Timepoint [2]

Development of a HAPI; Hospital Discharge (includes rehabilitation unit); or Day 28, whichever comes first.

Eligibility

Key inclusion criteria

Adults admitted to a study ward; expected LOS of greater/equal to 48 hours, at risk of PI as measured by limited mobility and able to provide informed consent.

Minimum age

18 Years

Maximum age

99 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous participation in trial, admitted to the hospital >24 hours prior to recruitment, palliative or dying patients, ICU patients, maternity patients, and emergency department patients.

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)

Potential ward patients will be approached by the charge nurse/champion nurse and a brief introduction to the study will be provided. Those patients who are eligible and interested in further study details will meet with the RA for a full explaination of study protocol and procedures. Allocation to either control or intervention groups will be based on a hospital cluster randomised trial, randomised via a central randomisation service.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer program will generate the random allocation sequence.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Multi-site and cluster Randomised Trial (c-RT)

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Demographic and clinical data of our sample will be compared to national data to assess the representativeness of our sample. Our primary hypothesis will be tested at cluster (i.e. hospital) level. However, further patient level analyses will also be carried out. Recent advances in statistics such as Generalized Estimation Equations (GEE) models, hierarchical or generalized mixed models and multi-level models will allow us to adjust for clustering of patient-level data. Within each approach, we will consider simple analyses such as t-tests, Chi-square tests or more complex approaches such as multivariate logistic regression models. Both allow the effect of the intervention on the incidence of HAPI and other secondary outcomes to be tested; however, only complex analyses allow adjustment for potential covariates, such as baseline performance. As we propose to collect covariate data on the hospital and individual patient level, the adjustment of these factors will be carried out in the appropriate level of analyses using GEE or multi-level models.
Cluster Level Analysis: The traditional approach to the analysis of c-RTs has been to calculate a summary measure for each cluster, such as a cluster mean or proportion. Because each cluster then provides only one data point, the data can be considered to be independent, allowing standard statistical tests to be used. Estimates of the HAPI incidence in each group, differences along with the 95% CI and p values will be reported. Other outcomes will also be compared at the cluster levels between the intervention and control group. Baseline variables and other covariates will be compared between the two groups to make sure the intervention and control groups do not differ in their baseline characters. If they do differ, further analyses to provide adjusted estimates will be considered. Such adjustment can be carried out at cluster level using multiple regression models to adjust for cluster level covariates directly, but can incorporate patient level covariates through a two-stage process using GEE or multi-level models.
Patient Level Analysis: Patient level analyses will primarily account for the intra-cluster correlation, thus increasing the statistical power of the analysis. Patient level data analyses will include simple statistical tests, adjusted to account for the clustering effect. Z-tests for comparing the proportion between the intervention and control groups or t-tests to compare the means between the groups, can be carried out at patient level using cluster adjusted Z-test or t-test, by dividing the Z or t-test values by the square root of for design effect. This is required to avoid spuriously low P-value and overly narrow CIs, over-emphasizing the impact of the intervention. However, the more comprehensive inferences in our study will be based on the use of new modelling techniques to incorporate patient level data such as mixed linear models, hierarchical linear modelling and GEE. These modelling techniques allow the direct correlation within clusters to be modelled explicitly, and many potential confounding factors would be included in the model when comparing the effect of the intervention. Such models will be developed for primary and secondary outcomes. The type of the model will depend on the type and nature of the outcome variable. Our detailed analysis plan will ensure that the modelling is hypothesis-led rather than data-driven. As such, our a priori model-fitting approach will identify the covariates to be considered for inclusion in any modelling approach to analysis and the potential confounding variables that are to be considered for inclusion in the model with the intervention. These modelling techniques adjust well for clustering and allow adjustment for both cluster level and patient level covariates. We will use SAS and STATA for the analyses of our data. An intention to treat analysis will be primary but we will also undertake a per protocol analysis.
Cost-effectiveness Analysis: An economic evaluation will be undertaken from the health system perspective to compare the total costs and effects of a PIPCB for the prevention of HAPI, relative to standard care. Detailed resource utilisation and costs assessed in this substudy will be used to undertake a stepped economic evaluation and estimate (i) the comparative per patient HAPI related healthcare prevention costs for each group, and (ii) the comparative incremental cost of preventing an additional case of HAPI. Hierarchical modelling approaches and cluster-adjusted non-parametric bootstrapping techniques will be employed to compare mean difference in the total costs between groups, and to estimate a confidence interval around the mean. In addition, a cost-effectiveness analysis will be undertaken based on the primary outcome measure (incidence of HAPI), to estimate the incremental cost per additional person remaining free from pressure injury. The comparative costs and cost-effectiveness estimates will inform recommendations on the adoption of the PIPCB for the prevention of pressure injury in clinical practice.

The incidence of HAPI in Australian hospitals ranges from 7.4% – 17.4%. The 2012 Qld Health statewide PI audit demonstrated that 15.1% of patients who were unable to reposition independently developed a HAPI. CID’s Cochrane review on support surfaces showed that pooled data from five studies showed a relative reduction in new PI of 60% (95% CI 0.21 – 0.74). In our sample size estimate we have taken a conservative approach of incidence of 10% HAPI (control) with an expected reduction of 50% or an absolute reduction of 5% (from 10% to 5%) in the intervention group and an intra-class correlation (ICC) of 0.001, the actual ICC in another c-RCT of a PIP strategy. We are fortunate to have this previous cRCT to base our ICC estimate, as we originally thought we would need more hospitals. To obtain 90% power with a two-sided a level of 0.05, 8 hospitals with 169 patients per hospital are required (PASS – Power Analysis and Sample Size system, NCSS, Utah). Thus, the total sample required will be 1,352. To allow for attrition, a further 18% (n = 248) will be recruited for a total sample of 1,600 (n = 200/site).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

23/06/2014

Actual

Date of last participant enrolment

Anticipated

30/11/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1600

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

Gold Coast Hospital - Southport

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [3]

Nambour General Hospital - Nambour

Recruitment hospital [4]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [5]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [6]

The Alfred - Prahran

Recruitment hospital [7]

Box Hill Hospital - Box Hill

Recruitment hospital [8]

Cabrini Hospital - Malvern - Malvern

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

GPO BOX 1421 CANBERRA ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Gold Coast Campus, Parklands Drive Southport. Qld 4222

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 Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

1 Hospital Boulevard, Southport Qld 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2013

Approval date [1]

28/04/2014

Ethics approval number [1]

13/QGC/192

Summary

Brief summary

The main aim of this study is to assess whether one on one education and training of patients in pressure injury prevention will prevent pressure injury. The 3 key messages are; i) keep moving, ii) good skin care; and iii) good nutrition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Wendy Chaboyer

Address

NHMRC Centre of Research Excellence in Nursing Interventions for Hospitalised Patients (NCREN)
Centre for Health Practice Innovation (HPI)
Griffith Health Institute, Gold Coast Campus,
Griffith University
Southport QLD 4222

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8526

[email protected]

Contact person for public queries

Name

Prof Wendy Chaboyer

Address

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8526

[email protected]

Contact person for scientific queries

Name

Prof Wendy Chaboyer

Address

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8526

[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

Source	Title	Year of Publication	DOI
Embase	INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial.	2015	https://dx.doi.org/10.1016/j.ijnurstu.2015.04.018
Embase	Adherence to evidence-based pressure injury prevention guidelines in routine clinical practice: a longitudinal study.	2017	https://dx.doi.org/10.1111/iwj.12798

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

Trial Review

Documents added manually

Documents added automatically