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Trial registered on ANZCTR


Registration number
ACTRN12616000544471
Ethics application status
Approved
Date submitted
15/04/2016
Date registered
27/04/2016
Date last updated
27/03/2023
Date data sharing statement initially provided
27/03/2023
Date results information initially provided
27/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Facilitation Intervention for Practice (FLIP) program for increasing adherence to clinical practice guidelines (CPG) relating to the management of the clinical deterioration of patients.
Scientific title
Prioritising Responses Of Nurses To deteriorating patient Observations (PRONTO)
Secondary ID [1] 288574 0
Nil known
Universal Trial Number (UTN)
U1111-1179-8527
Trial acronym
PRONTO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deteriorating patients in hospital settings 297703 0
Condition category
Condition code
Public Health 297887 297887 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group ward nursing staff will receive the standard implementation of Clinical Practice Guidelines (CPGs) plus the Facilitation Intervention for Practice improvement (FLIP). The Australian Commission on Safety and Quality in Health Care published a CPG titled "A guide to support implementation of the National Consensus Statement: Essential elements for recognising and responding to clinical deterioration". This CPG will be dissemination to all wards (both intervention and control wards). All wards will receive standard education support provided by the hospital related to this topic. Standard education consists of in-service presentations during work time to update staff on policy or practice changes, information on the CPG, its availability online as well as notification of the free online educational courses available to increase their knowledge and understanding about the identification and management of deteriorating patients. Information will be disseminated via posters on ward noticeboards and emails sent by the Nurse Unit Manager to all nursing staff.

In addition to the standard implementation, the intervention wards will receive additional educational support (FLIP) specifically targeting identified areas requiring practice improvement. FLIP comprises individuals in facilitator roles using facilitation methods (face to face contact) and processes in a flexible way to tailor implementation strategies to the local ward context, according to identified barriers and enablers. There will be two types of facilitator roles: hospital facilitators (HFLIP) and ward facilitators (WFLIP). A hospital facilitator (HFLIP) will be appointed to cover 4 or 5 intervention wards in each of the four hospitals, acting as the overall facilitation lead and a coordinator and mentor for the ward facilitators. In each intervention ward, two ward facilitators will be appointed to support and enable ward nurses to implement the CPGs into practice. Each HFLIP will work with 8-10 WFLIPs. The intervention wards will receive half a day per week support from the HFLIP for 6 months, reviewing barriers and enablers to implementing CPGs into practice during the intervention period and in discussion with the WFLIPs. The HFLIP will also review ward specific systems, processes, routines and audit practices in order to align systems of care to enable implementation of CPGs into daily practice. Training and a toolkit of methods and techniques will be given to all FLIPs to promote the transfer of CPGs into daily practice. At ward level, the 2 WFLIPs will work with the HFLIP to audit practice, identify barriers, strategies and areas for improvement; they will provide cover for each other during leave and support ward staff during practice hours, receiving one day per fortnight of protected time for conducting audits and meeting with the HFLIP to agree to tailored strategies to improve adherence to guidelines. The intervention will commence following the completion of training and when the HFLIPs can commence on the wards in the role. The intervention will last 6 months.

HFLIPs will have prior experience (e.g. in practice development or an education role) so that they can support and mentor the WFLIPS and deal with the more challenging contextual barriers that may arise.

Standardised procedure manuals will be provided to all facilitators with specific detail on roles and responsibilities. All facilitators will undergo monitoring procedures to ensure intervention fidelity. All Hospital and Ward FLIPs will receive training for a single day together and then the HFLIPs will continue for a further two days on advanced facilitation skills. Training will be conducted jointly by an investigator and a nurse educator. They will also receive mentoring and support during the trial consisting of monthly teleconferences for an hour with an investigator and support via a discussion blog asynchronously throughout the intervention period. The intensity of intervention will be assessed and monitored across sites. Examples of practices in the CPGs include documenting clinical assessments accurately; completing scope of practice activities such as administering medications; escalating care to the appropriate staff. All facilitators will enter data into the Electronic Activity and Communication Log (eACL). Data will be collected at time of activity and throughout the duration of the intervention on ward communication. Data captured will include methods and techniques outlined in the Facilitator Manuals, enablers and barriers, and measures of impact.
Intervention code [1] 293960 0
Behaviour
Comparator / control treatment
The control group ward staff will receive the standard implementation of Clinical Practice Guidelines (CPGs). The Australian Commission on Safety and Quality in Health Care published a CPG titled "A guide to support implementation of the National Consensus Statement: Essential elements for recognising and responding to clinical deterioration". This CPG will be dissemination to all wards allocated to Arm 2. The ward will receive standard education support provided by the hospital related to this topic. Standard education consists of in-service presentations during work time to update staff on policy or practice changes, information on the CPG, its availability online as well as notification of the free online educational courses available to increase their knowledge and understanding about the identification and management of deteriorating patients. Posters will be posted on ward noticeboards and emails with the information will be sent by the Nurse Unit Manager to all nursing staff.
Control group
Active

Outcomes
Primary outcome [1] 297407 0
Adherence to Clinical Practice Guidelines (CPGs) by nurses as measured by a composite score consisting of a complete set of vital signs, a repeated set of vital signs within 30 minutes, scope of practice interventions completed and escalation as per policy. Data is extracted from the observation charts. This is standard practice, as well as hospital policy, for nurses to document their assessments of patients and treatments or referrals in response to the assessments.
Timepoint [1] 297407 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [1] 320974 0
Clinical: Prevalence of urgent clinical review, Outcome assessed from review of medical records.
Timepoint [1] 320974 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [2] 323047 0
Medical Emergency team calls. Outcome assessed from review of medical records and risk management database.
Timepoint [2] 323047 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [3] 323048 0
Cardio-respiratory arrest. Outcome assessed from review of medical records and risk management database.
Timepoint [3] 323048 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [4] 323049 0
Unplanned admissions to ICU, Outcome assessed from review of medical records and risk management database.
Timepoint [4] 323049 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [5] 323050 0
Unexpected hospital mortality. Outcome assessed from review of medical records and risk management database.
Timepoint [5] 323050 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [6] 323051 0
Hospital length of stay. Outcome assessed from review of medical records and hospital admission and discharge database.
Timepoint [6] 323051 0
Assessed over three time points during a 24 hour period at baseline (pre-intervention), 6 & 12 months post-intervention start.
Secondary outcome [7] 323052 0
Economic Evaluation: Mean additional cost of implementing the intervention; Outcome assessed by study cost record review
Timepoint [7] 323052 0
Duration of intervention
Secondary outcome [8] 323053 0
Economic Evaluation: Mean total hospital cost. Outcome assessed by data linkage to hospital cost records.
Timepoint [8] 323053 0
Duration of hospital stay

Eligibility
Key inclusion criteria
All staff working within study wards delivering care will be involved in the project. Staff participating in focus groups or individual interviews for the process evaluation will be recruited via posters and consented. Each participating ward will be reviewed over 3 randomly selected 24 hour periods during one week at three time points (baseline, 6 and 12 months ) to determine all ward patients in a 24 hour period who have abnormal vital signs (VS). These cohorts of patients will be followed for the duration of their hospital stay and analysed according to ward (intervention or control), irrespective of subsequent ward transfers that may occur.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

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)
A central randomisation service not involved in the study will be used with concealment until the intervention is assigned. Assessment days will also be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random 1:1 block randomisation of wards to intervention or control group will be undertaken.
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
A cluster randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculations are based on 15% incidence of documented abnormal vital signs(VSs). To detect a 20% difference between (control and intervention) groups immediately following completion of the intervention and 6 months post-intervention, or an odds ratio of at least 1.8, using a two-sided Cochran-Mantel-Haenszel (CMH) test with 90% power, 270 documented abnormal VSs per time point per study arm are required. Our sample size has been inflated to allow for a design effect of 1.5, accounting for within hospital clustering effect. Type I error is set at 1% significance level accounting for multiple comparisons. For secondary outcomes, we have 80% power to detect a 5% difference (7% vs 25%) in unplanned ICU admissions, a 7% difference (9% vs 2%) for MET calls, and 2 day (SD=10) mean difference (26 VS 24) for hospital LOS. Due to a low incidence of cardiac arrests and hospital mortality, power analysis is based on combining 6 and 12 month data in intervention and control wards, resulting in 80% power to detect a 2.5% difference (3% VS 0.5%).

Quantitative methods will be used to analyse patient outcomes. The Cochran-Mantel-Haenszel (CMH) test will be used to compare the proportions of documented abnormal VS between groups. The CMH test takes account of the hospital clustering effect and allows for variation between the strata in the underlying rates. The common odds ratio and its 95% confidence interval will also be reported as well as the results of the Breslow-Day test for homogeneity of the odds ratios across the strata. If there is significant heterogeneity in the odds ratios, the treatment groups will also be compared, using Chi-squared tests, in three separate subset analyses, one for each of the hospitals. Similar analysis will be performed for all other secondary comparison of proportions. In supportive analyses, generalized linear mixed models (GLMMs) will be used to compare the proportion of documented measurement of vital signs at baseline, immediately following the completion of the intervention and 6 months post-intervention after adjusting for baseline measurements. Analogous linear mixed models will be used to analyse the continuous-scale secondary endpoints. A series of exploratory analyses will be conducted on subgroups and the impact of covariates, on estimates of the effect of the intervention, will also be examined. Hospital LOS will be considered as time to event data. Survival rates will be calculated and illustrated by the Kaplan–Meier method and further analysed by the log-rank test for univariate analysis (stratified by hospitals). Variables that revealed prognostic or effect modifying potential on the outcome as suggested by univariate analysis were subsequently evaluated by the proportional Cox regression for multivariate analysis. Hazard ratios with the corresponding 95% confidence intervals will be reported. P-values <0.05 is considered statistically significant. Data will be analysed using stata version 13 or later.
Cost-effectiveness analysis (CEA): Patients will be identified through the patient record audit over three separate 24 hour periods and at three time points (baseline, 6 and 12 months). Identified patients will be assumed to be part of their ward allocation (intervention or control) for their entire hospital LOS. This will enable comparison of total costs and patient outcomes (unplanned ICU admissions, mortality and HLOS) between intervention and control groups in the pre-intervention period (baseline) and at immediate post intervention(6 months) and 12 months. Patient level data will be retrieved from hospital admission and clinical costing systems for the entire hospital episode for each identified patient. Costs will be attributed to ICU admission and ward LOS through the hospital clinical costing system, therefore any between group differences in unplanned ICU admissions and/or total hospital length of stay will be reflected in the mean total cost. Costs will be attributed to the FLIP intervention based on the additional costs of the KT process (staff time) over standard in-hospital CPG training. In addition to CEA from a health system perspective based on change in mortality rates, cost minimisation or savings due to the FLIP intervention can be determined by changes in HLOS and ICU admissions between groups, offset by cost of FLIP.
Process Evaluation: Interviews, field observations and focus group transcripts will be analysed thematically. Analysis will be iterative, refining emerging themes, then comparing themes and relationships through a process of pattern matching to examine for data consistency. Themes and relationships will be re-examined and recoded by two members of the research team. Analysis will continue until no new themes emerge and agreement on themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/06/2016
Actual
27/06/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
25/11/2019
Sample size
Target
1620
Accrual to date
Final
6042
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5296 0
The Alfred - Prahran
Recruitment hospital [2] 5297 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 5298 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 5299 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 13084 0
3128 - Box Hill
Recruitment postcode(s) [2] 13082 0
3168 - Clayton
Recruitment postcode(s) [3] 13083 0
3175 - Dandenong
Recruitment postcode(s) [4] 13080 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 292925 0
Government body
Name [1] 292925 0
National Health and Medical Research Council (NHMRC)
Country [1] 292925 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Rd, Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 291681 0
Hospital
Name [1] 291681 0
Monash Medical Centre
Address [1] 291681 0
246 Clayton Rd, Clayton VIC 3168
Country [1] 291681 0
Australia
Secondary sponsor category [2] 291682 0
Hospital
Name [2] 291682 0
Eastern Health
Address [2] 291682 0
5 Arnold St, Box Hill VIC 3128
Country [2] 291682 0
Australia
Secondary sponsor category [3] 292201 0
Government body
Name [3] 292201 0
Australian Commission on Safety and Quality in Health Care
Address [3] 292201 0
GPO Box 5480
Sydney
NSW 2001
Country [3] 292201 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294430 0
The Alfred Ethics Committee
Ethics committee address [1] 294430 0
55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 294430 0
Australia
Date submitted for ethics approval [1] 294430 0
01/03/2016
Approval date [1] 294430 0
29/04/2016
Ethics approval number [1] 294430 0
Ethics committee name [2] 297357 0
Eastern Health
Ethics committee address [2] 297357 0
5 Arnold Street, Box Hill, Victoria 3128
Ethics committee country [2] 297357 0
Australia
Date submitted for ethics approval [2] 297357 0
11/05/2016
Approval date [2] 297357 0
26/05/2016
Ethics approval number [2] 297357 0
SERP20-2016
Ethics committee name [3] 297358 0
Monash Health
Ethics committee address [3] 297358 0
246 Clayton Road, Clayton Victoria 3168
Ethics committee country [3] 297358 0
Australia
Date submitted for ethics approval [3] 297358 0
21/04/2016
Approval date [3] 297358 0
22/06/2016
Ethics approval number [3] 297358 0
LNRSSA/16/MH/178

Summary
Brief summary
This knowledge translation (KT) study uses a pragmatic cluster randomised controlled trial (C-RCT) design that will measure the effectiveness and cost effectiveness of a facilitation intervention to improve nurses’ vital sign (VS) measurement, interpretation, treatment and escalation of patients with abnormal VS. We will compare outcomes and costs from standard implementation of clinical practice guidelines (CPGs) with facilitated implementation. This study will include both process and health economic evaluations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63670 0
Prof Tracey Bucknall
Address 63670 0
Deakin University
School of Nursing and Midwifery
221 Burwood Road
Burwood
Victoria 3125
Country 63670 0
Australia
Phone 63670 0
+61 3 92446529
Fax 63670 0
Email 63670 0
tracey.bucknall@deakin.edu.au
Contact person for public queries
Name 63671 0
Prof Tracey Bucknall
Address 63671 0
Deakin University
School of Nursing and Midwifery
221 Burwood Road
Burwood
Victoria 3125
Country 63671 0
Australia
Phone 63671 0
+61 3 92446529
Fax 63671 0
Email 63671 0
tracey.bucknall@deakin.edu.au
Contact person for scientific queries
Name 63672 0
Prof Tracey Bucknall
Address 63672 0
Deakin University
School of Nursing and Midwifery
221 Burwood Road
Burwood
Victoria 3125
Country 63672 0
Australia
Phone 63672 0
+61 3 92446529
Fax 63672 0
Email 63672 0
tracey.bucknall@deakin.edu.au

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


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://qualitysafety.bmj.com/content/31/11/818 370153-(Uploaded-24-03-2023-14-53-23)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrioritising Responses Of Nurses To deteriorating patient Observations (PRONTO) protocol: testing the effectiveness of a facilitation intervention in a pragmatic, cluster-randomised trial with an embedded process evaluation and cost analysis.2017https://dx.doi.org/10.1186/s13012-017-0617-5
N.B. These documents automatically identified may not have been verified by the study sponsor.