Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000430831
Ethics application status
Approved
Date submitted
26/02/2021
Date registered
16/04/2021
Date last updated
20/04/2022
Date data sharing statement initially provided
16/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a patient and clinician education program for falls prevention in hospitals
Scientific title
A mixed methods approach to investigating the effects of a patient and clinician hospital falls education program on knowledge, risk awareness and behaviour change
Secondary ID [1] 303549 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Falls 320899 0
Condition category
Condition code
Public Health 318713 318713 0 0
Health service research
Injuries and Accidents 318714 318714 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design will incorporate a mixed-methods approach. This will allow for both quantitative and qualitative methods to be utilised, enabling a more holistic understanding of the impact of the intervention. This study will utilise a convergent explanatory design with two arms: one arm is focused on patient education, while the other arm is focused on clinician training.

Patient Education

Traditionally, patients often receive falls education in a myriad of ways. These include receiving a falls prevention brochure, attending a falls prevention education group, receiving falls prevention education during therapy sessions with allied health staff, or through informal conversations with nurses. This is not usually consistent between every patient or health professional. Thus, this education intervention incorporates interprofessional collaboration to empower patients in managing their safety in hospital.

The patient education intervention (which is named EMPOWER) will include the standardised Healthscope falls prevention brochure plus a face-to-face semi-scripted conversation focused on clarifying the information, utilising teach-back methods and encouraging goal setting. Ward staff will be trained to share information and collaborate between professions to deliver the intervention effectively. Interprofessional communication about the patient education processes will ensure each patient on the ward receives the education. This can take place informally or through handovers via daily ‘huddles’. These ‘huddles’ are formal handover sessions between nurses-in-charge and the allied health team which are carried out at all hospital sites. They often occur in the morning and are an effective way to communicate health changes or updates relating to individual patients between health disciplines.

The semi-scripted conversation is based on the principles of the Safe Recovery Program (SRP). The 12 steps of the original SRP has been condensed into 3 steps: (i) identifying the ‘leverage point’ and linking back to falls prevention; (ii) setting a goal; and (iii) follow up. With these steps, this intervention aims to empower patients to take onus of their own falls prevention, while still being feasible for ward staff to carry out. The approximate duration of this intervention is 10 minutes.

This will be a ward-based intervention carried out collaboratively by allied health staff and nurses over 4 weeks. It is intended to be stand alone and separate to the admission process. Either nurses or allied health professionals will deliver this intervention within 24 hours of admission of the patient. Interactions between nurses and allied health professionals will occur following the intervention highlighting key issues for clinical handover and to ensure messaging is being reinforced. Based on interprofessional communications and delegations of responsibility, follow up conversations will be held by nurses or allied health professionals in the following 2-3 days. Once the initial education has been delivered, a paper labelled “EMPOWER” will be placed on the front of the patient’s bedside chart/file. This will serve as a reminder to staff that the education has already been delivered and follow up will be required. Clinical staff are given access to a laminated guide to the script which they can refer to during the conversation. The placement of an EMPOWER sign in the front pocket of a patient’s bedside chart will indicate if the intervention has been carried out.

Clinician Training

Eligible ward staff include all those involved in the care of the patients, including registered nurses, enrolled nurses, physiotherapists, occupational therapists and allied health assistants. Participants will receive a 1-hour high-quality education program using best educational design. This will educate clinicians on the latest evidence on patient education for falls prevention and support effective implementation of the patient education intervention, including the processes to achieve effective interprofessional collaborative practice.

A blended approach will be used to deliver the education program. The education intervention will be multifaceted and will utilise a mixture of interactive teaching methods suited to the learning needs of busy clinicians. Methods of educational delivery will include:
• Small group discussion on what the clinicians’ current falls prevention education to patients entails
• Small group critical thinking activity on the barriers and facilitators to clinicians delivering falls prevention education to patients
• Content delivery on the latest evidence on patient education and its role in falls prevention in hospitals
• Use of three recorded vignettes using simulated participants to demonstrate the delivery of falls prevention education to patients using a standardised Healthscope falls prevention brochure. The vignettes will include face-to-face semi-scripted conversations focused on clarifying the information, utilising teach-back methods and encouraging goal setting.

Clinician training will be provided by a Physiotherapy Research Fellow or a Nursing Professor. A session attendance checklist will be used to monitor adherence to complete the PICF, survey 1 and survey 2. A list of clinicians eligible for training will be provided by the Nurse Unit Manager on the ward.

Additional resources (Panopto recording and PowerPoint presentations) will be provided for those staff not able to attend the training and to supplement the learning for staff who attended.
Intervention code [1] 319835 0
Behaviour
Comparator / control treatment
Usual care. The control ward will continue with the usual falls prevention practice. This may include provision of falls prevention brochures, informal or formal education sessions, allied health therapy, medication reviews and so on.
Control group
Active

Outcomes
Primary outcome [1] 326650 0
PATIENT EDUCATION

Primary outcome 1: Level of knowledge, self-perceived falls risk and behaviour change (Kirkpatrick level 2 and 3). This is a composite outcome.

The Pre-test Survey asks participants to answer 7 questions using a Likert scale to identify their current level of knowledge, self-perceived falls risk and intentional behaviour. The pre/post survey is based on a validated questionnaire by Khong et al. (2018).

The Post-test Survey repeats the items from Pre-test Survey to determine if there have been any changes.
Timepoint [1] 326650 0
Pre-intervention, 2-4 days post intervention
Primary outcome [2] 326651 0
CLINICIAN TRAINING

Primary outcome 2: Level of knowledge and changes in attitude towards delivering effective falls prevention education to patients (Kirkpatrick levels 2 and 3). This is a composite outcome.

The Pre-test Survey asks participants to answer 8 questions using a Likert scale of their views on evidence-based practice patient education for falls prevention.

The Post-test Survey repeats the items from Pre-test Survey to determine if there have been any changes.

The surveys use a sub-scale of a survey developed for a previous study on clinician education on falls prevention and based on previous surveys related to attitudes towards evidence based practice and knowledge of evidence based practice.
Timepoint [2] 326651 0
Pre and post the receipt of clinician training.
Secondary outcome [1] 392274 0
PATIENT EDUCATION

Secondary outcome 1: Patients' views on the learning experience (Kirkpatrick level 1)

The Post-test survey will include one question where participants are asked to rate the importance of receiving education for falls prevention in hospital. It will also include an open-ended question about their views about the education.

Semi-structured telephone interviews about participants views will be conducted post implementation with consenting participants from the intervention ward.
Timepoint [1] 392274 0
2-4 days post intervention and approximately 1-2 weeks post participant discharge
Secondary outcome [2] 392276 0
CLINICIAN TRAINING

Secondary outcome 2: Level of knowledge and behaviour change towards capabilities in interprofessional collaboration (Kirkpatrick levels 2 and 3). This is a composite outcome.

In the pre-test survey, participants will be provided with 20 statements about interprofessional collaboration and be asked to rate their ability for each statement.

The Post-test Survey repeats the items from Pre-test Survey to determine if there have been any changes. The survey on interprofessional learning is the ‘The Interprofessional Collaborative Competency Attainment Scale’
Timepoint [2] 392276 0
Pre and post the receipt of clinician training.
Secondary outcome [3] 392279 0
CLINICIAN TRAINING

Secondary outcome 3: Clinicians' views on the learning experience (Kirkpatrick level 1)

In the post-test survey, participants will answer 7 questions about their views on the clinician education. There will be two open-ended questions where participants can provide comments about the education received. The survey was developed for this study based on questionnaires used in previously published educational research.

Three follow up semi-structured interviews will be conducted with consenting individuals for each intervention ward.
Timepoint [3] 392279 0
Immediately post the completion of clinician training.

Eligibility
Key inclusion criteria
Patient education

For patients to be eligible for the survey, they need to be: (i) Adults (>18 years); (ii) able to speak, read and understand English; and (iii) medically stable. Here, “medically stable” is defined as patients having a normal Glasgow Coma Scale score which indicates full consciousness and having stable vital signs. This will be determined by the nurse-in-charge who will provide a list of potential participants to a member of the research team. For the follow up phone interview, the inclusion criteria are the same with an additional criteria: participants must be from intervention wards.

Clinician training

For clinicians to be eligible, they need to provide informed consent and be: (i) Qualified registered nurses, enrolled nurses or allied health clinicians (Physiotherapist/Occupational therapist/Allied Health Assistants); and (ii) working in intervention wards.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have cognitive impairment or if they did not stay overnight in hospital. The nurse-in-charge of each ward will identify cognitively intact patients using their clinical judgement and past medical history before providing a list of names to a member of the research team. This research team member will have a clinical background and will also use their clinical judgement to ensure they agree with the nurse-in-charge.

Clinicians will be excluded if they work in non-inpatient settings or are not assigned to intervention wards.

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)
Allocation was concealed and involved contacting the holder of the allocation schedule who was ‘off-site’ at an Australian university not participating in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
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
The theoretical framework of Kirkpatrick’s model will be utilised across both arms of the study to evaluate the first three levels of Kirkpatrick outcomes. Kirkpatrick’s four level model has been used as a systematic framework to appraise training in different fields such as simulation-based training, medical education and general education training. This study seeks to use a version of the model which has been modified in the context of interprofessional learning evaluation with health professionals. In this modified version, the four levels of Kirkpatrick’s model are expanded to provide more in-depth evaluation of the intervention. Quantitative measures will evaluate levels 2 and 3 while qualitative measures will evaluate level 1.

Patient education

The demographic make-up of the patient groups (Control and Intervention) will be characterised by simple frequency statistics. Then, the chi-squared test will be used to check whether the two groups are sufficiently equivalent in terms of patient demographics. The patients’ responses to the Likert scale survey questions will be summarised using basic descriptive statistics (n, mean score, standard deviation, and 95% confidence interval).

Inferential statistics, the Independent Samples t-test (or its nonparametric equivalent, if the data normality assumption is not satisfied), will be used for between group (Control vs Intervention) comparisons of mean scores, and possibly for some within group comparisons as well.

With respect to statistical power and sample size calculations, we are seeking significant differences at the 95% confidence level, so a = 0.05. Further, we aim to achieve a statistical power of p = 0.8, and to detect effect sizes of Cohen’s d = 0.4 and larger. The corresponding sample size required is calculated to be n = 50 (using the program Power and Sample Size v.3.0, 2009).

Clinician training

The demographic make-up of the clinicians will be characterised by simple frequency statistics. The clinicians’ responses to the Likert scale survey questions will be summarised using basic descriptive statistics (n, mean score, standard deviation, and 95% confidence interval).

Inferential statistics, the Independent Samples t-test (or its nonparametric equivalent, if the data normality assumption is not satisfied), will be used for within group comparisons of mean scores.

All analyses will be conducted through SPSS.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
18/03/2021
Date of last participant enrolment
Anticipated
24/05/2021
Actual
10/06/2021
Date of last data collection
Anticipated
4/06/2021
Actual
3/07/2021
Sample size
Target
100
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307972 0
Government body
Name [1] 307972 0
National Health and Medical Research Council
Country [1] 307972 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Dr, Bundoora, Vic 3086
Country
Australia
Secondary sponsor category [1] 308693 0
Commercial sector/Industry
Name [1] 308693 0
Healthscope
Address [1] 308693 0
1/ 312 St Kilda Rd, Melbourne Vic 3004
Country [1] 308693 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307965 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 307965 0
Ethics committee country [1] 307965 0
Australia
Date submitted for ethics approval [1] 307965 0
19/01/2021
Approval date [1] 307965 0
22/02/2021
Ethics approval number [1] 307965 0
HEC21023

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

Contacts
Principal investigator
Name 109070 0
Prof Meg Morris
Address 109070 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 109070 0
Australia
Phone 109070 0
+61 3 9479 6080
Fax 109070 0
Email 109070 0
[email protected]
Contact person for public queries
Name 109071 0
Meg Morris
Address 109071 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 109071 0
Australia
Phone 109071 0
+61 3 9479 6080
Fax 109071 0
Email 109071 0
[email protected]
Contact person for scientific queries
Name 109072 0
Meg Morris
Address 109072 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 109072 0
Australia
Phone 109072 0
+61 3 9479 6080
Fax 109072 0
Email 109072 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
Individual patient data will not be made available due to patient confidentiality.


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
No additional documents have been identified.