Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000554662
Ethics application status
Approved
Date submitted
11/05/2023
Date registered
24/05/2023
Date last updated
24/05/2023
Date data sharing statement initially provided
24/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
INtegrative approaches for Optimizing Recognition, Management and Education of concussion at the community sports level
Scientific title
A randomised controlled trial, comparing the proportion of concussion diagnoses (primary outcome) in a telehealth program (intervention) to current practices (comparator), following sports-related head injuries
Secondary ID [1] 308866 0
Nil
Universal Trial Number (UTN)
NA
Trial acronym
INFORMED-V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports related concussion (SRC) 328851 0
Mild Traumatic Brain Injury (TBI) 329980 0
Condition category
Condition code
Injuries and Accidents 325849 325849 0 0
Other injuries and accidents
Neurological 325904 325904 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multidisciplinary telehealth program with neuropsychologists, physiotherapists, emergency physicians, neurologists, critical care nurse, neuroscientists and sports physicians will be available to the participant. Among participants randomised to the telehealth arm, the consultation will be conducted primarily by a neuropsychologist or physiotherapist, rostered 4 half-days per week. The neuropsychologist will be co-located with a medical specialist (emergency physician or neurologist) for assessment of symptoms related to the head injury outside the scope of possible concussion . Follow-up consultations using telehealth will be scheduled at 7 days and 14 days and may also occur at greater frequency if recommended by the assessing team. Should the telehealth team feel the need for in-person assessment and management, including physiotherapy or occupational therapy for example, this will be facilitated.
Additional nurse follow-up will occur at 30 days to assess satisfaction with the telehealth program. All other standard care processes will be continued as per normal clinical practice.

The telehealth consultation will be delivered via online video call by the neuropsychologist. The duration of the consult will be 45minutes. If the neuropsychologist deems that further in-person care is required, they will, with the participant’s consent, refer the participant to ED or their GP, or in the case of persistent concussive symptoms after 14 days, refer them to the Monash Turner clinic (https://www.monash.edu/turner-institute/turner-clinics). On day 30, the nurse will follow up with a telephone call. The follow-up will be less than 10 minutes unless the situation warrants further investigation. There are no specific strategies for monitoring adherence, but the episodes of intervention will be recorded.
Intervention code [1] 326076 0
Diagnosis / Prognosis
Comparator / control treatment
Participants randomised to the standard care arm will be provided with currently available online resources and mobile phone application (i.e. HeadCheck) for the assessment and management of concussion, including AFL’s RTP advice.
Follow-ups will be conducted, on an observatory basis (i.e. not clinical assessments), by research nurses by telephone on days 7 and 14.

The standard care arm will be guided through the online resource library by the research nurse via phone consultation. The resources are all currently readily available material which we have combined in one collection. We have not created any new resources for the purpose of this trial. These resources are collected on our website: https://www.informedtbi.org/advice-on-concussion
That site includes links to the following: AFL Approved HeadCheck app. ACI health mild head injury advice. Health Direct advice on concussion. Better Health advice on concussion. Australian Sports Commission advice on concussion, and the AFL return to play advice.
The participants can see this information at any point in the study and immediately after the participant enrols. The research nurse will guide the participants through these available resources over mobile phone telephone consultation. The intervals of usage of these tools will be as per the commercially available tools recommended. The nurse follow up will assess the symptoms related to concussion, using validated tools, such as RPQ. The duration of follow-ups will take approximately 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 333680 0
The primary Outcome will be the proportion of players diagnosed with concussion at 7 days post head injury

The primary Outcome is whether or not the player has received a diagnosis of concussion as measured by being told by a qualified medical practitioner or sports doctor that they have a concussion.

The data will be collected by a brief telephone follow-up in which the research nurse asks whether or not the participant has been diagnosed with a concussion.
Timepoint [1] 333680 0
7 Days post head injury
Secondary outcome [1] 417931 0
a) Longitudinal data on concussion symptoms on the Rivermead Post-concussion Questionnaire (RPQ), as reported by the participants, during telehealth with nurse, at 7 days
Timepoint [1] 417931 0
7 days post head injury
Secondary outcome [2] 417932 0
a) Longitudinal data on concussion symptoms on the Rivermead Post-concussion Questionnaire (RPQ), as reported by the participants, during telehealth with nurse, at 14 days
Timepoint [2] 417932 0
14 days post head injury
Secondary outcome [3] 417934 0
b) The proportion of adherence to current RTP guidelines, as reported by the participants, during telehealth with nurse, at 7 days
Timepoint [3] 417934 0
7 days post head injury
Secondary outcome [4] 421884 0
b) The proportion of adherence to current RTP guidelines, as reported by the participants, during telehealth with nurse, at 14 days
Timepoint [4] 421884 0
14 days post head injury
Secondary outcome [5] 421886 0
c) Consultation with a clinical specialist, as reported by the participants, during telehealth with nurse, at 7 days
Timepoint [5] 421886 0
7 days post head injury
Secondary outcome [6] 421887 0
c) Consultation with a clinical specialist, as reported by the participants, during telehealth with nurse, at 14 days
Timepoint [6] 421887 0
14 days post head injury
Secondary outcome [7] 421889 0
d) Satisfaction with the program, as reported by the participants, during telehealth with nurse, at 30 days

On day 30, we will assess the usability of the telehealth program using the Telehealth Usability Questionnaire as modified by Shore et al.(1) As well as, we will assess the participant satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8). (2)
Citations:
1) Shore J, Hutchison MG, Nalder E, Reed N, Hunt A. Tele-Active Rehabilitation for adolescents with concussion: a feasibility study. BMJ Open Sport Exerc Med [Internet]. 2022 Feb 1 [cited 2023 Jan 17];8(1):e001277. Available from: https://bmjopensem.bmj.com/content/8/1/e001277
2) Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233–7.
Timepoint [7] 421889 0
30 days post head injury
Secondary outcome [8] 421890 0
The proportion of players diagnosed with concussion at 14 days post head injury

This outcome assesses whether or not the player has received a diagnosis of concussion as measured by being told by a qualified medical practitioner or sports doctor that they have concussion.

The data will be collected by a brief telephone follow-up in which the research nurse asks whether or not the participant has been diagnosed with a concussion.
Timepoint [8] 421890 0
14 days post head injury

Eligibility
Key inclusion criteria
1. Adult patients (age >=18 years);
2. Medicare eligibility
3. Head injury sustained during sports event (either matches or training) through VAFA;
4. Concussion suspected by either club trainer, medical professionals, or players themselves
5. GCS 13-15
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Adolescent (<18 years)
2. Moderate or severe Traumatic Brain Injury (TBI)
3. Intracranial haemorrhage
4. GCS<13

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will use computerised randomisation method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will randomise using block randomisation (randomly selected block sizes of 4,6 or 8). The nurse will do the randomisation. Participants with suspected concussion will be referred either by themselves, club personnel or clinicians (e.g., their GP). Randomisation will occur after a critical care nurse has collected baseline data and ensured trial eligibility. The participant will have to provide consent prior to this contact (see sections 6.4 and 6.5). Prior to commencing the interview, the nurse will confirm that the participant has understood and agrees to the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
8.1 Power calculations and sample size
In this cohort of players, we conservatively estimate that 50% will have a diagnosis of concussion (this proportion may be higher as players would be screened by telephone advice and VAFA side-line, thereby increasing our power). In the intervention arm, we are aiming for a minimum clinically significant absolute difference of 15%, i.e., 50% of participants to have a diagnosis of concussion within 7 days compared to 35% in the standard care arm. Using 90% power and 0.05 significance level, we will require 480 players to be randomised. We will aim to recruit 500 players to account for loss to follow-up. In 2021, our pilot study of 60 teams (i.e., ~20% of VAFA), during an abridged season due to COVID-19 (~60% of the total length), we had 61 cases of concussions reported. As such, with full league involvement and a complete season, we estimate there to be 693 cases of concussion per year. Even if all clubs do not participate and some players do not enter the trial, we have a large enough eligible population over 2 years for the sample size to be comfortably achieved.

8.2 Analysis of results

8.2.1 Descriptive statistics and primary outcome
Patient characteristics will be presented in a table with descriptive statistics used to present the general characteristics of this cohort. Baseline characteristics will be summarised using means (with standard deviation) if continuous and normal or near-normally distributed, medians (with inter-quartile range) if skewed or ordinal and count (with proportions) if categorical. Differences between means will be assessed using Student's t-test, differences between medians will be assessed using the Wilcoxon rank sum test and differences between categorical variables assessed using the Chi-square test. The primary outcome – the proportion of concussion diagnosis in the two arms - will be computed using the Chi-square test and summarised using Odds Ratio (OR) and reported with 95% confidence intervals (95% CI). Potential variables associated with the primary outcome will be evaluated using ORs and presented with 95%CIs. Hosmer-Lemeshow purposeful variable selection approach will be used to select potential confounding factors identified in univariate analysis (p<0.25) into a generalised linear model with the most appropriate distribution family and link function32. Akaike information criterion and Bayesian Information Criterion will be used to fit the final model to determine independent predictors of concussion diagnosis. We will report results of the study after the first season (i.e. September 2023).

8.2.2 Secondary outcomes
We will use mixed effects linear models, in accordance with previous research,33,34 to assess whether the symptom severity scores changed between visits. A modified mixed effects Poisson models with random intercepts for participants will be used to estimate the relative risks (RR) for each binary outcome with 95%CI.35 These models accounted for positive correlation in the repeated outcomes from the same participant and use the information sandwich estimator to obtain variance estimates. These estimates are considered robust to the error misspecification, take account of any heteroskedasticity and have been found to be preferable for unbiased estimates of risk ratios.36 Mixed effects regression has been shown to produce robust findings even when imbalance in the data (e.g. loss to follow-up) is present, supporting the use of this model for this study. Time will be treated as a categorical variable (7 days and 14 days) in the models and potentially confounding variables where a demonstrated association (p < 0.1) is found with the exposure variable will be included in the models. Postestimation average proportions of the presence/absence of concussion over the two time points will be generated using the delta-method to calculate the standard errors of predictions and 95%CIs and graphed.34

8.2.3 Telehealth
We will report on the challenges and the length of the telehealth consults in a descriptive narrative way.
On day 30, we will assess the usability of the telehealth program using the Telehealth Usability Questionnaire as modified by Shore et al.37

8.2.4 Satisfaction
On day 30 we will assess the participant satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8).37,38

8.2.6 Missing data
Missingness of data will be examined using Little’s chi-square test. If data are missing completely at random, complete case analysis will be used. If data are missing at random, i.e., missingness is not completely random but can be fully accounted for by other variables, the associated variables will be included in all analyses. If data are missing not at random, i.e., missingness is systematically related to the unobserved data, sensitivity analyses will be performed to see how sensitive the results are under different scenarios.

8.2.7 Statistics
A p-value of <0.05 will be deemed as statistically significant. We will use Stata version 17 (Statacorp, College Station, TX) for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/05/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23893 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39375 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313087 0
Government body
Name [1] 313087 0
Medical Research Future Fund (MRFF) MRFF 2021 Traumatic Brain Injury Grant Opportunity (APP 2016112)
Country [1] 313087 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 314776 0
Hospital
Name [1] 314776 0
Alfred Health
Address [1] 314776 0
Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004
Country [1] 314776 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312332 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312332 0
Ethics committee country [1] 312332 0
Australia
Date submitted for ethics approval [1] 312332 0
23/03/2023
Approval date [1] 312332 0
11/05/2023
Ethics approval number [1] 312332 0
94074 (Local Reference: Project 128/23 )

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

Contacts
Principal investigator
Name 124286 0
Prof Biswadev Mitra
Address 124286 0
Alfred Health Emergency Services
55 Commerical Road
Melbourne VIC 3004
Country 124286 0
Australia
Phone 124286 0
+61 3 90762782
Fax 124286 0
Email 124286 0
biswadev.mitra@monash.edu
Contact person for public queries
Name 124287 0
Alexander Olaussen
Address 124287 0
Monash University
School of Public Health & Preventive Medicine
Level 3
553 St Kilda Rd
Melbourne VIC 3004, Australia
Country 124287 0
Australia
Phone 124287 0
+61 3 99044544
Fax 124287 0
Email 124287 0
alexander.olaussen@monash.edu
Contact person for scientific queries
Name 124288 0
Biswadev Mitra
Address 124288 0
Monash University
School of Public Health & Preventive Medicine
Level 3
553 St Kilda Rd
Melbourne VIC 3004, Australia
Country 124288 0
Australia
Phone 124288 0
+61 3 90762782
Fax 124288 0
Email 124288 0
biswadev.mitra@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not sought patient consent for the release of their deidentified data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19151Study protocol    INFORMED-V Study protocol 385307-(Uploaded-11-05-2023-22-13-40)-Study-related document.pdf
19152Ethical approval    385307-(Uploaded-11-05-2023-22-14-28)-Study-related document.pdf



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.