Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000868785
Ethics application status
Approved
Date submitted
13/05/2022
Date registered
17/06/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a telephone follow-up intervention on subsequent injuries: a feasibility study
Scientific title
The effect of a telephone follow-up intervention for individuals with musculoskeletal injury on the rate of subsequent injuries: A feasibility study
Secondary ID [1] 307112 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injury 326273 0
Condition category
Condition code
Injuries and Accidents 323580 323580 0 0
Fractures
Injuries and Accidents 323581 323581 0 0
Other injuries and accidents
Musculoskeletal 323806 323806 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve an Injury Liaison Interviewer/Kaiawhina Whara contacting participants by telephone, with REDCap software used in the administration of the study. These calls will include a set of questions designed to ascertain how the person is progressing with their rehabilitation, their current health status (e.g., tinana/physical, hinengaro/mental and emotional, whanau/family, wairua/connectedness), and whether there are resources or services to which the person can be directed for additional help/support. Interviews have been designed specifically for this study but include some questions developed by members of the research team for previous studies (e.g. the Prospective Outcomes of Injury Study), questions from the New Zealand Census (e.g. ethnicity), and the EQ-5D-5L (EuroQol Research Foundation). Positive feedback will be provided to those whose injury outcomes have improved (or not deteriorated) at subsequent interviews. Telephone Follow-Ups (TFUs) are planned to take approximately 15-20 minutes each. The interviewer role will be facilitatory, e.g. they might suggest the person contacts their healthcare professional or the Accident Compensation Corporation (ACC) for additional support as needed, or they may provide contact details for other relevant services such as Healthline or other helplines. The intervention will not be undertaken in a health professional capacity; Injury Liaison Interviewers/Kaiawhina Whara will be laypeople trained in the delivery of the intervention at a ~7 hour training day taken by the research team and through undertaking mock interviews with members of the research team. Written information about available support will also be sent by post to the intervention group shortly after our first TFU. TFUs are intended to be undertaken two weeks post-injury, then again at 1, 3, and 6 months post-injury. At the conclusion of the last TFU, we will ask brief questions about the timing and number of TFU’s.
Intervention code [1] 323575 0
Prevention
Intervention code [2] 323576 0
Rehabilitation
Comparator / control treatment
The control group will answer a smaller number of questions at the initial TFU and again in a TFU at 6 months post-injury, These will be a subset of the intervention group interviews that will not include, for example, aspects that are helping their recovery, reflection back of improvement/non-deterioration, or suggestions to contact support services (although all participants will be advised to contact their healthcare provider or ACC at the final 6-month TFU). Interviews have been designed specifically for this study but include some questions developed by members of the research team for previous studies (e.g. the Prospective Outcomes of Injury Study), questions from the New Zealand Census (e.g. ethnicity, and the EQ-5D-5L (EuroQol Research Foundation). Following the first TFU, the control group will be sent (by post) the same written information about available support services that is provided to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 331367 0
Feasibility measure: How soon post-injury can we recruit potential participants?
Assessed through quantitative descriptive analysis to determine the average number of days between injury and recruitment/first TFU (i.e. receipt of participant consent) assessed by audit of the study database.
Timepoint [1] 331367 0
At the conclusion of participant recruitment
Primary outcome [2] 331368 0
Feasibility measure: How long will it take to recruit the necessary number of Maori participants?
Assessed by determining the number of days taken to achieve the target sample size of Maori participants assessed by audit of study database and the rate of unsuccessful contact at recruitment/first TFU.
Timepoint [2] 331368 0
At the conclusion of participant recruitment
Primary outcome [3] 331369 0
Feasibility measure: What is the best timing and number of TFUs (and what is possible)?
Assessed through audit of the study database to determine the number of TFUs completed in the six months following recruitment, the average number of days to complete a phase of TFUs (i.e. for the planned 2 weeks, 1, 3 and 6 months TFUs the average number of days will be determined), and the rate of unsuccessful contact at recruitment/first TFU and each subsequent TFU. Also assessed through one-on-one, audio-recorded telephone interviews which will be semi-structured using a study-specific questionnaire.
Timepoint [3] 331369 0
Following completion of the final qualitative interview with intervention group participants undertaken after their 6-month post-injury TFU had been completed.
Secondary outcome [1] 409615 0
Feasibility measure: Is the nature and content of the TFU acceptable and appropriate to Maori participants?
Assessed through one-on-one, audio-recorded telephone/video-conference interviews with intervention group participants which will be semi-structured using a study-specific questionnaire.
Timepoint [1] 409615 0
Following completion of the final qualitative interview with intervention group participants undertaken after their 6-month post-injury TFU had been completed
Secondary outcome [2] 409616 0
Feasibility measure: Is the training programme adequate and delivery of the intervention acceptable to interviewers?
Assessed through one-on-one, audio-recorded telephone interviews which will be semi-structured using a study-specific questionnaire.
Timepoint [2] 409616 0
Following a qualitative interview with each of the Injury Liaison Interviewers/Kaiawhina Whara at the conclusion of the study, after all 6-month TFUs have been completed.
Secondary outcome [3] 410360 0
Primary Outcome: Feasibility measure: How long will it take to recruit the necessary number of non-Maori participants?
Assessed by determining the number of days taken to achieve the target sample size of non-Maori participants assessed by audit of study database and the rate of unsuccessful contact at recruitment/first TFU.
Timepoint [3] 410360 0
At the conclusion of participant recruitment
Secondary outcome [4] 410361 0
Feasibility measure: Is the nature and content of the TFU acceptable and appropriate to non-Maori participants?
Assessed through one-on-one, audio-recorded telephone/video-conference interviews with intervention group participants which will be semi-structured using a study-specific questionnaire.
Timepoint [4] 410361 0
Following completion of the final qualitative interview with intervention group participants undertaken after their 6-month post-injury TFU has been completed.
Secondary outcome [5] 410362 0
Feasibility measure: Is the nature and content of the TFU acceptable and appropriate to interviewers?
Assessed through one-on-one, audio-recorded telephone/video-conference/face-to-face interviews which will be semi-structured using a study-specific questionnaire.
Timepoint [5] 410362 0
Following the final qualitative interview with interviewers undertaken after the final 6m TFU has been completed

Eligibility
Key inclusion criteria
People aged 18 years or over from throughout NZ, newly entered on ACC’s entitlement claims register having sustained a musculoskeletal injury and had their claim accepted will be eligible to participate in the study.

Inclusion criteria for Injury Liaison Interviewers/Kaiawhina Whara: must have been employed as an Injury Liaison Interviewer/Kaiawhina Whara on the study. Interviewers were required to have excellent communication, organisational and time management skills, and the ability to maintain participant confidentiality. It was preferred (but not essential) that they had experience in health-related research, undertaking research interviews and using REDCap software, and had an understanding of injury and/or rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those aged less than 18 years, those who are unable to participate in a telephone interview and those who do not speak English will be excluded from this feasibility study as will those whose claim is categorised as a ‘sensitive claim’ with ACC.

Exclusion criteria for Injury Liaison Interviewers/Kaiawhina Whara: not applicable

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)
Randomisation will be carried out using the REDCap Randomisation Module following participant's giving their consent to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation); randomisation will be stratified by ethnicity (Maori and non-Maori).
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
Sample size: In this feasibility study we aim to recruit 20 Maori and 20 non-Maori participants. This means there will be approximately 10 Maori and 10 non-Maori in the intervention group and 10 Maori and 10 non-Maori in the control group.
Quantitative descriptive analyses will be undertaken to determine the: 1) average number of days between injury and recruitment/first TFU (i.e. receipt of participant consent), 2) number of TFUs completed in the six months following recruitment, 3) average number of days to complete a phase of TFUs (i.e. for the planned 2 weeks, 1, 3 and 6 months TFUs the average number of days will be determined), and 4) rate of unsuccessful contact at recruitment/first TFU and each subsequent TFU.

Qualitative analysis of interviews undertaken after the final TFU with participants and Injury Liaison Interviewers/Kaiawhina Whara will be audio-coded using NVivo software and thematic analysis undertaken.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2022
Actual
20/02/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
14/06/2023
Date of last data collection
Anticipated
31/01/2024
Actual
14/12/2023
Sample size
Target
42
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 24762 0
New Zealand
State/province [1] 24762 0

Funding & Sponsors
Funding source category [1] 311418 0
Government body
Name [1] 311418 0
Health Research Council of New Zealand
Country [1] 311418 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Harcombe
Address
Injury Prevention Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 312809 0
None
Name [1] 312809 0
Address [1] 312809 0
Country [1] 312809 0
Other collaborator category [1] 282295 0
Individual
Name [1] 282295 0
Professor Sarah Derrett
Address [1] 282295 0
Ngai Tahu Maori Health Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [1] 282295 0
New Zealand
Other collaborator category [2] 282296 0
Individual
Name [2] 282296 0
Associate Professor Emma Wyeth
Address [2] 282296 0
Ngai Tahu Maori Health Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [2] 282296 0
New Zealand
Other collaborator category [3] 282297 0
Individual
Name [3] 282297 0
Dr Brett Maclennan
Address [3] 282297 0
Ngai Tahu Maori Health Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [3] 282297 0
New Zealand
Other collaborator category [4] 282298 0
Individual
Name [4] 282298 0
Dave Barson
Address [4] 282298 0
Injury Prevention Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [4] 282298 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310896 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310896 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310896 0
New Zealand
Date submitted for ethics approval [1] 310896 0
24/03/2022
Approval date [1] 310896 0
31/05/2022
Ethics approval number [1] 310896 0

Summary
Brief summary
This study will examine feasibility aspects of a proposed larger randomised controlled trial involving a series of telephone follow-ups (TFUs) to people who have had a musculoskeletal injury with the aim of reducing subsequent injuries and improving outcomes. An Injury Liaison Interviewer/Kaiawhina Whara will contact participants by telephone during the six months following a musculoskeletal injury involving an ACC entitlement claim. These calls will include a set of questions designed to ascertain how the person is progressing with their rehabilitation, their current health status, and whether there are resources or services to which the person can be directed for additional help/support. The interviewer role will be facilitatory, e.g. they might suggest the person contacts their healthcare professional or ACC for additional support as needed. This feasibility study will examine aspects of the recruitment process and the timing, nature and content of the TFUs to inform the development of a future large randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119270 0
Dr Helen Harcombe
Address 119270 0
Injury Prevention Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 119270 0
New Zealand
Phone 119270 0
+64 3 479 9092
Fax 119270 0
Email 119270 0
[email protected]
Contact person for public queries
Name 119271 0
Helen Harcombe
Address 119271 0
Injury Prevention Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 119271 0
New Zealand
Phone 119271 0
+64 3 479 9092
Fax 119271 0
Email 119271 0
[email protected]
Contact person for scientific queries
Name 119272 0
Helen Harcombe
Address 119272 0
Injury Prevention Research Unit
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 119272 0
New Zealand
Phone 119272 0
+64 3 479 9092
Fax 119272 0
Email 119272 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


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.