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Trial registered on ANZCTR


Registration number
ACTRN12621000316808
Ethics application status
Approved
Date submitted
10/12/2020
Date registered
22/03/2021
Date last updated
12/04/2024
Date data sharing statement initially provided
22/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: a pilot study in a metropolitan tertiary mental health service.
Scientific title
Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: a pilot study investigating the the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service
Secondary ID [1] 302840 0
Nil known
Universal Trial Number (UTN)
U1111-1261-5234
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental illness
 319428 0
mental disorder 320389 0
Condition category
Condition code
Mental Health 317397 317397 0 0
Other mental health disorders
Public Health 318295 318295 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Needs in Recovery Assessment (NiRA) is a valid and reliable assessment tool designed to facilitate a discussion between mental health service users and mental health clinicians about a broad array of needs. It can be used in its paper-based form (NiRA) or as an electronic form (eNiRA).
The NiRA/eNiRA includes three sections: Sections 1 and 2 are completed in an initial appointment and Section 3 is completed in a follow-up appointment that should be conducted 1-2 weeks after the initial assessment.
Section 1 is presented in six sections. Each section is dedicated to a category of need (i.e. practical needs; daily activity needs; physical health needs; informational needs; emotional & psychological needs and relationship needs). Within these categories are a list of items of need that can be rated on a scale of 1 (no need) and 5 (urgent need).
Section 2 of the NiRA/eNiRA is used to prioritise the unmet needs that have been identified in Section 1. In this section, the service user and clinician are tasked with discussing an approach for meeting the need, identifying obstacles and barriers to meeting that need as well as planning the involvement of other individuals and/or organisations who may be able to assist.
Section 3 is designed to facilitate a follow-up appointment where the progress towards meeting needs is discussed and where any further assistance required to meet needs can be arranged.

The process for mental health service user participants will involve participating in face-to-face discussions with mental health clinicians. Clinicians, including Psychiatrists, Psychologist, Mental Health Nurses, Occupational Therapists and Social Workers who work in a multi-disciplinary mental heatlh team will be responsible for initiating an assessment using the NiRA. Mental health service users will be invited to participate in a discussion about their needs that will be guided by the questions on the NiRA. In the first appointment, Sections 1 and 2 will be completed. A service user will be able to attend follow-up discussions relating to their needs as required, and would be able to return to all applicable sections of the NiRA throughout the time they are admitted under the mental health team.
For mental health clinician participants, involvement will include reading a brief training package (expected time commitment of one hour) and undertaking one in-person training session that will last one hour. This training session will provide information about the NiRA and allow clinicians to explore the tool, practice using the tool and ask questions about the tool. Mental health clinicians will be tasked with using the NiRA to facilitate discussions about unmet needs with mental health service users who are admitted to the service. Clinicians will be required to explain the NiRA to service users and to document responses.
Participating in a discussion with clinicians about unmet needs using the NiRA will not be compulsory for service users who are admitted to the unit, but we will be encouraging clinicians to invite all service users to do so. The aim will be to recruit 80% of the service user cohort to participate and complete two assessment interviews where the NiRA is used.

The number of times that the NiRA will be used with each service user is anticipated to vary significantly based on length of admission to the unit, the type and severity of needs that are being experienced and the engagement of the service user with the service. We would be asking clinicians to use the tool a minimum of two times with service users so that both Sections 1 and 2 can be completed and to ensure appropriate follow-up regarding needs is undertaken.
Intervention code [1] 319119 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325987 0
Primary outcome (composite): 1. Type, volume, severity and prioritisation of needs that are reported by service users

Data collected from the NiRA and eNiRA forms and from face-to-face interviews will be collated and analysed (descriptive statistical analysis and descriptive qualitative analysis).
Timepoint [1] 325987 0
Data relating to the type, volume, severity and prioritisation of needs will be collected at the time the NiRA and eNiRA is completed (baseline) and at the follow-up appointment 1-2 weeks post initial assessment with NiRA/eNiRA. Further data collection using the NiRA/eNiRA may occur after these initial two assessments depending on the service users' needs, length of admission and desire to participate in ongoing needs assessments. Data collection may occur for a maximum of six months.

Data from face-to-face interviews with service users will be collected 2-4 weeks after their initial assessment with the NiRA/eNiRA and then at monthly intervals for up to 3 months.
Secondary outcome [1] 389782 0
Perceived barriers and facilitators for introducing the NiRA into clinical practice (composite outcome)

Data from interviews with service users and clinicians and from researcher observation notes will be collated and analysed (descriptive qualitative analysis).
Timepoint [1] 389782 0
Data from face-to-face interviews with service users will be collected 2-4 weeks after their initial assessment with the NiRA/eNiRA and then at monthly intervals for up to 3 months.

Data from face-to-face interviews with clinicians will be collected in the fourth and fifth months of the trial period.
Secondary outcome [2] 389783 0
Perceptions of mental health service users and clinicians regarding the service’s capacity to deliver recovery-oriented care prior to and after the introduction of the NiRA

Data from the Recovery Self Assessment (RSA) questionnaires and from interviews with service users and clinicians will be collated and analysed (descriptive statistical analysis and descriptive qualitative analysis)
Timepoint [2] 389783 0
Data regarding the perceptions of mental health service users and clinicians regarding the service's capacity to deliver recovery-oriented care prior to the introduction of the NiRA will be collected in the month before the NiRA and eNiRA are introduced by clinicians into practice.
Data regarding the perceptions of mental health service users and clinicians regarding the service's capacity to deliver recovery oriented care after the introduction of the NiRA will be collected when the tool has been in use in the service for 6 months.
Secondary outcome [3] 390849 0
Service users’ perception of empowerment and satisfaction relating to how needs are assessed

Data from interviews with service users will be collated and analysed (descriptive qualitative analysis)
Timepoint [3] 390849 0
Data from face-to-face interviews with service users will be collected 2-4 weeks after their initial assessment with the NiRA/eNiRA and then at monthly intervals for up to 3 months.
Secondary outcome [4] 390850 0
Appropriateness of referrals made by clinicians for service users when needs are identified

Data from NiRA and eNiRA forms will be analysed to determine whether the types of need that have been identified in the assessment have been appropriately addressed though referrals to other specialists or organisations. This will involve the clinical expertise of members of the research team.

Data from the interviews with service users may also be used to address this.
Timepoint [4] 390850 0
Data relating to the appropriateness of referrals will be collected at the time the NiRA and eNiRA is completed (baseline) and at the follow-up appointment 1-2 weeks post initial assessment with NiRA/eNiRA. Further data collection using the NiRA/eNiRA may occur after these initial two assessments depending on the service users' needs, length of admission and desire to participate in ongoing needs assessments. Data collection may occur for a maximum of six months.

Eligibility
Key inclusion criteria
For Service Users:
1. Service user of the participating mental health service at time of recruitment
2. 16 years of age or older
3. Considered by a senior member of the mental health team to be recovering from an episode of mental illness
4. Considered by a senior member of the mental health team to have the capacity to consent to participating in the study

For mental health clinicians:
1. Any clinical member of the mental health team in the participating service
2. Signed consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For service users:
1. Currently under a Community Treatment Order, forensic orders or Department of Child Protection intervention order
2. Diagnosis of intellectual disability or history of a significant brain injury

For clinicians:
1. Clinicians who are also members of the research team

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Descriptive statistics will be used to analyse the responses from questionnaires and from the collated NiRA forms. Analysis of RSA questionnaires will be weighted in accordance with the author’s recommendations (O'Connell et al., 2005). Qualitative descriptive analysis of data from face-to-face interviews with service users and clinicians will be undertaken using the methodological approaches and principles outlined by Milne and Orbele (2005) and Sandelowski (2000).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
8/01/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26395 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 26396 0
Glenside Campus - Glenside
Recruitment postcode(s) [1] 42372 0
5011 - Woodville
Recruitment postcode(s) [2] 42373 0
5065 - Glenside

Funding & Sponsors
Funding source category [1] 306987 0
University
Name [1] 306987 0
The University of Adelaide
Country [1] 306987 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Adelaide Nursing School
AHMS Building
4 North Terrace,
Adelaide, SA, 5005
Country
Australia
Secondary sponsor category [1] 308072 0
None
Name [1] 308072 0
Address [1] 308072 0
Country [1] 308072 0
Other collaborator category [1] 281567 0
University
Name [1] 281567 0
The University of South Australia
Address [1] 281567 0
101 Currie Street, Adelaide, SA, 5001
Country [1] 281567 0
Australia
Other collaborator category [2] 281568 0
University
Name [2] 281568 0
Flinders University
Address [2] 281568 0
Sturt Road
Bedford Park, South Australia, 5042
Country [2] 281568 0
Australia
Other collaborator category [3] 281569 0
Other
Name [3] 281569 0
Youth Mental Health Unit, Southern Adelaide Local Health Network
Address [3] 281569 0
GP Plus Marion
10 Milham St,
Oaklands Park SA, 5046
Country [3] 281569 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315106 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 315106 0
Ethics committee country [1] 315106 0
Australia
Date submitted for ethics approval [1] 315106 0
07/08/2023
Approval date [1] 315106 0
14/09/2023
Ethics approval number [1] 315106 0
2022/HRE00311
Ethics committee name [2] 315107 0
University of Adelaide HREC
Ethics committee address [2] 315107 0
Ethics committee country [2] 315107 0
Australia
Date submitted for ethics approval [2] 315107 0
18/09/2023
Approval date [2] 315107 0
26/09/2023
Ethics approval number [2] 315107 0
Application ID: 38185

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

Contacts
Principal investigator
Name 106098 0
A/Prof Ellen Davies
Address 106098 0
Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005
Country 106098 0
Australia
Phone 106098 0
+61 420497516
Fax 106098 0
Email 106098 0
ellen.davies@adelaide.edu.au
Contact person for public queries
Name 106099 0
Ellen Davies
Address 106099 0
Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005
Country 106099 0
Australia
Phone 106099 0
+61 420497516
Fax 106099 0
Email 106099 0
ellen.davies@adelaide.edu.au
Contact person for scientific queries
Name 106100 0
Ellen Davies
Address 106100 0
Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005
Country 106100 0
Australia
Phone 106100 0
+61 420497516
Fax 106100 0
Email 106100 0
ellen.davies@adelaide.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
Confidential medical and social data is being collected for this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22168Study protocolDavies, E. L., Gordon, A. L., Hooper, K. J., Laing, R. E., Lynch, E. A., Pelentsov, L. J., ... & Harvey, G. (2021). Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service. Pilot and Feasibility Studies, 7(1), NA-NA.https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00919-8ellen.davies@adelaide.edu.au 380760-(Uploaded-03-04-2024-15-21-49)-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
SourceTitleYear of PublicationDOI
EmbaseIntroducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service.2021https://dx.doi.org/10.1186/s40814-021-00919-8
N.B. These documents automatically identified may not have been verified by the study sponsor.