ANZCTR - Registration

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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]

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

mental disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Public Health

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]

Early detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [2]

Glenside Campus - Glenside

Recruitment postcode(s) [1]

5011 - Woodville

Recruitment postcode(s) [2]

5065 - Glenside

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Adelaide

Address [1]

Adelaide Nursing School
AHMS Building
4 North Terrace,
Adelaide, SA, 5005

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of South Australia

Address [1]

101 Currie Street, Adelaide, SA, 5001

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Flinders University

Address [2]

Sturt Road
Bedford Park, South Australia, 5042

Country [2]

Australia

Other collaborator category [3]

Other

Name [3]

Youth Mental Health Unit, Southern Adelaide Local Health Network

Address [3]

GP Plus Marion
10 Milham St,
Oaklands Park SA, 5046

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Level 3, Roma Mitchell Building
136 North Terrace, Adelaide, SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/08/2023

Approval date [1]

14/09/2023

Ethics approval number [1]

2022/HRE00311

Ethics committee name [2]

University of Adelaide HREC

Ethics committee address [2]

Research Services
The University of Adelaide
North Terrace, Adelaide, SA, 5005, Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

18/09/2023

Approval date [2]

26/09/2023

Ethics approval number [2]

Application ID: 38185

Summary

Brief summary

Background: The Needs in Recovery Assessment (NiRA) is a newly developed needs assessment tool, designed to identify the needs of people recovering from mental illness. This tool has been evaluated outside of the clinical context for validity and reliability. The aim of this study is to introduce the NiRA into clinical practice and to evaluate the value of the NiRA as an adjunct to service delivery from the perspectives of stakeholders and to evaluate the barriers and facilitators of embedding the NiRA in a mental health service.
Methods:
The implementation of the NiRA in a tertiary mental health unit over a six-month period will be evaluated using a mixed methods approach. Quantitative data will be collected using The Recovery Self-Assessment (RSA) administered to service users and clinicians pre- and post- administration of the NiRA. Face-to-face interviews with service users and clinicians will be conducted following initial completion of the NiRA, with a follow up interview for service users on discharge from the service. Regular informal follow-up with clinicians throughout the study will support the introduction of the NiRA. Descriptive statistics will be used to analyse quantitative data, and descriptive qualitative methods will be used to analyse data from interviews.
Discussion: Aligning mental health services with recovery-oriented frameworks of care is imperative. The NiRA is a tool that has been designed in accordance with recovery principles and may assist services to be more recovery-oriented. If the NiRA is able to achieve the aims and objectives of this project, a larger implementation study will be conducted.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Ellen Davies

Address

Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005

Country

Australia

Phone

+61 420497516

Fax

[email protected]

Contact person for public queries

Name

A/Prof Ellen Davies

Address

Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005

Country

Australia

Phone

+61 420497516

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Ellen Davies

Address

Adelaide Health Simulation, The University of Adelaide, Level 2, AHMS Building.
4 North Terrace, Adelaide, SA, 5005

Country

Australia

Phone

+61 420497516

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
22168	Study protocol	Davies, 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/s40814-021-00919-8	[email protected]		380760-(Uploaded-03-04-2024-15-21-49)-Study-related document.pdf

Results publications and other study-related documents

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2021	https://dx.doi.org/10.1186/s40814-021-00919-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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