ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000278730

Ethics application status

Approved

Date submitted

6/11/2021

Date registered

15/02/2022

Date last updated

15/02/2022

Date data sharing statement initially provided

15/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of Pasifika Intervention on uptake of urate-lowering therapy

Scientific title

Effect of Pasifika Intervention on uptake of urate-lowering therapy in Pasifika individuals with gout

Secondary ID [1]

‘Nil known’

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gout

Gout management - Lower uptake of urate-lowering therapy (allopurinol ) among Pacific

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this study is to develop, design, implement and evaluate a new innovative intervention to improve urate-lowering therapy uptake by Pasifika in South Auckland.

This study is governed by the Pacific research methodology Fa’afaletui which enables an approach that focuses on the importance of considering different perspectives. A co-design approach will be utilised where the participants work together alongside researchers to develop and construct the new intervention. Therefore, although the intervention has not been developed the following phases (phase two and three) will describe the designing, developing, implementation and evaluation of the new innovative intervention.

Phase 2: This phase involves the designing of the intervention and developing the implementation plan. The anticipated overall duration for this phase is 12 months. A stocktake of Aotearoa New Zealand gout programmes, including those not published in the peer-reviewed published literature, and a recent systematic review of interventions to improve the uptake of urate lowering therapy (ULT) undertaken by Masters in Health Leadership student Iqbal Gill will be utilised to provide a user-friendly summary of the types of complex interventions to inform key stakeholders on what has already been tried, and what has been shown to be effective in different contexts.

This information will then be used to develop the study intervention by informing participants/co-researchers about existing ULT interventions and their effectiveness through concise easy-to-understand information-sharing (i.e power point, story boards etc).

A series of workshops (anticipated to be 2 or 3) will be conducted with all members of the Pacific Peoples Health Advisory Group (PPHAG), the Pacific Practice-Based Research Network (PPBRN), Alliance Health Plus (AH+) and other key stakeholders. These workshops are expected to run throughout the day.

• The Pacific People’s Health Advisory Group (PPHAG): This group comprises male and female community members aged in their 20s to their 70s, of mixed Pacific ethnicities (Samoan, Tongan, Niuean) with a range of occupations including nursing student, teacher, social worker, broadcaster and retiree.

• Pacific Practice-Based Research Network (PPBRN): Is comprised of all PBRN research officers (who include general practitioners, nurses, and receptionists depending on the practice) from South Auckland practices in the Network.

• Patients with gout and their families: PPBRN practices will recruit Pacific patients diagnosed with gout, aged 20 years and over, both those successfully using ULT, and those who have been unable to take, or regularly maintain its use. The invitation will also be extended to their extended family members who would like to participate. We will use purposive sampling aiming for diversity of Pacific ethnicities, ages and other key characteristics of these participants.

• Other relevant stakeholders: Invitations to participate will be extended to other relevant stakeholders including community pharmacists, Primary Health Organisation (PHO) personnel, community members and/or others identified during the course of the study.

The workshops will be facilitated by six members from the Pacific Gout research team:
• 1 x Senior Lecturer with experience in Pacific community health, health promotion and community engagement.
• 2x General Practitioners with vast experience in teaching, general practice and Pacific health research.
• 1x Post-doc Research Fellow
• 1x Doctoral student (recently submitted)

Workshops will take place in-person if at all possible, at a venue which best suits the participants. Pacific patients and families will be engaged using appropriate cultural processes and protocols. Talanga (interactive talk with a purpose) will be used to ensure two-way dialogue takes place when communicating with Pacific people. Where relevant, focus groups will be gender-specific, to protect the sacred nature of the ‘va’ (relationship of mutual respect) between male and female.

Participants in the workshops will then brainstorm possible new ways to address the problem, including possible sites where this might occur (eg health centre, pharmacy, church, workplace), and personnel who will lead the intervention (eg nurse, pharmacist, community worker, lay person, GP). Qualitative enquiry using nominal group technique will help guide the discussions to ensure all voices are heard. Although face-to-face workshops are preferred and prioritized for this project, other options such as virtual zoom workshops have been planned and put in place in case of unforeseen circumstances such as general health recommendations during the global pandemic.

Once an intervention has been drafted, PPHAG, PPBRN and researchers will collectively refine it through workshopping and other digital communications with key stakeholders into a strategy that can be implemented in South Auckland. Factors to be addressed in the intervention include what components it entails (eg health promotion, education, prescribing, dispensing, serum urate monitoring, patient reminders, family/whanau involvement), who leads it (eg doctor, nurse, pharmacist, team, community-led), and where it takes place (eg health premises, community location).

Implementation plan
A framework to map the intervention implementation will be developed. A logic model of change (a graphic representation of the relationship between the intervention, mechanisms of change, and behavioural and health outcomes), will be created using an intervention mapping framework. The logic model will define the inputs (resources, investment needed to implement intervention), key activities (tasks needed to successfully implement the intervention), outputs (measures to be made to demonstrate that the activities have been undertaken) and short-term outcomes (changes expected to result).

Phase 3: Intervention implementation and Evaluation
The intervention will then be trialled in South Auckland and tested to see how well it works. It is anticipated to start two months after Phase 2. Precise details of the evaluation will depend on the nature of the novel intervention and its characteristics. The intervention will be evaluated over a nine-month period (up to three three-month prescribing cycles for ULT).

Study approach
This Phase will use an implementation science approach, which is a systematic study of the activities that facilitate the successful uptake of an evidence-based health intervention, in this case a strategy and programme to improve ULT amongst Pasifika with gout in South Auckland. The design of the evaluation of the intervention implementation will be underpinned by a theoretical framework and informed by behavioural change theory, whereby a person’s attitudes, personal or subjective norms and their perceived behaviour controls (not doing what they think is wrong) shape an individual’s behavioural intentions and hence their actual behaviours.

Intervention code [1]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Regular prescriptions of gout specific urate lowering therapy determined by data linkage to medical records.

Timepoint [1]

3 months post-enrolment; 9 months post-intervention

Primary outcome [2]

Serum urate testing results during the evaluation period determined by data linkage to medical records.

Timepoint [2]

3 months post-enrolment; 9 months post-intervention

Primary outcome [3]

Hospitalisations for gout determined by data linkage to medical records.

Timepoint [3]

3 months post-enrolment; 9 months post-intervention

Secondary outcome [1]

Identify acceptability of intervention delivery. This will be collected in the form of survey responses (eg Likert scale, free text or both).

Timepoint [1]