Qualitative Study With Focus Groups of People Living With ANCA-associated Vasculitis (AAV) and Clinicians, to Explore Different Perspectives on Shared Decision-making in AAV. (PACT-AAV)
PACT-AAV Patients and Clinicians Together Shared Decision Making in ANCA Associated Vasculitis
This research aims to underpin qualitative work with people living with a diagnosis of AAV and healthcare professionals working with people living with AAV, to explore different perspectives on Shared Decision Making (SDM) in AAV. The aim is to develop key principles to consider in the future development of shared decision-making tools and interventions for use in clinical practice.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Detailní popis
The ANCA- associated vasculitides (AAVs) are multi-system autoimmune disorders characterised by inflammation of the small blood vessels. This collective term encompasses granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). People living with AAV can have organ and life-threatening disease, and live with a range of impacts on their health-related quality of life. Patients can be cared for across different medical specialities, e.g. nephrology and rheumatology departments. The National UK and Ireland Vasculitis Registry and the patient charities Vasculitis UK, Vasculitis Ireland Awareness and the UK Kidney Association have identified support for patients to help them manage and live well with their diseases as of key importance to people with AAV.
According to NICE, shared decision-making (SDM) should be adopted as an integral part across all healthcare settings for the day-to-day care of patients. It encourages healthcare professionals (HCPs) and people living with AAV to work together in making decisions about their treatment and care. The guidelines produced by NICE, are for HCPs and individuals accessing healthcare services. It includes training recommendations, how to communicate treatment benefits, risks and consequences and includes tools such as patient decisions aids. By embedding SDM into organisational culture and practices, people are empowered to make informed choices about their health based on their personal values and beliefs. SDM should be adopted for both immediate care decisions and those for the future and by empowering a patient with this knowledge, they can make considered decisions about what care they feel is right for them.
The recent EULAR recommendations for management of AAV highlight that SDM should be a key element of care, but at present this has not been implemented in any systematic way. The Outcome Measures in Rheumatology (OMERACT) SDM working group have developed and are trialling a core outcome set of SDM interventions for musculoskeletal and rheumatology health. Working on the basis that clinical trials must measure not only disease specific outcomes but also those of the intervention, OMERACT identified six outcome domains to be evaluated for their effectiveness and safety when used as SDM interventions within rheumatology. These are 1. knowledge of options, 2. alignment of chosen options with values, 3. confidence in the chosen options, 4. satisfaction with the decision-making process, 5. adherence to the chosen option and 6. potential negative consequences.
Recent research has evidenced that poor social determinants of health can impact patients with AAV which contribute as barriers to accessing healthcare. Those from lower socio-economic status can often struggle to attend appointments, which can lead to greater risk of flare-ups and emergency department visits. Regular attendance at specialist healthcare appointments can improve long-term adherence to medication, supporting improvement towards remission and preventing relapses. In AAV, SDM could mean people are supported to understand the care, treatment and support options available, whilst being educated on the risks, benefits and consequences of those options. This information sharing aims to support patients to make an informed decision about a preferred course of action, using evidence-based, good-quality information and their personal preferences. This is one of the aspects we will explore within these focus groups.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Professor Joanna C Robson, PhD FRCP
- Telefonní číslo: +44 117 3427418
- E-mail: Jo.Robson@uwe.ac.uk
Studijní záloha kontaktů
- Jméno: Avril C Rea, MSc, BSc
- Telefonní číslo: +44 117 3427418
- E-mail: Avril.Rea@uwe.ac.uk
Studijní místa
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Bristol, Spojené království
- Focus groups will be held online, no facility will be used
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
People living with AAV will be purposively sampled to include a spectrum of participants with a range of different diseases, stages and demographics (age, gender, geographical location).
Healthcare professionals (HCPs) will be purposively sampled to include a range of different specialities/roles, experience and geographical locations.
Popis
People living with ANCA-associated vasculitis focus groups:
Inclusion Criteria:
- People who have a diagnosis of ANCA- associated vasculitides (AAVs)
- Aged 18 years or older.
- People should have capacity to give informed consent.
- People should have a good understanding of spoken and written English to be able to understand the participant information sheets, and consent forms.
- People who live within the UK or Ireland.
Exclusion Criteria:
- People who do not have ANCA-associated vasculitis
- People less than 18 years of age
- People without capacity to give informed consent
- People who are not able to take part in the focus group in English
- People who live outside the UK or Ireland
- Members of the steering committee
Healthcare Professionals (HCPs) focus groups:
Inclusion Criteria:
- HCPs can include doctors, specialist nurses, physiotherapists, occupational therapists, psychologists, and pharmacists.
- HCPs who work with patients with AAV.
- HCPs working in the UK or Ireland.
Exclusion Criteria:
- HCPs who do not work with people with AAV
- HCPs who work outside of the UK or Ireland
- Member of the steering committee
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Počet skupin / kohort
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
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Patient focus group
Adults aged 18 years and over who are living with ANCA associated Vasculitis. There will be six patient focus groups be split into two. The first three groups will be asked to think-through and discuss any experience they had of SDM throughout diagnosis and starting treatment. The second three groups will be asked to think -through and discuss any experience they had of SDM during the process of maintenance, managing flares and stopping treatment. |
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Clinician focus group
There will be two online clinician focus groups. The clinicians will be recruited from a wider range of healthcare professionals (HCPs). These will include doctors, specialist nurses, physiotherapists, occupational therapists, psychologists, and pharmacists. These HCPs will be asked for their perspectives on key principles of shared decision making in ANCA associated vasculitis. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis.
Časové okno: Each participant will take part in one focus group
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This is a qualitative focus group study with patients living with ANCA-associated vasculitis and their clinicians. No specific quantitative outcome measures will be collected as part of the focus groups. Thematic analysis and Framework analysis will be used to determine themes of importance in relation to optimal shared decision making in terms of timing, disease duration, stage of treatment (induction, remission, maintenance, flare), who should take part in SDM and useful resources or education materials. |
Each participant will take part in one focus group
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Robson, PhD FRCP, University of the West of England
Publikace a užitečné odkazy
Obecné publikace
- Morrison T, Foster E, Dougherty J, Barton J. Shared decision making in rheumatology: A scoping review. Semin Arthritis Rheum. 2022 Oct;56:152041. doi: 10.1016/j.semarthrit.2022.152041. Epub 2022 Jun 3.
- Junek M, Choi S, Qi Y, Al-Magooshi ASA, Guyatt G, Thabane L, Mendel A, Khalidi N, Walsh M. Values, preferences, and informational needs of individuals living with ANCA-associated vasculitis: a systematic review. Rheumatol Adv Pract. 2026 Jun 12;10(3):rkag057. doi: 10.1093/rap/rkag057. eCollection 2026.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- PIMS REF 14452364
- Protocol: IIS-NA-2025-0027 (Jiné číslo grantu/financování: Vifor Pharma UK Ltd)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The anonymised dataset may be used for secondary analysis, and this will be included in the wording of all relevant patient documentation to reflect the potential future use of these data in research.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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