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- Essai clinique NCT07859995
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Professor Joanna C Robson, PhD FRCP
- Numéro de téléphone: +44 117 3427418
- E-mail: Jo.Robson@uwe.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Avril C Rea, MSc, BSc
- Numéro de téléphone: +44 117 3427418
- E-mail: Avril.Rea@uwe.ac.uk
Lieux d'étude
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Bristol, Royaume-Uni
- Focus groups will be held online, no facility will be used
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robson, PhD FRCP, University of the West of England
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PIMS REF 14452364
- Protocol: IIS-NA-2025-0027 (Autre subvention/numéro de financement: Vifor Pharma UK Ltd)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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