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Tytuł pozycji:

TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

Tytuł:
TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial
Autorzy:
Jessica Frost
J. Athene Lane
Nikki Cotterill
Mandy Fader
Lucy Hackshaw-McGeagh
Hashim Hashim
Margaret Macaulay
Stephanie J. MacNeill
Sian Noble
Jonathan Rees
Matthew J. Ridd
Luke Robles
Gordon Taylor
Jodi Taylor
Marcus J Drake
Jo Worthington
Temat:
TRIUMPH
Lower urinary tract symptoms
Cluster randomised controlled trial
Primary care
International Prostate Symptom Score
Medicine (General)
R5-920
Źródło:
Trials, Vol 20, Iss 1, Pp 1-12 (2019)
Wydawca:
BMC, 2019.
Rok publikacji:
2019
Kolekcja:
LCC:Medicine (General)
Typ dokumentu:
article
Opis pliku:
electronic resource
Język:
English
ISSN:
1745-6215
Relacje:
http://link.springer.com/article/10.1186/s13063-019-3648-1; https://doaj.org/toc/1745-6215
DOI:
10.1186/s13063-019-3648-1
Dostęp URL:
https://doaj.org/article/544c9ac25e0748f7be6ce9ad69aebf96  Link otwiera się w nowym oknie
Numer akcesji:
edsdoj.544c9ac25e0748f7be6ce9ad69aebf96
Czasopismo naukowe
Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their general practitioner (GP) in the first instance, with conservative therapies recommended as the initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods/design TRIUMPH is a two-arm, cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) general practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and healthcare professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient-reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines. Trial registration ISCRTN registry, ID: ISRCTN11669964. Registered on 12 April 2018.
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