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
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 t...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-09-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3648-1 |
| _version_ | 1819232052839448576 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Jessica Frost |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T11:54:44Z |
| format | Article |
| id | doaj.art-544c9ac25e0748f7be6ce9ad69aebf96 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T11:54:44Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-544c9ac25e0748f7be6ce9ad69aebf962022-12-21T17:48:07ZengBMCTrials1745-62152019-09-0120111210.1186/s13063-019-3648-1TReatIng 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 trialJessica Frost0J. Athene Lane1Nikki Cotterill2Mandy Fader3Lucy Hackshaw-McGeagh4Hashim Hashim5Margaret Macaulay6Stephanie J. MacNeill7Sian Noble8Jonathan Rees9Matthew J. Ridd10Luke Robles11Gordon Taylor12Jodi Taylor13Marcus J Drake14Jo Worthington15Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of BristolBristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of BristolBristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead HospitalFaculty of Health Sciences, University of SouthamptonNIHR Bristol Biomedical Research Centre, University of Bristol, Level 3, University Hospitals Bristol Education CentreBristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead HospitalFaculty of Health Sciences, University of SouthamptonBristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of BristolPopulation Health Sciences, Bristol Medical School, University of BristolNHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group, Brockway Medical Centre, Backwell and Nailsea Medical GroupPopulation Health Sciences, Bristol Medical School, University of BristolPopulation Health Sciences, Bristol Medical School, University of BristolPublic and Patient Involvement RepresentativeBristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of BristolTranslational Health Sciences, Bristol Medical School, University of Bristol, Bristol Urological InstituteBristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of BristolAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3648-1TRIUMPHLower urinary tract symptomsCluster randomised controlled trialPrimary careInternational Prostate Symptom Score |
| spellingShingle | 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 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 Trials TRIUMPH Lower urinary tract symptoms Cluster randomised controlled trial Primary care International Prostate Symptom Score |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | TRIUMPH Lower urinary tract symptoms Cluster randomised controlled trial Primary care International Prostate Symptom Score |
| url | http://link.springer.com/article/10.1186/s13063-019-3648-1 |
| work_keys_str_mv | AT jessicafrost treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT jathenelane treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT nikkicotterill treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT mandyfader treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT lucyhackshawmcgeagh treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT hashimhashim treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT margaretmacaulay treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT stephaniejmacneill treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT siannoble treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT jonathanrees treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT matthewjridd treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT lukerobles treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT gordontaylor treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT joditaylor treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT marcusjdrake treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial AT joworthington treatingurinarysymptomsinmeninprimaryhealthcareusingnonpharmacologicalandnonsurgicalinterventionstriumphcomparedwithusualcarestudyprotocolforaclusterrandomisedcontrolledtrial |