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Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

16. april 2021 opdateret af: SingHealth Polyclinics

Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial

In this study, the investigators show that by upskilling of primary care physicians (PCPs) in SDM and leveraging on a novel pictorial Visual Analogue Uroflowmetry Score (VAUS), they can enhance older men's recognition of LUTS and stimulated discussion with their PCPs.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lower urinary tract symptoms (LUTS), often related to prostatomegaly, is common but seldom sought medical attention amongst older men. Visual-aid and shared decision-making (SDM) are potential solutions to address LUTS. The study aimed to determine the effect of a novel pictorial Visual Analogue Uroflowmetry Score (VAUS) and primary care physicians (PCP) SDM training on the decisional quality amongst men selecting their treatment options for LUTS.

This study recruited 60 multi-ethnic Asian men aged ≥50 years with moderate-to-severe LUTS (International Prostate Symptoms Score≥8 and/or QOL≥3) in a Singapore public primary care clinic. Men used the VAUS to report their symptoms. 60 men were randomly assigned to PCPs trained in SDM in the intervention group (n=30) and the other 30 to the control group (PCPs without SDM-training). Patient-physician dyad decision quality was measured using the validated SDMQ-9 (patient) and SDMQ-Doc (physician) questionnaires.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Singapore
      • Singapore, Singapore, 150167
        • Haidee Ngu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease)
  • have moderate-to-severe LUTS and/or poor quality of life (QOL) as assessed by the validated International Prostate Symptom Score (IPSS) of eight or more and/or its individual QOL score of three or more
  • men of any local Asian ethnicity and were willing to provide written consent
  • can communicate with their allocated PCP in either of the three main local languages; English, Mandarin or Malay.

Exclusion Criteria:

  • have indwelling catheters
  • urinary incontinence requiring diapers
  • anuria due to any renal pathology
  • gross hematuria
  • acute urinary retention
  • symptoms consistent with an acute urinary tract infection
  • existing treatment of LUTS or other prostate pathology
  • visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent
  • men unwilling to discuss their LUTS treatment options with their PCP

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Shared decision making for men with lower urinary tract symptoms
Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making
Adfærdsmæssigt: Physicians trained in shared decision making
Physicians in this group were trained in shared decision making
Aktiv komparator: No shared decision making for men with lower urinary tract symptoms
Participants did not use the Visual Analogue Uroflowmetry Score to report their symptoms and received usual care by Primary Care Physicians not trained in shared decision making
Adfærdsmæssigt: Physicians were not trained in shared decision making
Physicians did not receive training in shared decision making

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
Tidsramme: Through study completion, an average of 6 months
The Shared Decision Making-9 (SDMQ9) Questionnaire measures decision quality from the perspective of the patient. Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 ("completely disagree") to 5 ("completely agree"). Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.
Through study completion, an average of 6 months
Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective
Tidsramme: Through study completion, an average of 6 months
The Shared Decision Making-Doctor (SDMQDoc) Questionnaire measures decision quality from the perspective of the physician. Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 ("completely disagree") to 5 ("completely agree"). Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.
Through study completion, an average of 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SingHealth Polyclinics

Samarbejdspartnere

Singapore General Hospital

Efterforskere

  • Studieleder: Tan Ngiap Chuan, MBBS, Singhealth polyclinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2019

Primær færdiggørelse (Faktiske)

30. november 2019

Studieafslutning (Faktiske)

31. marts 2020

Datoer for studieregistrering

Først indsendt

26. marts 2021

Først indsendt, der opfyldte QC-kriterier

16. april 2021

Først opslået (Faktiske)

20. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018/3106

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Patientengagement

Kliniske forsøg med Physicians trained in shared decision making

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Betingelser

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Placeringer

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