Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

NCT ID: NCT04851275

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2020-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Patient Engagement; Patient Preference

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Physicians trained in shared decision making

Intervention Type: BEHAVIORAL

Physicians in this group were trained in shared decision making

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

Group Type: ACTIVE_COMPARATOR

Physicians were not trained in shared decision making

Intervention Type: BEHAVIORAL

Physicians did not receive training in shared decision making

Interventions

Physicians trained in shared decision making

Physicians in this group were trained in shared decision making

Intervention Type: BEHAVIORAL

Physicians were not trained in shared decision making

Physicians did not receive training in shared decision making

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: collaborator

SingHealth Polyclinics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tan Ngiap Chuan, MBBS

Role: STUDY_DIRECTOR

Singhealth polyclinic

Locations

Haidee Ngu

Singapore, , Singapore

Countries

Singapore

References

Tiwari R, Ng MY, Neo SH, Mangat R, Ho H. Prospective validation of a novel visual analogue uroflowmetry score (VAUS) in 1000 men with lower urinary tract symptoms (LUTS). World J Urol. 2020 May;38(5):1267-1273. doi: 10.1007/s00345-019-02909-1. Epub 2019 Aug 27.

Reference Type: BACKGROUND

PMID: 31451932 (View on PubMed)

Other Identifiers

2018/3106

Identifier Type: -

Identifier Source: org_study_id