Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Not Applicable

Completed

• Conditions: Patient Preference; Patient Engagement
• Interventions: Behavioral: Physicians were not trained in shared decision making; Behavioral: Physicians trained in shared decision making

• Registration Number: NCT04851275
• Lead Sponsor: SingHealth Polyclinics

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.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-11-30
• Study Completion: 2020-03-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-16
• Last Update Submitted: 2021-04-16
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No shared decision making for men with lower urinary tract symptoms	Physicians were not trained in shared decision making	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
Shared decision making for men with lower urinary tract symptoms	Physicians trained in shared decision making	Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making

Primary Outcome Measures

Name	Time	Method
Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective	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.
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective	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.

Trial Locations

Locations (1)

Haidee Ngu; 🇸🇬 Singapore, Singapore