Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

NCT04851275 | Completed

• 1 other identifier: 2018/3106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Engagement; Patient Preference

Outcome Measures

Primary Outcomes (2)

• Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective

  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

  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

Study Arms (2)

Shared decision making for men with lower urinary tract symptoms

EXPERIMENTAL

Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making

Behavioral: Physicians trained in shared decision making

No shared decision making for men with lower urinary tract symptoms

ACTIVE COMPARATOR

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

Behavioral: Physicians were not trained in shared decision making

Interventions

Physicians trained in shared decision making BEHAVIORAL

Physicians in this group were trained in shared decision making

Shared decision making for men with lower urinary tract symptoms

Physicians were not trained in shared decision making BEHAVIORAL

Physicians did not receive training in shared decision making

No shared decision making for men with lower urinary tract symptoms

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SingHealth Polyclinics: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Haidee Ngu

Singapore, 150167, Singapore

Location

Related Publications (1)

• 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.

  PMID: 31451932 BACKGROUND

MeSH Terms

Conditions

Patient Participation; Patient Preference

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Satisfaction

Study Officials

• Tan Ngiap Chuan, MBBS

  Singhealth polyclinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 20, 2021
• Study Start: April 15, 2019
• Primary Completion: November 30, 2019
• Study Completion: March 31, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)