Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Patient Engagement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851275
• Other study ID #: 2018/3106
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2021
• Source: SingHealth Polyclinics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Patient Engagement
• Patient Preference

Intervention

Behavioral:
• Physicians trained in shared decision making
Physicians in this group were trained in shared decision making
• Physicians were not trained in shared decision making
Physicians did not receive training in shared decision making

Locations

Country	Name	City	State
Singapore	Haidee Ngu	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
SingHealth Polyclinics	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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