Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Sponsor

SingHealth Polyclinics (Other)

Overall Status

Completed

CT.gov ID

NCT04851275

Collaborator

Singapore General Hospital (Other)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Engagement Patient Preference	Behavioral: Physicians trained in shared decision making Behavioral: Physicians were not trained in shared decision making	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: Physicians trained in shared decision making Physicians in this group were trained in shared decision making
Active Comparator: 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	Behavioral: Physicians were not trained in shared decision making Physicians did not receive training in shared decision making

Arm

Intervention/Treatment

Experimental: 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

Behavioral: Physicians trained in shared decision making

Physicians in this group were trained in shared decision making

Active Comparator: 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

Behavioral: Physicians were not trained in shared decision making

Physicians did not receive training in shared decision making

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haidee Ngu	Singapore		Singapore	150167

Sponsors and Collaborators

SingHealth Polyclinics
Singapore General Hospital

Investigators

Study Director: Tan Ngiap Chuan, MBBS, Singhealth polyclinic

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

SingHealth Polyclinics

ClinicalTrials.gov Identifier:

NCT04851275

Other Study ID Numbers:

2018/3106

First Posted:

Apr 20, 2021

Last Update Posted:

Apr 20, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Apr 20, 2021