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Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Primary Purpose

Patient Engagement, Patient Preference

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Physicians trained in shared decision making

Physicians were not trained in shared decision making

About this trial

This is an interventional health services research trial for Patient Engagement

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Haidee Ngu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared decision making for men with lower urinary tract symptoms

No shared decision making for men with lower urinary tract symptoms

Arm Description

Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians 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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04851275

First Posted

March 26, 2021

Last Updated

April 16, 2021

Sponsor

SingHealth Polyclinics

Collaborators

Singapore General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04851275

Brief Title

Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2019 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SingHealth Polyclinics

Collaborators

Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patient Engagement, Patient Preference

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Shared decision making for men with lower urinary tract symptoms

Arm Type

Experimental

Arm Description

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

Arm Title

No shared decision making for men with lower urinary tract symptoms

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Physicians trained in shared decision making

Intervention Description

Physicians in this group were trained in shared decision making

Intervention Type

Behavioral

Intervention Name(s)

Physicians were not trained in shared decision making

Intervention Description

Physicians did not receive training in shared decision making

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Through study completion, an average of 6 months

Title

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

Description

Time Frame

Through study completion, an average of 6 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tan Ngiap Chuan, MBBS

Organizational Affiliation

Singhealth polyclinic

Official's Role

Study Director

Facility Information:

Facility Name

Haidee Ngu

City

Singapore

ZIP/Postal Code

150167

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31451932

Citation

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.

Results Reference

background

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Increasing Decision Quality for Men With Lower Urinary Tract Symptoms

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