Patient EngagementNCT04851275
Increasing Decision Quality for Men With Lower Urinary Tract Symptoms
A study testing Physicians trained in shared decision making and Physicians were not trained in shared decision making in people with Patient Engagement and Patient Preference, run by SingHealth Polyclinics at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Engagement, Patient Preference
- What is being tested?
- Physicians trained in shared decision making and Physicians were not trained in shared decision making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Patient Engagement, Patient Preference
- Being tested
- Physicians trained in shared decision making, Physicians were not trained in shared decision making
- Medical subject headings
- Patient Participation, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physicians trained in shared decision makingBehavioural
Physicians in this group were trained in shared decision making
Physicians were not trained in shared decision makingBehavioural
Physicians did not receive training in shared decision making
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Physicians were not trained in shared decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start15 Apr 2019
- Primary completion30 Nov 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Tan Ngiap Chuan, MBBS, Study director, SingHealth Polyclinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851275
- Sponsor's protocol ID
- 2018/3106
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31451932
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04851275
- Acronym / sponsor ID
- 2018/3106
- Conditions
- Patient Engagement, Patient Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision making for men with lower urinary tract symptoms | Experimental | Behavioral: Physicians trained in shared decision makingParticipants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making |
| No shared decision making for men with lower urinary tract symptoms | Active comparator | Behavioral: Physicians were not trained in shared decision makingParticipants 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- have indwelling catheters
- urinary incontinence requiring diapers
- anuria due to any renal pathology
- gross hematuria
- acute urinary retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physicians trained in shared decision makingPhysicians in this group were trained in shared decision making | Behavioural | Shared decision making for men with lower urinary tract symptoms |
| Physicians were not trained in shared decision makingPhysicians did not receive training in shared decision making | Behavioural | No shared decision making for men with lower urinary tract symptoms |
Primary outcome
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Background: PubMed 31451932Tiwari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tan Ngiap Chuan, MBBS study director
SingHealth Polyclinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physicians trained in shared decision making and Physicians were not trained in shared decision making in people with Patient Engagement and Patient Preference, run by SingHealth Polyclinics at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.