Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective
时间窗: 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.
Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
时间窗: 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.
次要结局
未报告次要终点