A Randomized Cross-over Clinical Trial to Evaluate the Use of Oral Health-Related Quality of Life in Dental Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- 9-item Consultation Satisfaction Questionnaire (CSQ) will be used in this study.
研究概览
简要总结
The aim of this study is to determine whether by incorporating an Oral Health-Related Quality of Life (OHRQoL) measure in dental practice will improve patient-dentist communication and enhance patient's satisfaction. The objectives of this study are: (i) To determine the measurement equivalence of Computer Touch Screen Assessment (CTSA) and Paper Based Assessment (PBA) of the Oral Health Impact Profile (OHIP-14). (ii) To evaluate and compare how useful a standardized OHRQoL assessment improves patient-dentist communication with regards to number of relevant OHRQoL issues addressed and percentage of most frequently items discussed between the intervention and control groups, assess the patient's active participation between the intervention and control groups and enhances patient's satisfaction between the intervention and control groups.
详细描述
The Oral Health Division of the Ministry of Health in Malaysia recognizes that customer centered/ patient-centered care (PCC) is of key importance in providing quality oral health care to the population. This paradigm shift in health care to 'patients' rather than 'providers' in determining health needs and service outcomes requires a more holistic approach relying on active patient involvement. This in turn has led to the development and use of patient-centred health status measures - termed 'health-related quality of life' [HRQoL] within medicine. These HRQoL have proved effective in understanding patients' health needs, ability to cope with illnesses, compliance with treatment and ultimately the overall success of care, thus ensuring PCC. In dentistry, considerable advances have been made in developing valid and reliable HRQoL for oral health [OHRQoL] . The most widely used and sophisticated measures being the Oral health Impact Profile which has been adapted for use and validated in Malaysia. The challenge now is to determine how effective such a measure is in attaining the goal of PCC for dentistry in Malaysia.
Method. This study id divided into two phase; phase 1 & phase 2.
Phase 1; Testing the measurement equivalence of 'Touch-screen' versus 'Paper-based' assessments of OHRQoL:
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Study design: This study is a randomized crossover study design.
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Study Area: Selangor
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Sample and Sampling method:
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The participants from the residential colleges at a university campus will be randomly assigned through block randomization in groups of four (ABBA) into two arms of the trial:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and older with presenting complaint of oral pain are eligible to participate in this study.
排除标准
- •Patients who are illiterate.
结局指标
主要结局
9-item Consultation Satisfaction Questionnaire (CSQ) will be used in this study.
时间窗: 1 day ( after dental consultation)
The CSQ-9 looks at 4 different areas of satisfaction; general satisfaction (2 questions), professional care (4 questions), depth of relationship (2 questions) and perceived time (1 questions).
The patient's participation between the intervention and control groups
时间窗: 1 day ( after dental consultation)
Patient's participation will be measured by determining the length of time patient speaks to the dentist. Estimated duration will be made based on the audiotape.
The number or percentage of relevant OHRQoL issues addressed
时间窗: 1 day ( after dental consultation)
For each consultation, score will be given based on the number of problems discussed. The composite score can range from 0-14; where 0 no issue discussed and 14 all issues discussed.
次要结局
未报告次要终点
研究者
Roslan Saub
Associate Professor
University of Malaya