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临床试验/NCT03962595
NCT03962595已完成不适用

Assessment Of Patient Satisfaction Of Outpatient Care In The Multi-Disciplinary Breast Clinic- Linguistic Validation Study

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2017年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
1
主要终点
Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi.

研究概览

简要总结

Patient satisfaction is the primary means of assessing the effectiveness of primary health care delivery. It helps in improving the quality of care by identifying and help resolving the potential problem areas. It assesses the effectiveness of the care provided and document the quality to accrediting organisations.In our institute, we have developed a patient satisfaction survey (PSS) questionnaire and have conducted a pilot study (Institutional review board approved) with fifty English speaking breast cancer patients receiving active cancer directed treatment in outpatient clinic, to evaluate the level of patient satisfaction in them. Therefore, we are now conducting a linguistic validation study using Hindi and Marathi PSS questionnaire to assess the overall level of patient satisfaction in a larger cohort of patients with diverse linguistic and economic background attending both general and private Outpatient Clinic.

The aim of the study is to evaluate the overall level of patient satisfaction and their satisfaction at various encounters in the multi-disciplinary Breast Clinic which can be helpful to improve various aspects of patient care delivery.

Methods:

All patients who have already sort primary consultation in surgical, medical and radiation oncology outpatient clinics for their treatment plan and have had their last consultation within the last one month will be screened for the study. The Patient Satisfaction Survey (PSS) questionnaire (in preferred language) will be administered independently by a clinical research student who is not directly involved in patient care. The PSS will be anonymous. It will be administered to patients in the out-patient clinics waiting area. Patients will be asked to complete 3 surveys: one each for surgical, medical and radiation oncology professionals. It will take approximately 12 months to enroll the required number of patients.

Sample size: Previous studies conducted in India and the pilot study conducted at Tata Memorial Hospital (TMH) with the PSS questionnaire have shown that approximately 70% of the patients are satisfied with the health care services. Assuming that the proportion of patients satisfied with the health services, when assessed by Hindi and Marathi PSS questionnaire will be ± 5% of 70%, i.e. between 65% to 75%, a sample size of 340 will be needed to produces a two-sided 95% confidence interval, which is determined by using Confidence Intervals Formula- Clopper-Pearson method.

Potential Impact of the Study

  1. Knowledge of patient satisfaction in breast cancer patients belonging to diverse linguistic and socio-economic background will help in improving the quality of life of patients using appropriate resources and measures relevant to Indian context.
  2. Awareness of patient dissatisfaction will help improve doctor patient relationship.
  3. Awareness of patient dissatisfaction will help to identify problem areas and improve the care delivery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women with histological confirmation of breast cancer.
  • Planned to receive multi-disciplinary curative active cancer directed treatment.
  • Aware of their diagnosis and treatment plan.
  • Willingness to participate in study.
  • Patient able to read and comprehend Hindi and Marathi. -

排除标准

  • Eastern Cooperative Oncology Group 4
  • Unable to read and fill the questionnaire -

结局指标

主要结局

Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi.

时间窗: 1 Year

Scoring: For each of the rated 25 items, a score of 1-5 will be assigned. This gives a maximum score of 125 and a minimum score of 25. A score of 75 or above indicates that patient is satisfied with the care provided. Construct validity for the instrument will be assessed using Pearson's correlation between the items and scales (It-Sc i.e. convergent validity) and between scales (Sc-Sc i.e. discriminant validity). The correlation coefficient should be \>0.4 and \<0.7 for these respectively. Internal consistency (scale reliability) of the multi item questionnaires will be tested by Cronbach alpha coefficient. The internal consistency should be 0.70 or higher when scales are used for group comparisons.

次要结局

  • Proportion of patients having mean overall satisfaction score <70(1 Year)
  • To compare the level of overall patient satisfaction between paid and service patients: percentage of patients having overall score below 75 of the maximum 125(1Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tabassum Wadasadawala

Associate Professor, Radiation Oncology, Breast Services

Tata Memorial Centre

研究点 (1)

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