Comparison of Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial (PSPVT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
The Purpose of this study is to measure patient satisfaction in standard Post- operative Breast Outpatient clinics versus teleclinics.
Post operative breast surgery patients who volunteer for this study will be randomized into either of the two groups Standard outpatient physical clinics or Telephone clinic and their satisfaction will be measured afterwards using a validated standardized questionnaire by a assessor who will be blind to the type of follow up.
This will be a single blinded randomized controlled trial.
详细描述
The incidence of Breast Cancer is increasing in Pakistan and worldwide. In 2018, 2.1 million new cases were reported, with 627,000 deaths. Pakistan has the highest incidence of breast cancer among Asian countries: one in nine women is at risk of being diagnosed with breast cancer during their lifetime. According to the International Agency of Research on Cancer 2018 report, 34,066 new cases of breast cancer had been reported in Pakistani women. The Outpatient department Clinics are a standard part of routine follow-up for post-operative patients. Conventional Outpatient clinics incur hefty financial costs on patients living in distant areas.
Access to the telephone is increasing worldwide as technology advances and becomes more accessible to patients. Its use in healthcare settings is inevitable. In post-operative setting, remote consultation is feasible as the usual discussion is about the histopathology report of the procedure performed along with referrals for Adjuvant treatment. Nonetheless, there are some hesitations with this type of consultation. For instance, a visit to a physical clinic may help in early detection of potential complications which may be missed in remote consultation. Similarly, patients may not be satisfied with remote consultation alone.
Tele clinics, which became popular in the wake of Coronavirus disease pandemic, have been instrumental in improving healthcare delivery in Breast Surgery patients and this has been demonstrated by multiple studies but the data regarding patient satisfaction is not available in our population and needs to be studied.
Study Design: Randomized Controlled Trial
Setting: Department of surgical oncology, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore.
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
- Single (Outcomes Assessor)
盲法说明
Assessor determining the patient satisfaction will be blinded to the type of follow up. This will be ensured by restricting the information available to accessor to only the name and contact number of the patient. The assessor will therefore have no access to the electronic health record of the patient on HIS and will not be able to determine the type of follow up of the patient.
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
- 否
入选标准
- •Diagnosis of Breast Cancer.
- •Written informed consent for participation in the trial.
排除标准
- •Stage IV Breast Cancer.
- •Chronic Pain.
- •Breast Surgery with reconstruction.
结局指标
主要结局
Patient Satisfaction
时间窗: 3 weeks
Patient satisfaction will be measured using Patient satisfaction questionnaire Short Form (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items tapping each of the seven dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. PSQ-18 is a free to use validated tool developed by RAND Corporation.
次要结局
- Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic(2 weeks)
- Post operative complications(6 weeks)
研究者
Dr. Muhammad Awais Kanwal
Principal Investigator
Shaukat Khanum Memorial Cancer Hospital & Research Centre