Evaluation of the Effect of Good Pain Management (GPM) Ward Program on Pattern of Care and Patient-Reported Outcomes of Moderate to Severe Cancer Pain Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Pain management index (PMI) assessment
研究概览
简要总结
This study aims to set up a standardized cancer pain ward - known as the Good Pain Management (GPM) Ward with streamlined assessment and management procedures to act as a pain management model. In particular, it will enforce regular pain assessment from and throughout hospital admission, and treatment protocols introducing the use of strong-opioids in moderate cancer pain patients, following National Cancer Care Network (NCCN) Adult Cancer Pain Guidelines. The GPM ward will be compared against current-practice controlled ward.
详细描述
This is a double-arm, randomized, multi-center, current practice-controlled study. Approximately 150 cancer pain patients with collecting questionnaires admitted to an inpatient department from 3 national hospitals: Kaohsiung Medical University Hospital, Kaohsiung Municipal Ta-Tung Hospital and Kaohsiung Municipal HsiaoKang Hospital will be invited into this study. Eligible patients will be randomized to one of the following pain control wards in a 1:1 ratio.
- GPM Ward: Good Pain management ward
- Control Ward: Current practice-controlled ward Surveys, pain level measurements and dosage used will be collected in 48±8 hours. The pain management index (PMI) will be assessed as primary objective. The patient satisfaction, outcome questionnaire (APS-POQ) and SF-36 will be assessed in secondary objectives.
Once patient is admitted to the ward and agrees to participate in the study, the patient will be randomly and blindly assigned to either GPM ward or Control Ward. In the Control Ward, patient will receive the current practice of pain management, with less assessment procedure.
This study will investigate the benefits and effect of good pain control on patient outcomes in hospitalized cancer pain patients. The results aim to demonstrate the viability of GPM ward in daily practices and its measurable impact on the patient outcomes including patient treatment satisfaction as well as quality of life.
- Primary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males aged ≥ 20
- •Understand Chinese/Taiwanese and able to finish the questionnaire
- •Alert enough to respond and understand
- •Hospitalized for ≥ 24 hours
- •Cancer patients with cancer-related pain
排除标准
- •Patient diagnosed with non-cancer pain or unexplained pain
- •Patient with moderate to severe mental disorder
- •Patient receiving operation or invasive procedure within 24 hours before admission
研究组 & 干预措施
GPM Ward
Good Pain management ward
干预措施: Good pain management (GPM) procedure (Other)
Control Ward
Current practice controlled ward
干预措施: Current practice procedure (Other)
结局指标
主要结局
Pain management index (PMI) assessment
时间窗: Up to 56 hours
The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index
次要结局
- Satisfaction of pain control during admission(Up to 56 hours)
- Patient outcome questionnaire (APS-POQ) analysis(Up to 56 hours)
- SF-36 Questionnaire analysis(Up to 24 hours in screening period)