Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,045
- 试验地点
- 22
- 主要终点
- Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
研究概览
简要总结
To test whether a culturally adapted multicomponent intervention for improving burns care and patient/family rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective. The comparator will be usual care plus brief written self-help advice (enhanced usual care). The study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.
详细描述
The Burns trial will be conducted in six cities of Pakistan; Karachi, Hyderabad, Lahore, Rawalpindi, Peshawar and Quetta to compare integrated intervention with enhanced usual care. Participants will be randomized either to the intervention or enhanced usual care. The intervention consists of multiple culturally adapted components such as psychological bundle, emergency care, surgical and rehab bundle to improve care within burn units, transitional care, and patient and family rehabilitation (known as 'Integrated case management for improved psychosocial and physical rehabilitation of burn survivors and their families'). The comparator will be usual care (emergency, surgical and rehab care ) plus brief written self-help booklets will be given(enhanced usual care).
The intervention will be carried out by case managers (trained allied health professionals such as nurses, physiotherapists, psychologists etc) and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care/ medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers.
Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and over
- •Accidental burn injury and meet the criteria for admission to burn centres
- •Clinician judgment for participation readiness
- •Ability to provide informed consent
排除标准
- •No intentional burn injuries
- •Lacking capacity to provide informed consent
研究组 & 干预措施
Integrated case manager care
comprises 8 sessions delivered by case managers. Case managers will provide up to 6 low-intensity sessions in the hospital or the community (if the patient is discharged before completing the required sessions), with content and duration tailored to patient preferences. Post-discharge, patients will receive 2 follow-up sessions with case managers to ensure a smooth transition into the community.
干预措施: Integrated case manager care (Behavioral)
Enhanced care as usual
includes their standard care, and all treatments recommended by attending physicians will be provided, plus a written self-help booklet
结局指标
主要结局
Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
时间窗: Baseline to 12th month post randomization
all-cause mortality followed by readmission rates and changes in health-related quality of life
次要结局
- Patient Health Questionnaire (PHQ-9)(Baseline to 3 months, 6 months and 12-months post-intervention)
- Burns Specific Health Scale(Baseline to 3 months, 6 months and 12-months post-intervention)
- Rosenburg Self-Esteem Scale(Baseline to 3 months, 6 months and 12-months post-intervention)
- Visual Analogue Scale(Baseline to 3 months, 6 months and 12-months post-intervention)
- International Trauma Questionnaire(Baseline to 3 months, 6 months and 12-months post-intervention)
- Perceived Stigma Questionnaire(Baseline to 3 months, 6 months and 12-months post-intervention)
- WHO disability assessment schedule(Baseline to 3 months, 6 months and 12-months post-intervention)
- Vancouver Scar Scale(Baseline to 3 months, 6 months and 12-months post-intervention)
- Quality of life scale EQ-5D(Baseline to 3 months, 6 months and 12-months post-intervention)