Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unintentional Burn Injury
- Sponsor
- Pakistan Institute of Living and Learning
- Enrollment
- 1146
- Locations
- 11
- Primary Endpoint
- Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •No intentional burn injuries
- •Lacking capacity to provide informed consent
Outcomes
Primary Outcomes
Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
Time Frame: Baseline to 12th month post randomization
all-cause mortality followed by readmission rates and changes in health-related quality of life
Secondary Outcomes
- 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)