Integrated Case Management for Burns Care in Pakistan
- Conditions
- BurnsDepressionAnxietyUnintentional Burn Injury
- Interventions
- Behavioral: Integrated case manager care
- Registration Number
- NCT06559501
- Lead Sponsor
- Pakistan Institute of Living and Learning
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1146
- 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
No intentional burn injuries
• Lacking capacity to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Integrated case manager care 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.
- Primary Outcome Measures
Name Time Method Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D) Baseline to 12th month post randomization all-cause mortality followed by readmission rates and changes in health-related quality of life
- Secondary Outcome Measures
Name Time Method Burns Specific Health Scale Baseline to 3 months, 6 months and 12-months post-intervention To quantify dysfunction and distress across six major domains of health, specifically burn injury related morbidity
Rosenburg Self-Esteem Scale Baseline to 3 months, 6 months and 12-months post-intervention A 10 item self-report instrument to measure individual self-esteem
Visual Analogue Scale Baseline to 3 months, 6 months and 12-months post-intervention It provides subjective magnitude estimation and consists of a straight line with limits that carry a verbal description of each extreme of the symptom both pain relief or pain severity
International Trauma Questionnaire Baseline to 3 months, 6 months and 12-months post-intervention It is a brief,18 item self-report questionnaire used to assess core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD.
Perceived Stigma Questionnaire Baseline to 3 months, 6 months and 12-months post-intervention It is used to measure stigmatizing behaviors commonly reported by people with appearance distinctions. Participants were asked to rate how often they experienced a behavior on a 5-point Likert scale
WHO disability assessment schedule Baseline to 3 months, 6 months and 12-months post-intervention It is used to measure the impact of health condition, functioning, disability, monitor the effectiveness of interventions as well as the burden of disease both mental and physical disorders
Vancouver Scar Scale Baseline to 3 months, 6 months and 12-months post-intervention It is used to document change in scar appearance. Index measures the scares on four parameters, Pigmentation, vascularity, pliability and heigh
Quality of life scale EQ-5D Baseline to 3 months, 6 months and 12-months post-intervention Health-related quality of life as measured for mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Patient Health Questionnaire (PHQ-9) Baseline to 3 months, 6 months and 12-months post-intervention To screen, diagnose, monitor and measure the severity of depression
Trial Locations
- Locations (12)
Burn Unit, Sandeman Provisional Hospital
🇵🇰Quetta, Baluchistan, Pakistan
Allied Burn and Reconstructive Surgery Centre
🇵🇰Faisalābad, Punjab, Pakistan
Pak Italian Modern Burn and Plastic Surgery Centre
🇵🇰Multān, Punjab, Pakistan
Allied Burn & Reconstructive Surgery Centre
🇵🇰Faisalābad, Pakistan
Plastic Surgery and Burn Unit, BMC, Quetta
🇵🇰Quetta, Balochistan, Pakistan
Burns and Plastic Surgery Center, Peshawar
🇵🇰Peshawar, KPK, Pakistan
Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University
🇵🇰Lahore, Punjab, Pakistan
Jinnah Burn & Reconstructive Surgery Centre, Lahore
🇵🇰Lahore, Punjab, Pakistan
Burn Centre, Civil Hospital Hyderabad
🇵🇰Hyderabad, Sindh, Pakistan
Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
🇵🇰Karachi, Sindh, Pakistan
Burns and Plastic Surgery, Patel Hospital, Karachi
🇵🇰Karachi, Sindh, Pakistan
Burn Care Centre, PIMS, Islamabad
🇵🇰Islamabad, Pakistan