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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
1,045
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.
Burn Unit, Sandeman Provisional Hospital
Quetta, Balochistan, 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 Province, Pakistan
Jinnah Burn & Reconstructive Surgery Centre, Lahore
Lahore, Punjab Province, Pakistan
Pak Italian Modern Burn and Plastic Surgery Centre
Multan Khurd, Punjab Province, Pakistan
Burn Centre, Civil Hospital Hyderabad
Hyderābād, Sindh, Pakistan
Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
Karachi, Sindh, Pakistan
Burns and Plastic Surgery, Patel Hospital, Karachi
Karachi, Sindh, Pakistan
Allied Burn & Reconstructive Surgery Centre
Faisalābad, Pakistan
...and 1 more locations
Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
all-cause mortality followed by readmission rates and changes in health-related quality of life
Time frame: Baseline to 12th month post randomization
Patient Health Questionnaire (PHQ-9)
To screen, diagnose, monitor and measure the severity of depression
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Burns Specific Health Scale
To quantify dysfunction and distress across six major domains of health, specifically burn injury related morbidity
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Rosenburg Self-Esteem Scale
A 10 item self-report instrument to measure individual self-esteem
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Visual Analogue Scale
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
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
International Trauma Questionnaire
It is a brief,18 item self-report questionnaire used to assess core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD.
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Perceived Stigma Questionnaire
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
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
WHO disability assessment schedule
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
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Vancouver Scar Scale
It is used to document change in scar appearance. Index measures the scares on four parameters, Pigmentation, vascularity, pliability and heigh
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Quality of life scale EQ-5D
Health-related quality of life as measured for mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
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