Anxiety, Burns, Depression, Unintentional Burn Injury
Conditions
Keywords
Burns Rehabilitation, culturally adapted, Cost effectiveness, Multicenter trial, Pakistan, Burns Injury
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.
Interventions
BEHAVIORALIntegrated 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.
Sponsors
Pakistan Institute of Living and Learning
University of Manchester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORNasim Chaudhry, MD
Pakistan Institute of Living and Learning
Outcome results
None listed