Clinical trial NCT06559501: Integrated Case Management for Burns Care in Pakistan
Official title: Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unintentional Burn Injury
Depression
Anxiety
Burns
Keywords: Burns Rehabilitation
culturally adapted
Cost effectiveness
Multicenter trial
Pakistan
Burns Injury
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2024-08-19
Enrollment: 1146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
timeFrame: Baseline to 12th month post randomization
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Burns Specific Health Scale
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Rosenburg Self-Esteem Scale
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Visual Analogue Scale
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: International Trauma Questionnaire
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Perceived Stigma Questionnaire
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: WHO disability assessment schedule
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Vancouver Scar Scale
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
measure: Quality of life scale EQ-5D
timeFrame: Baseline to 3 months, 6 months and 12-months post-intervention
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Plastic Surgery and Burn Unit, BMC, Quetta
state: Balochistan
city: Quetta
country: Pakistan
facility: Burn Unit, Sandeman Provisional Hospital
state: Baluchistan
city: Peshawar
country: Pakistan
facility: Burns and Plastic Surgery Center, Peshawar
state: KPK
city: Faisalābad
country: Pakistan
facility: Allied Burn and Reconstructive Surgery Centre
state: Punjab
city: Lahore
country: Pakistan
facility: Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University
state: Punjab
city: Lahore
country: Pakistan
facility: Jinnah Burn & Reconstructive Surgery Centre, Lahore
state: Punjab
city: Multān
country: Pakistan
facility: Pak Italian Modern Burn and Plastic Surgery Centre
state: Punjab
city: Hyderabad
country: Pakistan
facility: Burn Centre, Civil Hospital Hyderabad
state: Sindh
city: Karachi
country: Pakistan
facility: Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
state: Sindh
city: Karachi
country: Pakistan
facility: Burns and Plastic Surgery, Patel Hospital, Karachi
state: Sindh
city: Faisalābad
country: Pakistan
facility: Allied Burn & Reconstructive Surgery Centre
city: Islamabad
country: Pakistan
facility: Burn Care Centre, PIMS, Islamabad
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
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citation: Lawrence JW, Fauerbach JA, Heinberg LJ, Doctor M, Thombs BD. The reliability and validity of the Perceived Stigmatization Questionnaire (PSQ) and the Social Comfort Questionnaire (SCQ) among an adult burn survivor sample. Psychol Assess. 2006 Mar;18(1):106-11. doi: 10.1037/1040-3590.18.1.106.
citation: Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.
citation: Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.