Integrated Case Management for Burns Care in Pakistan (BURNS)

Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Burns; Anxiety; Unintentional Burn Injury
• Intervention / Treatment: Behavioral: Integrated case manager care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameer Khoso, PhD Fellow; Phone Number: +92-2135871845; Email: ameer.bukhsh@pill.org.pk
• Study Contact Backup: Name: sehrish Tofique, PhD Fellow; Phone Number: +92-2135871845; Email: Sehrishtofique@ymail.com

Study Locations

• Pakistan
  • Faisalābad, Pakistan
    • Recruiting
    • Allied Burn & Reconstructive Surgery Centre
    • Contact: Urwa Ahmed
  • Islamabad, Pakistan, 46300
    • Recruiting
    • Burn Care Centre, PIMS, Islamabad
    • Contact: Rehan Ahmed, MBBS
  • Balochistan
    • Quetta, Balochistan, Pakistan
      • Recruiting
      • Plastic Surgery and Burn Unit, BMC, Quetta
      • Contact: Dr Silsila Sherzad, MBBS
  • Baluchistan
    • Quetta, Baluchistan, Pakistan
      • Recruiting
      • Burn Unit, Sandeman Provisional Hospital
  • KPK
    • Peshawar, KPK, Pakistan
      • Recruiting
      • Burns and Plastic Surgery Center, Peshawar
      • Contact: Irfan Ullah
  • Punjab
    • Lahore, Punjab, Pakistan, 203393
      • Recruiting
      • Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University
      • Contact: Mustehsan Bashir
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Jinnah Burn & Reconstructive Surgery Centre, Lahore
      • Contact: Farrukh Aslam, FCPS
    • Multān, Punjab, Pakistan
      • Recruiting
      • Pak Italian Modern Burn and Plastic Surgery Centre
  • Sindh
    • Hyderabad, Sindh, Pakistan
      • Recruiting
      • Burn Centre, Civil Hospital Hyderabad
      • Contact: Saadia Rasheed
    • Karachi, Sindh, Pakistan, 203393
      • Recruiting
      • Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
      • Contact: Samia Tasleem
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Burns and Plastic Surgery, Patel Hospital, Karachi
      • Contact: Mazhar Nizam, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Enhanced care as usual; includes their standard care, and all treatments recommended by attending physicians will be provided, plus a written self-help booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 12th month post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	To screen, diagnose, monitor and measure the severity of depression	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	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	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	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.	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	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	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	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	Baseline to 3 months, 6 months and 12-months post-intervention

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: University of Manchester
• Investigators: Principal Investigator: Nasim Chaudhry, MD, Pakistan Institute of Living and Learning

Publications and helpful links

General Publications

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
• 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.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
• 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.
• Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
• Blades B, Mellis N, Munster AM. A burn specific health scale. J Trauma. 1982 Oct;22(10):872-5. doi: 10.1097/00005373-198210000-00012.
• Rosenberg M. Rosenberg self-esteem scale. Journal of Religion and Health. 1965
• 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.
• Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pakistan; Cost effectiveness; Multicenter trial; culturally adapted; Burns Rehabilitation; Burns Injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: PILL-BURNS-OO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No