This single-centre trial will be conducted at the Gansu Provincial Hospital, Lanzhou, People’s Republic of China. The hospital is a comprehensive top-ranked 3A facility integrating medical services with teaching, research, and preventive care. The facility was established in 1950 and is in the Northwestern part of China. The hospital currently has a total of 3370 beds across various medical and surgical specialties with outpatient facilities.
All burn survivors receiving burn care services at the study site will be screened for eligibility during the study period. Adult burn survivors aged ≥18 years with burn size ≥10% TBSA as assessed by the burn surgeon/ burn care nurse (irrespective of the depth of the burn), absence of a confirmed psychiatry condition, renal failure, or diabetes mellitus and reachable on phone and WeChat will be considered for inclusion. Adult burn survivors who are unable to communicate or are enrolled in another rehabilitation trial will be excluded. Participants for the follow-up process evaluation phase will be recruited from both arms of the trial. The intervention will be primarily provided and coordinated by a Burn Care Nurse with referrals to other members of the multi-disciplinary burns team. Burn care nurses recruited to deliver the intervention will have at least 4 years working experience in the burn unit at the study site and must complete a mandatory training programme which covers contents of the comprehensive transitional care program for burn patients with theory and practice (18 hours in total) and passed a competence test prior to participating in the study.
Eligible participants will be randomised to either the treatment or control group. Participants in the control group will continue to utilise the existing service at the hospital in addition to two social calls by a trained student nurse. Participants in the treatment group will receive the nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) in addition to existing service at the hospital. There are two phases to the 4Cs-TBRP:
- Phase 1 (Discharge planning/ preparation): This phase will take place at least 72 hours prior to the day of discharge. Guided by the Omaha System, a comprehensive patient assessment based on a care plan covering environmental, physiological, psychosocial, and health-related behaviour domains will be carried out (27). The bundle of interventions available is based on the identified need which include environmental (health education to improve sanitation and environmental hygiene within residence); physiological (pain management, itch management, comprehensive scar management, range of motion activities, management of heat sensitivity, skin care, nutritional assessment/ support, infection prevention and control measures); psychosocial (social skills training, counseling care, health education, positive reinforcement, spiritual care, meditation, and music therapy); and health-related behaviour (strategies to improve sleep/ rest, physical therapy, and participation in activities of daily living).
- Phase 2 (Follow-up Phase): This phase comprises of 2 structured WeChat telehealth, 6 structured telephone follow-ups and daytime patient/ family-initiated telephone service over an 8-week period. Like the discharge planning phase, care planning and intervention are undertaken using the Omaha System as a guide for the 8-week period. The bundle of interventions available based on the identified need/ domain include environmental (health education to improve sanitation and environmental hygiene within residence); physiological (pain management, itch management, comprehensive scar management, range of motion activities, management of heat sensitivity, skin care, nutritional assessment/ support, infection prevention and control measures); psychosocial (social skills training, counseling care, health education, positive reinforcement, spiritual care, meditation, music therapy and aromatherapy); and health-related behaviour (strategies to improve sleep/ rest, physical therapy, and participation in activities of daily living). Where referrals are required, a referral form will be completed for the service to be provided. Home visits will be carried out if the adult burn survivor has concerns which can best be handled face to face by the nurse (example: assistance with wound care or reinforcing scar management education).
Strategies to improve adherence/ fidelity of the intervention
Fidelity will be ensured in this study by using the guidelines offered by Bellg et al.(28) which comprises of 1) ensuring that the intervention dose is the same for all participants across each condition, (2) standardizing interventionist training, (3) monitoring the intervention delivery, (4) evaluating participants’ understanding of information provided, and (5) ensuring that participants use the skills taught in the intervention. Adherence reminders will also be given every week to participants during the follow-up via WeChat or telephone.
Quality of life: Quality of life which is defined as the adult burn survivors’ perceptions of their health status and well-being is the primary outcome for the trial and will be assessed at baseline (T0), following completion of the intervention at 8 weeks (T1) and at 4 weeks post-intervention (T2). The outcome will be objectively assessed using the Chinese version of the Burn Specific Health Scale-Brief and EQ-5D-5L. The BSHS is an outcome scale designed specifically for burns patients. It comprises of four areas: physical, psychological, social relations and general health condition, that is consistent with the biopsychosocial model. A recent review has suggested that generic scales are more sensitive than the BSHS-B domains from one-month post-burn (29). Thus, as the study will cover up to three months post-discharge, the BSHS-B and EQ-5D will be used to measure quality of life in the study. The BSHS-B comprises of 40 questions, 9 sub-scales, and 3 domains (physical, mental, and social). Internal consistency of the total instrument has been reported to be α=0.94 with test-retest reliability suggesting that the Intraclass Correlation Coefficient (ICC) ranged from 0.81 to 0.96 with a total score of 0.93 (30). The Chinese version has 38 items with a reported Cronbach alpha 0.97 and split half reliability of 0.98 (31). The EQ-5D-5L is a generic tool to assess quality of life. The instrument has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ-5D-5L is a valid extension of the 3-level system (EQ-5D-3L) which is found to have improved measurement properties, with reduced ceiling effect, strengthened discriminatory power and established convergent and known-groups validity (32).
Assessment of secondary outcomes will also commence at baseline T0 (recruitment to the study), following completion of the intervention at 8 weeks (T1) and at 4 weeks post-intervention (T2):
Psychological functioning: The Chinese version of the Hospital Anxiety and Depression Scale (HADS) will be used to evaluate psychological functioning (anxiety and depression). The 14-item HADS was designed as a tool to screen for anxiety and depressive symptoms in medical settings, and has well-demonstrated solid psychometric properties for use in medical settings (33-35) and commonly used in burn care settings to screen anxiety and depression (36).
Sleep pattern improvement: The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate sleep improvement. It includes 19 items with a total score that ranges from 0 to 21. A higher PSQI score implies poorer quality of sleep (37). In general, a PSQI score greater than 5 is considered to indicate poor sleep quality (37).
Pain: The Chinese version of the Brief Pain Inventory will be used to evaluate pain among participants. It has 15 items, of which 11 items have numeric rating scale, on the experience of pain, the area of severe pain, the presence of pain, minimum and maximum pain on the previous day, current pain level, analgesia and pain relief, and the interference of pain on the patient’s functioning (38).
Itch: The Chinese version of a visual analogue scale (VAS) will be used to evaluate this outcome among participants. The VAS has been observed to have an intraclass correlation coefficient of 0.88 (39).
Physical role functioning/ performance: The Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH) will be used to evaluate this outcome (40). The DASH tool is a 30-item questionnaire that asks the patient to grade symptoms and physical function during the preceding week on a five-point Likert scale. The reliability of the DASH is excellent (intraclass correlation coefficient 0.97 with Cronbach's alpha of 0.97) (40).
Scarring: The Vancouver Scar Scale (VSS) will be used to assess this outcome in the current study. The VSS is a validated subjective tool that assesses vascularity, pigmentation, pliability, and height of scars (41). The tool remains the main tool used to evaluate scarring in burn care research (41). The total score ranges from 0-13 with lower scores implying improved scars.
Participants will be assessed for eligibility and enrolled to the study 72 hours to discharge from the burn unit. Baseline data collection with a battery of outcome measures along with demographic data. The intervention commences for participants in the treatment group with the pre-discharge component of the programme of care. Weekly follow-ups will be conducted by the nurse case managers. The second phase of data collection will be completed by 8 weeks post-intervention. Follow-up data will be obtained at 4 weeks following the second data collection phase (see figure 2).
Sampling and Sample size estimation
Purposive sampling will be used to recruit adult burn survivors with burn size ≥10% TBSA from the Burn Unit. Upon recruitment, randomisation to either control or treatment group (ratio 1:1) with a blinded approach will be carried out. For the pilot phase of the project, the pilot feasibility sample size rule suggested by Whitehead, Julius, Cooper, & Campbell will be used (42). The rule specifies that a total sample size of 25 participants per arm. Considering possible attrition rate of 20% that has been reported in burn care literature implies that an additional 5 participants will be added to both arms summing up to 30 participants per arm (total = 60 participants).
For the main trial, the sample size calculation based on the primary outcome measure (Burn Specific Health Scale) at 95% confidence level and 90% statistical power will yield a total of 38 participants per arm (43, 44). Considering an attrition rate of 20%, the final sample size will be 45 participants per arm (total = 90 participants). In all, 150 participants will be recruited for the entire study. For the follow-up process evaluation phase, we will conveniently recruit up to fifteen (15) participants from each arm whilst being guided by the principle of data saturation.
A research nurse at the study site will identify potential subjects’ eligibility for enrolment in the study based on the inclusion and exclusion criteria described above. All participants will be enrolled/ recruited by a Registered Nurse (RN-1) who will not be involved in the delivery of the intervention or outcome assessment (see figure 1). RN-1 will follow-up on patient’s case notes on daily basis to ascertain if any adult burn survivor has a pending discharge status. If pending discharge is noted, RN-1 will check if the adult burn survivor fulfils the criteria for inclusion; if so, the patient will be invited to participate. Details of the study will be made known and information sheet duly explained. Thereafter, RN-1 will ensure that two consent forms (covering both outcome and process evaluation phases) are signed, or thumb printed by the adult burn survivor which will then be forwarded to a research assistant (RA) who will complete the baseline assessment. A research team member (RTM) who is not involved in clinical services and have no knowledge about the potential subjects will take over from this phase and proceed to work on randomisation and allocation. The subjects allocated to the intervention arm will be referred to the nurse case manager to commence the intervention. Following the exit of participants from the intervention, they will be contacted and invited to participate in the process evaluation phase.
Methods (Assignment of intervention)
Randomisation and Allocation
Prior blocked randomisation list with 75 sets of numbers will be generated using the Research Randomizer. As soon as the consent form is received, the RTM will sequentially open the sealed envelopes containing the paper with the number assignment and unfold it. The number written specifies the group to which the adult burn survivor will be allocated. The allocation sequence will be concealed to RN-1 and the research assistant (RA) to minimise bias in the study.
Following recruitment, any possible identifying material that could indicate to the blinded assessors, which group a participant was allocated to, will be removed. Participants will not be blinded as to the group they have been assigned to. Additionally, it will not be possible to blind the interventionists, that is, the burn care nurses who will deliver the intervention only to participants in the treatment group.
Data collection, Management and Analysis
Data collection methods and management
All outcomes will be assessed at baseline (T0), that is after the patient has been recruited. Following the completion of the intervention, the second phase of data collection (T1) will be undertaken, that is at the 8th week. The third phase of data collection (T2) will be the follow-up phase at 4 weeks post-intervention. Data collection will be in the form of completion of questionnaires. The data collection process will be undertaken by three research assistants who will be blinded to the groups of the participants. The research assistants have completed a 10-hour training programme covering the outcome measures to be used. Following the training, they undertook a role play to enable the research team ascertain the inter-rater reliability/ percentage agreement with the following results: Burn Specific Health Scale-B (87.7%), EQ-5D-5L (100%), HADS (92.5%), PSQI (86.7%), DASH (84.4%), VAS (100%), BPI (100%) and VSS (100%). All quantitative data will be entered and stored in SPSS Version 25 (SPSS, an IBM company, Chicago, Illinois, USA). All hard copies of documents relating to the study will be stored under lock and key only accessible to designated research team member.
For the follow-up process evaluation phase, face to face semi-structured interviews with an interview guide will be utilised to collect data after the intervention period has elapsed. All interview proceedings will be audiotaped and transcribed verbatim in the Trint Automated Transcription Software. Interview transcripts will be exported to QSR NVivo version 10 will be used to manage the data. All soft files related to the study will be kept in a password protected computer only accessible to the principal investigator and the doctoral student investigator. Paper files will be kept under lock and key.
Statistical Methods and Analysis
The data analysis plan will proceed through data entry and cleaning, missing data management and statistical analysis. All quantitative data will be coded and entered to SPSS Version 25 (SPSS, an IBM company, Chicago, Illinois, USA). The data will be inspected visually with random searches and frequency counts to ascertain its completeness. Demographic and clinical characteristics will be compared using chi square test (for normally distributed data) or Mann Whitney U test (data that is not normally distributed). Between group differences will be assessed using independent t test (for continuous data). Both per-protocol (PP) and intention to treat analysis (ITT) will be performed respectively on participants who completed the entire intervention and those recruited to participate. Methods for longitudinal data such as generalized estimating equations (GEE) will be employed. All statistical tests will be conducted at 95% confidence interval.
Qualitative data emerging from the follow-up process evaluation phase will be analyzed using content analysis. All audio recordings will be transcribed verbatim and translated from Chinese to English using the Trint Automation Software. The transcripts will be inspected for correctness and completeness by two native speakers who are also fluent in English. The final versions will be exported to the NVivo version 10 software. In the early stage of analysis, a broad question will be posed to grasp the whole picture. As analysis progresses, the researcher will go beyond the initial theoretical scaffolding to develop an understanding and interpretation of the data (45).
Minimal adverse effects are expected from the proposed intervention. Standardised protocols exist at the study centre regarding the management of known of potential adverse effects such as infection. Adverse events related to the intervention will be monitored through review of the patient’s records, participant self-report and by the clinicians. All adverse events will be reported to the Institutional Review Board of the Hong Kong Polytechnic University.
Ethics and dissemination
Ethical clearance for the study has been granted by the Institutional Review Board of the Hong Kong Polytechnic University (HSEARS20200730001). Additionally, the study has been prospectively registered with a trial registry and currently available in public domain (NCT04517721). The IRB and trial registry will be informed of any modifications that may occur during the conduct of the trial. Consent will be obtained from participants before completing the recruitment process. All data emerging from the studies will be kept under lock kept by authorized personnel. Confidentiality and anonymity will be ensured throughout the study. Data emerging from the study will be accessed only by the research and clinical teams. Trial auditing will be conducted every six weeks. The investigators plan to disseminate the trial results via publication in peer reviewed journals and at conferences. All research and clinical team members meeting authorship criteria will have final authority over manuscript content. The study protocol, if published, will be available in public domain. However, participant-level dataset will be maintained by the research/ team which can be made available on reasonable request.