Clinical trial NCT04517721: Effects of a Nurse-led Transitional Burns Rehabilitation Programme
Official title: Effects of a Nurse-led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) for Adult Burn Survivors at the Gansu Provincial Hospital, Lanzhou: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns Multiple
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomised to either the control or intervention groups with the former receiving the existing care at the hospital and the latter receiving the both the new intervention and existing standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The number of adult burn survivors is increasing gradually, and attention is drawn towards how they can be supported during the transitioning period. Considering the impact of nurse-led programmes in chronic disease management, it is being argued that an appropriate nurse-led bridging transitional programme of care may be an essential extended/ add-on service for adult burn survivors. Guided by the Medical Research Council Framework for Complex Interventions, a nurse-led programme has been developed. This phase seeks to implement the intervention, evaluate its effects, and understand the mechanisms of implementation at the Gansu Provincial Hospital, Lanzhou.

A randomized controlled trial approach with a nested process evaluation phase will be used. Participants will be recruited from the Burn Unit of the Gansu Provincial Hospital, Lanzhou and the intervention commenced from at least 72 hours to discharge up to 2 months post-discharge. Participants will be randomized to either control or treatment group using a blinded approach. Following the completion of the intervention, up to 15 participants will be recruited for face to face interviews.

Detailed description: Recovery following burn injury is a complex process which involves re-fitting one's new form into an already known world. The aftermath of burns and complex responses by affected persons makes it difficult to map a clear recovery pathway. At the initial phase of recovery, the patient may show several responses such as disbelief, fear, and pain. These responses may become more pronounced as the patient comes to terms with the losses associated with injury. Further challenges associated with appearance changes and function may accrue as healing progresses and the scars evolve through maturation. Subsequently by discharge, burn survivors need to adapt to a new situation as they return to the community and assume full responsibility of their care. Hospital discharge, therefore, does not imply an end to treatment but a transitional period when the burn patient is still coming to terms with the reality of the injury, identifying new approaches to thriving and adapting to the changes thereof. To facilitate this ongoing recovery of adult burn survivors, there is therefore a need for continuous contact with rehabilitation services to ensure that needs that emerge in the process are identified and actively resolved.

Considering the importance of rehabilitation in the recovery process of the adult burn patient, it becomes essential to ensure that all burn patients receive rehabilitative care as and when needed. However, burn rehabilitation practices vary across settings. In developed countries, the burn patients often undergo intensive rehabilitation concurrently with acute care and later stepped down to continue an inpatient rehabilitation programme before discharge. In contrast, burn centres in developing countries may not have such step down services to a unique inpatient rehabilitation service; thus, the patient benefits only from the rehabilitation service that occurs alongside acute care and thereafter discharged home. Pressure on beds and limited financial resources in some developing settings may also trigger early discharge from the burn unit which further shortens the patient's contact with rehabilitation services.

In Mainland China, the concept of rehabilitation is still under development, not commonly practiced and where available, burn patients may face limited access due to inadequate personnel. The escalating chronic disease burden and ageing population further leaves limited resources allocated to burns rehabilitation in Mainland China. Even in healthcare facilities with rehabilitation services, the cultural belief among Chinese citizens that rehabilitation is a natural outcome of diseases, rather than an active management of dysfunctional issues of the body may affect the level of service utilization. Previous studies in Mainland China have also highlighted the significant focus on medical management of burn injuries with limited attention to comprehensive rehabilitative support. Thus, at the time of discharge the adult burn survivors may not have received adequate rehabilitative support commensurate with their needs and have to live with serious disabilities.

As the adult burn survivor transitions from the hospital to the community, anxiety and uncertainties may ensue. Other emotional responses may become more pronounced as the adult burn survivor comes to terms with the injury and the losses associated with it. Thus, the adult burn survivor transitions to the early post-discharge period with several physical, psychological, and social needs whilst at the same time, they are expected to assume full responsibility for their care. By 3 months post-discharge, burn survivors experience increasing psychological burden, poor physical role performances and poor quality of life. Within 6 months to 1 year post-discharge without professional support, the adult burn patient may experience further emotional distress reflected by the high rates of depression, sleep disturbance, body image concerns and sexual problems. Although statistically insignificant, several studies have reported an improvement in burn-specific health beyond 1year post-burn. Besides, psychosocial distress may still persist by 9 years post-discharge. These strengthen the need for ongoing comprehensive and continuous care to facilitate early identification and resolution of biopsychosocial needs that may emerge; a care pathway similar to persons living with chronic conditions.

Along the recovery trajectory for adult burn survivors, findings from several studies suggest that the greatest physical and psychosocial decline may be experienced by 2-3 months post-discharge. This assertion implies that the discharge to early post-discharge period, that is, 2 months following discharge represent a vulnerable period which can impact adversely on the long-term recovery outcomes of adult burn survivors. The period has been described as unpredictable with the emergence of varied needs requiring an individualized approach to care on regular basis than is provided by interval outpatient clinic visits. Despite these assertions, it is around this period that professional support may be limited or unavailable and some adult burn survivors may not return to the hospital due to issues such as long travel distances and associated costs. These raise an interest regarding how professional support can be organized and delivered as the patient transitions to the early post-discharge period in the home or community to ensure that they receive the sustained and comprehensive rehabilitative support. Thus, the current study to develop a nurse-led transitional rehabilitation programme and evaluate its effects among adult burn survivors.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years
2. Burn size ≥10% TBSA
3. Reachable on phone and WeChat
4. Absence of confirmed psychiatric condition
5. Absence of confirmed chronic diagnosis of renal failure or diabetes mellitus with foot ulcers

Exclusion Criteria:

Unable to communicate Not reachable via phone Confirmed underlying psychiatry or renal failure or diabetes mellitus with foot ulcers Already engaged in another burn rehabilitation programme Will not reside in the specified location within three months of recruitment

Primary outcomes:
measure: Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D.
timeFrame: Three months
Secondary outcomes:
measure: Chinese version of the Hospital Anxiety and Depression Scale
timeFrame: Three months
measure: Chinese version of the Pittsburgh Sleep Quality Index
timeFrame: Three months
measure: Chinese version of the Brief Pain Inventory
timeFrame: Three months
measure: Chinese version of a visual analogue scale
timeFrame: Three months
measure: Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH)
timeFrame: Three months
Other outcomes:
Locations:
city: Gansu
country: China
facility: Gansu Provincial Hospital
state: Lanzhou
Study officials:
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