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临床试验/NCT04517721
NCT04517721已完成不适用

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

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will receive same care at the pre-discharge phase. However in the post-discharge phase where participants are not likely to interact with each other, persons in the control group will continue to receive the usual care whilst persons in the treatment group receives the new intervention. The assigned group of participants will not be disclosed to the outcome assessors.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D.

时间窗: Three months

The Burn Specific Health Scale-Brief comprises of 40 questions, 9 sub-scales, and 3 domains (physical, mental, and social). Each item is scored on a 5-point scale ranging from 0 (extremely) to 4 (not at all). The maximum score is 140. Lower scores suggest poor quality of life and higher scores imply good quality of life. 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. The 5-level EQ-5D has five response levels: level 1 (no problem) to level 5 (extreme problem). The possible health states are defined by combining one level from each dimension. An EQ-5D-5L index value is calculated ranging from 0 (death) to 1 (full health). Decreasing scores therefore suggest poor health whilst increasing scores suggest good health.

次要结局

  • Chinese version of the Brief Pain Inventory(Three months)
  • Chinese version of a visual analogue scale(Three months)
  • Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH)(Three months)
  • Chinese version of the Hospital Anxiety and Depression Scale(Three months)
  • Chinese version of the Pittsburgh Sleep Quality Index(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frances Kam Yuet WONG

Prof

The Hong Kong Polytechnic University

研究点 (2)

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