Clincosm LogoSign in Get a demo

Effects of a Nurse-led Transitional Burns Rehabilitation Programme

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT04517721
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

The 4C's-TBuRP for adult burn survivors comprises of two phases: Phase 1: Discharge planning/ preparation and day of discharge (Comprehensive assessment and evaluation, Education, guidance, and counselling, Treatment and procedures, Case management (referral for nursing follow-up), multi-disciplinary follow-up and Surveillance) Phase 2: Follow-up Phase (2 WeChat Telehealth, 6 structured telephone follow-ups and daytime patient/ family-initiated telephone service; home visit based on meeting criteria) over an 8-week follow-up with delivery of rehabilitation care across the spectrum by trained nurse case managers ongoing assessment, intervention using the Omaha System and delivery of evidence-based care.

Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)
The nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) is presented as an 8-week interventional programme that supports holistic care for adult burn survivors led by a specialist burn care nurse and supported by the burn care team. The intervention posits that as the adult burn survivor transitions, several physiological, psychosocial, health-related behaviour and environmental needs emerge which lead to poor quality of life. Despite this, they may be unable to return to utilise available healthcare services or have inadequate contact with rehabilitation services. To facilitate their recovery and enhance the attainment of rehabilitation outcomes, the 4Cs-TBuRP views the burn care nurse as the link between rehabilitation services and the adult burn survivor. Thus, the burn care nurse serves as the coordinator of care and actively collaborates with the burn care team and the patient/ family to ensure that continuous care is delivered in a timely manner.
Active Comparator: Control group

Participants in the control group will receive the care at the discharge planning phase and thereafter continue to utilise the exiting service available at the hospital, that is, medical review in the hospital.

Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)
The nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) is presented as an 8-week interventional programme that supports holistic care for adult burn survivors led by a specialist burn care nurse and supported by the burn care team. The intervention posits that as the adult burn survivor transitions, several physiological, psychosocial, health-related behaviour and environmental needs emerge which lead to poor quality of life. Despite this, they may be unable to return to utilise available healthcare services or have inadequate contact with rehabilitation services. To facilitate their recovery and enhance the attainment of rehabilitation outcomes, the 4Cs-TBuRP views the burn care nurse as the link between rehabilitation services and the adult burn survivor. Thus, the burn care nurse serves as the coordinator of care and actively collaborates with the burn care team and the patient/ family to ensure that continuous care is delivered in a timely manner.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Chinese version of the Hospital Anxiety and Depression Scale [Three months]

    The 14-item Hospital Anxiety and Depression Scale 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 and commonly used in burn care settings to screen anxiety and depression. The total score is 42 (21 per subscale). Scores per subscale can range from 0-21. Higher scores indicate greater levels of anxiety and depression and lower scores imply low levels of anxiety and depression.

  2. Chinese version of the Pittsburgh Sleep Quality Index [Three months]

    The Chinese version of the Pittsburgh Sleep Quality Index is a widely recognized instrument used to evaluate the quality of sleep. It includes 19 items with a total score that ranges from 0 to 21. A higher PSQI score implies poorer quality of sleep and lower scores imply good sleep patterns. In general, a PSQI score greater than 5 is considered to indicate poor sleep quality.

  3. Chinese version of the Brief Pain Inventory [Three months]

    : 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. Pain severity and interference scores are calculated out of a total score of 10. Higher scores represent increasing pain severity and interference.

  4. Chinese version of a visual analogue scale [Three months]

    The Chinese version of a visual analogue scale will be used to evaluate this itch intensity among participants. Intraclass correlation coefficient has been recorded as 0.88 (Reich et al., 2012). The tool ranges from 0 (no itch) to 10 (worst imaginable itch). Thus, increasing scores represent worsening itch.

  5. Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH) [Three months]

    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. The tool is scored from 0 (no disability) to 100. Increasing scores suggest the existence of a disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gansu Provincial Hospital Gansu Lanzhou China 076

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Frances Kam Yuet WONG, Prof, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT04517721
Other Study ID Numbers:
  • HSEARS20200730001
First Posted:
Aug 18, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Burns

Study Results

No Results Posted as of Jun 21, 2022