eCASH Concept-Based Care for Patients With Small-Area Burns: A Pilot Randomized Controlled Trial

According to the World Health Organization, approximately 180 000 people die of burns each year.¹ In WHO’s report, burn injuries occur primarily in low- and middle-income countries (almost two-thirds occur in the WHO African and South-East Asian Regions, which is one of the main reasons for the decline in disability-adjusted life years). In China, approximately 0.33 million people (equivalent to 0.76% of the population) experienced burns of varying degrees from 2009 to 2018,² which indicates that burns are a serious public health problem in China. 

During the past 20 years, burn pain has been recognized as a pressing problem, and burns are considered one of the most painful experiences in a person’s lifetime. Some researchers have described the pain of acute burns as catastrophic.³ Repetitive procedures in wound care—including dressing removal, debridement, application of new dressings, and functional training—are the main causes of procedural pain experienced by patients.⁴ In recent years, the application of wound dressings in burn care has become more widespread in patients with small burns, for whom procedural pain is inevitable.⁵

Chinese researchers noted that 42% of patients with burns met the criteria for posttraumatic stress disorder,⁶ with results of 18% to 33% reported by Nosanov et al.⁷ Pain and anxiety have been shown to be detrimental factors that delay the wound healing process, leading to the development of a vicious cycle. Typically, small-area burns are not life-threatening; however, if not treated promptly and correctly, such burns can lead to serious complications,⁸ including infection, increased pain, delayed wound healing, excessive scar growth, wound contracture, and long-term organ dysfunction.^9,10 Therefore, clinicians need to be concerned about not only speeding up wound healing but also improving the quality of that healing. Although successful burn care interventions have been reported (eg, the integration of burn treatment and rehabilitation, clinical care pathways, and health education models based on behavioral change theory combined with psychological nursing), these interventions emphasize only early treatment, psychological care during rehabilitation, or functional exercise after healing in patients with burns. Currently, there is no standard operating procedure in China for treating patients with burns. Effective and satisfactory burn care intervention is necessary to reduce patients’ pain and anxiety and improve burn healing quality.

In 2016, Vincent et al¹¹ introduced the concept of eCASH, which is a patient-centered, nurse-led type of care that promotes early implementation, priority analgesia, minimal sedation, and maximum humanistic care. The eCASH concept was originally applied in intensive care units and has since gradually been extended to medicine and surgery. Use of this concept has effectively reduced the incidence of delirium in patients with extensive burns, regulated the stress level of patients with trauma, and improved patients’ quality of life. A recent randomized controlled trial demonstrated that use of the eCASH concept helped reduce pain and anxiety and managed inflammatory reactions during wound healing.¹² Another study found that treatment combined with the eCASH concept decreased the positive rate of bacterial detection and the incidence of complications in second-degree burn wounds.¹³ These results show that the eCASH concept is equally relevant in clinical practice for the management of small burns.

eCASH has provided an evidence-based approach to burn care protocols, which is conducive to improving the quality of care for patients with burns. It emphasizes the use of analgesia, minimal sedatives, and maximal humane care to achieve better outcomes.^11,12 This concept has been increasingly adopted in burn care protocols owing to its proven efficacy in enhancing wound healing and reducing complications.

The purpose of the current study was to explore whether an eCASH concept–based care protocol (ie, eBCare) can improve the quality of wound healing in patients with small-area burns compared with the use of standard treatment. Specifically, the study aimed to assess the efficacy of eBCare in accelerating wound healing, evaluate the effect of such care on patients’ pain and anxiety levels, and compare the long-term outcomes of patients treated with eBCare with those treated using standard therapy. The authors hypothesized that patients treated with eBCare would experience faster wound healing, lower levels of pain and anxiety, and better long-term outcomes compared with patients who received standard treatment.

This was a single-masked, randomized controlled trial. Seventy patients with small-area burns were recruited from a tertiary hospital, with 35 randomized to eBCare (eCASH concept-based care) and 35 to standard of care (control group). The primary outcomes were VAS scores, HAM-A scores, and wound healing rates. The secondary outcomes were heart rate and long-term PSAS scores. 

Study participants

Patients with a diagnosis of deep second-degree burns with less than 10% TBSA and who were capable of normal communication were enrolled in this study. Exclusion criteria were as follows: (1) pregnancy and puerperium; (2) burns on the face and neck, perineum, or scrotum; (3) severe burns or serious deterioration; (4) severe organ failure (ie, heart failure, renal failure, or liver failure); (5) connective tissue disease or immune system disorders; and (6) patients or families who did not fully agree with the intervention. All participants or their family members signed an informed consent form. This study was approved by the ethics committee of the Affiliated Hospital of Jiangnan University (Z201710), Wuxi, China.

Sample size calculation

The recommended sample size was based on the primary outcome of the VAS pain scores. Considering other similar studies and the reported mean ± SD values,¹⁴ the current study required a total of 78 patients using the power formula, assuming an alpha of .05, a power of 80%, and a dropout rate of 15%.¹⁵ The calculated sample size of the 2 groups was 62 before dropout. Sample size was calculated as follows, assuming a 15% dropout rate: 62 × 0.15 = 9.3 ≈ 10. The total sample size after dropout was calculated as follows: 62 + 10 = 72. The total sample size of each group was calculated as follows: 72 / 2 = 36.

Randomization and masking

A research assistant completed a simple randomization procedure and produced numbered randomization cards, which were placed in sealed opaque envelopes. Patients were given a randomized number in order of entry, and then they followed instructions to enter either the control group or the eBCare group. Before the experiment, the researchers explained the intervention to the enrolled patients; however, the patients were not informed of their group allocations.

Multidisciplinary team

All eBCare researchers completed training before patient recruitment. Attending physicians were responsible for recruiting patients and determining wound treatment measures. Specialist wound nurses were available for wound dressing changes and patient health education. Bedside nurses were trained in daily care and in recording the admitted patients’ baseline data as well as in collecting their VAS score, HAM-A score,¹⁶ and heart rate. The main researchers (Q.Y., Y.H.) took images of wounds and followed up with patients. To evaluate scarring in patients who had been discharged at least 4 years ago, the authors sent messages, informed consent forms, and a short follow-up survey (ie, the PSAS portion of the POSAS) to be completed by the patients. The authors explained the meaning of the PSAS and provided the Chinese-language version of it as recommended by the Chinese Expert Consensus on Clinical Scar Control.¹⁷ 

Groups and interventions

Seventy patients were screened and randomized into the control group (n = 35) or the eBCare group (n = 35) for 2 weeks of intervention (Figure). 

Control group. Patients with burns who were randomized to the control group were admitted to the hospital and received standard wound treatment, including debridement, dressing changes, anti-infectives, and care to improve microcirculation. However, these patients did not receive targeted interventions to manage pain and anxiety. The control group received standardized burn care, which included the use of sterile gauze dressings. Dressings were changed every 48 hours.

eBCare group. Patients in the eBCare group were admitted to an eCASH comfort ward. Researchers informed the patients of the implications of eCASH and intervened as early as possible. Attending physicians were responsible for providing wound treatment, wound specialist nurses were available for scale assessment and wound dressing changes, and bedside nurses were trained in daily care and patient health education. Rehabilitation therapists created training programs individualized to each patient’s condition. Before, during, and 30 minutes after dressing changes, nurses noted patient VAS and HAM-A scores and heart rate, and they recorded data for the first 3 dressing changes.

eBCare (eCASH concept-based care): analgesia priority. Each patient’s pain level was assessed using the VAS, with analgesic goals equivalent to a score of 0 to 2. Pain was assessed before, during, and 30 minutes after dressing changes. A VAS pain score of 0 to 2 indicated that patients did not feel pain and no analgesia was needed. Patients were given ibuprofen extended-release capsules as a basal analgesic. Patients with a score of 3 to 4 (ie, mild pain, which they could not tolerate) received ibuprofen extended-release capsules (0.1 g orally) for analgesia. Those with a score of 5 to 6 (ie, which showed moderate pain) received ibuprofen extended-release capsules (0.2 to approximately 0.3 g orally) or indomethacin (100 mg anally). Patients with a score of 7 to 8 (ie, represented severe pain) received diazoxide (5 mg intramuscularly). Patients with a score of 9 to 10 (ie, described suffering from very extreme pain) received diazoxide (10 mg intramuscularly) or tramadol hydrochloride injection (100 mg intramuscularly). If pain persisted, assistance with nitrous oxide inhalation was used as an adjunct to medication.

eBCare: minimized sedation. Based on the eCASH concept, sedation could be unnecessary if the analgesia was effective. A Richmond Agitation-Sedation Scale score of −1 (drowsy) to 0 (alert and calm) indicated that the patient was comfortable and calm. Patients’ anxiety levels were assessed using the HAM-A scale, a 14-item instrument in which each item is scored on a scale of 0 (not present) to 4 (severe). In the current study, a score of 0 to 7 reported no anxiety and no need for intervention. For a score of 8 to 13 (ie, probable anxiety), eszopiclone and diazepam were recommended, and for a score of 14 to 20 (ie, definite anxiety), dexmedetomidine or midazolam was approximately administered. For a score of 21 to 28 (ie, definite marked anxiety), dexmedetomidine to midazolam was given. For scores of 29 and over (ie, probable severe anxiety), antidepressants were increased as prescribed. During treatment, bedside nurses were expected to provide prompt feedback on patients’ anxiety concerns. In addition to the use of medication, non-pharmacological treatments (eg, music therapy) were used to improve patient discomfort. After the daily bedside rounds, the nurses and attending physicians adjusted care as necessary and evaluated the effectiveness of those adjustments.

eBCare: maximizing humanistic care. The eCASH unit was equipped with a central thermostat with temperature-adjustable delivery that was set to ensure the appropriate temperature in the unit to prevent cold irritation of the wounds; this also provided localized limb warmth for patients’ needs. The ward was painted a warm pink color, and the beds were numbered after traditional Chinese positive numerals, such as 6 and 8, to provide subconscious psychological support to patients. The bedrooms were equipped with sofas and LCD televisions for daily activities and for patients visiting with their families. Soothing music and videos were played from 9 AM to 10 AM and from 2 PM to 3:30 PM to relieve patients’ tension and anxiety. The eCASH ward had bed curtains and soundproof panels between the beds to ensure patient privacy and reduce noise. The eCASH ward was limited to daytime visits only. Room lights were turned off from 10 PM to 8 AM to minimize stimulation and promote sleep. This rigorous care was given to reduce disturbance to patients at night.

eBCare: mental stimulation and early rehabilitation. Attending physicians and nurses communicated with patients appropriately during bedside rounds to answer questions. After the attending physicians had assessed a patient’s wound healing as stable, rehabilitators instructed the patient to commence functional training as soon as possible.

eBCare: family engagement. Under the direction of trained nurses and rehabilitators, family members and patients performed nonmedical procedures, such as assisting with limb training and postural placement. Families were also encouraged to actively participate in patients’ rehabilitation activities, and video tutorials on assisting patients’ training were made available to family members. 

Both groups. For all patients, wound healing was measured on day 7 and day 14 after intervention. 

Reliability and validity

All scales used in the study were validated and demonstrated good reliability (Cronbach α > 0.8) and validity.

Primary outcomes

The VAS is one instrument used to measure pain. This scale uses a combination of facial expressions and numbers along a horizontal line, from 0 (no pain) on the left to 10 (worst pain) on the right.¹⁸ The HAM-A scale is a self-rating scale containing psychological and physical symptoms.¹⁹ It includes 14 symptom-defining elements, each of which is rated on a scale of 0 (not present) to 4 (severe). 

The wound healing rate reflects wound percent area reduction on 7 and 14 days after the intervention and was calculated using ImageJ software: (wound healing rate = [original wound area − residual wound area] / original wound area × 100%). According to the diagnostic treatment criteria for trauma in traditional Chinese medicine,²⁰ a wound healing rate of 100% indicated complete healing, and a rate of 75% indicated effective healing.

Secondary outcomes

Patient heart rate was used as a physiological measure of pain,^21,22 and the PSAS of the POSAS was used for patients to self-report the long-term outcome of post-burn scarring. The PSAS consists of 6 items on scar characteristics (pain, itching, color, stiffness, thickness, and irregularity) and an overall patient rating of the scar.²³ Each item is rated on a scale of 1 to 10, with 1 indicating no difference in the scar compared with normal skin and 10 indicating the worst imaginable degree of scarring, with a major difference compared with normal skin.

Statistical analysis

All data were analyzed using SPSS for Windows version 25.0 (IBM Corporation). For qualitative data, the chi-square test and Fisher exact test were used to compare the frequencies of the 2 groups, presented as number (%). For quantitative data following normal distributions, an independent-samples t test was adopted for comparisons between the 2 groups, which were presented as mean ± SD. For quantitative data with nonnormal distributions, between-group differences were analyzed using the Mann-Whitney U test and presented as median (IQR). Statistical significance was set at alpha of .05.

Ethics

This study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Affiliated Hospital of Jiangnan University. Informed consent was signed by all participants in this study.

Seventy patients were included in the analysis. Table 1 reports the epidemiology of the patients’ burn characteristics and compares their baseline levels. The majority of the 70 patients were male (43 males; 27 females). The mean patient age was 44.31 years ± 15.89 in the eBCare group and 45.23 years ± 15.62 in the control group. 

There were no significant differences between the 2 groups in terms of sex, age, burn area, body mass index, smoking history, drinking history, hypertension, diabetes, other comorbidities, body temperature, pulse rate, respiration rate, systolic blood pressure, diastolic blood pressure, VAS score, or HAM-A score (all P > .05). The 2 groups of patients were comparable in demographic and physiological aspects; this can serve as the basis for further research.

Primary outcomes

Pain. At dressing change 1, the median pain scores in the eBCare group were significantly lower than those of the control group both during the dressing change (MD, −5.00; 95% CI, −5.00 to −4.00; P < .001) and after new dressing application (MD, −5.00; 95% CI, −6.00 to −5.00; P < .001). Table 2 shows the same trend for dressing changes 2 and 3, with statistically significant differences between the 2 groups. 

Anxiety. From dressing change 1 through dressing change 3, the eBCare group had statistically lower calculated anxiety (HAM-A) scores compared with those of the control group (P < .001) during dressing change and after new dressing application. 

Wound healing rate. Wound healing rates were calculated on days 7 and 14 after the intervention. The analysis showed no statistical difference in median wound healing rates between the eBCare group and the control group on day 7 after the intervention (P = .755). On day 14 after the intervention, the median wound healing rate was significantly higher in the eBCare group (72.5 [range, 63.6–87.5]) than in the control group (66.7 [range, 57.2–75]) (MD, 7.50; 95% CI, 0.00-15.00; P = .029) (Table 2). 

Other outcomes

Median heart rate during dressing changes was very significantly lower in the eBCare group than in the control group at dressing change 1 (MD, −13; 95% CI, −16 to −10; P < .001), dressing change 2 (MD, −13; 95% CI, −16 to −10; P < .001), and dressing change 3 (MD, −7; 95% CI, −10 to −4; P < .001). However, the difference in median heart rate recorded after the 3 dressing changes was not significant between the 2 groups for dressing change 1 (P = .855), dressing change 2 (P = .822), or dressing change 3 (P = .696). (Table 2). 

At long-term follow-up (≥4 years), the mean PSAS scores were significantly closer to those of normal skin for the patients in the eBCare group (1.948 ± 0.457) compared with those in the control group (2.961 ± 0.833) (MD), −1.013; 95% CI, −1.611 to −0.415; P = .002) (Table 3). The median scar color score was significantly lower in the eBCare group (3 [range, 2–3]) compared with the control group (4 [range, 3–4]) (MD, −1; 95% CI, −2 to 0; P = .015). In addition, there was a significant difference in median scar thickness between the eBCare group (1 [range, 1–2]) and the control group (2 [range, 2–3]) (MD, −1; 95% CI, −1 to 0; P = .023). The results of the PSAS should be interpreted with caution, however, owing to the small number of patients with available data.

Several studies have highlighted the importance of early and effective burn care in improving patient outcomes.^24,25 However, there is a lack of consensus concerning the best approach, making the present study pertinent.

In the current study, patient VAS scores and heart rates—which are vital subjective and objective indicators of pain—indicated that those who received the eBCare intervention had significantly lower levels of pain than those in the control group. Pain relief for patients during dressing changes can effectively be achieved through the implementation of planned analgesia guided by the eCASH concept. Chester et al²⁶ also measured heart rate to assess changes in pain; in their studies, an increase in heart rate indicated an increase in pain. 

Similarly, in the current study the HAM-A scores at the first 3 dressing changes all showed significantly lower anxiety levels in the eBCare group compared with the control group. Nurses used the HAM-A scale to initially determine whether patients had anxiety symptoms and to provide early psychological intervention. In this study, a psychological intervention treatment based on the eCASH concept in the early stages of treatment was effective in reducing patients’ anxiety. Patients with burns often experience sleep disorders and significant stress, and the body’s immune function is compromised, which slows wound healing. The current study incorporated the sleep-promoting strategy advocated by eCASH.¹¹ As mentioned above, nursing staff sought to promote sleep through regulating the ward environment and nursing activities, centralized nursing operations, reducing nighttime light and noise, using earplugs, and listening to soothing music in an effort to maintain a normal sleep-wake rhythm, which may be useful. After environmental noise was reduced, wound healing time was reduced as well. 

The follow-up rate of 31.43% (n = 22) was lower than expected, with 68.57% of patients (n = 48) having no follow-up. Reasons for lack of follow-up included invalid contact details (n = 30), refusal to participate in follow-up visits (n = 16), and death (n = 2). Some patients expressed the view that follow-up years later would not be meaningful for skin recovery and might incur associated costs, while others said they were not obliged to cooperate with follow-up visits. This indicated a need to strengthen health education for patients so that they understand burn-related information and the significance of follow-up visits. Two patients reported that small blisters appeared on the healing edges of their burns during the 4 years after healing and that the blisters healed independently in about 1 week. Other similar studies reported follow-up rates of 48.5%,²⁷ and patients with psychiatric disorders had follow-up rates of 49.38%.²⁸ 

Physical and mental health and quality of life of patients with burns deteriorate over time 20 years after the injury. The effects of burns on the neuro-endocrine-immune system and other systems could accompany the patient for life; Barrett et al deemed that burn injury was associated with a number of secondary pathologies, many of which appear long after the initial injury had healed.²⁹ In addition, the scars of varying degrees after the burn injury would not only affect the appearance and function, but also cause subsequent economic burden and social obstacles, which might often result in long-term physical and psychological sequelae.^6,30,31 Luo et al³² suggested that burns should be regarded as a chronic disease, with a focus not only on wound closure but also on long-term improvements in outcomes after healing. Thus, additional study is needed on long-term follow-up of burn healing to inform theory and clinical practice. 

Long-term adherence to follow-up care of burn injury decreases over time, mostly owing to socioeconomic factors such as transportation modes, costs, educational attainment, and insurance type.^29,33 This makes it difficult to study the long-term effects of burn care. To effectively improve the efficiency of follow-up, the following improvements to medical services could be considered: (1) Before discharge, assign patients targeted, specific rehabilitation interventions and inform them of the purpose and plan of the follow-up, thereby gaining patient acceptance and cooperation in advance. (2) Register as many valid patient contact details as possible to avoid losing contact. (3) Burn and trauma clinics could consider providing carpooling services for patients to attend follow-up appointments in clinics. 

The findings of this study have substantial implications for nursing practice and education. The authors emphasize the need for specialized training in burn care and recommend incorporating this knowledge into the nursing curriculum. 

In addition, the authors of the present study noted the vulnerability of elderly people in burn healing. In the future, the authors plan to investigate whether eBCare is equally effective in the elderly population and adapt the eBCare intervention to improve precision care and provide practical experience in establishing standard burn care processes in hospitals. Further research is needed to determine whether nurse-led eCASH concept-based care could have the same positive effect on more severe burn wounds. 

One of the major limitations of this study is its small sample size. This restricts the generalizability of the findings. Future research should aim to include a more diverse patient population and perhaps employ multicenter trials to improve the robustness of the data. Another limitation is that implementing eCASH concept-based care requires a high level of commitment from and training of the care team. The authors of the current study had to propose and then educate staff to adopt this new approach as well as had to overcome some resistance and challenges. The attitudes and satisfaction of the care team toward this method, which could be an important factor for its sustainability and scalability, were not evaluated. Future studies should include the perspectives of both the care providers and the patients. A third limitation is that the incremental cost of eCASH concept-based care in terms of the additional staff and facilities required was not estimated. This is an important factor that may affect the feasibility and sustainability of eCASH in different hospitals. The authors plan to conduct a cost-effectiveness analysis of eCASH in future research, based on their experience and the relevant literature.

Recent and long-term studies indicate that eBCare can relieve pain and anxiety and can improve the quality of wound healing. The findings of this study suggest that application of the eCASH concept could benefit patients with small-area burns. Thus, for patients with burns health care providers should focus on early intervention to accelerate healing.