Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Treatment group
研究概览
简要总结
ACE is a clinical decision support system for selecting appropriate products for the local treatment of chronic wounds. It was designed with a user-centered approach, and its usability and feasibility have been previously validated in pilot studies with nurses. This protocol will allow for the clinical validation of the software in 18 primary care centers, including the quantification of the clinical and economic effects of using the tool over 9 months. It is a mixed-methods design that includes a randomized controlled trial in which nursing staff incorporate the use of ACE into their routine clinical practice to support their decision-making process for chronic wound treatment. It also includes a usability evaluation throughout the study.
详细描述
To estimate the clinical and economic impact of ACE, wounds will be reviewed at baseline and every two weeks until closure or until the end of the study period. Wound size will be recorded, and whether or not the wound is closed will be noted, with a maximum follow-up period of 16 weeks. A follow-up will be conducted four weeks after wound closure to assess wound dehiscence or other adverse events. Given these wound follow-up periods, only wounds incurred during the first three months of the study, after the completion of professional recruitment and training, will be included for those assigned to the ACE group. A longitudinal study will be conducted in 18 primary care centers in Galicia.
Once the study period is complete, the clinical and economic impact will be evaluated by comparing the following indicators between the two groups: the primary outcome will be wound closure, and secondary outcomes will include wound evolution (including its size every two weeks from the first ulcer assessment and wound bed tissue assessment), length of hospital stay, readmissions, incidence of hospital-acquired injuries, and the cost of products used for wound treatment. Comparative analyses will be performed by subdividing the groups according to the users' experience in chronic wound treatment at the start of the study and according to the type of chronic wound. In addition, instances in which users in the ACE group choose not to follow the application's recommendations will be recorded and quantified.
To evaluate the usability and acceptability of ACE by nursing staff, validated quantitative and standardized tools will be used. Only professionals assigned to the ACE group will participate, using ACE as a decision support tool whenever they need to select products for wound treatment. On one day during the second week of months 2, 4, and 6, the usability and acceptance of the application will be evaluated by the professionals assigned to the ACE group using the System Usability Scale (SUS). Simultaneously, the NASA TLX scale, which quantifies mental workload as an aspect of usability, will be evaluated in both groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare professionals responsible for selecting products for the local treatment of chronic, curable wounds in adult patients.
- •Patients with chronic wounds, aged 18 to 100 years.
- •Patients with wounds healing by secondary intention, aged 18 to 100 years.
- •Patients and/or professionals who have signed the informed consent form for the study.
排除标准
- •Wounds of patients with acute surgical wounds, aged between 18 and 100 years.
- •Images containing features that allow patient identification, such as tattoos and/or moles, or where part of the face is visible.
- •Wounds corresponding to third-degree burns, tumor wounds, ischemic ulcers, pyoderma gangrenosum, and ulcers with osteomyelitis without systemic antibiotic treatment.
- •Patients and professionals who declined to participate after reading the report Informed Consent Form.
- •Exclusion criteria:
- •During the study, exclusion criteria include wounds lost to follow-up before completing 4 weeks of treatment, except for those that complete follow-up due to wound healing and discharge. Additionally, healthcare professionals and patients who withdraw their consent and wish to leave the study will be excluded.
结局指标
主要结局
Treatment group
时间窗: Day 0
ACE or non-ACE
Health center
时间窗: Day 0
Open Field
Years of experience of healthcare professionals
时间窗: Day 0, at the start of the professional's participation
Years of experience of healthcare professionals in healing chronic wounds
Gender
时间窗: Day 0, at the start of recruitment
Male or female
Recurrent medication
时间窗: Day 0, at the start of recruitment
Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.
Date of first consultation
时间窗: Day 0, at the start of recruitment
Date
Reason of loss to follow-up (if applicable)
时间窗: Day of loss to follow-up after follow-up
Open field
Tissues in the wound bed
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Indicate the following option(s): Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema
Exudate level
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Select one of the options: 0 none, 1 scarce, 2 moderate, 3 abundant
Training of healthcare professionals
时间窗: Day 0, at the start of the professional's participation
Academic training of healthcare professionals
SUS
时间窗: At month 1, month 3 and month 5 after the professional's participation
Score obtained after completing the System Usability Scale questionnaire
Patient age
时间窗: Day 0, at the start of recruitment
Patient's age in years
NASA TLX
时间窗: At month 1, month 3 and month 5 after the professional's participation
Score obtained after completing the NASA TLX questionnaire
Wound location
时间窗: Day 0, at the start of recruitment
Open field
Date of loss to follow-up (if applicable)
时间窗: Day of loss to follow-up after follow-up
Date
Use of ACE?
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Yes or No
Wound size
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Width, length and depth (if applicable) measured in cm
Dominant tissue in the wound bed
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Select one of the options: Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema
Adverse Event classification (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Indicate the following option(s): Severe, Not severe, Expected, Unexpected, Related, Possibly related, Not related
Measure taken after Adverse Event (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Select one of the options: None, Change of treatment, Other.
Diseases
时间窗: Day 0, at the start of recruitment
Indicate, if applicable, the following option(s): DM I or II, venous and/or arterial insufficiency, ischemia, obesity, osteomyelitis, diabetic neuropathy, others.
History of chronic wounds
时间窗: Day 0, at the start of recruitment
Indicate, if applicable, etiology, highest classification, location, and if healed, the approximate closing date.
Number of wounds in the same patient
时间窗: Day 0 and follow-up day every 2 weeks until end of recruitment
Number
Date of wound closure
时间窗: Day of wound closure after follow-up
Date
Allergies
时间窗: Day 0, at the start of recruitment
Open field
Date of treatment decision
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Date
Condition of the perilesional skin
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Indicate the following option(s): Macerated, Erythema or inflammation, Eczema, Fragile skin
Etiology of the wound
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Select one of the options: LESCAH, Diabetic foot, Burn, Arterial, Pressure, Venous, Not determined
Category of the wound
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Indicate the corresponding one according to the selected etiology: LESCAH: 1A/1B/2A/2B; Diabetic foot (Wagner): I/II/III/IV/V; Burn: 1st/2nd/2nd deep/3rd; Arterial: hypertensive ulcer (of Martorell)/arteriosclerotic ulcer/angitic ulcer (of Buerger); Pressure: I/II/III/IV; Venous: C2 (varicose veins)/C3 (edema)/C4a (pigmentation and/or eczema)/C4b (lipodermatosclerosis or white atrophy)/C5 (healed ulceration)/C6 (active ulceration).
Applied products
时间窗: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Indicate the following option(s): Actisorb plus 25, Allevyn Adhesive 12, Allevyn Gentle Border 7, Allevyn Heel 13, Allevyn Sacrum 22 x 22 cm, Aquacel Ag, Aquacel Ag + Extra, Aquacel Ag Tape, Aquacel Ag Foam, Aquacel tape, Aquacel Extra, Adhesive Aquacel Foam, Non-Adhesive Aquacel Foam, Aquacel foam pro, Askina carbosorb, Biatain Contact, Biatain non adhesive, Biatain, Silicone with border, Biatain Silicone Without Rim, Cavilon, Comfeel plus sacral, Comfeel plus transparent, Convamax Superabsorb, Conveen Protact, Corpitol, Topical corticosteroid, Cutimed Alginate, Cutimed Sorbact, Cutmed Epiona, Non-sterile Granudacyn, Transparent Hydrotac, Intrasite gel, Iodosorb, Iruxol, Mepilex Border Flex Lite, Mepilex border flex oval, Mepilex border sacrum, Microdacyn 60 Sterile, Trionic, Urgo K2, Urgoclean, Urgoclean AG, Urgostart Plus Pad, Urgotul, Urgotul AG, Varihesive Extra Fine, Varihesive Gel Control, Vliwaktiv AG, Others.
Date of Adverse Event (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Date
Description of Adverse Event (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Open field describing the event, device deficiency (if applicable), clinical signs, clinical impact, patient action/treatment/outcome.
Outcome of the Adverse Event (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Select one of the options: Recovered, Recovering, Not recovered, Recovered with sequelae, Fatal, Unknown
Date of resolution of the Adverse Event (if applicable)
时间窗: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Date
次要结局
未报告次要终点