Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tehran University of Medical Sciences | OTHER |
| Hamadan University of Medical Science | OTHER |
| Tabriz University of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.
The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities. These components are categorized into three groups to facilitate understanding and enhance patient engagement in PIP care: (1) Education; (2) assessment of patient's condition; and (3) Care intervention. Therefore, the investigators will conduct a c-RCT with three arm parallel design for hospitalized patients to assessed the effect of IDEAL SKIIN CARES bundle to prevent of occurrence HAPI in three groups of study and compare with routine standard care for PIP care bundle.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Educational packages including a pamphlet, brochure, and visual poster that outlines three key components of the IDEAL SKIIN CARES bundle (Education, Assessment of patient's condition and Care intervention) will be provided along with sub-items. These materials will be explained in detail by a trained research assistant in a workshop. Patients will be encouraged by the research assistant to actively participate in PIP self-care activities following the IDEAL SKIIN CARES approach shortly after recruitment and will continue to provide patient education throughout the study period. This training will begin before data collection and will be maintained as needed. Each hospital's study investigator will oversee the training activities at their site to guarantee consistency and adherence to the intervention protocol. In addition, patients will receive the IDEAL SKIIN CARES bundle from WSNs. |
|
| Placebo group | Placebo Comparator | The placebo group will receive training in an unrelated topic, specifically respiratory care. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care, mirroring the approach taken with the intervention group. Despite the focus on respiratory care education, patients in the placebo group will also benefit from specialized PIP care through the IDEAL SKIIN CARES bundle, administered by trained WSNs. These WSNs will provide interventions focused on PIP strategies based on the IDEAL SKIIN CARES bundle, ensuring that patients in the placebo group receive comprehensive wound care support throughout the study period. |
|
| Control group | No Intervention | The control group will not receive any relevant or irrelevant training or educational materials. They will only receive routine standard care for the PIP care bundle, following the care plans as routine by the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEAL SKIIN CARES bundles | Other | The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in the intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospital-acquired pressure injury (HAPI) | All patients in the three groups will be closely monitored for the development of HAPI. Two independent and experienced WSNs will oversee the intervention and placebo groups, while two independent and experienced research assistants will supervise the control group. They will conduct separate examinations of the patients to assess the presence or absence of PI, following the NPUAP guidelines. These assessments will occur three times a day during morning, evening, and night shifts to ensure comprehensive monitoring of at-risk patients, and with daily evaluations for patients without PI risk factors. The occurrence time of PI will be recorded for each patient based on the day. To ensure consistency and accuracy in PI assessment, the agreement between the two assessors will be evaluated using the Kappa agreement test for inter-rater reliability | Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Injury Stage | Wound specialist nurses and experienced research assistants will determine the stage of PIs among patients and monitor the progression of PI stages (increased severity in PI stages) in all three study groups. The stages of a pressure ulcer typically range from Stage 1 to Stage 4, with each stage indicating the severity of tissue damage. The assessment of PI stages will involve evaluating factors such as skin integrity, tissue involvement, and the presence of necrosis. Any changes in the stage of a PI will be carefully documented to track the progression of the injury over time. To ensure consistency and accuracy in PI stage determination, the agreement between the two assessors will be evaluated using the Kappa agreement test for inter-rater reliability on stage of PI. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir vahedian-azimi, Professor | Contact | 09196017138 | 0098 | amirvahedian63@gmail.com |
| Keivan Goharimoghadam, Professor | Contact | 09128116381 | 0098 | kgoharimoghadam@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amir vahedian-azimi, Professor | Baqiyatallah University of Medical Sciences, Tehran, Iran. | Principal Investigator |
| Keivan Goharimoghadam, Professor | Tehran University of Medical Scienecs, Tehran, Iran | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41887642 | Derived | Bahramnezhad F, Probst S, Moradi A, Gohari-Moghadam K, Rahimi-Bashar F, Mahmoodpoor A, Ghamari AA, Jafari I, Vahedian-Azimi A, Pokorna A. Development and validation of the Pressure Injury after Hospital Admission (PIAHA) screening tool for early assessment of hospital-acquired pressure injuries: a multiphase multicentre study protocol in acute care settings. BMJ Open. 2026 Mar 26;16(3):e114550. doi: 10.1136/bmjopen-2025-114550. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group.
Not provided
Not provided
In this placebo-controlled trial, patients will be blinded to their group allocations. Additionally, WSNs, who are trained for delivering special PIP care bundles, as well as nursing staff who are responsible for measuring wounds and collecting data, and data analyst, will also be blinded.
|
| IDEAL SKIIN CARES bundles workshop | Other | IDEAL SKIIN CARES bundles will be explained in detail by a trained research assistant in a workshop. This workshop is different from clinical training and following up about the IDEAL SKIIN CARES bundles. |
|
| Respiratory care workshop | Other | An unrelated topic, specifically respiratory care will be held in a workshop. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care |
|
| Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days |
| Patient participation in care | When patients reach the trial endpoint, the assessor (the research assistants and WSNs) will utilize the Patient Participation Scale as a secondary outcome measure. | Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days |
| Healthcare costs | The costs linked to providing the IDEAL SKIIN CARES bundle, including time spent on patient education, training WSNs, and developing educational resources like brochures, posters, and pamphlets, will be gathered for all participants in the trial. Additionally, data on the length of hospital stays will be collected. Over a 28-day observational period, detailed micro-costing data will be collected by a dedicated research assistant. Specifically, the number of repositioning episodes per participant, the clinical staff required for repositioning, and the nurse time needed per repositioning will be determined. Other resources utilized for IDEAL SKIIN CARES or standard care bundles, such as special mattresses, skincare products, and incontinence care, will also be documented. The direct costs will then be allocated to each resource unit using established costing references. | Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days |
| Self-report Patient participation in care | Patients will be asked to self-report their level of participation in PIP by providing a score from 0 to 10. This self-assessment will offer insights into the patient's perception of their involvement in their care plan. | Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days |
| Farshid Rahimi-bashar, Professor | Hamadan University of Medical Sciences, Hamadan, Iran. | Study Director |
| Ata Mahmoodpoor, Professor | Tabriz university of Medical Sciences, Tabriz, Iran. | Study Director |