IDEAL SKIIN CARES Bundle to Prevent Pressure Injury (IdealSkinCares)

Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Ulcer; Pressure Ulcer; Pressure Injury; Decubitus Ulcer; Pressure Sore; Bed Sore; Decubitus Sore
• Intervention / Treatment: Other: IDEAL SKIIN CARES bundles; Other: IDEAL SKIIN CARES bundles workshop; Other: Respiratory care workshop

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1620
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir vahedian-azimi, Professor; Phone Number: 0098 09196017138; Email: amirvahedian63@gmail.com
• Study Contact Backup: Name: Keivan Goharimoghadam, Professor; Phone Number: 0098 09128116381; Email: kgoharimoghadam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• be adults aged 18 years or older;
• have been hospitalized for a minimum of 48 hours;
• be willing to participate.

Exclusion Criteria:

• patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;
• have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);
• be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);
• individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;
• patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;
• admitted to the hospital for >28 days;
• those with prior experience of PIs or training in PIs care and prevention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Other: IDEAL SKIIN CARES bundles; 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.; Other: IDEAL SKIIN CARES bundles workshop; 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.
Placebo Comparator: Placebo group; 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.	Other: IDEAL SKIIN CARES bundles; 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.; Other: Respiratory care workshop; 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
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University
• Collaborators: Tehran University of Medical Sciences; Hamadan University of Medical Science; Tabriz University of Medical Sciences
• Investigators: Principal Investigator: Amir vahedian-azimi, Professor, Baqiyatallah University of Medical Sciences, Tehran, Iran.; Study Director: Keivan Goharimoghadam, Professor, Tehran University of Medical Scienecs, Tehran, Iran; Study Director: Farshid Rahimi-bashar, Professor, Hamadan University of Medical Sciences, Hamadan, Iran.; Study Director: Ata Mahmoodpoor, Professor, Tabriz university of Medical Sciences, Tabriz, Iran.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Pressure Injury; Care Bundle; Hospital-acquired pressure injury; IDEAL SKIIN CARES
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer; Skin Ulcer
• Other Study ID Numbers: Baqiyatallah University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No