IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

NCT ID: NCT06369688

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-10-01

Brief Summary

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.

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.

Conditions

Pressure Ulcer; Pressure Injury; Bed Sore; Pressure Sore; Decubitus Sore; Decubitus Ulcer; Skin Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IDEAL SKIIN CARES bundles

Intervention Type: 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.

IDEAL SKIIN CARES bundles workshop

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

IDEAL SKIIN CARES bundles

Intervention Type: 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.

Respiratory care workshop

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: collaborator

Hamadan University of Medical Science

OTHER

Sponsor Role: collaborator

Tabriz University of Medical Sciences

OTHER

Sponsor Role: collaborator

Baqiyatallah Medical Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Amir Vahedian-Azimi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir vahedian-azimi, Professor

Role: PRINCIPAL_INVESTIGATOR

Baqiyatallah University of Medical Sciences, Tehran, Iran.

Keivan Goharimoghadam, Professor

Role: STUDY_DIRECTOR

Tehran University of Medical Scienecs, Tehran, Iran

Farshid Rahimi-bashar, Professor

Role: STUDY_DIRECTOR

Hamadan University of Medical Sciences, Hamadan, Iran.

Ata Mahmoodpoor, Professor

Role: STUDY_DIRECTOR

Tabriz university of Medical Sciences, Tabriz, Iran.

Central Contacts

Amir vahedian-azimi, Professor

Role: CONTACT

amirvahedian63@gmail.com

09196017138 ext. 0098

Keivan Goharimoghadam, Professor

Role: CONTACT

kgoharimoghadam@gmail.com

09128116381 ext. 0098

Other Identifiers

Baqiyatallah University

Identifier Type: -

Identifier Source: org_study_id