IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

NCT06369688 | Not Yet Recruiting DMC

• 1 other identifier: Baqiyatallah University
• Study Type: interventional
• Target: 1,620
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Pressure Injury; Care Bundle; Hospital-acquired pressure injury; Randomized Clinical Trial; IDEAL SKIIN CARES

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pressure Injury Stage

  Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days

• Patient participation in care

  Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days

• Healthcare costs

  Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days

• Self-report Patient participation in care

  Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days

Study Arms (3)

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.

Other: IDEAL SKIIN CARES bundles; Other: IDEAL SKIIN CARES bundles workshop

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.

Other: IDEAL SKIIN CARES bundles; Other: Respiratory care workshop

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.

Interventions

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.

Intervention group; Placebo group

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.

Intervention group

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead
• Tehran University of Medical Sciences: collaborator
• Hamadan University of Medical Science: collaborator
• Tabriz University of Medical Sciences: collaborator

MeSH Terms

Conditions

Pressure Ulcer; Skin Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

• 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

Central Study Contacts

Amir vahedian-azimi, Professor

CONTACT

09196017138; amirvahedian63@gmail.com

Keivan Goharimoghadam, Professor

CONTACT

09128116381; kgoharimoghadam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04