Clinical trial NCT06369688: IDEAL SKIIN CARES Bundle to Prevent Pressure Injury
Official title: Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
name: Hamadan University of Medical Science
name: Tabriz University of Medical Sciences
First posted: 2024-04-17
Enrollment: 1620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of hospital-acquired pressure injury (HAPI)
timeFrame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Secondary outcomes:
measure: Pressure Injury Stage
timeFrame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
measure: Patient participation in care
timeFrame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
measure: Healthcare costs
timeFrame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
measure: Self-report Patient participation in care
timeFrame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Baqiyatallah University of Medical Sciences, Tehran, Iran.
name: Amir vahedian-azimi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Scienecs, Tehran, Iran
name: Keivan Goharimoghadam, Professor
role: STUDY_DIRECTOR
affiliation: Hamadan University of Medical Sciences, Hamadan, Iran.
name: Farshid Rahimi-bashar, Professor
role: STUDY_DIRECTOR
affiliation: Tabriz university of Medical Sciences, Tabriz, Iran.
name: Ata Mahmoodpoor, Professor
role: STUDY_DIRECTOR
References: