Enhancing SKIN Health and Safety in Aged CARE (SKINCARE)

PD Dr. Jan Kottner

Status: Completed

Conditions: Skin Tear; Xerosis Cutis; Incontinence-associated Dermatitis; Pressure Ulcer; Intertrigo; Dry Skin; Skin Care; Pruritus

Treatments: Other: Implementation of skin care algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03824886

CRC-SP-A-30

Details and patient eligibility

About

Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo and many more. Prevention of these skin problems and the provision of general hygiene and skin care activities are key areas of nursing practice. Numerous condition specific guidelines are available and are implemented separately. The more guidelines exist, the more difficult it is for nurses to implement them all. On the other hand, there is a huge overlap in terms of aetiology, pathogenesis and prevention of aforementioned skin conditions.

The overall aim of this trial is to test the feasibility and to estimate possible effects of a comprehensive skin care package targeting main nursing relevant skin problems at the same time. Therefore a study will be performed in nursing homes of the state of Berlin comparing the skin care package to standard care. Residents' safety and subjective wellbeing will increase combined with improvements in professional competence of nurses. An advisory board consisting of international experts agreed already to supervise the trial.

Full description

Objectives and aims:

Aged and care dependent patients suffer from many adverse skin conditions like xerosis cutis (including pruritus), pressure ulcers, skin tears, intertrigo and incontinence-associated dermatitis. Separate preventive strategies for these particular risks and diseases are available and partly implemented. Although distinct clinical diagnoses, there are substantial overlaps in terms of etiology (e.g. skin fragility, immobility) pathophysiology, prevention (e.g. safe handling, off-loading) and treatment (e.g. skin protection and care). Facilities are challenged to implement fragmented, condition-specific guidelines, neglecting shared etiologies and prevention and treatment principles, which has been shown to be an important barrier for implementation of evidence-based practice.

Recently an evidence-based comprehensive skin care algorithm was developed. The objective of this trial is to investigate the feasibility of the implementation of this skin care package, to describe context factors for implementation, to estimate effect sizes and intracluster coefficients.

Study design:

An exploratory cluster randomized trial in aged nursing home residents will be conducted. The cluster design was chosen to avoid contamination between groups. A total of n = 500 residents from n = 20 nursing homes (randomly selected from the population of nursing homes of the state of Berlin) will be included in the study. In the intervention group (n = 10 nursing homes), the developed evidence-based algorithm will be implemented. The control group (n = 10 nursing homes) receives the usual standard care of the respective nursing home.

Enrollment: 405 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/ Exclusion Criteria for Residents:

Inclusion Criteria:

• Living in the nursing home,
• 65+ years,
• 'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social Law)),
• Written informed consent (by legal representative if required)

Exclusion Criteria:

• Residents at end of life,
• Any dermatological condition or skin affection requiring dermatological treatment,
• Known allergies to any product ingredients

Inclusion/ Exclusion Criteria for Nursing Homes:

Inclusion Criteria:

• Nursing home in the federal state of Berlin with at least n = 70 or more residents.
• Expression of a clear commitment to implement the skin care algorithm if assigned to the intervention group,
• Valid pressure ulcer prevention standard/algorithm is in place,
• Written commitment to adherence to the trial procedures regardless of the outcome of randomisation. Exclusion criteria:
• Nursing homes with less than n = 70 residents in the federal state of Berlin.

Exclusion Criteria:

• Nursing homes with less than n = 70 residents in the federal state of Berlin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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405 participants in 2 patient groups

Implementation of skin care algorithm

Experimental group

Description:

In the interventional nursing homes, a structured skin care prevention package based on a newly developed evidence-based skin care algorithm will be implemented at the nursing homes and delivered by nurses.

Treatment:

Other: Implementation of skin care algorithm

Standard Care

No Intervention group

Description:

In the control group, no additional intervention will be implemented. PU and IAD prevention and basic hygiene and skin care activities are routinely conducted in German nursing homes. This is considered as 'usual practice'.