Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

Seeing Red: Towards Improving 'Recognition, Documentation and Outcome 'Measurement of Incontinence-associated 'Dermatitis and Intertrigo

This research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (IAD) and intertrigo (ITD)) at Valley Regional Hospital.

This is an exploratory study to assess the utility and accuracy of a structured documentation tool for IAD and ITD in hospitals. Current documentation involves a mostly verbal description of the location, size, and general features of the rash. Without a standardized approach to documentation, it can be challenging to accurately evaluate the evolution of the rash and the response to treatment from day to day and from different nurses. The reliability of the documentation tool will be assessed by comparing the results of the bedside assessment tool with that completed by wound care experts using standardized digital live photographs. The utility documentation tool from a nursing perspective will also be assessed using a structured questionnaire. Analysis of digital live photographs using a standard algorithm will be done to determine whether such an analysis can objectively and accurately track the healing of moisture-associated skin damage.

Study Overview

• Status: Not yet recruiting
• Conditions: Intertrigo; Incontinence-associated Dermatitis; Moisture Associated Skin Damage
• Intervention / Treatment: Other: Screening

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann K Gordon, MD; Phone Number: 902-698-8372; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≥ 18 years
• Intertrigo (ITD) and or incontinence-associated dermatitis (IAD)
• Expected length of stay of seven (7) days
• life expectancy greater than one week
• written informed consent by the patient or his/her representative including explicit consent to take daily photographs of the rash associated with MASD.

Exclusion Criteria:

• known allergy to standard MASD treatments
• life expectancy less than seven days
• complex skin disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Screening Rash; This is an exploratory study to assess the usefulness and reliability of the ITD-IAD-M for diagnosing, tracking, and treating IAD and ITD in hospitals.Participants for the study will be identified by nursing staff from admitted patients. After informed consent, the primary care nurse will collect qualitative information from the patient based on the history of their skin condition, whether the rash is new or recurring for them, and their pain, irritation, and discomfort measures. All patients participating in the study will receive the standard of care for patients presenting with MASD as prescribed by their primary care physician. The nurse will complete the ITD-IAD-M tool daily along with routine patient care. Each day the nurse documents the rash status and whether the treatment can be stopped based on the nursing assessment. The nurse/research assistant will also take a standardized digital live picture of the rash (without any identifying features) daily for a maximum of 7 days.

Other: Screening; Clinical nurse (CN) notifies research coordinator (RC) about patients with rashes. RC assesses eligibility criteria of patient based on inclusion criteria. RC provide CN with appropriate documentation tool (DT), smart device (SD), standardized red adhesive label (SRAL), and adhesive QRcode. Intervention: With written informed consent, demographic information will be collected. QRcode adhesive will be placed in the DT to track subject documentation throughout the study. Baseline live photograph (LP) of the rash will be taken with SD at day 0. LP will be taken daily. A SRAL, and a QR adhesive code will be included in the LP. LP will be automatically saved in a secure file on the cloud server under the QR code. CN will complete the DT for all rashes included in the study. Treatment of the rash will be at the discretion of the clinical team; the treatment regimen will be recorded daily. The procedure will be repeated daily for all rashes during the patient stay to a maximum of 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ITD-IAD-M Assessment tool	The primary outcome measurement is the correlation between the assessment of the rash by the primary care nurse and the assessment by the wound care expert, with respect to the categorization of the rash, the surface area involvement, and the timing of termination of treatment.	7 days

Collaborators and Investigators

• Sponsor: Scotiaderm

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Intertrigo
• Other Study ID Numbers: Seeing Red

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study data will not be shared with other researchers.

Drug and device information, study documents

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