Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

Sponsor

Scotiaderm (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05760469

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Incontinence-associated Dermatitis Moisture Associated Skin Damage Intertrigo	Other: Screening	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Data for this study will be collected daily until you are discharged from the hospital, up to a maximum of 7 days. Study data will be collected by the nurses/research assistants during regular patient check-ins and will require minimal time to complete (15-20min maximum). Participants for the study will be identified by nursing staff from patients admitted to the Valley Regional Hospital. After informed consent, where possible, 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.Data for this study will be collected daily until you are discharged from the hospital, up to a maximum of 7 days. Study data will be collected by the nurses/research assistants during regular patient check-ins and will require minimal time to complete (15-20min maximum). Participants for the study will be identified by nursing staff from patients admitted to the Valley Regional Hospital. After informed consent, where possible, 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.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

ITD-IAD-M Assessment tool [7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Scotiaderm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scotiaderm

ClinicalTrials.gov Identifier:

NCT05760469

Other Study ID Numbers:

Seeing Red

First Posted:

Mar 8, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis

Intertrigo

Study Results

No Results Posted as of Mar 15, 2023