Viewing Study NCT04649853



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Last Modification Date: 2024-10-26 @ 1:50 PM
Study NCT ID: NCT04649853
Status: UNKNOWN
Last Update Posted: 2020-12-02
First Post: 2020-08-17

Brief Title: Wound Care and Pressure Injury Through the Continuum of Care
Sponsor: Regional Medical Center of San Jose
Organization: Regional Medical Center of San Jose

Study Overview

Official Title: Wound Care and Pressure Injury Through the Continuum of Care
Status: UNKNOWN
Status Verified Date: 2020-11
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Our primary objective is to understand the impact of our quality improvement objectives on pressure injury and wound care outcomes We will follow patients admitted to our facility who receive the standard of care for a up to a year Patients to be followed will fall into one of four groups acute wounds chronic wounds pressure injuries present at time of admission and at risk for pressure injuries
Detailed Description: Overall Objective The main objective is to understand the impact of an evidence-based best practice model for wounds and pressure injuries that follows a patient through the continuum of care

Specific Aims The specific aim is to measure the rates of healing using tissue analytics and the rates of pressure injuries

The secondary aim measured is patients understanding of their health and the impact on their wound healing prevention of wound re-opening and pressure injury

Once we identify the rates we can translate the impact of rates into healthcare dollars and begin to understand the fiscal impact of evidence based practice

BACKGROUND AND SIGNIFICANCE

Over the past decade researchers published the benefit of advanced wound care and the need to implement pressure injury prevention To date there is very little literature connecting the acute care and post-acute care as a continuum by following a patient Little is known about what the outcomes for wound care and pressure injury would be if a patient were followed through the trajectory of care The medical home model suggests that placing the patient at the center of care is the best practice for best outcomes However at times in the hustle of the healthcare system the patient is lost Implementing evidence-based best practice that follows the patient through the continuum of care is one approach to keeping the patient at the center of care Currently wound care and pressure injury care or prevention is practiced in silos between acute-care and post-acute care There is little literature that links the impact of continuing care throughout the continuum

RESEARCH DESIGN AND METHODS Overview This quantitative study will utilize both primary and secondary data The secondary data source will come from chart review and be the comparison group for outcomes Patients will be enrolled upon admission as they are identified as meeting criteria which includes either having a chronic wound that is not followed by a vascular team or an acute wound or a pressure injury The fourth group of individuals to be enrolled into the study are those patients who are immobile and are expected to remain immobile at the time of discharge Patients will be identified by admitting clinical staff and then enrolled and consented by the study coordinator or principal investigator Once enrolled in the study patients will have evidence based best practice interventions implemented based on their needs while in the acute care setting For patients with wounds this will include that their cover dressing will be an antimicrobial foam bordered dressing that minimizes dressing changes For immobile patients they will have the evidence based best practice pressure injury prevention bundle implemented During the acute care admission the patient will receive education regarding their wound care and or pressure injury prevention Once the target post-admission site is identified education for the caregiver at the receiving site will be provided The patient will continue to be followed in the post-acute setting until the wound is healed or six months has passed on a weekly basis for a maximum of time frame of one year The wounds will be measured weekly using tissue analytics Re-education and coaching will be provided to the post-acute care facility As patients are discharged from the study they will be asked to complete an evaluation survey of their satisfaction with the care and the impact on their lives The caregivers in the post-acute care will be asked to complete a survey to evaluate the education and support provided

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None