Clinical trial NCT04649853: Wound Care and Pressure Injury Through the Continuum of Care
Official title: Wound Care and Pressure Injury Through the Continuum of Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Pressure Injury
Lead sponsor: Regional Medical Center of San Jose
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target study sample are adults who have either an acute wound, chronic wound, pressure injury or at risk for a pressure injury that are admitted to the acute care organization. The primary site is a community based acute-care organization. Patients will be identified upon admission.

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.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria includes:

* 18 years and older
* admitted into acute care with acute wound
* admitted with chronic wound
* admitted with pressure injury
* at risk for pressure injury

Exclusion Criteria:

* pregnant patients
* patients under 18
* known vascular disease

Primary outcomes:
measure: The implementation of evidence-based best practice for wound care in the acute-care setting that is extended into post-acute care will improve outcomes.
timeFrame: 1 year
measure: The implementation of an evidence based pressure injury prevention bundle in acute care that is extended into post-acute care will prevent pressure injuries in high-risk patients.
timeFrame: 1 year
measure: The implementation of an evidence based pressure injury prevention bundle for patients with existing pressure injuries will prevent new pressure injuries from occurring
timeFrame: 1 year
measure: The extension of a best practice prevention bundle implemented in acute-care and extending into post-acute care will reduce fiscal expenditure.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Regional Medical Center San Jose
state: California
Study officials:
affiliation: Regional Medical Center San Jose
name: Lee Thorpe, MSN
role: STUDY_CHAIR
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