Wound Care and Pressure Injury Through the Continuum of Care

November 24, 2020 updated by: Charleen Singh, Regional Medical Center of San Jose
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

352

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95116
        • Regional Medical Center San Jose

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Wounds
Patient with either traumatic or surgical wounds
Chronic Wounds
Patient with chronic wounds either peripheral vascular disease related or surgical/traumatic wound
Pressure Injuries Present on Admission
Patient admitted with one or more pressure injury of any stage on admission
Other: Standardized nursing care
All patients will receive standardized evidence based nursing care
At Risk for Pressure Injury
Patient admitted with risk for pressure injury and has no pressure injuries at time of admission. Identified as at risk for based on mobility.
Other: Standardized nursing care
All patients will receive standardized evidence based nursing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year
Rate of wound healing
1 year
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.
Time Frame: 1 year
Number of individuals who are at risk to develop a pressure injury actually develop pressure injuries
1 year
The implementation of an evidence based pressure injury prevention bundle for patients with existing pressure injuries will prevent new pressure injuries from occurring
Time Frame: 1 year
Measurement of occurrence of new pressure injuries for individuals with existing pressure injuries
1 year
The extension of a best practice prevention bundle implemented in acute-care and extending into post-acute care will reduce fiscal expenditure.
Time Frame: 1 year
Comparison of number of individuals admitted from post acute with pressure injuries to acute acute after receiving education and the fiscal impact.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Medical Center of San Jose

Investigators

  • Study Chair: Lee Thorpe, MSN, Regional Medical Center San Jose

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1267389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data is coded and stored on the hospital password protected server. We don't plan to share the data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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