Wound Care and Pressure Injury Through the Continuum of Care
NCT ID: NCT04649853
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
352 participants
OBSERVATIONAL
2020-08-17
2021-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Acute Wounds
Patient with either traumatic or surgical wounds
No interventions assigned to this group
Chronic Wounds
Patient with chronic wounds either peripheral vascular disease related or surgical/traumatic wound
No interventions assigned to this group
Pressure Injuries Present on Admission
Patient admitted with one or more pressure injury of any stage on admission
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.
Standardized nursing care
All patients will receive standardized evidence based nursing care
Interventions
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Standardized nursing care
All patients will receive standardized evidence based nursing care
Eligibility Criteria
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Inclusion Criteria
* admitted into acute care with acute wound
* admitted with chronic wound
* admitted with pressure injury
* at risk for pressure injury
Exclusion Criteria
* patients under 18
* known vascular disease
18 Years
ALL
Yes
Sponsors
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Regional Medical Center of San Jose
OTHER
Responsible Party
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Charleen Singh
Director of Wound Care Services
Principal Investigators
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Lee Thorpe, MSN
Role: STUDY_CHAIR
Regional Medical Center San Jose
Locations
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Regional Medical Center San Jose
San Jose, California, United States
Countries
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References
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Pal A, Goswami D, Cuellar HE, Castro B, Kuang S, Martinez RV. Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. Biosens Bioelectron. 2018 Oct 15;117:696-705. doi: 10.1016/j.bios.2018.06.060. Epub 2018 Jul 5.
Brain D, Tulleners R, Lee X, Cheng Q, Graves N, Pacella R. Cost-effectiveness analysis of an innovative model of care for chronic wounds patients. PLoS One. 2019 Mar 6;14(3):e0212366. doi: 10.1371/journal.pone.0212366. eCollection 2019.
Olsson M, Jarbrink K, Divakar U, Bajpai R, Upton Z, Schmidtchen A, Car J. The humanistic and economic burden of chronic wounds: A systematic review. Wound Repair Regen. 2019 Jan;27(1):114-125. doi: 10.1111/wrr.12683. Epub 2018 Dec 2.
Padula WV, Pronovost PJ, Makic MBF, Wald HL, Moran D, Mishra MK, Meltzer DO. Value of hospital resources for effective pressure injury prevention: a cost-effectiveness analysis. BMJ Qual Saf. 2019 Feb;28(2):132-141. doi: 10.1136/bmjqs-2017-007505. Epub 2018 Aug 10.
Cheng Q, Graves N, Pacella RE. Economic Evaluations of Guideline-Based Care for Chronic Wounds: a Systematic Review. Appl Health Econ Health Policy. 2018 Oct;16(5):633-651. doi: 10.1007/s40258-018-0403-9.
Kapp S, Miller C, Santamaria N. The quality of life of people who have chronic wounds and who self-treat. J Clin Nurs. 2018 Jan;27(1-2):182-192. doi: 10.1111/jocn.13870. Epub 2017 Aug 9.
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Padula WV, Pronovost PJ. Addressing the multisectoral impact of pressure injuries in the USA, UK and abroad. BMJ Qual Saf. 2018 Mar;27(3):171-173. doi: 10.1136/bmjqs-2017-007021. Epub 2017 Sep 19. No abstract available.
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Dreyfus J, Gayle J, Trueman P, Delhougne G, Siddiqui A. Assessment of Risk Factors Associated With Hospital-Acquired Pressure Injuries and Impact on Health Care Utilization and Cost Outcomes in US Hospitals. Am J Med Qual. 2018 Jul;33(4):348-358. doi: 10.1177/1062860617746741. Epub 2017 Dec 20.
Other Identifiers
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1267389
Identifier Type: -
Identifier Source: org_study_id