Wound Care and Pressure Injury Through the Continuum of Care

Wound Clinical Trial

Official title:

Wound Care and Pressure Injury Through the Continuum of Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04649853
• Other study ID #: 1267389
• Status: Enrolling by invitation
• Start date: August 17, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2020
• Source: Regional Medical Center of San Jose
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 352
• Est. completion date: December 30, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Wound
• Wounds and Injuries

Intervention

Other:
• Standardized nursing care
All patients will receive standardized evidence based nursing care

Locations

Country	Name	City	State
United States	Regional Medical Center San Jose	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Regional Medical Center of San Jose

Country where clinical trial is conducted

United States, 

References & Publications (18)

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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. — View Citation

Campbell Britton M, Petersen-Pickett J, Hodshon B, Chaudhry SI. Mapping the care transition from hospital to skilled nursing facility. J Eval Clin Pract. 2020 Jun;26(3):786-790. doi: 10.1111/jep.13238. Epub 2019 Jul 16. — View Citation

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. — View Citation

Courvoisier DS, Righi L, Béné N, Rae AC, Chopard P. Variation in pressure ulcer prevalence and prevention in nursing homes: A multicenter study. Appl Nurs Res. 2018 Aug;42:45-50. doi: 10.1016/j.apnr.2018.06.001. Epub 2018 Jun 5. — View Citation

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. — View Citation

Holscher CM, Hicks CW, Canner JK, Sherman RL, Malas MB, Black JH 3rd, Mathioudakis N, Abularrage CJ. Unplanned 30-day readmission in patients with diabetic foot wounds treated in a multidisciplinary setting. J Vasc Surg. 2018 Mar;67(3):876-886. doi: 10.10 — View Citation

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. — View Citation

Martinengo L, Olsson M, Bajpai R, Soljak M, Upton Z, Schmidtchen A, Car J, Järbrink K. Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Ann Epidemiol. 2019 Jan;29:8-15. doi: 10.1016/j.an — View Citation

Meehan R. Transitions From Acute Care to Long-Term Care: Evaluation of the Continued Access Model. J Appl Gerontol. 2019 Apr;38(4):510-529. doi: 10.1177/0733464817723565. Epub 2017 Aug 8. — View Citation

Molloy MA, Cary MP Jr, Brennan-Cook J, Cantey DS, Tocchi C, Bailey DE Jr, Oermann MH. Preparing Clinicians for Transitioning Patients Across Care Settings and Into the Home Through Simulation. Home Healthc Now. 2018 Jul/Aug;36(4):225-231. doi: 10.1097/NHH — View Citation

Nussbaum SR, Carter MJ, Fife CE, DaVanzo J, Haught R, Nusgart M, Cartwright D. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007. — View Citation

Olsson M, Järbrink 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. — View Citation

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 20 — View Citation

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. — View Citation

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 — View Citation

Swietek KE, Domino ME, Beadles C, Ellis AR, Farley JF, Grove LR, Jackson C, DuBard CA. Do Medical Homes Improve Quality of Care for Persons with Multiple Chronic Conditions? Health Serv Res. 2018 Dec;53(6):4667-4681. doi: 10.1111/1475-6773.13024. Epub 201 — View Citation

Van Eenoo L, van der Roest H, Onder G, Finne-Soveri H, Garms-Homolova V, Jonsson PV, Draisma S, van Hout H, Declercq A. Organizational home care models across Europe: A cross sectional study. Int J Nurs Stud. 2018 Jan;77:39-45. doi: 10.1016/j.ijnurstu.201 — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

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