36
April 2014 • Nursing Management
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SKIN
series
Under pressure:
Nursing interventions help prevent HAPUs By Anna Omery, DNSc, RN, NEA-BC; Deanna Mussell, BSN, RN; June Rondinelli, MSN, RN, CNS; Margaret Ecker, MS, RN; John Baker, BS, CPHQ, CHDA; Helana Shanks, MSN, RN; and Pam Kleinhelter, MSN, RN, NE-BC
www.nursingmanagement.com
N
ational pressure ulcer prevalence rates in the United States are decreasing. Prevalence statistics have shown an overall reduction in pressure ulcer rates from 19% in 1999 to 12.3% in 2009.1,2 The risk for developing a hospital-acquired pressure ulcer (HAPU) is highest for adults in the ICU; however, even in this challenging patient-care environment, the prevalence rate has decreased to 10.2% in 2009.2,3 Even with significant improvements in reduction of incidence and prevalence, the development of a HAPU is always consequential to the individual patient with potentially devastating consequences that can include pain, infection, longer lengths of hospital stay, and even death.4,5 Although pressure ulcer prevention programs have resulted in a decrease in the prevalence of HAPUs, no study or quality improvement program has eliminated them completely.5 Nurses and other healthcare providers
increasingly suggest that there’s a clinical phenomenon where the patient develops a pressure ulcer despite diligent application of evidence-based prevention measures. This clinical phenomenon has been described in the literature as skin failure, Kennedy terminal pressure ulcer, and unavoidable pressure ulcers.6-11 This article describes the findings of a secondary aim to a larger multisite study that investigated predictors of HAPUs. The goal of the secondary aim was to determine if differences existed in the nursing care provided to patients who did and didn’t develop a HAPU. If results of this inquiry concluded that there’s no difference between evidence-based interventions for those who develop HAPUs and those who don’t, it would prove that nursing care is conceivably controlled. Then, evidence of other risk factors or new risk factors could be suggested as part of the complex picture of HAPU development in the adult ICU setting.
Nursing Management • April 2014 37
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Under pressure: Nursing interventions help prevent HAPUs
Breaking down SKIN™ Interventions to prevent pressure ulcers are complex and increasingly evidence-based. Systematic reviews exist that demonstrate a pooled body of evidence for HAPU preventive strategies.12-14 Prevention strategies include, but aren’t exclusive to, the provision of support surfaces, addressing impaired mobility, potential pressure redistribution devices, moisture assessment of skin, and nutritional assessment.
care, nutritional status, careful lifting, assess risk and the skin, reduce head of bed to 30 degrees, and elevate heels.20 Neither program describes tracking the amount or consistency of completion of nursing interventions. In addition, these authors didn’t use a randomized and/or case-controlled comparison group of non-HAPU patients. The interventions used to measure the nursing care in our study
Interventions to prevent pressure ulcers are complex and increasingly evidence-based. The systematic reviews and additional primary research subsequently support current evidencebased guidelines for HAPU prevention, identification, and treatment published by professional woundcare organizations.15-17 A few descriptive studies are beginning to report the number of nursing interventions documented on patients who develop HAPUs.18,19 Literature is emerging with the use of acronyms by organizations to promote consistent nursing intervention implementation. One organization used NO ULCERS: nutrition and fluids, observation of skin, up and walking or turn and position, lift and not drag skin, clean skin and continence care, elevate heels, risk assessment, and support surfaces.4 Another program used SKIN CARE: support surfaces, keep repositioning, incontinence
also used an acronym: SKIN.™7 Each letter is associated with a unique set of nursing interventions. • S stands for surface and prompts the nurse to ensure that the patient is on the correct bed or chair surface. • K stands for keep turning, which prompts the nurse to critically assess the patient’s mobility and to turn the patient at least every 2 hours while in bed, reposition every hour while in a chair, limit up in chair hours, and use incremental positioning for patients with hemodynamic instability. • I stands for incontinence and triggers the nurse to utilize interventions that maintain appropriate skin protection during episodes where the skin is at risk for maceration. • N stands for nutrition and prompts the nurse to seek appropriate consultation for assessment and
38 April 2014 • Nursing Management
maintenance of adequate nutrition and hydration status.7,8 Although nurses believe that they’re giving all care possible to prevent HAPUs, only a few projects have captured interventions given and none have described frequencies or “dose” of the care provided by nurses. The hypothesis tested in our study sought to determine if there was a difference in the number and type of HAPU preventive nursing interventions between adult ICU patients who develop a HAPU and those who don’t using a retrospective, noninferiority methodology. A noninferiority design establishes that two treatments aren’t less than each other in efficacy by demonstrating that the response to two or more treatments differs only by a margin that’s statistically and clinically unimportant.21-27 Using a placebo control is unethical in evaluating HAPU preventive interventions, so an active control of non-HAPU patients was used for comparison. The active control (non-HAPU subjects) was compared with HAPU subjects to establish that there was no clinical or statistical meaningful difference between the “dose” or amount of nursing interventions, even though the outcomes for the two groups were different.
Sample at risk All the patients enrolled in this study were adult ICU patients with a Braden risk assessment score of 18 or less. These eligible patients were separated into two study groups: the HAPU group and the non-HAPU group. Inclusion criteria further required that the HAPU patient developed a HAPU while in the ICU or within 5 days of admission to the ICU that wasn’t present at or within 24 hours of admission www.nursingmanagement.com
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
to the facility. The non-HAPU patient was selected from the population of ICU patients without a pressure ulcer who were in the same ICU at the same time as the HAPU patient. The non-HAPU group was a pooled group of both randomly selected (n = 71) patients and matched (n = 36) patients on gender, age, and diagnosis. The final sample size was 106 HAPU patients and 107 non-HAPU patients. This multisite study included coinvestigators at 11 acute care California hospitals within the same integrated healthcare system, and two community hospitals from outside of the system. Many hospitals within this sample had reached an overall HAPU prevalence rate of less than 1%. Data collection occurred between August 2010 and November 2011. To ensure consistency in data collection, coinvestigators from each of the sites received orientation on the collection of all the variables within the study in addition to participating in monthly web-based coinvestigator meetings to sustain and standardize the data collection processes. Deidentified data were collected and placed into an access database that was submitted monthly to the study analyst. A project manager was available for any enrollment and data collection questions. Reliability checks were completed on data entry for 10% of patients enrolled. Interrater reliability ranged between 88% and 100%. The stage of pressure ulcer was validated by a Wound Ostomy Continence nurse in conjunction with the physician’s staging of the pressure ulcers in the medical record. The pressure ulcer staging system employed by all sites was the staging system of the National Pressure Ulcer Advisory Panel. (See supplemental www.nursingmanagement.com
content on the Nursing Management iPad app.)15 The components of SKIN™ were extracted from the medical records of patients enrolled into this study by retrospective chart review. Data were collected for all variables for both groups for the same retrospective 72-hour period that started at the time when the HAPU was first identified in the medical record. Assumptions for this study included the following: RNs can deliver SKIN™ interventions regardless of their degree, years of experience, or personal demographics; interventions for HAPU prevention represent a professional practice expectation; and the documentation in the medical record reflected nursing professional practice.
Preventive measures Data were collected on SKIN™ interventions for the hospitalized patients in the sample. The four separate components of SKIN™ were assigned numerical values to measure adherence to interventions within each component. The scoring decision was based on investigator group consensus and influenced by the “bundle” concept set forth by the Institute for Health Care Improvement (IHI). The IHI defines a bundle as a set of three to five practices based in evidence and/or improvement science that when used reliably improve patient outcomes.28 (See Table 1.) A total numerical score of 11 is possible when a patient has received every component of SKIN™ (S + K + I + N = 11). The data collection tool included a “if no, why” area to write about why an intervention wasn’t checked as complete. This option was helpful in determining when a component was genuinely out of the nurses’ ability to complete. For example, if turning couldn’t be accomplished
because the patient was hemodynamically unstable. If an intervention wasn’t documented, even if it was considered to be routine in a particular unit, then it was considered not done by the researchers and the component was scored as incomplete. Data were analyzed using chisquares and t-tests to compare demographic variables between the two groups. Prevention intervention variables were compared using independent t-test analysis for equality of means and Levine’s test for equality of variances. Significance was set for the P at 0.05. For this study, the assessment of noninferiority is a function of the noninferiority margin (M), that is, the differences between group scores that are either statistically or clinically meaningful. Literature cites M statistics between 10% to 20% as acceptable.21 Noninferiority was established if the lower limit of the 95% confidence interval limit of the difference between the means was equal to or less than 10% of the mean score of the non-HAPU (the active control) for the total SKIN™ scale and for each SKIN™ subscale.
Interventions that work When comparing the patients, there were no statistically significant differences between demographic variables with the exception of serum albumin levels. Albumin levels for the non-HAPU group were higher (2.25 versus 2.55; t(152) = 2.734, P = 0.007). An age-adjusted Charlson Comorbidity Index was used in this study as a composite score to measure the impact of multiple chronic comorbidities versus individual diagnoses.29 The most common pressure ulcer developed in this study was deep tissue injury. Stage I pressure ulcers were included in this study. (See Table 2.)
Nursing Management • April 2014 39
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Under pressure: Nursing interventions help prevent HAPUs
In examining each individual component of SKIN™ and the total SKIN™ score, there were no statistically significant differences except for one component, nutrition. Those who had a HAPU had a higher mean score for the nutrition subscale than those who didn’t develop a HAPU (3.61 versus 3.37; t(193.6) = -2.443, P = 0.015). (See Table 3.) Using the noninferiority framework, the margin (M) was determined for the total SKIN™ score and each individual component of SKIN.TM
The margin was below 10% for each measurement except for nutrition, which had a margin value of 12.82%. The patients in the HAPU group had a higher mean score that was statistically significant for this subscale, thus translating into HAPU patients receiving more nutritional interventions than the non-HAPU group.
Beyond nursing interventions This exploratory study examined the care that nurses give to patients
before pressure ulcers develop in the acute care ICU setting. In examining this group of patients, this study revealed no statistical difference between the interventions received by patients with and without a HAPU with the exception of nutrition. The HAPU patients in this study had, on average, a lower serum albumin level than the non-HAPU patients. When albumin is low, the healthcare team may identify the need for improved nutritional care for
Table 1: SKINTM data collection tool Component
Data collection
Scoring range
S
Appropriate bed selected_____________ If not, why?________________________________
0-2
If not bed bound, pressure redistribution pad used? If not, why?______________________________________________________________________ Is bed bound_____________ K
Repositioned every 2 hours and every 1 hour if in chair _____________ If not, why?______________________________________________________________________
0-4
Heels elevated_____________ If not, why?___________________________________________ Head of bed elevated 30 degrees _____________ If not, why?______________________________________________________________________ Relieved pressure under devices_____________ If not, why?______________________________________________________________________ I
Continent?_______________________________________________________________________
0-1
Moisture barrier cream applied to clean perineum_____________ If not, why?______________________________________________________________________ Absorbent underpad in place If not, why?______________________________________________________________________ N
Obtain dietary consult_____________ If not, why?______________________________________________________________________
0-4
Nutrition orders carried out_____________ If not, why?______________________________________________________________________ Prealbumin or albumin levels monitored within the last 7 days ___________ If not, why?______________________________________________________________________ Intake and output recorded_____________ If not, why?______________________________________________________________________ Notes___________________________________________________________________________ TM
Total SKIN
0-11
40 April 2014 • Nursing Management
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Table 2: Demographics and pressure ulcer stages Demographics
HAPU patients* (n = 106)
non-HAPU patients* (n = 107)
p value
Female
38% (40)
49% (52)
0.096
Male
62% (66)
51% (54)
White
60% (64)
54% (57)
Hispanic
17% (18)
18% (19)
Black
14% (15)
12% (13)
Asian
6% (6)
6% (6)
Missing
3% (3)
10% (12)
Light
51% (54)
47% (50)
Medium
24% (25)
30% (32)
Dark
13% (14)
14% (15)
Missing
12% (13)
9% (10)
Age
68 (15.20)
64 (15.16)
0.071
Albumin (g/dL)
2.25 (0.651) n = 78
2.55 (0.704) n =76
0.007
Body mass index
28.06 (8.03)
30.12 (8.33)
0.076
Charlson age adjusted comorbidity index
3.50 (3.12)
3.53 (2.94)
0.947
Gender
Race
Skin tone
HAPU stages
Stage I
7.5% (8)
Stage II
30.2% (32)
Stage III
0.9% (1)
Stage IV
0% (0)
Deep tissue injury
51.9% (55)
Unstageable
6.6% (7)
Mucosal injury
2.8% (3)
0.371
0.633
*Stated as percentage (frequency) or mean (standard deviation). Tabulations that don’t equal 106 (HAPU) or 107 (non-HAPU) have missing data. Percentages that don’t equal 100% are rounded.
this patient population, and this may drive the result that the same patients generally received more nutrition in the SKIN™ interventions. That is, a low albumin may be a clinical driver for HAPU patients receiving more nutritional www.nursingmanagement.com
interventions. The noninferiority margin further validates this conclusion. Use of a noninferiority framework provided the opportunity to examine HAPU prevention interventions between groups in a situation where
the use of a placebo control would be unethical. A noninferiority framework may be very useful for investigations of nursing care in other nurse-sensitive quality indicators such as prevention of falls with injury. In the past, the work of Nursing Management • April 2014 41
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Under pressure: Nursing interventions help prevent HAPUs
Table 3: Study results Mean (standard deviation)
Significance set at P < 0.05 (2 tailed)
SKINTM HAPU
9.33 (1.29)
Non-HAPU
9.24 (1.53)
95% confidence of the difference of the means
M statistic lower limit
-0.469 to -0.295
5.07%
-0.037 to -0.152
1.99%
-0.166 to -0.374
5.56%
-0.063 to -0.026
6.58%
-0.432 to -0.046
12.82%
0.653
(score range 0-11)
S HAPU
1.84 (0.39)
Non-HAPU
1.90 (0.31)
0.235
(score range 0-2) K HAPU
2.90 (0.93)
Non-HAPU
3.00 (1.07)
0.451
(score range 0-4) I HAPU
0.98 (0.14)
Non-HAPU
0.96 (0.19)
0.417
(score range 0-1) N HAPU
3.61 (0.59)
Non-HAPU
3.37 (0.82)
0.015
(score range 0-4)
nursing has been described as “invisible work.” Nursing practice is frequently driven by the lack of negative outcomes such as the pressure ulcer or the fall after surgery that didn’t happen. Use of noninferiority or equivalence trials to track the “dose” of nursing interventions to determine that an intervention is noninferior or equivalent may open up a meaningful avenue for nursing research. Clinical nurses have worked diligently to implement evidence-based nursing interventions to assist with
the reduction of HAPUs. This is evident by changes within the hospital culture and also by the reduction of national HAPU rates. Nurses at the point of care have proposed for some time now that there’s a small group of patients who will develop HAPUs even though their care is equitable to care for patients who haven’t developed a pressure ulcer. That is, there’s a group of HAPU patients where the differences reflect their personal characteristics or other aspects of their care, not the nursing care. Other
42 April 2014 • Nursing Management
authors have come to this conclusion; that many, if not most, of the patients who develop pressure ulcers in the acute care setting develop them due to sources other than nursing care.2,30-31 The next logical step would be to ask what are the defining characteristics of those patients who continue to develop HAPUs even in the face of documented evidence-based nursing care? Recommendations for future research are to continue to examine risk factors for HAPU development, and further, to evaluate current www.nursingmanagement.com
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study findings to determine if a meta-analysis of said factors is warranted. NM
REFERENCES 1. Whittington KT, Briones R. National Prevalence and Incidence Study: 6-year sequential acute care data. Adv Skin Wound Care. 2004;17(9):490-494. 2. VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009;55(11): 39-45. 3. Baumgarten M, Margolis DJ, Localio AR, et al. Extrinsic risk factors for pressure ulcers early in the hospital stay: a nested casecontrol study. J Gerontol A Biol Sci Med Sci. 2008;63(4):408-413. 4. Ayello EA, Lyder CH. Protecting patients from harm: preventing pressure ulcers in hospital patients. Nursing. 2007;37(10): 36-40. 5. Lyder CH, Ayello EA. Pressure ulcers: a patient safety issue. In: Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Health Care Research and Quality; 2008:1-33. 6. Curry K, Kutash M, Chambers T, Evans A, Holt M, Purcell S. A prospective, descriptive study of characteristics associated with skin failure in critically ill adults. Ostomy Wound Manage. 2012;58(5):36-38, 40-43. 7. Gibbons W, Shanks HT, Kleinhelter P, Jones P. Eliminating facility-acquired pressure ulcers at Ascension Health. Jt Comm J Qual Patient Saf. 2006;32(9):488-496. 8. Shanks H, Kleinhelter P, Baker J. Skin failure: a retrospective review of patients with hospital-acquired pressure ulcers. WCET J. 29. 2009. 9. Witkowski JA, Parish LC. The decubitus ulcer: skin failure and destructive behavior. Int J Dermatol. 2000;39(12):894-896. 10. Kennedy KL. The prevalence of pressure ulcers in an intermediate care facility. Decubitus. 1989;2(2):44-45. 11. Black JM, Edsberg LE, Baharestani MM, et al. Pressure ulcers: avoidable or unavoidable? Results of the National Pressure Ulcer Advisory Panel Consensus Conference. Ostomy Wound Manage. 2011;57(2):24-37. 12. McInnes E, Dumville JC, Jammali-Blasi A, Bell-Syer SE. Support surfaces for treating pressure ulcers. Cochrane Database Syst Rev. 2011;(12):CD009490. www.nursingmanagement.com
13. Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006;296(8):974-984. 14. Cullum N, Petherick E. Pressure ulcers. Clin Evid (Online). 2008;2008. 15. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Pressure ulcer prevention recommendations. In: Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: National Pressure Ulcer Advisory Panel; 2009:21-50. 16. Wound, Ostomy and Continence Nurses Society. Guideline for the prevention and management of pressure ulcers. http:// www guideline gov/search/search aspx? term=pressure+ulcer+prevention. 17. Association for the Advancement of Wound Care. Association for the Advancement of Wound Care Guidelines for Pressure Ulcers. Malvern, PA: Association for the Advancement of Wound Care; 2010. 18. Wann-Hansson C, Hagell P, Willman A. Risk factors and prevention among patients with hospital-acquired and pre-existing pressure ulcers in an acute care hospital. J Clin Nurs. 2008;17(13):1718-1727. 19. Bry KE, Buescher D, Sandrik M. Never say never: a descriptive study of hospitalacquired pressure ulcers in a hospital setting. J Wound Ostomy Continence Nurs. 2012;39(3):274-281. 20. Carson D, Emmons K, Falone W, Preston AM. Development of pressure ulcer program across a university health system. J Nurs Care Qual. 2012;279(1):20-27. 21. D’Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003; 22(2):169-186. 22. European Medicines Agency. Guideline on the choice of a non-inferiority margin. http://www.ema.europa.edu/docs/en_ GB/document_library/Scientific_ guideline/2009/09/WC500003636 pdf. 23. Kinley H, Czoski-Murray C, George S, et al. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002;325(7376):1323. 24. Wiens BL. Choosing an equivalence limit for noninferiority or equivalence studies. Control Clin Trials. 2002;23(1):2-14. 25. Blackwelder WC. Showing a treatment is good because it is not bad: when does “noninferiority” imply effectiveness? Control Clin Trials. 2002;23(1):52-54.
26. Kaul S, Diamond GA. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials. Prog Cardiovasc Dis. 2007;49(4):284-299. 27. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006; 145(1):62-69. 28. Resar R, Pronovost P, Haraden C, Simmonds T, Rainey T, Nolan T. Using a bundle approach to improve ventilator care processes and reduce ventilator-associated pneumonia. Jt Comm J Qual Patient Saf. 2005;31(5):243-248. 29. Hall WH, Ramachandran R, Narayan S, Jani AB, Vijayakumar S. An electronic application for rapidly calculating Charlson comorbidity score. BMC Cancer. 2004;4:94. 30. Frankel H, Sperry J, Kaplan L. Risk factors for pressure ulcer development in a best practice surgical intensive care unit. Am Surg. 2007;73(12):1215-1217. 31. Parish LC, Sibbald RG. 25 years of pressure ulcers and Advances in Skin & Wound Care. Adv Skin Wound Care. 2012;25(2): 57-58.
At the time of the study, within Kaiser Permanente, Southern Calif., Anna Omery, nurse scientist, was director of nursing research, Deanna Mussell an ICU charge nurse, June Rondinelli a project manager for the Regional Nursing Research program, and Margaret Ecker a retired nursing quality director. John Baker remains a statistical consultant based out of Alachua, Fla. Helana Shanks was the director of nursing and Pam Kleinhelter was an ICU/Dialysis nurse manager at St. Vincent’s Medical Center, Ascension Healthcare, Jacksonville Fla. The authors would also like to acknowledge Regina Valdez and Cecelia Crawford, Kaiser Permanente, Southern California Regional Nursing Research Program for data assistance.
The authors have disclosed that this investigation was partially sponsored by the National Kaiser Permanente Quality and Patient Safety Management Program in Oakland, Calif. The remainder of operations was supported through the Nursing Research Program, Patient Care Services, Kaiser Permanente in Southern Calif.
DOI-10.1097/01.NUMA.0000444876.62569.51
Nursing Management • April 2014 43
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
April 2014 • Nursing Management
www.nursingmanagement.com
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
SKIN
series
Under pressure:
Nursing interventions help prevent HAPUs By Anna Omery, DNSc, RN, NEA-BC; Deanna Mussell, BSN, RN; June Rondinelli, MSN, RN, CNS; Margaret Ecker, MS, RN; John Baker, BS, CPHQ, CHDA; Helana Shanks, MSN, RN; and Pam Kleinhelter, MSN, RN, NE-BC
www.nursingmanagement.com
N
ational pressure ulcer prevalence rates in the United States are decreasing. Prevalence statistics have shown an overall reduction in pressure ulcer rates from 19% in 1999 to 12.3% in 2009.1,2 The risk for developing a hospital-acquired pressure ulcer (HAPU) is highest for adults in the ICU; however, even in this challenging patient-care environment, the prevalence rate has decreased to 10.2% in 2009.2,3 Even with significant improvements in reduction of incidence and prevalence, the development of a HAPU is always consequential to the individual patient with potentially devastating consequences that can include pain, infection, longer lengths of hospital stay, and even death.4,5 Although pressure ulcer prevention programs have resulted in a decrease in the prevalence of HAPUs, no study or quality improvement program has eliminated them completely.5 Nurses and other healthcare providers
increasingly suggest that there’s a clinical phenomenon where the patient develops a pressure ulcer despite diligent application of evidence-based prevention measures. This clinical phenomenon has been described in the literature as skin failure, Kennedy terminal pressure ulcer, and unavoidable pressure ulcers.6-11 This article describes the findings of a secondary aim to a larger multisite study that investigated predictors of HAPUs. The goal of the secondary aim was to determine if differences existed in the nursing care provided to patients who did and didn’t develop a HAPU. If results of this inquiry concluded that there’s no difference between evidence-based interventions for those who develop HAPUs and those who don’t, it would prove that nursing care is conceivably controlled. Then, evidence of other risk factors or new risk factors could be suggested as part of the complex picture of HAPU development in the adult ICU setting.
Nursing Management • April 2014 37
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Under pressure: Nursing interventions help prevent HAPUs
Breaking down SKIN™ Interventions to prevent pressure ulcers are complex and increasingly evidence-based. Systematic reviews exist that demonstrate a pooled body of evidence for HAPU preventive strategies.12-14 Prevention strategies include, but aren’t exclusive to, the provision of support surfaces, addressing impaired mobility, potential pressure redistribution devices, moisture assessment of skin, and nutritional assessment.
care, nutritional status, careful lifting, assess risk and the skin, reduce head of bed to 30 degrees, and elevate heels.20 Neither program describes tracking the amount or consistency of completion of nursing interventions. In addition, these authors didn’t use a randomized and/or case-controlled comparison group of non-HAPU patients. The interventions used to measure the nursing care in our study
Interventions to prevent pressure ulcers are complex and increasingly evidence-based. The systematic reviews and additional primary research subsequently support current evidencebased guidelines for HAPU prevention, identification, and treatment published by professional woundcare organizations.15-17 A few descriptive studies are beginning to report the number of nursing interventions documented on patients who develop HAPUs.18,19 Literature is emerging with the use of acronyms by organizations to promote consistent nursing intervention implementation. One organization used NO ULCERS: nutrition and fluids, observation of skin, up and walking or turn and position, lift and not drag skin, clean skin and continence care, elevate heels, risk assessment, and support surfaces.4 Another program used SKIN CARE: support surfaces, keep repositioning, incontinence
also used an acronym: SKIN.™7 Each letter is associated with a unique set of nursing interventions. • S stands for surface and prompts the nurse to ensure that the patient is on the correct bed or chair surface. • K stands for keep turning, which prompts the nurse to critically assess the patient’s mobility and to turn the patient at least every 2 hours while in bed, reposition every hour while in a chair, limit up in chair hours, and use incremental positioning for patients with hemodynamic instability. • I stands for incontinence and triggers the nurse to utilize interventions that maintain appropriate skin protection during episodes where the skin is at risk for maceration. • N stands for nutrition and prompts the nurse to seek appropriate consultation for assessment and
38 April 2014 • Nursing Management
maintenance of adequate nutrition and hydration status.7,8 Although nurses believe that they’re giving all care possible to prevent HAPUs, only a few projects have captured interventions given and none have described frequencies or “dose” of the care provided by nurses. The hypothesis tested in our study sought to determine if there was a difference in the number and type of HAPU preventive nursing interventions between adult ICU patients who develop a HAPU and those who don’t using a retrospective, noninferiority methodology. A noninferiority design establishes that two treatments aren’t less than each other in efficacy by demonstrating that the response to two or more treatments differs only by a margin that’s statistically and clinically unimportant.21-27 Using a placebo control is unethical in evaluating HAPU preventive interventions, so an active control of non-HAPU patients was used for comparison. The active control (non-HAPU subjects) was compared with HAPU subjects to establish that there was no clinical or statistical meaningful difference between the “dose” or amount of nursing interventions, even though the outcomes for the two groups were different.
Sample at risk All the patients enrolled in this study were adult ICU patients with a Braden risk assessment score of 18 or less. These eligible patients were separated into two study groups: the HAPU group and the non-HAPU group. Inclusion criteria further required that the HAPU patient developed a HAPU while in the ICU or within 5 days of admission to the ICU that wasn’t present at or within 24 hours of admission www.nursingmanagement.com
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
to the facility. The non-HAPU patient was selected from the population of ICU patients without a pressure ulcer who were in the same ICU at the same time as the HAPU patient. The non-HAPU group was a pooled group of both randomly selected (n = 71) patients and matched (n = 36) patients on gender, age, and diagnosis. The final sample size was 106 HAPU patients and 107 non-HAPU patients. This multisite study included coinvestigators at 11 acute care California hospitals within the same integrated healthcare system, and two community hospitals from outside of the system. Many hospitals within this sample had reached an overall HAPU prevalence rate of less than 1%. Data collection occurred between August 2010 and November 2011. To ensure consistency in data collection, coinvestigators from each of the sites received orientation on the collection of all the variables within the study in addition to participating in monthly web-based coinvestigator meetings to sustain and standardize the data collection processes. Deidentified data were collected and placed into an access database that was submitted monthly to the study analyst. A project manager was available for any enrollment and data collection questions. Reliability checks were completed on data entry for 10% of patients enrolled. Interrater reliability ranged between 88% and 100%. The stage of pressure ulcer was validated by a Wound Ostomy Continence nurse in conjunction with the physician’s staging of the pressure ulcers in the medical record. The pressure ulcer staging system employed by all sites was the staging system of the National Pressure Ulcer Advisory Panel. (See supplemental www.nursingmanagement.com
content on the Nursing Management iPad app.)15 The components of SKIN™ were extracted from the medical records of patients enrolled into this study by retrospective chart review. Data were collected for all variables for both groups for the same retrospective 72-hour period that started at the time when the HAPU was first identified in the medical record. Assumptions for this study included the following: RNs can deliver SKIN™ interventions regardless of their degree, years of experience, or personal demographics; interventions for HAPU prevention represent a professional practice expectation; and the documentation in the medical record reflected nursing professional practice.
Preventive measures Data were collected on SKIN™ interventions for the hospitalized patients in the sample. The four separate components of SKIN™ were assigned numerical values to measure adherence to interventions within each component. The scoring decision was based on investigator group consensus and influenced by the “bundle” concept set forth by the Institute for Health Care Improvement (IHI). The IHI defines a bundle as a set of three to five practices based in evidence and/or improvement science that when used reliably improve patient outcomes.28 (See Table 1.) A total numerical score of 11 is possible when a patient has received every component of SKIN™ (S + K + I + N = 11). The data collection tool included a “if no, why” area to write about why an intervention wasn’t checked as complete. This option was helpful in determining when a component was genuinely out of the nurses’ ability to complete. For example, if turning couldn’t be accomplished
because the patient was hemodynamically unstable. If an intervention wasn’t documented, even if it was considered to be routine in a particular unit, then it was considered not done by the researchers and the component was scored as incomplete. Data were analyzed using chisquares and t-tests to compare demographic variables between the two groups. Prevention intervention variables were compared using independent t-test analysis for equality of means and Levine’s test for equality of variances. Significance was set for the P at 0.05. For this study, the assessment of noninferiority is a function of the noninferiority margin (M), that is, the differences between group scores that are either statistically or clinically meaningful. Literature cites M statistics between 10% to 20% as acceptable.21 Noninferiority was established if the lower limit of the 95% confidence interval limit of the difference between the means was equal to or less than 10% of the mean score of the non-HAPU (the active control) for the total SKIN™ scale and for each SKIN™ subscale.
Interventions that work When comparing the patients, there were no statistically significant differences between demographic variables with the exception of serum albumin levels. Albumin levels for the non-HAPU group were higher (2.25 versus 2.55; t(152) = 2.734, P = 0.007). An age-adjusted Charlson Comorbidity Index was used in this study as a composite score to measure the impact of multiple chronic comorbidities versus individual diagnoses.29 The most common pressure ulcer developed in this study was deep tissue injury. Stage I pressure ulcers were included in this study. (See Table 2.)
Nursing Management • April 2014 39
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Under pressure: Nursing interventions help prevent HAPUs
In examining each individual component of SKIN™ and the total SKIN™ score, there were no statistically significant differences except for one component, nutrition. Those who had a HAPU had a higher mean score for the nutrition subscale than those who didn’t develop a HAPU (3.61 versus 3.37; t(193.6) = -2.443, P = 0.015). (See Table 3.) Using the noninferiority framework, the margin (M) was determined for the total SKIN™ score and each individual component of SKIN.TM
The margin was below 10% for each measurement except for nutrition, which had a margin value of 12.82%. The patients in the HAPU group had a higher mean score that was statistically significant for this subscale, thus translating into HAPU patients receiving more nutritional interventions than the non-HAPU group.
Beyond nursing interventions This exploratory study examined the care that nurses give to patients
before pressure ulcers develop in the acute care ICU setting. In examining this group of patients, this study revealed no statistical difference between the interventions received by patients with and without a HAPU with the exception of nutrition. The HAPU patients in this study had, on average, a lower serum albumin level than the non-HAPU patients. When albumin is low, the healthcare team may identify the need for improved nutritional care for
Table 1: SKINTM data collection tool Component
Data collection
Scoring range
S
Appropriate bed selected_____________ If not, why?________________________________
0-2
If not bed bound, pressure redistribution pad used? If not, why?______________________________________________________________________ Is bed bound_____________ K
Repositioned every 2 hours and every 1 hour if in chair _____________ If not, why?______________________________________________________________________
0-4
Heels elevated_____________ If not, why?___________________________________________ Head of bed elevated 30 degrees _____________ If not, why?______________________________________________________________________ Relieved pressure under devices_____________ If not, why?______________________________________________________________________ I
Continent?_______________________________________________________________________
0-1
Moisture barrier cream applied to clean perineum_____________ If not, why?______________________________________________________________________ Absorbent underpad in place If not, why?______________________________________________________________________ N
Obtain dietary consult_____________ If not, why?______________________________________________________________________
0-4
Nutrition orders carried out_____________ If not, why?______________________________________________________________________ Prealbumin or albumin levels monitored within the last 7 days ___________ If not, why?______________________________________________________________________ Intake and output recorded_____________ If not, why?______________________________________________________________________ Notes___________________________________________________________________________ TM
Total SKIN
0-11
40 April 2014 • Nursing Management
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Table 2: Demographics and pressure ulcer stages Demographics
HAPU patients* (n = 106)
non-HAPU patients* (n = 107)
p value
Female
38% (40)
49% (52)
0.096
Male
62% (66)
51% (54)
White
60% (64)
54% (57)
Hispanic
17% (18)
18% (19)
Black
14% (15)
12% (13)
Asian
6% (6)
6% (6)
Missing
3% (3)
10% (12)
Light
51% (54)
47% (50)
Medium
24% (25)
30% (32)
Dark
13% (14)
14% (15)
Missing
12% (13)
9% (10)
Age
68 (15.20)
64 (15.16)
0.071
Albumin (g/dL)
2.25 (0.651) n = 78
2.55 (0.704) n =76
0.007
Body mass index
28.06 (8.03)
30.12 (8.33)
0.076
Charlson age adjusted comorbidity index
3.50 (3.12)
3.53 (2.94)
0.947
Gender
Race
Skin tone
HAPU stages
Stage I
7.5% (8)
Stage II
30.2% (32)
Stage III
0.9% (1)
Stage IV
0% (0)
Deep tissue injury
51.9% (55)
Unstageable
6.6% (7)
Mucosal injury
2.8% (3)
0.371
0.633
*Stated as percentage (frequency) or mean (standard deviation). Tabulations that don’t equal 106 (HAPU) or 107 (non-HAPU) have missing data. Percentages that don’t equal 100% are rounded.
this patient population, and this may drive the result that the same patients generally received more nutrition in the SKIN™ interventions. That is, a low albumin may be a clinical driver for HAPU patients receiving more nutritional www.nursingmanagement.com
interventions. The noninferiority margin further validates this conclusion. Use of a noninferiority framework provided the opportunity to examine HAPU prevention interventions between groups in a situation where
the use of a placebo control would be unethical. A noninferiority framework may be very useful for investigations of nursing care in other nurse-sensitive quality indicators such as prevention of falls with injury. In the past, the work of Nursing Management • April 2014 41
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Under pressure: Nursing interventions help prevent HAPUs
Table 3: Study results Mean (standard deviation)
Significance set at P < 0.05 (2 tailed)
SKINTM HAPU
9.33 (1.29)
Non-HAPU
9.24 (1.53)
95% confidence of the difference of the means
M statistic lower limit
-0.469 to -0.295
5.07%
-0.037 to -0.152
1.99%
-0.166 to -0.374
5.56%
-0.063 to -0.026
6.58%
-0.432 to -0.046
12.82%
0.653
(score range 0-11)
S HAPU
1.84 (0.39)
Non-HAPU
1.90 (0.31)
0.235
(score range 0-2) K HAPU
2.90 (0.93)
Non-HAPU
3.00 (1.07)
0.451
(score range 0-4) I HAPU
0.98 (0.14)
Non-HAPU
0.96 (0.19)
0.417
(score range 0-1) N HAPU
3.61 (0.59)
Non-HAPU
3.37 (0.82)
0.015
(score range 0-4)
nursing has been described as “invisible work.” Nursing practice is frequently driven by the lack of negative outcomes such as the pressure ulcer or the fall after surgery that didn’t happen. Use of noninferiority or equivalence trials to track the “dose” of nursing interventions to determine that an intervention is noninferior or equivalent may open up a meaningful avenue for nursing research. Clinical nurses have worked diligently to implement evidence-based nursing interventions to assist with
the reduction of HAPUs. This is evident by changes within the hospital culture and also by the reduction of national HAPU rates. Nurses at the point of care have proposed for some time now that there’s a small group of patients who will develop HAPUs even though their care is equitable to care for patients who haven’t developed a pressure ulcer. That is, there’s a group of HAPU patients where the differences reflect their personal characteristics or other aspects of their care, not the nursing care. Other
42 April 2014 • Nursing Management
authors have come to this conclusion; that many, if not most, of the patients who develop pressure ulcers in the acute care setting develop them due to sources other than nursing care.2,30-31 The next logical step would be to ask what are the defining characteristics of those patients who continue to develop HAPUs even in the face of documented evidence-based nursing care? Recommendations for future research are to continue to examine risk factors for HAPU development, and further, to evaluate current www.nursingmanagement.com
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study findings to determine if a meta-analysis of said factors is warranted. NM
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13. Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006;296(8):974-984. 14. Cullum N, Petherick E. Pressure ulcers. Clin Evid (Online). 2008;2008. 15. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Pressure ulcer prevention recommendations. In: Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: National Pressure Ulcer Advisory Panel; 2009:21-50. 16. Wound, Ostomy and Continence Nurses Society. Guideline for the prevention and management of pressure ulcers. http:// www guideline gov/search/search aspx? term=pressure+ulcer+prevention. 17. Association for the Advancement of Wound Care. Association for the Advancement of Wound Care Guidelines for Pressure Ulcers. Malvern, PA: Association for the Advancement of Wound Care; 2010. 18. Wann-Hansson C, Hagell P, Willman A. Risk factors and prevention among patients with hospital-acquired and pre-existing pressure ulcers in an acute care hospital. J Clin Nurs. 2008;17(13):1718-1727. 19. Bry KE, Buescher D, Sandrik M. Never say never: a descriptive study of hospitalacquired pressure ulcers in a hospital setting. J Wound Ostomy Continence Nurs. 2012;39(3):274-281. 20. Carson D, Emmons K, Falone W, Preston AM. Development of pressure ulcer program across a university health system. J Nurs Care Qual. 2012;279(1):20-27. 21. D’Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003; 22(2):169-186. 22. European Medicines Agency. Guideline on the choice of a non-inferiority margin. http://www.ema.europa.edu/docs/en_ GB/document_library/Scientific_ guideline/2009/09/WC500003636 pdf. 23. Kinley H, Czoski-Murray C, George S, et al. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002;325(7376):1323. 24. Wiens BL. Choosing an equivalence limit for noninferiority or equivalence studies. Control Clin Trials. 2002;23(1):2-14. 25. Blackwelder WC. Showing a treatment is good because it is not bad: when does “noninferiority” imply effectiveness? Control Clin Trials. 2002;23(1):52-54.
26. Kaul S, Diamond GA. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials. Prog Cardiovasc Dis. 2007;49(4):284-299. 27. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006; 145(1):62-69. 28. Resar R, Pronovost P, Haraden C, Simmonds T, Rainey T, Nolan T. Using a bundle approach to improve ventilator care processes and reduce ventilator-associated pneumonia. Jt Comm J Qual Patient Saf. 2005;31(5):243-248. 29. Hall WH, Ramachandran R, Narayan S, Jani AB, Vijayakumar S. An electronic application for rapidly calculating Charlson comorbidity score. BMC Cancer. 2004;4:94. 30. Frankel H, Sperry J, Kaplan L. Risk factors for pressure ulcer development in a best practice surgical intensive care unit. Am Surg. 2007;73(12):1215-1217. 31. Parish LC, Sibbald RG. 25 years of pressure ulcers and Advances in Skin & Wound Care. Adv Skin Wound Care. 2012;25(2): 57-58.
At the time of the study, within Kaiser Permanente, Southern Calif., Anna Omery, nurse scientist, was director of nursing research, Deanna Mussell an ICU charge nurse, June Rondinelli a project manager for the Regional Nursing Research program, and Margaret Ecker a retired nursing quality director. John Baker remains a statistical consultant based out of Alachua, Fla. Helana Shanks was the director of nursing and Pam Kleinhelter was an ICU/Dialysis nurse manager at St. Vincent’s Medical Center, Ascension Healthcare, Jacksonville Fla. The authors would also like to acknowledge Regina Valdez and Cecelia Crawford, Kaiser Permanente, Southern California Regional Nursing Research Program for data assistance.
The authors have disclosed that this investigation was partially sponsored by the National Kaiser Permanente Quality and Patient Safety Management Program in Oakland, Calif. The remainder of operations was supported through the Nursing Research Program, Patient Care Services, Kaiser Permanente in Southern Calif.
DOI-10.1097/01.NUMA.0000444876.62569.51
Nursing Management • April 2014 43
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