1. DNP Clinical Capstone Project Summary
Integrating HIV-Related Evidence-Based
Renal Care Guidelines into
Adult HIV Clinics
Brian K. Goodroad, CNP, AACRN
DNP Student
Minnesota State University Moorhead
Committee Chair: Tracy Wright, RN, PhD, CNE
Committee Members: Jane Bergland, RN, PhD
Frank S. Rhame, MD
1
2. Objectives
To synthesize and present the essential aspects of this
capstone project.
To demonstrate competence in each graduate outcome
area.
2
3. Background of Problem
More people living with HIV than ever before
Globally at end of 2007 (World Health Organization,
2007)
33 million people with HIV
2.5 million new infections
2.1 million deaths
Most impacted are sub-Saharan African, Southeast Asia,
India where resources for prevention, detection, and
treatment are scarce.
3
4. Background of Problem
In the United States at end of 2006:
One million people living with HIV (Centers for Disease
Control and Prevention [CDC], 2008a)
56, 000 new infections yearly (CDC, 2008b)
People living longer
More problems with:
Cardiovascular disease
Renal and hepatic complications (The Strategies for Management
of Antiretroviral Therapy [SMART] Study Group, 2008)
4
5. HIV and Renal Dysfunction
About 15-30% of people with HIV have renal dysfunction (Gupta et
al., 2005) and about 10% of those will progress to end-stage renal
disease (ESRD) if not detected (Winston, 2007)
Spectrum of disease ranges from early dysfunction to renal failure
Acute Renal Failure and Chronic Renal/Kidney Disease (CKD)
HIV-associated Nephropathy (HIVAN):
Specific renal issues almost exclusively seen in African Americans
with HIV
3rd leading cause of ESRD in African Americans over 20 years of
age
Usually seen late in infection with CD4 < 200 cells/mm3
Treatment is to control HIV infection (Gupta et al., 2005)
5
6. Risk Factors for Renal Dysfunction
Similar as general public:
Hypertension
Diabetes Mellitus
African American
Hepatitis C-coinfection
Specific to HIV-infected people:
CD4 < 200
Viral load > 4000
On tenofovir especially when combined with
lopinavir/ritonavir
Source: (Gupta et al., 2005)
6
7. Measuring Renal Function
Historically:
Creatinine clearance (mL/min) by 24-hour urine (Grey, Huether, &
Forshee, 2006)
Serum Creatinine
This is a poor measure since as much as 50% of function may already
be lost prior to serum creatinine level reaching greater than normal
readings (Coresh, Astor, Greene, Eknoyan, & Levey, 2003)
Current recommendations:
Estimated creatinine clearance (CrCl) with Cockroft-Gault formula
or
Estimated glomerular filtration rate (eGFR) with modification of
diet in renal disease (MDRD) formula (De Silva, Post, Griffin, &
Dockbell, 2007)
7
8. Published Renal Screening and
Management Guidelines
Concern over HIV-related renal issues
Published guidelines in June 2005 (Gupta et al., 2005)
Extensive review of literature failed to reveal data on the
rate of implementation and use of the guidelines
8
9. Renal Health
Need a more holistic definition incorporating health
promotion and disease prevention (Pender, Murdaugh, &
Parsons, 2006)
Renal health in HIV disease should be defined as both
health promotion and disease prevention behaviors
undertaken by the person living with HIV or promoted by
the health care provider
Health Promotion: Including education to assist the
individual in maintaining a healthy weight, utilize exercise,
manage stress, and avoid cigarette smoking or second-
Earl
hand smoke exposure. y
Disease Prevention: Screening program to detect now
early/manage aggressively acute or chronic renal disease. 9
10. Background Summary
People with HIV are at risk for acute and chronic renal
disease
Population of HIV positive people is aging, increasing in
number, and experiencing other chronic conditions (e.g.,
HTN, DM II) that increase risk for renal dysfunction
Evidence-based guidelines exist but have not been
systematically incorporated into the clinical practice
settings utilized in this project
10
11. Background Summary
Smoking, obesity, and elevated cholesterol may also be
related to renal dysfunction in people with HIV (Miguez-
Burbano, Rodriguez, Hadrigan, & Shor-Posner, 2006;
Nitsch et al., 2006)
General health promotion and disease prevention efforts
are important aspects of care
No specific effort to promote health related to renal
disease prevention existed in the clinics under study
11
12. Statement of Purpose
P a
rim ry:
Im le e e e e a e re l c reg e sa s nd rd
p m nt vid nc -b s d na a uid line s ta a
c rein thec
a linic und r s y.
s e tud
Se o a
c nd ry:
De lo a im le e are l a g ne l he lth
ve p nd p m nt na nd e ra a
m inte nc e uc tio p g mfo c
a na e d a n ro ra r linicp tie .
a nts
Ed a n w sc m le db nurs , d ta a s c l
uc tio a o p te y ing ie ry, nd o ia
w rk s ff in thetw s tting .
o ta o e s
12
13. Clinical Practice Problem Question
PICO Question Format:
In physician care providers of two Midwestern,
metropolitan HIV clinics, does adoption of renal health
care guidelines as standard of practice improve the
completion of renal health evaluations as compared to
standard care (no official adoption of guidelines)?
13
14. Methodology
Rogers’ (2003) Diffusion of Innovations theory guided the
evidence-based practice implementation and guided
change necessary for successful renal guideline adoption.
“Diffusion is a special type of communication in which the
messages are about a new idea” (Haider & Kreps, 2004,
p. 4).
Four main interacting factors:
• An innovation
• Communication channels
• Social systems
• Time
14
15. Methodology
Innovation—Decision process:
Stage-based process for adoption of innovation
Knowledge
Persuasion
Decision
Implementation
Confirmation (Rogers, 2003, p. 169)
15
16. Knowledge
Rogers (2003) noted that an innovation is more likely to
be accepted and diffused if the knowledge underlying the
change is the most current and highest level of literature
available.
Review of current guidelines (AGREE Instrument)
Search for other guidelines
Search for RCT or large cohort studies providing updated
recommendations for guidelines
16
17. Guideline Review
Objective: Examine the methodological quality of the
published recommendations to determine usability in the
clinical settings under study.
The AGREE Instrument completed by three clinicians with HIV
expertise (The Agree Collaboration, 2001)
Final evaluation: Recommended for use with provisos to ensure
ongoing review and update of the recommendations
Other guideline searched/reviewed:
Key terms “ “
HIV, renal”and “
, kidney”
National Guideline Clearinghouse
Cochrane Collaborative Library
17
18. Literature Search
Goal: Find well-designed cohort and available
randomized clinical trial data that might suggest new
practice recommendations or might support the
continued use of the current HIV renal guidelines.
Search strategy:
Keyword terms “HIV” and “renal” in search limited from May
2004- May 2008
CINAHL, MEDLINE, Evidence-Based Medicine, Evidence
Based Nursing, Academic Search Premier
18
19. Literature Search
982 citation results
After removing duplicates, 613 remained. Citations and
abstracts of all reviewed.
Excluded:
Review articles
Studies outside of United States
HIVAN specific literature
15 articles included
19
20. Literature Search
Keyword Terms “HIV” and “renal” used in search on
abstract databases from the following:
CROI: 2004 through 2008 (n=22)
IAS: 2005 and 2007 (n=32)
World AIDS Conference: 2004 and 2006 (n=35)
Problem: Evaluation of quality difficult given sparse
information provided. Reviewed all abstracts. Used only
key 8 in final guideline update.
20
21. Literature Search
Summary
Gupta et al. (2005) guidelines remain clinically relevant
with some minor changes.
Risk-factor related literature broadened what was known
by extending the level of knowledge for recommendation
support (expert opinion-based recommendations now
support by well-designed cohort studies).
The published guidelines were examined in light of the
guideline review, literature review, and were specifically
adapted or “reinvented” as noted by Rogers (2003) by
three expert HIV clinicians working in the clinical settings
under study.
21
22. Intervention Level of Key Citations
Supporta
First assessment at time of HIV diagnosis or initial clinic visit should include Heffelfinger et al., 2006
a UA and eGFR on all patients. Level IV Jacobson et al., 2007
All HIV-infected patients should have an annual UA and eGFR. Kalayjian et al., 2008
Level IV Szczech et al., 2007
Additional lab evaluations and consideration referral to a nephrologist are Levey et al., 2003
recommended if proteinuria of grade > 1+ by dipstick or eGFR < 60 mL/min. Level IV
If evidence of nephropathy is present, blood pressure should be controlled Levey et al., 2003
to < 125/75 and treatment for HTN should include ACE or ARB. Level II
Patients receiving tenofovir should be monitored at least biannually for Arribas, et al.,2008
measurements of renal function, and UA for proteinuria and glycosuria. Level I Kiser et al., 2008
22
23. Knowledge
Must include assessment of organization, identification of
stakeholders, and assessment of readiness for change
Project involved two clinic sites:
Large multidisciplinary Infectious Disease Clinic in 633 bed
metropolitan regional medical center
Ambulatory care clinic with primary care focus but it incorporates an
HIV specialty
Total HIV population approximately 800 patients
Both sites are part of a larger health system.
Some decisions unit-based
Other initiatives system-wide (diabetes) in the primary
care clinics
23
24. Stakeholders
Medical Director
Clinic Managers:
ID Clinic
Primary Care Clinic
Research Director
Nurse Practitioner
Clinic patients
24
25. Persuasion
Rogers’ (2003) persuasion stage occurred after
stakeholder identification.
Facilitators
Electronic Health Record (EHR) reminder
“Living Healthy with HIV” teaching tool
Project champion on site
Nursing, dietary, social work/case manager staff
Potential Barriers
Resistance to nurse-led practice change
Complex guideline recommendations through
“reinvention”
Part-time medical staff
EHR limitations 25
26. Persuasion
Early and ongoing involvement of stakeholders and
individuals identified as potential barriers successfully
made facilitators and even a project champion.
Utilized to:
Provide expert opinion during guideline reinvention
Provide suggestions and ongoing support in development
of renal health education tool
Despite several potential barriers, the renal care
guideline implementation remained feasible.
Decision: To move forward with adoption of the
guidelines.
26
27. Implementation
Project received approval from both the clinical setting
IRB and the university IRB.
Pre-guideline rates of completion of specific renal care
aspects associated with the renal recommendations were
determined.
Training to providers and support staff.
Clinic-specific guidelines implemented.
Post-guideline rates of completion of recommended
renal care aspects were collected and compared to pre-
implementation rates.
Renal Health Education rate of completion collected
on post-implementation sample.
27
28. Guideline Implementation
Provider education in small groups
Data on care prior to guideline implementation
Review of clinic specific guidelines
Review of EMR reminder
Nursing, dietary, and social work/case management
education in small groups:
Review “Living Healthy with HIV” teaching/discussion tool
Role-played providing education in short 3-4 minute
education session
Developed “Smart Phrase” to include in nursing
assessment section of the EHR progress note
28
29. Guideline Implementation
Renal Health Education:
Completed by nursing staff
Health information provided in written form (see handout)
Health information provided in consistent follow-up
messages by dietary and social work staff
“Living Healthy with HIV” teaching tool:
SMOG assessment for reading level (Redman, 2006)
Grade 9
29
30. Measures
• Data: Proportion of people with appropriate:
• Initial visit: UA and eGFR
• If not on tenofovir regimen: UA and eGFR yearly
• If on tenofovir regimen: UA and eGFR every six months
• Follow-up if > 1+ protein on UA or eGFR < 60 mL/Min:
• Repeat UA
• Urine protein: creatinine ratio
• Referral to nephrologist
• Renal Ultrasound
• BP Management
• < 125/75
30
31. Sample
Sample Characteristic (N=600):
Pre-implementation (n=300)
Post-implementation (n=300)
Pre-implementation sample:
Convenience sample of 150 from each of the two clinical
settings under study collected in the three month period
prior to guideline implementation (prior to October 13,
2008).
Post-implementation sample:
Convenience sample of 150 patients from each site
collected in the three month period after guideline
implementation (November 17, 2009).
31
32. Sample Demographics and Disease
Characteristics
Pre Implementation Post Implementation
n = 300 n = 300
Mean (SD) Mean (SD) Significance of
Variable Difference
Age in years 44.1 (10.5) 43.6 (10.1) t = 0.58, p = 0.57
CD4 Count 516.3 (305.1) 554.9 (307.8) t = -1.64, p= 0.10
Viral Load 27,256.0 (62,686.8) 51,727.5 (189,039.8) t = -1.20, p = 0.24
Serum Creatinine 0.93 (0.20) 0.93 (0.19) t = 0.06, p = 0.95
32
33. Sample Demographics
Pre Implementation Post Implementation
n (%) n (%) Significance of
Difference
Ethnicity:
American Indian 11 (3.7) 15 (5.0) χ2 = 9.91, p = 0.08
Asian/Pacific Islander 8 (2.7) 5 (1.7)
Black 55 (18.3) 39 (13.0)
Hispanic 5 (1.7) 7 (2.3)
White 214 (71.3) 215 (71.7)
Not indicated 7 (2.3) 19 (6.3)
Gender:
Male 234 (78.0) 239 (79.7) χ2 = 0.25, p = 0.89
Female 65 ( 21.7) 60 (20.0)
Transgender 1 (0.3) 1 (0.3)
33
34. Sample Disease Characteristics
Pre Implementation Post Implementation Significance of
n (%) n (%) Difference
Hypertension:
Yes 48 (16.0) 34 (11.3) χ2 = 2.76, p = 0.12a
No 252 (84.0) 266 (88.7)
Hepatitis C:
Yes 51 (17.0) 28 (9.3) χ2 = 7.71, p = 0.01a,b
No 249 (83.0) 272 (94.7)
Diabetes Mellitus:
Yes 18 ( 6.0) 16 (5.3) χ2 = 1.13, p = 0.58a
No 282 (93.7) 284 (94.7)
Viread Use:
Yes 191 (63.7) 203 (67.7) χ2 = 1.07, p = 0.34a
No 109 (36.3) 97 (32.3)
NOTE: a. Fisher’s Exact Test p-value used, b. Significant at α = .05 34
35. Adoption of Technology
Planned Use of Technology Reminders
EHR
Primary care clinic: HIV Smartset
Hospital-based clinic: HIV Outpatient Order Set
Nursing Order Protocol
Reinvention
35
36. Evaluation
Confirmation of diffusion of the practice innovation
completed through determination of the proportion of
people with correct renal testing three months after
guideline implementation and proportion of people with
completion of Renal Health Education noted on EHR.
Success:
Completion rates of > 70% of sample on renal health
education
Significant (p < 0.05) increase in proportion of correct renal
testing
36
37. Results
Renal Health Education
Overall completion rate noted in EHR: 61% (183/300)
Hospital-based Clinic: 88% (132/150)
Primary care clinic overall: 33% (49/150)
Primary care clinic including only those patients eligible for the
education, rate was 92% (22/24)
37
38. Results: Significance Testing
Pre-Implementation Post-Implementation Significance
n (%)a n (%)a of Differenceb
Initial UA 40 (35.4) 6 (75.0) χ2 = 7.06, p = 0.01c
Initial eGFR 29 (25.7) 7 (87.5) χ2 = 11.51, p = 0.002c
Yearly UA 18 (20.0) 77 (80.2) χ2 = 69.96, p < 0.001c
Yearly eGFR 4 (4.7) 93 (96.9) χ2 = 154.02, p < 0.001c
Twice Yearly UA 20 (11.0) 160 (78.4) χ2 = 175.80, p < 0.001c
Twice Yearly eGFR 8 (4.4) 201 (98.5) χ2 = 342.28, p < 0.001c
If UA 1+ protein or eGFR
< 60 mL/min:
Repeat UA 6 (11.0) 17 (73.9) χ2 = 29.8, p < 0.001c
Protein/Creat Ratio 1 (1.0) 3 (12.5) χ2 = 3.8, p = 0.09
Renal Ultrasound 15 (29.4) 9 (40.9) χ2 = 0.9, p = 0.24
Refer to Nephrology 13 (25.0) 5 (22.7) χ2 = 0.4, p = 0.54
BP < 125/75 22 (44.9) 14 (58.3) χ2 = 1.2, p = 0.20
NOTE: a. Conditional Probability: denominator is dependent upon sample group condition being present (e.g. Post
Implementation probability denominator = number of subjects who had initial visit since guideline implementation), b. Fisher’s
Exact Test p-value used, c. Significant at α = 0.05
38
39. Clinical Practice Implications
A nurse-led evidence-based practice improvement
project was successfully implemented with the
multidisciplinary team in these HIV clinical settings
Practice changes occurred among:
Nurses
Physicians
Social Worker/Case Manager
Dietician
Resulted in improved renal care sustained for three
months
39
40. Clinical Practice Implications
Revealed other areas for practice improvement (e.g., HTN
diagnosis and management).
Revealed need for determination of specific
recommendations for follow-up testing of abnormal renal
screening tests.
Flexibility and reinvention were essential for successful
diffusion in this clinic practice setting.
Supported use of the Rogers’ (2003) Diffusion of
Innovations theory in a clinical setting.
Simplicity of screening program underscores ease
with which it could be replicated in other similar
clinical settings.
40
41. Limitations
Short follow-up period
Small number of subjects actually experiencing abnormal
renal screening tests. There was limited power to detect
differences pre- and post-guideline implementation.
Lack of formal cost/benefit analysis
“Living Healthy with HIV” teaching tool SMOG grade 9
reading level (Redman, 1997).
Need for examination of health literacy and cultural
influences on learning from the teaching tool.
41
42. Moving Forward
To ensure practice changes are sustained:
Reinvention of method of delivery of Renal Health
Education at primary care setting
Data collection of a convenience sample at each clinical
setting every 3-6 months
Share this and ongoing data with clinic and leadership staff
Changes to the program (reinvention) will be made as
needed
Education regarding the program added to unit orientation
for new staff, resident physicians and medical students
Future assessment to include further details on what
type of care is required when referral to nephrologist is
made.
42
43. References
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44. References
Gupta, S. K., Eustace, J. A., Winston, J. A., Boydstun, I. I., Ahuja, T. S., Rodriguez, R. A., et al. (2005). Guidelines
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