Low risk express care: A nurse- centered model for the management of stable patients on combination antiretroviral therapy (cART) K. Wools-Kaloustian , R. Kosgei, S. Kimaiyo, P. Braitstein, E. Sang, B. Musick, C. Yiannoutsos, A. Siika
Jan 15, 2016
Low risk express care: A nurse-centered model for the management of stable
patients on combination antiretroviral therapy (cART)
K. Wools-Kaloustian, R. Kosgei, S. Kimaiyo, P. Braitstein, E. Sang, B. Musick, C. Yiannoutsos, A. Siika
Low Risk Express Care
Background• ART rollout in resource-constrained settings has been
slow. • More than 5 million of the 9.5 million people living in low- and
middle-income countries in need of ART are still without access to treatment.
• Delays in rollout are in part due to the substantial financial and human resources necessary to establish and maintain an HIV care delivery infrastructure.
• Sub-Saharan Africa is the home of two thirds of persons living with HIV/AIDS but only 3% of the world’s health care workers and commands less than 1% of the world’s health expenditures.
Low Risk Express Care
Background• To maximize access to ART in resource-constrained
settings, leaders in international health have advocated:• The decentralization of HIV care
• Use of existing infrastructure
• A shift from physician-centered care models to those utilizing non-physician health workers trained in simplified and standardized approaches to care
• Experience with feasible models of task shifting in HIV care programs in resource poor areas is limited
Low Risk Express Care
Methods: Objective
• To evaluated the impact of “Low Risk Express Care” (LREC), a program in line with WHO's recommendation to shift much of the responsibility of HIV-care from physicians and mid-level practitioners (clinicians) to nurses.
Methods: SettingLow Risk Express Care
USAID-AMPATH Partnership Clinics
Low Risk Express Care
Methods: Eligibility
LREC eligibility criteria:
•>18 years
•Stable on cART > 6 mo
•CD4 count > 200 cells/µl
• No active opportunistic infection
• No history of adherence issues
Low Risk Express Care
Methods: Model
Task Shifting with the LREC Model (derived from WHO Task shifting: Global Recommendations and guidelines)
Standard of Care LREC Model
P CO N P CO N
Clinical Monitoring
Monitor and support ART adherence ▪▪▪ ▪▪▪ ▪▪▪ ▪ ▪ ▪▪▪Take weight ▪▪▪ ▪Take vitals ▪▪▪ ▪Determine Functional Status ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Request CD4 Count and Viral Load ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪Identify ART Side Effects ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Manage ART Side Effects ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪Identify OI Symptoms ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Manage OIs ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪
▪▪▪ Responsible during all visits▪▪ Responsible during two thirds of visits▪ Responsible during one third of visits
P= Physician; CO= Clinical Officer; N = Nurse
Low Risk Express Care
Methods: Analysis
• A retrospective analysis including data from the 12-month period both pre and post introduction of LREC
Introduction ofLREC – 12 mo.
Introduction ofLREC
Introduction ofLREC + 12 mo
Patient 1
Patient 2
Patient 3
Patient 4
Low Risk Express Care
Methods: Analysis
• Outcomes of interest between groups and time dependent
– Adherence– CD4 Response ( square root of CD4)– Death/LTFU (LTFU define as no visit for 6 months)
• Data were analyzed using:• Descriptive statistics• Longitudinal analyses • Proportional hazards regression models addressing time
until loss-to-follow-up or death • Analyses were weighted by propensity scores to adjust for
differential LREC enrollment
Low Risk Express Care
Results: Univariate Analysis• 17,922 patients were eligible for LREC with 38.2% enrolling • Enrolled and non-enrolled groups were equivalent with regard to:
• Gender : 70% female • Median age: 36 years
• The LREC-enrolled group had a significantly:• Higher median CD4 count at:
– cART initiation: 143 versus 135 cells/µl (p = 0.015)
– LREC eligibility: 326 versus 301 cells/µl (p< 0.0001)
• Lower WHO stage at:– cART initiation: Stage I/II 49.7 versus 46.6% (p = 0.0002)
– LREC eligibility: Stage I/II 52.0% versus 47.4% (p< 0.0001)
• Less likely to be cared for at the Referral Hospital – 20.6% versus 34.1% (p< 0.0001)
Low Risk Express Care
Results: Logistic-Regression Model for Enrollment
Factor Odds Ratio 95% WaldConfidence Limits
p-value
Referral Hospital (yes versus no) 0.298 0.265 0.336 <.0001
Gender (male versus female) 1.321 1.175 1.485 <.0001
Age at EC eligibility (per year) 0.985 0.979 0.991 <.0001
WHO stage closest to EC eligibility (3,4 versus 1,2)
0.787 0.709 0.874 <.0001
CD4 count within 9 months of EC eligibility (per cell increase)
1.001 1.001 1.001 <.0001
First 12 visits from AMPATH enrollment to EC eligibility (per visit)
1.537 1.454 1.624 <.0001
13 visits or more from AMPATH enrollment to EC eligibility (per visit)
1.058 1.052 1.064 <.0001
Low Risk Express Care
Results: Adherence Longitudinal Model
FactorOdds ratio
estimate95% Confidence
Limitsp-value
Referral Hospital (yes versus no) 1.053 0.802 1.383 0.711
Gender (male versus female) 1.018 0.733 1.414 0.915
Age at eligibility (per year) 1.016 0.997 1.034 0.103
EC (available versus not available) 1.248 0.950 1.639 0.112
EC (enrolled versus not enrolled) 0.384 0.083 1.783 0.222
Log of week after EC eligibility 0.615 0.553 0.682 <0.001
EC availability-by-log-week interaction 1.377 0.965 1.965 0.078
CD4 (<200 cells/μl versus >200 cells/μl) 3.827 2.780 5.268 <0.001
WHO stage (3,4 versus 1,2) 0.719 0.543 0.952 0.021
Low Risk Express Care
Results: Adherence
Average probability of being perfectly adherent by weeks from eligibility for EC
Low Risk Express Care
Results: Factors associated with square root CD4 counts after EC eligibility
Factor Regression Co-efficient
95% Confidence Limits
p-value
Week after EC eligibility 0.0188 0.0169 0.0207 <.0001
Enrolled in EC -0.1824 -0.3288 -0.0359 0.0147
EC availability 0.5023 0.3898 0.6148 <.0001
Gender (male versus female) -1.2218 -1.4088 -1.0349 <.0001
Referral Hospital (yes versus no) -0.4488 -0.6247 -0.2729 <.0001
WHO stage at last observation (3,4 versus 1,2)
-0.2322 -0.4016 -0.0628 0.0072
Low Risk Express Care
Results: CD4 Trajectory
Adjusted analysis of CD4 trajectory for enrollees in EC and those patients not enrolled
CD
4 c
ount (c
ells
/ml)
350
360
370
380
390
400
410
420
430
440
450
460
Weeks since EC availability at clinic
0 20 40 60 80 100
Adjusted analysis
Not enrolled in EC Enrolled in EC
Low Risk Express Care
Results: Risk of LTFU/Death
EFFECT HazardRatio
95% Hazard Ratio Confidence
Limits
p-value
Referral Hospital (yes versus no) 0.714 0.653 0.781 <0.0001
Gender (male versus female) 1.096 1.020 1.178 0.0126
Age at eligibility (years) 0.984 0.980 0.988 <0.0001
EC available at the site 0.629 0.575 0.688 <0.0001
Enrollment in EC 0.630 0.569 0.696 <0.0001
Enrollment in EC-by-Referral Hospital interaction
0.897 0.732 1.098 0.2916
CD4 count (<200 cells/μl versus >200 cells/μl) 0.920 0.808 1.046 0.2040
WHO stage (3,4 versus 1,2) 1.274 1.193 1.360 <0.0001
Low Risk Express Care
Limitations
• Biases Related to:• Referral versus non-referral clinic site• Make-up of cohort and duration of cohort involved in each of
these sites • Frequency of CD4 count testing (variability between Referral
Hospital and other sites)• Frequency of Adherence assessment
Low Risk Express Care
Conclusions• Patients with higher CD4 counts and less advanced HIV disease,
treated at rural health centers, were preferentially enrolled into LREC.
• After adjusting for this finding, LREC appears to have no adverse impact on patient outcomes and may decrease the rate of loss to program (LTFU or Death).
• More rigorous assessments of task shifting are necessary in order to unequivocally conclude that these models are equivalent or better than the current standard of care.
• Randomized Controlled Trials
Acknowledgements• Indiana University School of Medicine
• Moi University School of Medicine
• Moi Teaching and Referral Hospital
• This research was supported in part by a grant to the USAID-AMPATH Partnership from the United States Agency for International Development as part of the President’s Emergency Plan for AIDS Relief (PEPFAR).
Moi Teaching and Referral Hospital