Culture Conversion and Self- Administered Therapy in Privately Managed Tuberculosis Patients Melissa Ehman MPH, Jennifer Flood MD MPH, Pennan Barry MD MPH Tuberculosis Control Branch, Division of Communicable Disease Control, Center for Infectious Diseases, California Department of Public Health

Background Private medical providers (PMPs) provide majority of care for 1/3 of patients with tuberculosis (TB) in California  increasing trend as of 2009  Affordable Care Act may further increase PMP role in TB patient care Local health departments (LHDs) maintain responsibility for oversight Proportion of cases cared for by PMPs varies widely between LHDs, from 3% to 100% Differences in indicator results between LHD- and PMP- managed patients point to possible differences in care, and opportunities for improvement

Provider Types* in California, by LHD, *proportion of patients cared for by both PMP and HD not shown

Objective Determine whether patient characteristics explain indicator performance differences between patients managed by PMPs and LHDs

Methods Study population: TB cases counted in California during 2003, 2004, 2005, 2006, 2008 Data sources: RVCT, and Office of AIDS Registry Match Data for California TB cases were stratified according to provider type “LHD” or “PMP/Other” Exclusions –“Both” provider type: variation in reporting across LHDs –Diagnosed at death: provider type not routinely reported Associations between PMP care and indicator outcomes modeled using multivariable regression, adjusting for patient demographic and clinical characteristics

Study Indicators First two indicators chosen for inclusion based on: –Public health impact of TB control activity –Known differences in results between PMP and LHD patients on univariable analysis 1.Culture Conversion Documented sputum culture conversion to negative within 70 days of treatment start, for sputum culture-positive TB patients who do not die during the first 70 days of treatment 2.Inappropriate Self-Administered Therapy (SAT) Patients receiving only SAT, of those starting treatment and for whom DOT is indicated under California guidelines: AIDS, drug-resistance, previous TB, culture conversion >60 days, cavitary TB, sputum smear-positive TB, homelessness, drug use, age <18 years, recent incarceration

Results

No Documented Culture Conversion ≤70 Days Selected Univariable Analysis Results Patient Characteristic All Patients N (%) No CC ≤70d n (%) P value ALL PATIENTS6328 (100)1850 (29)-- Age 0-4 years7 (0.1)5 (71)0.026 Any MDR74 (1.2)30 (41)0.030 PMP managed1849 (29)730 (39)<0.001 Disseminated disease109 (1.7)40 (37)0.084 Cavitary disease1712 (28)580 (34)<0.001 Born in United States1144 (18)390 (34)<0.001 Homeless or drug/alcohol use1155 (18)379 (33)0.003 HIV positive148 (2.3)45 (30)0.752 Female2238 (35)584 (26)<0.001 DOT for ≥10 weeks3935 (62)951 (24)<0.001

No Documented Culture Conversion ≤70 Days Multivariable Model Results Patient Characteristic Relative Risk 95% Confidence Interval (CI) Age 0-4 years – 3.86 PMP managed – 1.68 Any MDR – 2.19 Disseminated disease – 1.63 Cavitary disease – 1.36 Homeless or drug/alcohol use – 1.06 Born in United States – 1.23 HIV positive – 1.31 Female – 0.95 DOT for ≥10 weeks – 0.66

SAT in Patients with Indications for DOT Selected Univariable Analysis Results Patient Characteristic All Patients N (%) SAT n (%) P value ALL PATIENTS6824 (100)746 (11)-- PMP managed2271 (33)568 (25)< No culture conversion ≤ 60 days2027 (42)300 (15)<0.001 History of TB622 (9.2)78 (13)0.174 INH or Rifampin resistance783 (14)97 (12)0.128 Long-term care facility213 (3.1)23 (11)0.948 HIV positive201 (2.9)17 (8.4)0.254 Age < 18 years863 (13)70 (8.1)0.005 Cavitary disease1823 (29)129 (7.1)<0.001 Sputum smear-positive3839 (63)212 (5.7)<0.001 Homeless or drug/alcohol use1498 (22)81 (5.4)<0.001 Correctional facility204 (3.0)10 (4.9)0.005

SAT in Patients with Indications for DOT Multivariable Model Results Patient CharacteristicOdds Ratio95% CI PMP managed – No culture conversion ≤ 60 days – 2.15 Born in United States – 1.90 History of TB – 1.20 Cavitary disease – 0.70 INH or Rifampin resistance – 0.74 Age < 18 years – 0.97 HIV positive – 1.14 Correctional facility – 0.67 Homeless or drug/alcohol use – 0.39 Smear positive – 0.30 Long-term care facility – 0.49 Disseminated disease – 0.52

Summary Documented Sputum Culture Conversion ≤ 70 Days After adjustment for confounders, PMP-managed TB patients less likely to culture convert, vs. LHD-managed Patients with MDR TB or cavitary disease less likely to document culture conversion ≤ 70 days Patients receiving ≥ 10 weeks of DOT more likely to document culture conversion ≤ 70 days SAT When DOT Is Indicated PMP-managed TB patients more likely to receive SAT throughout treatment when DOT is indicated Patients slow to culture convert more likely to receive SAT, vs. those with other DOT indications

Limitations Preliminary results Caution for interpretation at local level –Reporting of provider type varies across LHDs –Influence of patient characteristics may also vary Unmeasured confounders, e.g., comorbidities and culture conversion Odds ratios are likely overestimates of magnitude of true associations

California Interventions to Improve PMP-Managed TB Patient Care (1) TB Indicators Project (TIP) Partnership between state and 14 local TB control programs with highest TB incidence in California Culture Conversion and DOT/SAT among most-selected indicators Outcomes improved after TIP interventions in most LHDs

California Interventions to Improve PMP-Managed TB Patient Care (2) State TB Program Interventions Fact sheets on DOT and culture conversion –targeted to PMPs LHD TB Program Interventions Letter to PMP at diagnosis –outlining standards of care and LHD role Provide DOT and sputum collection for PMP patients Regular case management conferences –identify patients not on DOT or without documented culture conversion

Conclusions When other characteristics are taken into account, PMP-managed patients are at higher risk for: not having a documented, timely culture conversion receiving SAT when DOT is indicated When TB patients cannot be managed by the LHD, strategies to ensure a consistent level of TB care for PMP patients are needed Outcomes might improve by LHD overseeing culture conversion and providing DOT

Next Steps Sensitivity analysis of culture conversion within 70 vs. 60 days Assess additional indicators of interest Completion of therapy, to inform feasibility of improving performance Deaths during therapy, to avert preventable deaths in the future Include new surveillance fields: Comorbidities Patients receiving only inpatient care Measure effectiveness of specific LHD interventions to improve outcomes for patients under PMP care

Acknowledgements Anne Cass Alex Golden Linda Johnson Lisa Pascopella Fei Fei Qin For more information, please contact Melissa Ehman: