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Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers

Makarov, Danil V; Feuer, Zachary; Ciprut, Shannon; Lopez, Natalia Martinez; Fagerlin, Angela; Shedlin, Michele; Gold, Heather T; Li, Huilin; Lynch, Gina; Warren, Rueben; Ubel, Peter; Ravenell, Joseph E
BACKGROUND:Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specific antigen (PSA) testing decisions to be based on shared decision-making (SDM) clinician professional judgment, and patient preferences. However, evidence suggests that SDM is underutilized in clinical practice, especially among the most vulnerable patients. The purpose of this study is to evaluate the efficacy of a community health worker (CHW)-led decision-coaching program to facilitate SDM for prostate cancer screening among Black men in the primary care setting, with the ultimate aim of improving/optimizing decision quality. METHODS:We proposed a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening discussions in Black men at a primary care FQHC. This study enrolled Black men who were patients at the participating clinical site and up to 15 providers who cared for them. We estimated to recruit 228 participants, ages 40-69 to be randomized to either (1) a decision aid along with decision coaching on PSA screening from a CHW or (2) receiving a decision aid along with CHW-led interaction on modifying dietary and lifestyle to serve as an attention control. The independent randomization process was implemented within each provider and we controlled for age by dividing patients into two strata: 40-54 years and 55-69 years. This sample size sufficiently powered the detection differences in the primary study outcomes: knowledge, indicative of decision quality, and differences in PSA screening rates. Primary outcome measures for patients will be decision quality and decision regarding whether to undergo PSA screening. Primary outcome measures for providers will be acceptability and feasibility of the intervention. We will examine how decision coaching about prostate cancer screening impact patient-provider communication. These outcomes will be analyzed quantitatively through objective, validated scales and qualitatively through semi-structured, in-depth interviews, and thematic analysis of clinical encounters. Through a conceptual model combining elements of the Preventative Health Care Model (PHM) and Informed Decision-Making Model, we hypothesize that the prostate cancer screening decision coaching intervention will result in a preference-congruent decision and decisional satisfaction. We also hypothesize that this intervention will improve physician satisfaction with counseling patients about prostate cancer screening. DISCUSSION/CONCLUSIONS:Decision coaching is an evidence-based approach to improve decision quality in many clinical contexts, but its efficacy is incompletely explored for PSA screening among Black men in primary care. Our proposal to evaluate a CHW-led decision-coaching program for PSA screening has high potential for scalability and public health impact. Our results will determine the efficacy, cost-effectiveness, and sustainability of a CHW intervention in a community clinic setting in order to inform subsequent widespread dissemination, a critical research area highlighted by USPSTF. TRIAL REGISTRATION/BACKGROUND:The trial was registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration number NCT03726320 , on October 31, 2018.
PMCID:7876807
PMID: 33568208
ISSN: 1745-6215
CID: 4779852

A practice facilitation-guided intervention in primary care settings to reduce cardiovascular disease risk: a cost analysis

Gold, Heather T; Siman, Nina; Cuthel, Allison M; Nguyen, Ann M; Pham-Singer, Hang; Berry, Carolyn A; Shelley, Donna R
BACKGROUND:A stepped-wedge, cluster randomized controlled trial assessed the effectiveness of practice facilitation (PF) for adoption of guidelines for prevention and treatment of cardiovascular disease risk factors. This study estimated the associated cost of PF for guideline adoption in small, private primary care practices. METHODS:The cost analysis included categories for start-up costs, intervention costs, and practice staff costs for the implemented PF-guided intervention. We estimated the total 1-year costs to operate the program and calculated the mean and range of the cost-per-practice by quarter of the intervention. We estimated the lower and upper bounds for all salary expenses, rounding to the nearest $100. RESULTS:Total 1-year intervention costs for all 261 practices ranged from $7,900,000 to $10,200,000, with program and practice salaries comprising $6,600,000-$8,400,000 of the total. Start-up costs were a small proportion (3%) of the total 1-year costs. Excluding start-up costs, quarter 1 cost-per-practice was the most expensive at $20,400-$26,700, and quarter 4 was the least expensive at about $10,000. Practice staff time (compared with program staff time) was the majority of the staffing costs at 75-84%. CONCLUSIONS:The PF strategy costs approximately $10,000 per practice per quarter for program and practice costs, once implemented and running at highest efficiency. Whether this program is "worth it" to the decision-maker depends on the relative costs and effectiveness of their other options for improving cardiovascular risk reduction. TRIAL REGISTRATION/BACKGROUND:This study is retrospectively registered on January 5, 2016, at www.clinicaltrials.gov as NCT02646488 .
PMCID:7868016
PMID: 33549152
ISSN: 2662-2211
CID: 4837702

Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers [Editorial]

V. Makarov, Danil; Ciprut, Shannon; Martinez-Lopez, Natalia; Fagerlin, Angela; Thomas, Jerry; Shedlin, Michele; Gold, Heather T.; Li, Huilin; Bhat, Sandeep; Warren, Rueben; Ubel, Peter; Ravenell, Joseph E.
ISI:000719424800005
ISSN: 2405-4569
CID: 5142662

Diabetes mellitus and colorectal carcinoma outcomes: a meta-analysis

Becker, Daniel J; Iyengar, Arjun D; Punekar, Salman R; Kaakour, Dalia; Griffin, Megan; Nicholson, Joseph; Gold, Heather T
OBJECTIVES/OBJECTIVE:The impact of diabetes mellitus (DM) on colorectal cancer (CRC) outcomes remains unknown. We studied this by conducting a meta-analysis to evaluate (1) CRC outcomes with and without DM and (2) treatment patterns. METHODS:We searched PubMed, EMBASE, Google Scholar, and CINAHL for full-text English studies from 1970 to 12/31/2017. We searched keywords, subject headings, and MESH terms to locate studies of CRC outcomes/treatment and DM. Studies were evaluated by two oncologists. Of 14,332, 48 met inclusion criteria. In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method, we extracted study location, design, DM definition, covariates, comparison groups, outcomes, and relative risks and/or hazard ratios. We utilized a random-effects model to pool adjusted risk estimates. Primary outcomes were all-cause mortality (ACM), disease-free survival (DFS), relapse-free survival (RFS), and cancer-specific survival (CSS). The secondary outcome was treatment patterns. RESULTS:Forty-eight studies were included, 42 in the meta-analysis, and 6 in the descriptive analysis, totaling > 240,000 patients. ACM was 21% worse (OR 1.21, 95% CI 1.15-1.28) and DFS was 75% worse (OR 1.75, 95% CI: 1.33-2.31) in patients with DM. No differences were detected in CSS (OR 1.10, 95% CI 0.98-1.23) or RFS (OR 1.12, 95% CI 0.91-1.38). Descriptive analysis of treatment patterns in CRC and DM suggested potentially less adjuvant therapy use in cases with DM and CRC. CONCLUSIONS:Our meta-analysis suggests that patients with CRC and DM have worse ACM and DFS than patients without DM, suggesting that non-cancer causes of death in may account for worse outcomes.
PMID: 32564124
ISSN: 1432-1262
CID: 4492662

Estimating Downstream Budget Impacts in Implementation Research

Wagner, Todd H; Dopp, Alex R; Gold, Heather T
Health care decision makers often request information showing how a new treatment or intervention will affect their budget (i.e., a budget impact analysis; BIA). In this article, we present key topics for considering how to measure downstream health care costs, a key component of the BIA, when implementing an evidence-based program designed to reduce a quality gap. Tracking health care utilization can be done with administrative or self-reported data, but estimating costs for these utilization data raises 2 issues that are often overlooked in implementation science. The first issue has to do with applicability: are the cost estimates applicable to the health care system that is implementing the quality improvement program? We often use national cost estimates or average payments, without considering whether these cost estimates are appropriate. Second, we need to determine the decision maker's time horizon to identify the costs that vary in that time horizon. If the BIA takes a short-term time horizon, then we should focus on costs that vary in the short run and exclude costs that are fixed over this time. BIA is an increasingly popular tool for health care decision makers interested in understanding the financial effect of implementing an evidence-based program. Without careful consideration of some key conceptual issues, we run the risk of misleading decision makers when presenting results from implementation studies.
PMID: 32951506
ISSN: 1552-681x
CID: 4615662

Outcomes of a First Total Knee Arthroplasty Are Associated With Outcomes of the Subsequent Contralateral Total Knee Arthroplasty

Schwarzkopf, Ran; Kaplan, Daniel J; Friedlander, Scott; Gold, Heather T
BACKGROUND:To determine if preoperative characteristics and postoperative outcomes of a first total knee arthroplasty (TKA) were predictive of characteristics and outcomes of the subsequent contralateral TKA in the same patient. METHODS:Retrospective administrative claims data from (SPARCS) database were analyzed for patients who underwent sequential TKAs from September 2015 to September 2017 (n = 5,331). Hierarchical multivariable Poisson regression (length of stay [LOS]) and multivariable logistic regression (all other outcomes), controlling for sex, age, and Elixhauser comorbidity scores were performed. RESULTS:The cohort comprised 65% women, with an average age of 66 years and an average duration of 7.3 months between surgeries (SD: 4.7 months). LOS was significantly shorter for the second TKA (2.6 days) than for the first TKA (2.8 days; P < .001). Patients discharged to a facility after their first TKA had a probability of 76% of discharge to facility after the second TKA and were significantly more likely to be discharged to a facility compared with those discharged home after the first TKA (odds ratio [OR]: 63.7; 95% confidence interval [CI]: 52.1-77.8). The probability of a readmission at 30 and 90 days for the second TKA if the patient was readmitted for the first TKA was 1.0% (OR: 3.70; 95% CI: 0.98-14.0) and 6.4% (OR: 9; 95% CI: 5.1-16.0), respectively. Patients with complications after their first TKA had a 27% probability of a complication after the second TKA compared with a 1.6% probability if there was no complication during the first TKA (OR: 14.6; 95% CI: 7.8.1-27.2). CONCLUSION/CONCLUSIONS:The LOS, discharge disposition, 90-day readmission rate, and complication rate for a second contralateral TKA are strongly associated with the patient's first TKA experience. The second surgery was found to be associated with an overall shorter LOS, fewer readmissions, and higher likelihood of home discharge. LEVEL OF EVIDENCE/METHODS:Level 3-retrospective cohort study.
PMID: 32061478
ISSN: 1532-8406
CID: 4313042

Diagnosis of depression and other patient factors impacts length of stay after total knee arthroplasty

Oh, Cheongeun; Gold, Heather; Slover, James
Background/UNASSIGNED:The length of in-hospital stay (LOS) is an important measure of efficiency in the use of hospital resources and care quality outcomes after orthopaedic surgery. This study investigated the influence of patients' characteristics including demographic factors and the presence of comorbid preoperative depression on LOS after primary total knee arthroplasty (TKA). Methods/UNASSIGNED:Data were extracted from the California Healthcare Cost and Utilization Project database for hospital discharges after primary TKA for adults aged 50 years and older from 2007 to 2010 (n = 133,603). LOS was defined as the difference in days between the date of admission and the date of discharge. We included demographic data (age, sex, race), comorbidity of depression, and years of admission as covariates in the multivariable model. Negative binomial regression was used to model the effect(s) of covariates on the LOS. As a secondary analysis, the association of covariates with the extended LOS (>9 days) was also investigated using logistic regression. Results/UNASSIGNED:Our study showed that female sex, age, Medicaid insurance, and race were associated with a longer LOS. Most importantly, a diagnosis of depression was associated with a significantly longer LOS (1.05 times longer: 95% CI: 1.04-1.06) and was independently associated with 1.83 times higher odds (95% CI: 1.50-2.23) of belonging to the extended LOS group. Compared to 2007, significant reductions of both LOS and a longer LOS were noted throughout all later years from 2008 to 2010. Conclusions/UNASSIGNED:Our study revealed that a diagnosis of depression and patient's characteristic such as age, female sex, Medicaid, nonwhite race resulted in a statistically significant increased LOS. These findings can be useful for planning and resource allocation for total knee replacement programs.
PMCID:7083721
PMID: 32211480
ISSN: 2352-3441
CID: 4358532

Association of Diabetes and Other Clinical and Sociodemographic Factors With Guideline-concordant Breast Cancer Treatment for Breast Cancer

Gold, Heather T; Shao, Huibo; Oratz, Ruth; Yu, Onchee; Hammer, Marilyn; Richardson, Stephen; Boudreau, Denise
BACKGROUND:Women with breast cancer have worse health outcomes with co-occurring type 2 diabetes, possibly due to suboptimal breast cancer treatment. METHODS:We created a cohort of women ages 66 to 85 y with stage I to III breast cancer from 1993 to 2012 from an integrated health care delivery system (n=1612) and fee-for-service Medicare beneficiaries (n=98,915), linked to Surveillance, Epidemiology, and End Results (SEER) data (total n=100,527). We evaluated associations between type 2 diabetes and other factors with undergoing guideline-concordant cancer treatment. We estimated χ tests for univariate analysis and relative risks (RRs) using multivariable log-binomial models for outcomes of (1) overall guideline-concordant treatment, (2) definitive surgical therapy (mastectomy or lumpectomy with radiation), (3) chemotherapy if indicated, and (4) endocrine therapy. RESULTS:Our cohort included 60% of subjects with stage 1 tumors, one quarter below 70 years old, 23% had diabetes, 35% underwent overall guideline-concordant treatment, 24% chemotherapy, and 83% endocrine therapy. Women with diabetes were less likely to undergo overall guideline-concordant treatment (RR: 0.96; 95% confidence interval: 0.94-0.98), and only slightly less likely to undergo guideline-concordant definitive surgical therapy (RR: 0.99; 95% confidence interval: 0.99-1.00). No differences were found for chemotherapy or endocrine therapy. Other factors significantly associated with a lower risk of guideline-concordant care were cancer stages II to III (vs. I; RR=0.47-0.69, P<0.0001), older age (vs. 66 to 69 y; RR=0.56-0.90, P<0.0001), higher comorbidity burden, and Medicaid dual-eligibility. CONCLUSIONS:Diabetes was associated with lower adherence to overall guideline-concordant breast cancer treatment. However, higher stage, older age, higher comorbidity burden, and Medicaid insurance were more strongly associated with lower use of guideline-concordant treatment. Given the heavy burden of breast cancer and diabetes, long-term outcomes analysis should consider guideline-concordant treatment. IMPACT/CONCLUSIONS:Other factors besides diabetes are more strongly associated with guideline-concordant breast cancer treatment.
PMID: 31850918
ISSN: 1537-453x
CID: 4242682

Pediatric Fingertip Injuries: Association With Child Abuse

Klifto, Christopher S; Lavery, Jessica A; Gold, Heather T; Milone, Michael T; Karia, Raj; Palusci, Vincent; Chu, Alice
Purpose/UNASSIGNED:Pediatric fingertip injuries are most commonly reported in the setting of an accidental occurrence. The purpose of this study was to determine whether there is an association of child abuse and neglect with pediatric fingertip injuries. Methods/UNASSIGNED:The New York Statewide Planning and Research Cooperative System (2004 to 2013) administrative database was used to identify children aged 0 to 12 years who presented in the inpatient or outpatient (emergency department or ambulatory surgery) setting. International Classification of Diseases, Ninth Revision diagnosis codes were used to identify fingertip injuries (amputation, avulsion, or crushed finger) and abuse. Cohort demographics of children presenting with fingertip injuries were described. We analyzed the association between fingertip injuries and child abuse using multivariable logistic regression, with variables for insurance status, race, ethnicity, sex, and behavioral risks including depression, attention-deficit hyperactivity disorder, aggressive behavior, and autism. Results/UNASSIGNED:Of the 4,870,299 children aged 0 to 12 years in the cohort, 79,108 patients (1.62%) during the study period (2004 to 2013) presented with fingertip injuries. Of those with a fingertip injury, 0.27% (n = 216) presented either at that visit or in other visits with a code for child abuse, compared with 0.22% of pediatric patients without a fingertip injury (n = 10,483). In an adjusted analysis, the odds of a fingertip injury were 23% higher (odds ratio [OR] = 1.23; 95% confidence interval [CI], 1.07-1.41) for children who had been abused, compared with those who had not. Patients were more likely to present with fingertip injuries if they had ever had Medicaid insurance (OR = 1.40; 95% CI, 1.37-1.42) or had a behavioral risk factor (OR = 1.35; 95% CI, 1.30-1.40). Conclusions/UNASSIGNED:Patients presenting with abuse are significantly more likely to have fingertip injuries during childhood compared with those without recorded abuse, which suggests that these injuries may be ones of abuse or neglect. Medicaid insurance, white race, and behavioral diagnoses of depression, attention-deficit hyperactivity disorder, aggressive behavior, and autism were also associated with increased odds of presenting with fingertip injuries. Type of study/level of evidence/UNASSIGNED:Prognostic III.
PMCID:8991547
PMID: 35415471
ISSN: 2589-5141
CID: 5232462

The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes

Lim, Sahnah; Wyatt, Laura C; Mammen, Shinu; Zanowiak, Jennifer M; Mohaimin, Sadia; Goldfeld, Keith S; Shelley, Donna; Gold, Heather T; Islam, Nadia S
BACKGROUND:Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes. METHODS/DESIGN/METHODS:The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss. DISCUSSION/CONCLUSIONS:This study will be the first to test the efficacy of an integrated EHR-CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study's implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways. TRIAL REGISTRATION/BACKGROUND:This study protocol has been approved and is made available on ClinicalTrials.gov by NCT03188094 as of 15 June 2017.
PMID: 31752964
ISSN: 1745-6215
CID: 4209272