Abstract
Background:
Inflammatory bowel disease (IBD) patients are known to benefit from care delivered in a specialized, inter-disciplinary setting. We aimed to evaluate the impact of this model on health outcomes, quality metrics, and healthcare resource utilization (HRU) in IBD patients insured with Medicaid.
Methods:
In July 2017, IBD patients at our tertiary hospital were transitioned from a fellows’ general gastroenterology (GI) clinic to a fellows’ inter-disciplinary IBD clinic. IBD patients were included if they were insured with Medicaid, had at least one visit in the general GI clinic between July 1, 2016 and June 30, 2017, and at least one visit between July 1, 2017 and June 30, 2018 in the IBD clinic. Characteristics related to patients’ IBD course, overall healthcare maintenance, and HRU were compared.
Results:
A total of 170 patients (51% male, mean age 39 years) were included. After transition to the IBD clinic, use of corticosteroids (37% vs. 25%; p=0.004) and combination therapy were significantly lower (55% vs. 38%; p=0.0004), while use of high-dose biologics numerically increased (58.5% vs. 67%; p=0.05). Post-transition, patients showed significantly lower levels of mean C-reactive protein (p=0.04). After transition, patients attended significantly fewer outpatient GI visits (p=0.0008) but were more often seen by other healthcare specialists (p=0.0003), and experienced a numeric decrease in HRU with fewer emergency department visits, hospitalizations, and surgeries.
Conclusions:
Care in an inter-disciplinary, IBD specialty setting is associated with significantly decreased corticosteroid use, decreased C-reactive protein levels, and improved access to ancillary services in Medicaid patients.
Keywords: inflammatory bowel diseases, Medicaid, patient care management
Introduction
Inflammatory bowel diseases (IBD) are chronic diseases that may benefit from inter-disciplinary care for effective long-term management. Annual healthcare expenditures for IBD patients are at least three times greater than those for non-IBD patients [1]. A trend towards higher rates of emergency room (ER) visits and inpatients admissions for IBD care has been witnessed over the past 15 years [2]. IBD patients with public insurance (Medicaid) tend to have greater healthcare costs due to higher utilization of these services [3,4]. Additionally, IBD patients of lower socioeconomic status demonstrate increased use of opiates, corticosteroids, and psychiatric medications, as well as increased rates of all-cause admissions to intensive care units and all-cause mortality [5].
Given the complexity and chronicity of IBD, as well as its multi-organ effects, there is growing acceptance of the need for inter-disciplinary IBD centers where patients can obtain care in a focused space from a variety of specialists that includes, but is not limited to, gastroenterologists, colorectal surgeons, nutritionists, pharmacists, and psychologists [6]. Prior studies have shown that inter-disciplinary IBD centers are associated with reduced disease activity, decreased use of opiates and corticosteroids, and fewer hospitalizations and emergency department visits [7–10]. There are limited data on the outcomes of IBD patients insured with Medicaid, who may be at greater risk for a worsened disease course and adverse events due to socioeconomic and access disparities [11–13]. However, it is unknown whether this vulnerable Medicaid population would benefit from an IBD specialty clinic to improve health outcomes and quality metrics and to reduce inappropriate healthcare utilization [14]. Therefore, we aimed to determine the impact of transition to a fellows’ inter-disciplinary IBD specialty clinic from a fellows’ general gastrointestinal (GI) clinic on IBD-related outcomes and quality metrics with regards to the use of IBD medical therapies, secondary care visits, healthcare resource utilization (HRU), and rates of remission for patients insured with Medicaid.
Materials and Methods
Patient Selection
In July 2017, adult IBD patients (age>18 years) insured with Medicaid at the Mount Sinai Hospital were transitioned from a fellows’ general GI clinic to a fellows’ inter-disciplinary IBD specialty clinic. This inter-disciplinary IBD clinic included management from attending physicians who were IBD-trained, as well as a nutritionist, pharmacist, psychologist, and social workers, who were all housed in one facility with a focus on administering IBD related care and care coordination. Ancillary services offered by these additional specialties in the IBD center aim to provide tailored and personalized care to improve the lives of patients with IBD and to reduce complications of IBD, and include dietary assessments from an IBD-specialized nutritionist, medication therapy management with a pharmacist to optimize adherence, safety, and efficacy of all medications taken by an IBD patient, and psychological support to teach patients how to manage living with IBD while building resilience [15]. In contrast, the general GI clinic provided management from any attending physician within the division of gastroenterology (including general GI physicians who did not have specialized IBD training) and did not offer ancillary services from nutrition, pharmacy, psychology or social work. In order for patients of the general GI clinic to access these ancillary services, referrals had to be obtained and coordinated through a primary care physician to specialists who were not always trained to provide management on living with IBD. Records of all IBD patients (defined by ICD-10 codes K50.xx and K51.xx) insured with Medicaid and seen in the general GI clinic between July 1, 2016 and June 30, 2017 were reviewed to confirm the diagnosis of either ulcerative colitis (UC) or Crohn’s disease (CD). Among those with confirmed IBD, only patients who had at least 1 visit in the general GI clinic between July 1, 2016 and June 30, 2017, and at least 1 visit in the inter-disciplinary IBD specialty clinic between July 1, 2017 and June 30, 2018 were included.
Clinical Variables
Electronic medical chart review was performed to collect data on patient, sociodemographic information including age at index visit (first general GI clinic visit between July 1, 2016 and June 30, 2017), sex, age at time of IBD diagnosis, time from IBD diagnosis, and smoking status. Clinical data was collected from the years pre- (July 1, 2016 through June 30, 2017) and post-transition to the IBD center (July 1, 2017 through June 30, 2018) for each patient. IBD related information that was collected included IBD subtype, disease location and phenotype, history of IBD related surgeries, IBD medical therapies, time to initiation of biologic therapy, and number of times biologic levels were checked.
The primary outcomes of our study was healthcare utilization and use of IBD medical therapies, such as corticosteroids, combination therapy and high dose biologic therapy. Healthcare utilization data included occurrence and frequency of emergency room visits, hospitalizations, IBD surgery, outpatient GI clinic visits with a gastroenterologist, visits with nutrition, pharmacy, social work or psychology, smoking cessation counseling, and completion of age and gender directed healthcare maintenance screens (such as completion of influenza vaccination, Pap smear, and DEXA scan). The HRU variable combined emergency department visit, hospitalization, and IBD surgery into one variable. High dose biologic therapy was defined as higher dose or frequency than infliximab 5mg/kg every 8 weeks, adalimumab 40mg every 2 weeks, certolizumab 400mg every 4 weeks or 200mg every 2 weeks, golimumab 100mg every 4 weeks, ustekinumab 90mg every 8 weeks, and vedolizumab 300mg every 8 weeks.
Secondary outcomes included biochemical, endoscopic and histologic remission. Biochemical remission was defined as C-reactive protein (CRP) level < 5mg/L. Endoscopic evaluation was defined as completion of any colonoscopy either prior to transition to the IBD center (anytime between July 1, 2016 and June 30, 2017) or after transition to the IBD center (anytime between July 1, 2017 and June 30, 2018). Endoscopic remission was defined as Mayo score of 1 or less for UC, Simple Endoscopic Score for Crohn’s Disease (SES-CD) of 0–2 total for CD, and Rutgeerts i0 or i1 for post-surgical CD patients. Given the retrospective nature of the study, we did not have access to formal histopathologic scoring such as Geboe’s score for our patients. As a result, histologic remission for UC and CD was defined as the absence of active chronic colitis or active chronic ileitis on mucosal biopsies. Other laboratory data assessed included ferritin, vitamin D and vitamin B12 levels. Anemia was defined as ferritin <20ng/ml. Vitamin D deficiency was defined as level <30ng/ml and vitamin B12 deficiency was defined as level <211pg/ml. Body mass index (BMI) was noted, and patients were categorized as underweight (<18.5 kg/m2), normal weight (18.5–24.9 kg/m2), overweight (25.0–29.9 kg/m2) and obese (>29.9 kg/m2).
Statistical Analysis
IBD related variables, general health variables, and healthcare utilization in the year before and after the transition to the IBD specialty center were compared using paired t-tests for continuous variables and McNemar tests for categorical variables. SAS version 9.4 (Cary, NC) was used for all analyses. The Institutional Review Board at the Icahn School of Medicine at Mount Sinai approved this study (ID: STUDY-16–01321).
Results
Six hundred and thirty-three patients insured with Medicaid were seen in the general GI clinic in the defined time period, of which 243 had confirmed IBD and transitioned to the inter-disciplinary IBD specialty clinic. After applying the exclusion criteria, 170 patients with IBD who were seen in both designated time periods were identified. This included 111 patients with CD and 59 patients with UC. Baseline demographic and disease characteristics prior to index visit are shown in Table 1. The mean age at time of index visit was 39 years (standard deviation [SD] 13.1), and patients were evenly split by sex. The majority of the cohort (65.3%) identified as non-smokers. In our cohort, the mean age at time of IBD diagnosis was 26 years (SD 12.0) and the mean disease duration was 13 years (SD 10.7). A large percentage of patients had a history of IBD surgeries (46.5%) with a mean number of 2 prior surgeries (SD 1.6). At baseline, the majority of patients were on biologic therapy (60.0%) with infliximab being the most commonly used agent (93.1%). Of the patients on biologic therapy, 52.9% were also on combination therapy.
Table 1.
Demographic and Disease Characteristics of IBD Patients at Time of Index Visit Prior to Transition to IBD Specialty Clinic
| IBD patients, total = 170 N (%) |
|
|---|---|
| Mean age, in years (± SD) | 39 (± 13.1) |
| Male sex | 86 (50.6%) |
| Smoking status | |
| Current smoker | 22 (12.9%) |
| Former smoker | 37 (21.8%) |
| Never smoker | 111 (65.3%) |
| Mean age at diagnosis, in years (± SD) | 26 (± 12.0) |
| Mean duration of disease, in years (± SD) | 13 (± 10.7) |
| Ulcerative colitis | 59 (34.7%) |
| Proctitis | 1 (1.7%) |
| Left sided colitis | 14 (23.7%) |
| Pancolitis | 38 (64.4%) |
| Location not specified | 6 (10.2%) |
| Crohn’s disease | 111 (65.3%) |
| Ileitis | 26 (23.6%) |
| Colitis | 22 (20.0%) |
| Ileocolitis | 62 (56.4%) |
| Draining perianal fistulas | 38 (22.4%) |
| Prior IBD surgeries | 79 (46.5%) |
| Mean number of IBD surgeries (± SD) | 2 (± 1.6) |
| Prior use of biologic therapy | 102 (60.0%) |
| Prior use of combination therapy | 54 (52.9%) |
| None | 48 (47.1%) |
| Methotrexate | 10 (9.8%) |
| Azathioprine | 44 (43.1%) |
| Prior or current biologic or small molecule therapy | |
| Infliximab | 95 (93.1%) |
| Adalimumab | 50 (49.0%) |
| Certolizumab | 5 (4.9%) |
| Golimumab | 2 (2.0%) |
| Ustekinumab | 5 (4.9%) |
| Vedolizumab | 15 (13.3%) |
| Tofacitinib | 0 |
| Other | 0 |
SD = standard deviation
A comparison of IBD related outcomes and quality metrics pre- and post-transition to the IBD clinic are shown in Table 2. After transition to the IBD clinic, use of corticosteroids (37% vs. 25%; p=0.004) and combination therapy was significantly lower (55% vs. 38%; p=0.0004). Although use of high dose biologic therapy numerically increased following transition (58.5% vs. 67%; p=0.05), this finding did not reach statistical significance. There was no significant difference between the groups with regards to rates of biochemical, endoscopic or histological remission or with regards to rate of biologic use, though mean latest CRP was significantly lower post-transition (7.4mg/L ±12.0) compared to prior to transition (13.9mg/L ± 29.9, p=0.04).
Table 2.
Comparison of IBD Outcomes and Quality Metrics Before and After Transition to the IBD Specialty Clinic
| Pre N (%) |
Post N (%) |
P value | |
|---|---|---|---|
| Current use of biologic therapy | 114 (67.1%) | 122 (71.8%) | 0.10 |
| High dose biologic therapy | 62 (58.5%) | 71 (67.0%) | 0.05 |
| Mean time from prescription to initiation of biologic therapy, in days (± SD) | 19.9 (± 9.7) | 43.6 (± 39.8) | 1.0 |
| Number of times biologic drug level checked | 0.79 | ||
| 0 | 61 (57.6%) | 65 (61.3%) | |
| 1 | 31 (29.3%) | 28 (26.4%) | |
| 2 or more | 14 (13.2%) | 13 (12.3%) | |
| Use of combination therapy | 58 (54.7%) | 40 (37.7%) | 0.0004 |
| Use of corticosteroids | 62 (36.5%) | 43 (25.3%) | 0.004 |
| Mean initial CRP, in mg/L (± SD) | 14.5 (± 22.4) | 12.6 (± 25.2) | 0.92 |
| Mean latest CRP, in mg/L (± SD) | 13.9 (± 29.9) | 7.4 (± 12.0) | 0.04 |
| Biochemical remission | 62 (55.4%) | 72 (64.3%) | 0.07 |
| Endoscopic remission | 16 (28.6%) | 22 (39.9%) | 0.10 |
| Histologic remission | 7 (13.5%) | 9 (17.3%) | 0.6 |
Pre = IBD patients seen in general gastroenterology clinic before transition to IBD specialty clinic, Post = IBD patients seen after transition to IBD specialty clinic, SD = standard deviation, CRP = C reactive protein
Table 3 compares IBD related quality metrics and healthcare resource utilization before and after transition to the IBD center. After the transition, patients attended fewer mean outpatient GI visits (p=0.0008) and were more likely to have at least one visit with an ancillary service (psychologist, social worker, nutritionist, or pharmacist; p=0.0003). After transition, numerically there was greater detection of vitamin B12 deficiency, reduced detection of vitamin D deficiency and anemia, reduced number of ER visits, hospitalizations, and IBD-related surgeries, and overall lower HRU, though these findings did not reach statistical significance. When the composite for healthcare maintenance was analyzed by its disaggregated components, completion of Pap smear screening had significantly increased following transition to the IBD center (p=0.001).
Table 3.
Comparison of IBD Quality Metrics and Healthcare Resource Utilization Before and After Transition to the IBD Specialty Clinic
| Pre N (%) |
Post N (%) |
P value | |
|---|---|---|---|
| BMI category at initial visit | 0.34 | ||
| Underweight (<18.5) | 104 (61.2%) | 95 (55.9%) | |
| Normal weight (18.5–24.9) | 44 (25.9%) | 47 (27.7%) | |
| Overweight (25.0–29.9) | 15 (8.8%) | 17 (10.0%) | |
| Obese (>29.9) | 7 (4.1%) | 11 (6.5%) | |
| BMI category at last visit | 0.77 | ||
| Underweight (<18.5) | 96 (56.5%) | 101 (59.4%) | |
| Normal weight (18.5–24.9) | 46 (27.1%) | 41 (24.1%) | |
| Overweight (25.0–29.9) | 17 (10.0%) | 18 (10.6%) | |
| Obese (>29.9) | 11 (6.5%) | 10 (5.9%) | |
| Anemia at last visit | 99 (58.2%) | 93 (54.7%) | 0.41 |
| Vitamin D deficiency | 27 (81.8%) | 24 (72.7%) | 0.26 |
| Vitamin B12 deficiency | 1 (3.7%) | 4 (14.8%) | 0.08 |
| Visit with either psychologist, social worker, nutritionist, or pharmacist | 28 (16.5%) | 49 (28.8%) | 0.0003 |
| Smoking cessation counseling | 15 (79.0%) | 15 (78.9%) | 1.0 |
| Healthcare maintenance up to date1 | 99 (58.2%) | 90 (52.9%) | 0.16 |
| Influenza vaccine completed | 71 (41.8%) | 73 (42.9%) | 0.77 |
| Pap smear completed | 39 (46.9%) | 53 (66.6%) | 0.001 |
| DEXA scan completed | 6 (40.0%) | 4 (28.6%) | ---- |
| Hospitalization during the year | 51 (30.0%) | 38 (22.4%) | 0.09 |
| Emergency department visit during the year | 74 (43.5%) | 63 (37.1%) | 0.18 |
| Mean number of emergency department visits (± SD) | 0.75 (± 1.4) | 1 (± 2.1) | 0.09 |
| Mean number of outpatient GI visits (± SD) | 3 (± 1.8) | 2 (± 1.6) | 0.0008 |
| Any IBD-related surgery | 30 (17.7%) | 20 (11.8%) | 0.06 |
| HRU | 89 (52.4%) | 74 (43.5%) | 0.08 |
Pre = IBD patients seen in general gastroenterology clinic before transition to IBD specialty clinic, Post = IBD patients seen after transition to IBD specialty clinic, BMI = body mass index, SD = standard deviation, HRU = healthcare resource utilization
Healthcare maintenance combines completion of Influenza vaccine, Pap smear, and DEXA scan
---- small sample size limited ability to compare groups. Of note, proportion of DEXA scan completed reflects total completed over total ordered
Discussion
To our knowledge, this is the first study that evaluates the impact of transition from a fellows’ general GI clinic to a fellows’ inter-disciplinary IBD specialty clinic on IBD-related health outcomes, quality metrics, and HRU among patients insured with Medicaid. Within one year of transition to the inter-disciplinary IBD specialty clinic, patients experienced decreased corticosteroid use, improved CRP, improved access to ancillary services, and greater completion of Pap smears. Following transition, numerically there was greater detection of vitamin B12 deficiency, decreased detection of vitamin D deficiency and anemia, and a greater proportion of patients who had completed recommended healthcare maintenance evaluations for vaccination, though these findings did not reach statistical significance. Finally, the median number of attended, outpatient GI visits decreased after the transition, with a numeric decrease in HRU.
Several prior studies have highlighted the challenges regarding the delivery of high-impact care to patients insured with Medicaid. Despite the intent to enhance healthcare access, Medicaid expansion did not improve outcomes across several different primary care measures, like cancer screening and diabetes monitoring [16]. Furthermore, Medicaid patients demonstrate higher rates of medication non-adherence, emergency room evaluations, and inpatient admissions; they are also less likely to attend outpatient visits as compared to patients insured with private insurance [17, 18, 19].
Our study observed that within one year of transition to an inter-disciplinary IBD specialty clinic, Medicaid patients were less likely to use corticosteroids and were more likely to experience an improvement in mean CRP, suggesting reduced disease activity. These findings could be explained by differences in specialty care provided in the IBD clinic which were staffed solely by IBD-trained gastroenterologists rather than general gastroenterologists, as well as increased access to inter-disciplinary services in the IBD center which were not available in the general GI clinic, such as medication teaching and psychosocial support to reinforce adherence to biologic therapy and to limit corticosteroid dependance. Our findings are noteworthy in that they suggest that transition to an inter-disciplinary IBD center may result in decreased corticosteroid use in a patient population that has been known to use these medications at higher rates than privately insured patients [13]. Following transition, while these patients attended fewer outpatient visits with a gastroenterologist, they were more often seen by a psychologist, social worker, nutritionist, or pharmacist, thus demonstrating continued patient engagement with the medical system, their receipt of comprehensive medical care, and the importance of a personalized and multi-disciplinary approach to management in order to reduce complications associated with IBD. While traditionally, publicly insured patients have been found to experience higher utilization of inpatient rather than outpatient services [3,18], in our study, with transition to the inter-disciplinary IBD specialty clinic, Medicaid patients demonstrated numerically fewer emergency room evaluations, surgical procedures, and inpatient admissions, which is suggestive of reduced disease activity. These findings further highlight the importance of IBD specialty care as well as the need for integration of additional services that address comorbid mental health conditions and the social determinants of health that often exacerbate disease processes and result in increased utilization of acute care services [10,11].
There are several limitations to this study. The study was limited by a small sample size and a short follow-up period of one year following the transition, which may have been underpowered to detect significant differences in certain outcomes (e.g. rates of endoscopic and histologic remission or rates of healthcare resource utilization may not be adequately captured in a one year period). The improvement in CRP and decreased utilization of additional disease controlling agents (e.g., corticosteroids and combination therapy) may be a consequence of the natural progression of the disease course with implementation of biologic therapy, however rates of high dose biologic use numerically increased following the transition, perhaps reflecting a preference for optimized biologic monotherapy. Given the observational nature of this study, we cannot rule out the impact of time-related effects on treatment trajectory or care patterns. We lack a comparable set of controls (IBD patients insured with Medicaid were only seen in the IBD center after July 2017; furthermore, differences in resources and access limit any comparison that can be made between our cohort and non-Medicaid IBD patients) through which measures like statistical process control charts could otherwise be used to mitigate the possibility that our observed outcomes were a result of non-operational changes. Future prospective studies are certainly needed in which similar patient populations are randomly assigned to different clinic settings and followed for differences in their treatment and care paths. Finally, there is a learning curve with any significant transition. Some of these differences may be minimized by the change in workflow and variability in fellow-driven care, which could have impacted trends in smoking cessation counseling and adherence to healthcare maintenance recommendations.
In conclusion, we observed that transition of Medicaid insured IBD patients to a dedicated IBD center with inter-disciplinary resources was associated with significantly lower corticosteroid use, improved CRP, improved access to ancillary services, greater completion of Pap smears, and numerically lower HRU. To our knowledge, this is the first study to evaluate the impact of IBD specialty, inter-disciplinary care on health outcomes in such a medically vulnerable population. Future studies that prospectively examine the long-term impact of specialty care on disease complications and quality metrics of IBD care in Medicaid insured patients are needed.
Abbreviations
- BMI
body mass index
- CRP
C-reactive protein
- CD
Crohn’s disease
- DEXA
dual-energy X-ray absorptiometry
- ER
emergency room
- GI
gastrointestinal
- HRU
healthcare resource utilization
- IBD
inflammatory bowel disease
- SES-CD
Simple Endoscopic Score for Crohn’s Disease
- SD
standard deviation
- UC
ulcerative colitis
Footnotes
Conflicts of interest and source of funding:
CPW declares research support by the National Cancer Institute of the National Institutes of Health under Award Number T32CA225617. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
RPH declares consulting fees from HealthMode,Inc, Janssen Pharmaceuticals. Research support from Intralytix Inc. and a Crohn’s and Colitis Foundation Career Development Award (grant number 607934).
BES reports personal fees for consulting and service on advisory boards for bbvie, Abivax, Alimentiv, Allergan, Amgen, Arena Pharmaceuticals, AstraZeneca, Bacainn Therapeutics, Baxalta Bioscience India, Boehringer-Ingelheim, Boston Pharmaceuticals, Calibr, Capella Bioscience, Celgene, Celltrion Healthcare, ClostraBio, F.Hoffmann-La Roche, Galapagos, Gilead, Gossamer Bio, Immunic, Index Pharmaceuticals, Innovation Pharmaceuticals, Ironwood Pharmaceuticals, Janssen, Johnson & Johnson, Lilly, Morphic Therapeutic, Oppilan Pharma, OSE Immunotherapeutics, Otsuka, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Redhill Biopharma, Rheos Medicines, Salix Pharmaceuticals, Seres Therapeutics, Shire, Surrozen, Takeda, Target RWE, Theravance Biopharma R&D, USWM Enterprises, and Vivelix Pharmaceuticals, and research grants from Arena Pharmaceutical and Theravance Biopharma.
RCU has served as an advisory board member or consultant for AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer, and Takeda; research support from AbbVie, Boehringer Ingelheim, and Pfizer. RCU is funded by an NIH Career Development Award (K23KD111995–01A1).
HZM, ZAB, SE, RY, BLC, and BBR have no disclosures to declare.
Declaration of funding source:
No funding was received for conducting this study.
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