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Clinical Studies

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  • A Randomized Evaluation of Changes in Anxiety and Depression, Patient Reported Outcomes, Service Utilization and Patient Satisfaction Scores in IBD Patients: Standard of Care versus Additional Structured Psychosocial Care Rochester, Minn.

    The purpose of the study is to compare the addition of structured psychosocial care versus standard medical care alone for the treatment of adult patients who have inflammatory bowel disease

  • PIANO: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease (PIANO) Rochester, Minn.

    A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.

  • Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes Rochester, Minn.

    This study is conducted to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) taking azathioprine/6MP or biologic therapy (Remicade®, Humira®, Cimzia™, Tysabri®, or Stelara®) are different from those among IBD - affected women not taking these medications.

  • Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I (PUCCINI) Rochester, Minn.

    Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery.

    By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases.

    If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.

  • Use of Medication Therapy Management to Optimize Care Through Effective Resource Management in Inflammatory Bowel Disease Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Eau Claire, Wis., Mankato, Minn., La Crosse, Wis.

    The management of Inflammatory Bowel Disease (IBD) is complex and time consuming. While Current Procedural Terminology for MTM services are available they are under-utilized given the time constraints placed on practitioners trying to address multiple health care issues during a single visit. There are companies that specialize in patient pharmacy services to improve health care outcomes. Our aim is to utilize these services in a small number of IBD patients to assess effectiveness of such services within a tertiary care practice.