Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol.

BACKGROUND: Functional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders. METHODS: The "MANTRA" (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist ('biofeedback') and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures. DISCUSSION: There have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders. TRIAL REGISTRATION NUMBER: Clinicaltrials.govNCT03078634 Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017. Ethics and Dissemination: Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences. Protocol version 1.2.

Development of quality measures for use of self-injectable biologic therapy in inflammatory bowel disease: An integrated specialty pharmacy initiative.

PURPOSE: The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described. SUMMARY: Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. CONCLUSION: The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.

Who is Responsible for What Happens Before, During, and After Colonoscopy? Results of a National Survey of Primary Care Physicians.

BACKGROUND AND AIMS: Primary care providers (PCPs) play a critical role in colon cancer screening by initiating referrals to gastroenterologists for colonoscopy, but little is known about their role in pre-colonoscopy bowel preparation selection and pre-colonoscopy follow-up care. This study aimed to better understand coordination of care between PCPs and gastroenterologists as well as the current availability of "open-access" screening colonoscopy. METHODS: A multiple-choice survey was developed to assess PCPs' experiences with open-access colonoscopy, their involvement in the pre-colonoscopy process, and follow-up after colonoscopy. The survey was distributed electronically to a nationally representative sample of PCPs, via the American College of Physicians (ACP) Research Center's Internal Medicine Insider Research Panel. RESULTS: Of 442 PCPs invited to participate, 210 responded (response rate, 210/442, 48%), and 29 were ineligible (spent <25% of their time on clinical care or placed no referrals to colonoscopy), yielding 181 completed surveys. A total of 39% reported that open access was "rarely" or "never" available in their practice setting. The majority reported that pre-colonoscopy care was coordinated by gastroenterologists rather than PCPs. For example, 93% reported that gastroenterologists were responsible for bowel preparation selection in their practice setting. Post-colonoscopy, 54% of PCPs reported that they were responsible for ordering subsequent colonoscopies. CONCLUSIONS: PCPs frequently coordinate follow-up care postprocedure but play a relatively minor role in the pre-colonoscopy bowel preparation process. Open access availability for screening colonoscopy remains limited in this national sample of PCPs.