Study to measure impact of MTM on outcomes for IBD patients

Dr Andros

The effectiveness of an inflammatory bowel disease (IBD)medication therapy management (MTM) patient fulfillment model and its impact on adherence compared to standard care will be evaluated in a new study.

Curant Health, provider of enhanced medication therapy management and specialty pharmacy services, is launching A.L.I.V.E (Adherence and Long-term IBD Value-added Effectiveness), a study with the Meyerhoff Inflammatory Bowel Disease Center of the Johns Hopkins University School of Medicine.

According to principal investigator and assistant professor of medicine at Johns Hopkins University Sharon Dudley-Brown, PhD, Crohn's disease (CD) and ulcerative colitis (UC) are chronic, debilitating conditions that can have important economic and clinical implications. In 2004, the annual cost of IBD in the United States was estimated at $1.84 billion. IBD is associated with high morbidity, loss of work productivity and impaired quality of life.

“There is no study that we know of in an IBD population that shows results and outcomes for an MTM model that tracks patient outcomes including adverse drug events, hospital readmissions, and adherence rates,” according to Vickie Andros, PharmD, director of clinical services for Curant Health and contributing author for A.L.I.V.E.

Likewise, systematic review of the literature validates there is no reported long term adherence data for CD or UC, according to Dr Andros. 

The Meyerhoff Center at Johns Hopkins provides “standard of care” for patients. This study supplements this standard of care.

For the study, adult patients aged 18 years or older, diagnosed with CD or UC and receiving IBD therapy will be enrolled during a 4-month period. Patients will be randomly assigned to 1 of 3 treatment arms:

1. The treatment group will receive standard of care with the IBD MTM patient fulfillment model, which includes fulfillment of medications and medication therapy management.

2. Control group 1 will receive standard of care with fulfillment of medications.

3. Control group 2 will receive standard of care with no fulfillment of medications or MTM.

During each MTM session with the patient, pharmacists will complete a medication reconciliation, identify any medication-related issues, monitor therapy and provide patient education on the importance of adherence with treatment and provider follow-up, instructions on how to take/administer medications and side effects of medications.

The team will evaluate results at 30 days, 60 days, 6 months, 9 months and 12 months from the initiation of the IBD MTM patient fulfillment model.

The researchers will be reporting on symptom and quality-of-life scores, medication adherence rates, hospitalizations, adverse drug events and smoking rates among the study population.

“This study should help clarify, in real-world results, the proper utilization and effect of adherence to medication therapies on clinical outcomes in a population of IBD patients,” Dr Andros said.

“The hypothesis is more patients will be adherent to IBD medication therapy and experience a better quality of life, fewer hospitalizations and an overall lower healthcare spend applicable across the population of Americans suffering from IBD,” she added.