University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT04388865
This is a 2-arm randomized trial aimed at leveraging behavioral science principles to improve patient engagement between office visits among patients with inflammatory bowel disease (IBD).
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are common chronic gastrointestinal diseases with significant morbidity and decreased quality of life. Care for patients with IBD has been transformed by biologic therapies which dramatically improve inflammation and clinical outcomes. As they are delivered through infusion or injection with long intervals between doses, it can be challenging for patients to maintain adherence due to systems issues such as prior authorization and site of service limitations, in addition to traditional reasons for non-adherence such as inertia and present-time bias. Despite evidence that high adherence is needed for effectiveness, estimates are as low as 66%.
Preliminary observations and interviews show that an important gap for providers is lack of knowledge of how their patients are doing between visits. Specifically, patients may not adhere to necessary therapy, and physicians are unaware of changes in course of the disease. A large cross-sectional study has shown that patient-reported outcomes are associated with control of the disease, but serially monitoring these measures has not been tested prospectively. A prior study found that assessing symptoms weekly is highly correlated with information collected with a more cumbersome daily diary. This may provide additional data to clinicians to better manage symptoms and therapy.
Text messaging is an attractive tool to engage with patients due to the high prevalence of cell phones. The investigators will develop and test a new IBD hovering program that improves the care of patients between office visits. The investigators will enroll patients prescribed biologic therapy and provide text message reminders about scheduled infusions or injections that incorporate behavioral science principles such as anticipated regret, precommitment, and reciprocity. The investigators will also have the patient identify a friend or family member to serve as a support partner to encourage adherence and provide assistance as needed. The platform will communicate with patients weekly to ask about the course of their symptoms, send messaging to the feedback partner, and send alerts to physicians as needed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will engage with their providers as is standard of care.
Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.
Time frame: 4 months
The change in patient response to the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), which is a 10 question validated instrument to measure quality of life in IBD patients.
Time frame: 4 months
Patient satisfaction, adapted from the CACHE questionnaire, will be measured by the percent who agree/totally agree (scored as 1 or 2 on a scale of 1-5) to each survey question. A net promoter score (scored as percent 9 or 10 minus percent 1-6 on a scale of 1-10) will also be calculated for the intervention group only.
Time frame: 4 months
Medication adherence will be measured as show rate for infusions and percent dispensed by pharmacy for injectables based on chart review at pre- and post-intervention, along with the change in percent reported adherence at the baseline and post-study survey.
University of Pennsylvania
Other
Clinical Hovering to Improve Patient Engagement in Inflammatory Bowel Disease
Acronym: PATH-IBD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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