None listed
Conditions
Brief summary
This is a study that is aiming to help assess whether a virtual biologic clinic (VBC) used for managing patients on escalated doses of biologic medicines can improve rates of healthcare utilisation and reduce the socio-economic burden of Inflammatory bowel disease whilst maintaining the quality of care delivery and clinical outcomes currently experienced by inflammatory bowel disease patients. In doing so, we hope to evaluate the role that VBC’s can have in the development and implementation of a novel model of care for IBD patients, values-based healthcare. This study will use a combination of clinically reported patient outcomes, objective markers of disease assessment (C-Reactive protein, Faecal Calprotectin and Intestinal Ultrasound), healthcare utilisation costing information as well as patient reported outcomes which aim to determine patients’ quality of life, quality of care provision and patient reported disease activity scores. All of these datasets will allow us to determine whether the virtual clinic model of care delivers the outcomes as stated above and also meets secondary outcomes of improved rates of healthcare utilisation, reduced burden of IBD to society and parity in terms of quality of care delivery to IBD patients.
Interventions
A single tertiary centre that has an established virtual biologics clinic, where enrolled patients are reviewed in their absence with up to date clinical and objective disease assessment, captured through a patient reported outcome monitoring portal, IBD nurse/pharmacist pphone review and standardised objective disease assessment. All patients at the intervention site (Austin Health) that meet inclusion criteria who are deemed appropriate for dosage intensification of their biologic regimen from
A single tertiary centre that has an established virtual biologics clinic, where enrolled patients are reviewed in their absence with up to date clinical and objective disease assessment, captured through a patient reported outcome monitoring portal, IBD nurse/pharmacist pphone review and standardised objective disease assessment. All patients at the intervention site (Austin Health) that meet inclusion criteria who are deemed appropriate for dosage intensification of their biologic regimen from their baseline dosage and who agree to participate in the study will have their ongoing treatment and assessments outlined via the virtual clinic model. Patients in the standard care cohort will have treatment, monitoring and follow up scheduled by their individual clinician. Patients in intervention cohort will be managed through protocolised multidisciplinary care, with follow up assessment and virtual clinic review, in addition to TWO in person clinic reviews, scheduled as per the individual needs of the patient and as agreed by the multidisciplinary team including clinician, IBD pharmacist and IBD nurse over the 48 week study timeframe. There will be no limit on the number of virtual clinic reviews conducted for each patient with rveiews scheduled as per the individual needs of that patient. Patients in both study cohorts will undergo objective and clinical disease assessment at baseline, week 12, week 24 and week 48.
Sponsors
Austin Health Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with inflammatory bowel disease (IBD) (Crohn’s disease or Ulcerative colitis) will be recruited from two tertiary, metropolitan IBD centres in Australia (Austin Health, Melbourne and Mater Misericordiae Ltd via outpatient clinics, nurse-led clinics, pharmacist-led outpatient referrals or multidisciplinary meetings. Patients will be enrolled into the study, once their primary treating clinician determines that dosage intensification is required, from standard maintenance dosing or from their maintenance dose at the time of study commencement, due to secondary loss of response or pharmacokinetic failure in the setting of subtherapeutic serum drug levels
Exclusion criteria
Non-English speaking patients will be excluded due to a fundamental need for accurately completed online questionnaires to determine the impact of the intervention. Limited resources mean that translational assistance will not be available throughout the study duration. Patients without access to computers/or smartphone devices or who for any other reason would not be able to complete online surveys People highly dependent on medical care who may be unable to give consent People with a cognitive impairment and/or intellectual disability Patients undergoing dosage intensification of there biologic therapy for a severe flare of their IBD where the patient is at high risk of acute deterioration AND is commenced on corticosteroids AND it is the view of the IBD MDT that the patient would not be suitable for ongoing management through the virtual clinic pathway only Patients whom are discovered to be pregnant and or are imminently planning pregnancy due to the increased monitoring required in this patient population.
Outcome results
None listed