None listed
Conditions
Brief summary
Stepping Up is a cluster randomised controlled trial that examines the effectiveness of the “Stepping Up” program in general practice to help patients with poorly controlled type 2 diabetes for whom insulin is indicated move onto insulin in a timely evidence-based manner. The Stepping Up program involves two elements that address key factors we have found to be important and influential in the way insulin is or is not initiated in general practice. These elements are: -supportive education for GP, Practice Nurse (PN) and Credentialed Diabetes Educator–Registered Nurse (CDE-RN) that addresses inter-professional culture and clarifies roles and -practice systems change that is congruent with work practices of GP and PN and needs of patients to facilitate timely introduction and titration of insulin.
Interventions
The Stepping Up program involves two elements that address key factors that are important and influential in the way insulin is initiated and titrated in general practice:
a. Supportive education for GP and Practice Nurse (PN) that addresses inter-professional culture and clarifies roles particularly in enhanced role for PN
b. Practice systems change that is congruent with work practices of GP and PN and needs of patients to facilitate timely introduction and titration of insulin glargine and gl
The Stepping Up program involves two elements that address key factors that are important and influential in the way insulin is initiated and titrated in general practice: a. Supportive education for GP and Practice Nurse (PN) that addresses inter-professional culture and clarifies roles particularly in enhanced role for PN b. Practice systems change that is congruent with work practices of GP and PN and needs of patients to facilitate timely introduction and titration of insulin glargine and glulisine The Stepping Up program training will be delivered by the study team during practice visit. The 1-2 hour training session covers evidence around insulin initiation, common barriers and how to deal with them, motivational interviewing and goal setting strategies, and hands on familiarisation with insulin delivery systems and insulin titration tools. Case studies derived from general practices patients are used as the basis of the training. Referrals to an endocrinologist, diabetes educators or other health professionals will be part of management options for GPs managing study patients. GP and PN will be supported by Study Diabetes Nurse Educator (DNE) as required during 12-month follow-up period via practice visits, telephone and emails to individualise and embed the model of care to their in-practice systems.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. T2D patients who are insulin naive. 2. At least 2 oral hypoglycaemic agents (OHA) (eg. metformin, sulphonylurea, TZDs, DPP-4 inhibitor) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary. 3. Doses of the OHAs should be stable for at least 3 months prior to enrollment into the study (or medical practitioner discretion). 4. HbA1c>=7.5% in the last 6 months 5. T2D patients willing to monitor glucose levels at least twice daily.
Exclusion criteria
1. Type 1 diabetes. 2. Previous or current treatment with insulin (excluding the short term (<2 weeks) use of insulin in acute illness or during hospitalization). 3. Non-English speaking. 4. Significant cognitive impairment. 5. Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin. 6. Significant renal impairment (eGFR < 20). 7. Any life-threatening illness. 8. Pregnancy or planned pregnancy. 9. Major psychiatric disorder. 10. Substance misuse (alcoholism, drug addiction, etc)
Outcome results
None listed