NDLI: Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

Content Provider	Springer Nature : BioMed Central
Author	Furler, John S Young, Doris Best, James Patterson, Elizabeth O’Neal, David Liew, Danny Speight, Jane Segal, Leonie May, Carl Manski-Nankervis, Jo-Anne Holmes-Truscott, Elizabeth Ginnivan, Louise Blackberry, Irene D
Abstract	Background Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. Methods This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice. Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs. Discussion The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612001028897
Related Links	https://implementationscience.biomedcentral.com/counter/pdf/10.1186/1748-5908-9-20.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	17485908
DOI	10.1186/1748-5908-9-20
Journal	Implementation Science
Issue Number	1
Volume Number	9
Language	English
Publisher	BioMed Central
Publisher Date	2014-02-14
Access Restriction	Open
Subject Keyword	Health Services Research Public Health Health Informatics Health Policy Health Administration Health Promotion and Disease Prevention Type 2 diabetes Primary care Nursing Randomized trial Insulin Implementation Australia
Content Type	Text
Resource Type	Article
Subject	Health Policy Public Health, Environmental and Occupational Health Health Informatics
Journal Impact Factor	8.8/2023
5-Year Journal Impact Factor	9.2/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial

HeLP-Diabetes: randomised controlled trial protocol

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial

Cluster randomised controlled trial of a theory-based multiple behaviour change intervention aimed at healthcare professionals to improve their management of type 2 diabetes in primary care

A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369]

Financial incentives to improve glycemic control in African American adults with type 2 diabetes: a pilot randomized controlled trial

Shared decision making for patients with type 2 diabetes: a randomized trial in primary care

Primary Care Behavioral Health in Sweden – a protocol of a cluster randomized trial evaluating outcomes related to implementation, organization, and patients (KAIROS)

Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

Similar Documents

Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial

HeLP-Diabetes: randomised controlled trial protocol

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial

Cluster randomised controlled trial of a theory-based multiple behaviour change intervention aimed at healthcare professionals to improve their management of type 2 diabetes in primary care

A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369]

Financial incentives to improve glycemic control in African American adults with type 2 diabetes: a pilot randomized controlled trial

Shared decision making for patients with type 2 diabetes: a randomized trial in primary care

Primary Care Behavioral Health in Sweden – a protocol of a cluster randomized trial evaluating outcomes related to implementation, organization, and patients (KAIROS)

Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol