Clinical trial NCT06746714: Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients
Official title: Testing a New Population Management Model for Hypoglycemia Prevention in High-Risk KPNC Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: hypoglycemia
population management
clinical guideline
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Severe low blood sugar (hypoglycemia) is a serious problem for people with diabetes. It can lead to dangerous falls, heart problems, memory issues, and even death. However, many healthcare providers don't recognize or manage this problem well. The investigators believe that creating a clear set of guidelines for preventing hypoglycemia, along with having a clinical pharmacist actively help high-risk patients, can make diabetes treatment safer.

In this study, the investigators developed a simple, evidence-based guide called "Hypoglycemia on a Page" (HOAP) to prevent low blood sugars. The investigators then tested it by comparing two groups of patients with type 2 diabetes who are at high risk for hypoglycemia. One group received active support from a clinical pharmacist using the HOAP guidelines, while the other group received standard care.

The main goal of this study is to see if the pharmacist's support leads to safer diabetes treatment. The investigators will also look at other factors, such as whether patients are prescribed glucagon (a medicine for severe low blood sugar), if they use continuous glucose monitoring, and whether they have worse blood sugar control or end up in the hospital for hypoglycemia. This trial aims to improve patient safety, health outcomes, and possibly lower healthcare costs.

Detailed description: The primary research question is whether using a "Hypoglycemia Champion" (HC) to target high risk patients with type 2 diabetes (T2D) is a feasible and effective model of care to reduce hypoglycemia risk in this population.

The goals of this study are to:

1. Develop an evidence-based, expert consensus clinical guideline, "Hypoglycemia on a Page" (HOAP), for hypoglycemia prevention in patients with T2D at high risk of hypoglycemia. Guideline development will include stakeholders across multiple Kaiser Permanente regions.
2. Develop a workflow for use by a "Hypoglycemia Champion" (HC), a clinical pharmacist who will apply the HOAP guideline in the proactive, protocol-driven management of Kaiser Permanente Northern California (KPNC) members identified as having high hypoglycemic risk;
3. Conduct a pragmatic, randomized trial of the proactive HC intervention vs. usual care on diabetes regimen safety among KPNC members at high risk of hypoglycemia. The investigators hypothesize that at 6 months, high-risk members assigned to the HC intervention will be prescribed safer diabetes regimens (defined as discontinuation of sulfonylureas and/or rapid-/short-acting or mixed insulins) compared to usual care.

The study design will include: 1) Engaging expert clinical stakeholders and experienced KP guideline developers to create an evidence-based hypoglycemia prevention algorithm (HOAP) analogous to KPNC's successful "PHASE on a Page" guideline for cardiovascular risk management; 2) Crafting a population-based workflow protocol for proactive outreach by the HC (specifically trained clinical pharmacist) to apply this new guideline to high-risk members; and 3) Performing a pragmatic randomized trial comparing proximal clinical outcomes (diabetes medication changes) available directly from the EHR between the intervention arm (pro-active outreach by the HC) vs. controls (usual care, including availability of the HOAP). The primary analysis will be intent-to-treat and will assess differences in the proportion of patients using safer diabetes regimens (relative to their baseline regimen) between study arms. The investigators will also examine heterogeneity of treatment effects by age, race/ethnicity, and prior severe hypoglycemia events. Deliverables include: 1) Inter-regional dissemination of the HOAP algorithm and the HC workflow protocol, 2) High quality, pragmatic RCT results to inform operational decision-making, and 3) Presentations and manuscripts to further disseminate findings. This study is highly relevant to TPMG and KP because: 1) Hypoglycemia is common, morbid, and costly, 2) Providers are challenged to address the competing demands of prescribing diabetes medications to meet glycemic targets while avoiding iatrogenic hypoglycemia, 3) No regional strategies currently exist to reduce hypoglycemia risk. This work has strategic implications for our organization because a new HEDIS measure proposed for measurement year 2023 will assess emergency department admissions for hypoglycemia in older adults with diabetes. Our proposal will address this gap in organizational clinical care by developing and evaluating a practical, proactive, population management approach to hypoglycemia prevention for members with T2D at high risk of hypoglycemia.

Eligibility criteria: Inclusion Criteria:

1. Active KPNC members with valid MRNs at baseline (06/01/2023),
2. age \>=18 years,
3. in the KPNC diabetes registry,
4. likely type 2 diabetes (determined using a validated algorithm
5. high risk for hypoglycemia, determined using the hypoglycemia risk stratification tool developed by the investigator team

Exclusion Criteria:

1. Dementia or impaired cognition,
2. psychosis or schizophrenia diagnosis,
3. end-stage renal disease,
4. "no contact" preferences on file,
5. no primary care physician or home facility,
6. receiving care at skill nursing facilities,
7. deceased,
8. enrolled in concurrent pharmacy deprescribing pilots

Primary outcomes:
measure: Number of patients with sulfonylureas, mealtime, or mixed insulin discontinued
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants prescribed CGM
timeFrame: 6 months
measure: Number of participants prescribed glucagon
timeFrame: 6 months
measure: Number of participants with A1c <8%
timeFrame: 6 months
measure: Number of participants with ED visit or hospitalization for hypoglycemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Department of Research
state: California
Study officials:
affiliation: The Permanente Medical Group
name: Lisa K Gilliam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karter AJ, Warton EM, Lipska KJ, Ralston JD, Moffet HH, Jackson GG, Huang ES, Miller DR. Development and Validation of a Tool to Identify Patients With Type 2 Diabetes at High Risk of Hypoglycemia-Related Emergency Department or Hospital Use. JAMA Intern Med. 2017 Oct 1;177(10):1461-1470. doi: 10.1001/jamainternmed.2017.3844.
citation: Schroeder EB, Donahoo WT, Goodrich GK, Raebel MA. Validation of an algorithm for identifying type 1 diabetes in adults based on electronic health record data. Pharmacoepidemiol Drug Saf. 2018 Oct;27(10):1053-1059. doi: 10.1002/pds.4377. Epub 2018 Jan 2.
citation: Klompas M, Eggleston E, McVetta J, Lazarus R, Li L, Platt R. Automated detection and classification of type 1 versus type 2 diabetes using electronic health record data. Diabetes Care. 2013 Apr;36(4):914-21. doi: 10.2337/dc12-0964. Epub 2012 Nov 27.
citation: Parker MM, Moffet HH, Adams A, Karter AJ. An algorithm to identify medication nonpersistence using electronic pharmacy databases. J Am Med Inform Assoc. 2015 Sep;22(5):957-61. doi: 10.1093/jamia/ocv054. Epub 2015 Jun 15.
citation: Karter AJ, Parker MM, Moffet HH, Ahmed AT, Schmittdiel JA, Selby JV. New prescription medication gaps: a comprehensive measure of adherence to new prescriptions. Health Serv Res. 2009 Oct;44(5 Pt 1):1640-61. doi: 10.1111/j.1475-6773.2009.00989.x. Epub 2009 Jun 3.
citation: Moffet HH, Adler N, Schillinger D, Ahmed AT, Laraia B, Selby JV, Neugebauer R, Liu JY, Parker MM, Warton M, Karter AJ. Cohort Profile: The Diabetes Study of Northern California (DISTANCE)--objectives and design of a survey follow-up study of social health disparities in a managed care population. Int J Epidemiol. 2009 Feb;38(1):38-47. doi: 10.1093/ije/dyn040. Epub 2008 Mar 7. No abstract available.
citation: Hui RL, Chang CC, Niu F, Tang YK, Harano D, Deguzman L, Kao DJ, Awsare S, Draves M. Evaluation of a Pharmacist-Managed Antidiabetic Deprescribing Program in an Integrated Health Care System. J Manag Care Spec Pharm. 2019 Aug;25(8):927-934. doi: 10.18553/jmcp.2019.25.8.927.
citation: Kaur U, Machado M, Mistry A. Hypoglycemia: A closer look at a community pharmacist's impact in optimizing diabetes care. J Am Pharm Assoc (2003). 2022 Sep-Oct;62(5):1686-1693.e6. doi: 10.1016/j.japh.2022.04.002. Epub 2022 Apr 12.
citation: Whitfield N, Gregory P, Liu B, Spratt S, Smith BH. Impact of pharmacist outreach on glucagon prescribing. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1384-1388.e1. doi: 10.1016/j.japh.2022.01.017. Epub 2022 Jan 31.
citation: Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S. Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care. 2005 Apr;11(4):253-60.
citation: Lipska KJ, Warton EM, Huang ES, Moffet HH, Inzucchi SE, Krumholz HM, Karter AJ. HbA1c and risk of severe hypoglycemia in type 2 diabetes: the Diabetes and Aging Study. Diabetes Care. 2013 Nov;36(11):3535-42. doi: 10.2337/dc13-0610. Epub 2013 Jul 30.
citation: Kunutsor SK, Balasubramanian VG, Zaccardi F, Gillies CL, Aroda VR, Seidu S, Khunti K. Glycaemic control and macrovascular and microvascular outcomes: A systematic review and meta-analysis of trials investigating intensive glucose-lowering strategies in people with type 2 diabetes. Diabetes Obes Metab. 2024 Jun;26(6):2069-2081. doi: 10.1111/dom.15511. Epub 2024 Feb 26.
citation: Vijayakumar P, Liu S, McCoy RG, Karter AJ, Lipska KJ. Changes in Management of Type 2 Diabetes Before and After Severe Hypoglycemia. Diabetes Care. 2020 Nov;43(11):e188-e189. doi: 10.2337/dc20-0458. Epub 2020 Sep 17. No abstract available.
citation: Zhao Y, Shi Q, Wang Y, Fonseca V, Shi L. Economic burden of hypoglycemia: Utilization of emergency department and outpatient services in the United States (2005-2009). J Med Econ. 2016 Sep;19(9):852-7. doi: 10.1080/13696998.2016.1178126. Epub 2016 May 4.
citation: Lipska KJ, Ross JS, Wang Y, Inzucchi SE, Minges K, Karter AJ, Huang ES, Desai MM, Gill TM, Krumholz HM. National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med. 2014 Jul;174(7):1116-24. doi: 10.1001/jamainternmed.2014.1824.
citation: Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. JAMA. 2016 Nov 22;316(20):2115-2125. doi: 10.1001/jama.2016.16201.
citation: Karter AJ, Moffet HH, Liu JY, Lipska KJ. Surveillance of Hypoglycemia-Limitations of Emergency Department and Hospital Utilization Data. JAMA Intern Med. 2018 Jul 1;178(7):987-988. doi: 10.1001/jamainternmed.2018.1014.