Julie C Lauffenburger1, Jennifer Lewey2, Saira Jan3, Gina Nanchanatt4, Sagar Makanji5, Christina A Ferro5, John Sheehan6, Eric Wittbrodt6, Kyle Morawski1, Jessica Lee1, Roya Ghazinouri1, Niteesh K Choudhry7. 1. Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. 2. Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA. 3. Horizon Blue Cross Blue Shield, NJ, USA; Rutgers State University of New Jersey, New Brunswick, NJ, USA. 4. Horizon Blue Cross Blue Shield, NJ, USA. 5. Magellan Rx Management, Newport, RI, USA. 6. AstraZeneca, US-Medical Affairs, Fort Washington, PA, USA. 7. Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: nkchoudhry@bwh.harvard.edu.
Abstract
BACKGROUND: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making). OBJECTIVE: To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes. METHODS/ DESIGN: ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data. CONCLUSIONS: This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes.
RCT Entities:
BACKGROUND: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making). OBJECTIVE: To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes. METHODS/ DESIGN: ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data. CONCLUSIONS: This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes.
Authors: Julie C Lauffenburger; Roya Ghazinouri; Saira Jan; Sagar Makanji; Christina A Ferro; Jennifer Lewey; Eric Wittbrodt; Jessica Lee; Nancy Haff; Constance P Fontanet; Niteesh K Choudhry Journal: PLoS One Date: 2019-04-02 Impact factor: 3.240