Viewing Study NCT00272402



Ignite Creation Date: 2024-05-05 @ 4:35 PM
Last Modification Date: 2024-10-26 @ 9:22 AM
Study NCT ID: NCT00272402
Status: COMPLETED
Last Update Posted: 2012-09-05
First Post: 2006-01-03

Brief Title: Reducing Clinical Inertia in Diabetes Care
Sponsor: HealthPartners Institute
Organization: HealthPartners Institute

Study Overview

Official Title: Reducing Clinical Inertia in Diabetes Care
Status: COMPLETED
Status Verified Date: 2012-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this randomized trial we evaluate two conceptually distinct but potentially synergistic interventions designed to reduce clinical inertia in the outpatient care of adults with type 2 diabetes The project addresses the following specific aims

Specific Aim 1 Implement and assess two conceptually distinct but potentially synergistic interventions to reduce clinical inertia related to control of A1c SBP and LDL in adults with diabetes

Hypothesis 1 Patients of physicians who receive the Cognitive Behavioral Intervention CBI Group 1 will subsequently have less Clinical Inertia than those who receive no intervention Group 4
Hypothesis 2 Patients of physicians who receive the Office Systems Redesign intervention CBI Group 2 will subsequently have less Clinical Inertia than those who receive no intervention Group 4
Hypothesis 3 Patients of physicians who receive the combined CBI plus OSR intervention Group 3 will subsequently have less Clinical Inertia than those who receive CBI alone Group 1 or OSR alone Group 2

Specific Aim 2 Assess the impact of interventions to reduce clinical inertia on health care charges

Hypothesis 4 After adjustment for baseline measures of health care charges those who receive no intervention Group 4 will have higher total health care charges over a 24-month follow-up relative to the patients of physicians in intervention Group 1 Group 2 or Group 3
Detailed Description: The objective of this project is to improve the care of adults with diabetes DM by implementing effective interventions to reduce Clinical Inertia related to control of glycated hemoglobin A1c systolic blood pressure SBP and LDL-Cholesterol LDL in primary care office settings Clinical inertia is defined as lack of treatment intensification in a patient not at evidence-based goals for A1c SBP or LDL Clinical Inertia CI has been implicated as a major factor that contributes to inadequate A1c SBP and LDL control and has been documented in over 80 of primary care office visits in various settingsdespite the fact that only 3 to 23 of adults with diabetes have simultaneously achieved A1c 7 SBP 130 mm Hg and LDL 100 mgdl

In this project we test two interventions designed to reduce clinical inertia The Cognitive Behavioral Intervention CBI is directed at individual primary care physicians and has three components a analyze each physicians clinical moves with diabetes patients to identify patterns that indicate clinical inertia b engage each physician in a series of simulated clinical cases to assess the underlying causes of clinical inertia and c provide each physician with a series of tailored simulated clinical scenarios that are designed to correct the failures of thinking and decision making that result in that physicians observed patterns of clinical inertia The CBI intervention is based on recent work in cognitive science and learning theory and has been successfully applied in other research and educational settings

The Office Systems Redesign OSR Intervention is also directed to primary care physicians and has three major components a identify specific patients in need of intensified diabetes care and schedule four consecutive monthly office visits with their primary care physician b provide the physician with tailored and specific clinical decision support at the time of each visit based on evidence-based treatment algorithms c implement physician visit resolution and accountability reporting immediately after each visit using tools adapted from clinical trial protocols

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01DK068314 NIH None httpsreporternihgovquickSearchR01DK068314