Ignite Creation Date:
2024-05-06 @ 1:09 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01743963
Status:
COMPLETED
Last Update Posted:
2015-07-02
First Post:
2012-11-20
Brief Title:
Intervention to Increase Screening for Glucocorticoid Induced Diabetes
Sponsor:
VA Eastern Colorado Health Care System
Organization:
VA Eastern Colorado Health Care System
Study Overview
Official Title:
Intervention to Increase Screening for Glucocorticoid Induced Diabetes
Status:
COMPLETED
Status Verified Date:
2015-06
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:
CDA-GID
Brief Summary:
Using glucocorticoid induced diabetes GID we will conduct a small feasibility randomized intervention trial to improve GID management for veterans who are prescribed chronic glucocorticoids Approximately 20 primary care providers caring for approximately 100 veterans on chronic steroids will receive decisional support automatically-derived orders for hemoglobin A1C to be co-signed by providers Approximately 20 providers caring for 100 veterans who did not receive decisional support will serve as the control population We will measure the time from randomization until the provider signs an order for hemoglobin A1C for both groups The trial will be conducted at the VAs Eastern Colorado Health Care System ECHCS and will last approximately 6 months After the completion of the trial for each provider we will conduct a brief interview and survey of the participating providers to assess the acceptability of decisional support interventions to manage GID protocol page 1-2 No patient data PHI will be collected by the providers
Detailed Description:
Aim 1 Conduct a single site randomized controlled feasibility trial of a decisional support intervention to reduce ADRLLS by improving providers adherence to GID prevention measures Approximately 20 primary care providers caring for approximately 100 veterans on chronic steroids who have not been screened for diabetes in the last year will be randomly assigned to receive decisional support for GID prevention measures automatically-derived orders for hemoglobin A1C to be co-signed by providers These providers will be compared with 20 providers caring for 100 veterans not screened for diabetes in the last year who are randomly assigned to not receive decisional support for management of GID ie the control group The trial will be conducted at the VAs Eastern Colorado Health Care System ECHCS and will last approximately 6 months Study administration will be coordinated through the Colorado Research Award Enhancement Program Colorado REAP
Aim 1a Procedural Endpoints As a feasibility trial this study includes multiple procedural endpoints such as provider participation rates to assess the viability of the intervention rather than a single primary efficacy outcome measure for details pages 6-7
Aim 1b Preliminary Estimates of Efficacy We will determine the Delay Interval-the number of days from when a provider is randomized until the provider orders the GID prevention measure Use of this continuous measure will maximize the power of this feasibility study though we will also determine proportions of patients for whom these measures were ordered at six months so that we may estimate the sample size for a subsequent multi-center randomized control trial
Aim 1c Post-trial de-briefing Using structured interviews we will examine the opinions of providers after they have participated in the GID feasibility trial in order to gather additional qualitative data regarding the ADRLL framework and refine the intervention for a subsequent randomized controlled trial Providers will also complete a brief survey assessing their preference for the intervention
Aim 1a Procedural Endpoints As a feasibility trial this study includes multiple procedural endpoints such as provider participation rates to assess the viability of the intervention rather than a single primary efficacy outcome measure for details pages 6-7
Aim 1b Preliminary Estimates of Efficacy We will determine the Delay Interval-the number of days from when a provider is randomized until the provider orders the GID prevention measure Use of this continuous measure will maximize the power of this feasibility study though we will also determine proportions of patients for whom these measures were ordered at six months so that we may estimate the sample size for a subsequent multi-center randomized control trial
Aim 1c Post-trial de-briefing Using structured interviews we will examine the opinions of providers after they have participated in the GID feasibility trial in order to gather additional qualitative data regarding the ADRLL framework and refine the intervention for a subsequent randomized controlled trial Providers will also complete a brief survey assessing their preference for the intervention
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