Intervention to Increase Screening for Glucocorticoid Induced Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/1/2014 |
| Start Date: | December 2012 |
| End Date: | December 2015 |
| Contact: | Liron Caplan, MD, PhD |
| Email: | liron.caplan@ucdenver.edu |
| Phone: | 7208575103 |
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 VA's 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.
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 VA's 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.
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 (i.e. the control
group). The trial will be conducted at the VA's 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.
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 (i.e. the control
group). The trial will be conducted at the VA's 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.
Inclusion criteria:
- Must be 18-90 years old
- Must be served by the ECHCS VA sytem
- Must have chronic glucocorticoid exposure (greater than or equal to 90 days of oral
glucocorticoids)
- Eligible providers will consist of those primary care practitioners within the ECHCS
with at least one patient meeting the above criteria. For each veteran, the primary
care provider (PCP) will be defined as the patient's current general internal
medicine or family practice practitioner. In the rare instance in which the patient
has no PCP within the VA system, the specialist with the greatest number of patient
encounters during the past 12 months will be eligible for inclusion. For every
patient, only one provider will be randomized (to avoid multiple exposure to the
intervention for some patients). The consent procedure is described below.
Exclusion Criteria:
- Veterans who have had a hgbA1C test within the previous 12 months will be excluded.
- Providers without eligible patients (described above), will be excluded.
- Providers declining to give consent will be excluded.
We found this trial at
1
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