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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Support Intervention | Experimental | Clinical pharmacists mediated computerized decision support |
|
| Usual Care | Active Comparator | Clinicians' typical approach for GID monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision support | Behavioral | Clinical pharmacists mediated computerized decision support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level). | For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention. | 6 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility/Reach/Adoption | Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | 12 months |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liron Caplan, MD, PhD | Veteran Affairs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liron Caplan | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Support Intervention | Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support |
| FG001 | Usual Care | Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Support Intervention | Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | We were not authorized by the IRB to record this information; however, all participants were between the ages of 18 and 90, as specified in the inclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level). | For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention. | 21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm. | Posted | Mean | 95% Confidence Interval | Days | 6 MONTHS |
|
Entire duration of study
No adverse events were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Support Intervention | Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liron Caplan, Primary Investigator | Eastern Colorado Health Care System, VA | 7208575103 | liron.caplan@ucdenver.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Usual Care | Behavioral | clinicians typical apporach for GID monitering |
|
| Feasibility/Reach/Adoption | Measurements of intervention delivery include the "representativeness" of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | 12 months |
| Feasibility/Reach/Adoption | Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | 12 months |
| Feasibility/Reach/Adoption | Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | 12 months |
Clinicians' typical approach for GID monitoring
Usual Care: clinicians typical apporach for GID monitering
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | We were not authorized by IRB to record this information. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering |
|
|
| Secondary | Feasibility/Reach/Adoption | Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | Not Posted | 12 months |
| Secondary | Feasibility/Reach/Adoption | Measurements of intervention delivery include the "representativeness" of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | Not Posted | 12 months |
| Secondary | Feasibility/Reach/Adoption | Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | Not Posted | 12 months |
| Secondary | Feasibility/Reach/Adoption | Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges). | Not Posted | 12 months |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Usual Care | Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering | 0 | 17 | 0 | 17 |
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