Trial Outcomes & Findings for Intervention to Increase Screening for Glucocorticoid Induced Diabetes (NCT NCT01743963)

NCT ID: NCT01743963

Last Updated: 2015-07-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 6 MONTHS
• Results posted on: 2015-07-02

Participant Flow

Participant milestones

Measure	Decision Support Intervention Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support	Usual Care Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering
Overall Study STARTED	21	17
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention to Increase Screening for Glucocorticoid Induced Diabetes

Baseline characteristics by cohort

Measure	Decision Support Intervention n=21 Participants Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support	Usual Care n=17 Participants Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering	Total n=38 Participants Total of all reporting groups
Age, Customized 18 to 90 years	21 participants n=5 Participants	17 participants n=7 Participants	38 participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	17 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 MONTHS

Population: 21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm.

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.

Outcome measures

Measure	Decision Support Intervention n=21 Participants Clinical pharmacists mediated computerized decision support Decision support: Clinical pharmacists mediated computerized decision support	Usual Care n=17 Participants Clinicians' typical approach for GID monitoring Usual Care: clinicians typical apporach for GID monitering
Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).	12 Days Interval 6.3 to 398.7	104 Days Interval 6.3 to 398.7

SECONDARY outcome

Timeframe: 12 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).

Outcome measures

Outcome data not reported

Adverse Events

Decision Support Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Liron Caplan, Primary Investigator

Eastern Colorado Health Care System, VA

Phone: 7208575103

Email: liron.caplan@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place