Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000840886
Ethics application status
Approved
Date submitted
3/08/2012
Date registered
10/08/2012
Date last updated
10/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of wording and presentation of electronic alerts on behavior of providers caring for out-of-control diabetics
Scientific title
The effect of active/passive wording and plain/enhanced presentation of electronic alerts on ordering of insulin by providers caring for out-of-control diabetics on 2 or more oral hypoglycemic agents
Secondary ID [1] 280969 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Look and feel of electronic alerts 287079 0
Diabetes 287137 0
Condition category
Condition code
Metabolic and Endocrine 287402 287402 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During a direct patient encounter, an electronic message to the provider caring for an out-of-control diabetic suggests the patient be placed on insulin. This message appears on the screen of the Electronic Health Record during the time the provider is charting on the patient. The message appears once per provider per encounter. The same message appears to all providers at the same health center. Messages are changed every month for 4 months without a washout period based on the randomization schedule. Messages differ by wording (active vs passive voice) and presentation (all black text vs black and red text).
Arm 1: Wording in active voice plus all black text presentation
Arm 2: Wording in active voice plus black and red text presentation
Arm 3: Wording in passive voice plus all black text presentation
Arm 4: Wording in passive voice plus black and red text presentation
Intervention code [1] 285410 0
Behaviour
Comparator / control treatment
During a direct patient encounter, an electronic message to the provider caring for an out-of-control diabetic suggests the patient be placed on insulin. This message appears on the screen of the Electronic Health Record during the time the provider is charting on the patient. The message appears once per provider per encounter. The same message appears to all providers at the same health center. Messages are changed every month for 4 months without a washout period based on the randomization schedule. Messages differ by wording (active vs passive voice) and presentation (all black text vs black and red text).
Arm 1: Wording in active voice plus all black text presentation
Arm 2: Wording in active voice plus black and red text presentation
Arm 3: Wording in passive voice plus all black text presentation
Arm 4: Wording in passive voice plus black and red text presentation
Control group
Active

Outcomes
Primary outcome [1] 287666 0
Number of insulin preparations prescribed at each medical center in each of the four 1-month study periods.
Timepoint [1] 287666 0
Five month baseline followed by Four, 1-month cross-over periods
Secondary outcome [1] 298608 0
none
Timepoint [1] 298608 0
none

Eligibility
Key inclusion criteria
Patients in diabetic registry with HgA1C > 8.0 on at least 2 oral hypoglycemic agents. All physicians and advanced practioners caring for these patients. Only practioners in adult primary care, cardiology, endocrinology, and nephrology are included.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
on insulin, not on at least 2 oral agents, HgA1C not > 8.0

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Four -arm block randomized cross over trial. All providers meeting iniclusion criteria are automatically enrolled. All patients meeting inclusion criteria are automatically enrolled. The randomization schedule was determined centrally and concealed from both providers and patients the allocation of which message the providers received was not related to their inclusions or exclusion into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin flip to determine which of 4 sequences. Sequences are a balanced series of interventions: ABCD, DCBA, BDAC, CADB
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
No wash out period after crossing over
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4458 0
United States of America
State/province [1] 4458 0

Funding & Sponsors
Funding source category [1] 285752 0
Charities/Societies/Foundations
Name [1] 285752 0
Kaiser Permanente
Country [1] 285752 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Kaiser Permanente
Address
Systems Solutions and Deployment
74 North Pasadena Ave,
Pasadena, CA 91103
Country
United States of America
Secondary sponsor category [1] 284579 0
None
Name [1] 284579 0
none
Address [1] 284579 0
none
Country [1] 284579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287765 0
Kaiser Permanente IRB
Ethics committee address [1] 287765 0
Ethics committee country [1] 287765 0
United States of America
Date submitted for ethics approval [1] 287765 0
17/04/2012
Approval date [1] 287765 0
23/04/2012
Ethics approval number [1] 287765 0
(Note: the IRB felt this was a quality improvement project and did not meet the criteria for human subjects research as defined by 45 CFR 46.102 (d) and (f).)
These alerts triggered in the background (unseen by and unknown to the providers) for a 5 month period (starting February 2012). These baseline data were used to obtain information for our power analysis and also to be able to do a pre- post intervention analysis in addition to the RCT analysis. Providers started seeing the alerts in July 2012 (after letter from IRB).

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34534 0
Address 34534 0
Country 34534 0
Phone 34534 0
Fax 34534 0
Email 34534 0
Contact person for public queries
Name 17781 0
Erin G. Stone, MD
Address 17781 0
Systems Solutions and Deployment
Parsons West Annex, 5th Floor
74 North Pasadena Ave.
Pasadena, CA 91103
Country 17781 0
United States of America
Phone 17781 0
+1-626-381-3121
Fax 17781 0
Email 17781 0
[email protected]
Contact person for scientific queries
Name 8709 0
Erin G. Stone, MD
Address 8709 0
Systems Solutions and Deployment
Parsons West Annex, 5th Floor
74 North Pasadena Ave.
Pasadena, CA 91103
Country 8709 0
United States of America
Phone 8709 0
+1-626-381-3121
Fax 8709 0
Email 8709 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.