Assessing the Effectiveness and Cost-effectiveness of Audit and Feedback on physician's prescribing indicators: a Randomized Controlled Trial with Economic evaluation
One of the most important duties of health authorities is to ensure the efficacy and cost-effectiveness of health care system services. Developing countries have limited budgets for health care sector; therefore they need good planning to implement interventions for promoting rational drug use. Audit and feedback is used as an intervention to improve professional practice. The aim of this study is to evaluate the efficacy and cost-effectiveness of audit and feedback on rational drug use indicators. Interventions include feedback on prescribing indicators and educational printed materials. There are three intervention groups and one control group in this randomized trial study. The prescribing indicators including injectable dosage form of dexamethasone, oral dosage forms of cefixim and amoxicillin, which prescribed by general practitioners, pediatricians and infectious diseases specialists, will be evaluated. The change rates of mentioned indicators are criteria for efficacy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106086740N1
Registration date:2011-08-20, 1390/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-20, 1390/05/29
Registrant information
Name
Fatemeh Soleymani
Name of organization / entity
Food and drug organization, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
00982188923192/00982166482606
Email address
fsolemani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2011-07-06, 1390/04/15
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effectiveness and Cost-effectiveness of Audit and Feedback on physician's prescribing indicators: a Randomized Controlled Trial with Economic evaluation
Public title
Assessing the Effectiveness and Cost-effectiveness of Audit and Feedback on physician's prescribing indicators
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: General practitioners, Infectious disease specialists and Pediatericians who have at least 100 insured prescriptions. Exclusion criteria: No access to insured prescriptions of physicians; No access to physicians' office adress.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
800
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
pharmaceutical science research center of Tehran University of Medical Sciences
Street address
16 azar street, Enghelab avenue
City
Tehran
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
90-02-27-07
Health conditions studied
1
Description of health condition studied
drug use indicators
ICD-10 code
Z74.9
ICD-10 code description
Problem related to care-provider dependency, unspecified
Primary outcomes
1
Description
injectable dosage form of dexamethasone, oral dosage form of amoxicillin and cefixim
Timepoint
0, 1th, and 3th months
Method of measurement
based on prescriptions
Secondary outcomes
1
Description
mean items per prescriptions
Timepoint
0, 1th and 3th months
Method of measurement
based on prescriptions
Intervention groups
1
Description
Sending educational package that desined in this study for study group 3
Category
Other
2
Description
Sending routine audi and feedbacks for study group 1
Category
Other
3
Description
No intervention in control group
Category
N/A
4
Description
Sendind audit and feedbacks which designed by focused on injection dosage form of dexamethasone, oral dosage form of amoxicillin and cefixim for study group 2
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran
Full name of responsible person
Dr. Fatemeh Soleymani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanselor for Research of Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Ghods street, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanselor for Research of Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Dr. Fatemeh Soleymani
Position
PhD candidate of pharmacoeconomics and pharmaceutical management
Other areas of specialty/work
Street address
16 azar street, Enghelab avenue
City
Tehran
Postal code
Phone
+98 21 8892 3192
Fax
+98 21 8889 2992
Email
fsolemani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Arash Rashidian
Position
PhD in health policy
Other areas of specialty/work
Street address
Enghelab avenue
City
Tehran
Postal code
Phone
+98 21 8899 1112
Fax
+98 21 8899 1113
Email
arashidian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of pharmacy,Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Fatemeh Soleymani
Position
PhD candidate of pharmacoeconomics and pharmaceutical management
Other areas of specialty/work
Street address
16 azar street
City
Tehran
Postal code
Phone
+98 21 8892 3192
Fax
+98 21 8889 2992
Email
fsolemani@yahoo.com ; fsolemani@tums.razi.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)