Laboratory tests order communication system optimization: a randomised controlled trial
ISRCTN | ISRCTN45427977 |
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DOI | https://doi.org/10.1186/ISRCTN45427977 |
Secondary identifying numbers | N/A |
- Submission date
- 15/04/2014
- Registration date
- 01/05/2014
- Last edited
- 22/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
When inefficiently designed software is combined with a non-evidence based medical practice, the result can be disastrous, leading to patient harm, significant impact to quality of life and damage to the health system due to unnecessary costs. The aim of this study is to compare the effects of modifying the electronic health record ordering communication system, by changing the basic shortcut menu and adding a clinical decision support system.
Who can participate
All the doctors working in the Western Oporto Group of Health Centers (except the Health Center where the researchers work).
What does the study involve
This study involved a modification of tests ordering system software. Doctors are randomly allocated to one of two groups: group 1 (system as it is now) or group 2 (a modified version of the electronic health record ordering communication system).
What are the possible benefits and risks of participating?
For group 1 participants, benefits include the use of a more complete software solution with a decision support tool and the risk is the difficulty to adapt to a new version of the system.
Where is the study run from?
Western Oporto Group of Health Centers (Portugal)
When is the study starting and how long is it expected to run for?
January 2012 to September 2012
Who is funding the study?
Astrazeneca Portugal Foundation's 2010 program for support of research
Who is the main contact?
Dr Carlos Martins
Contact information
Scientific
Faculdade de Medicina da Universidade do Porto
Al. Prof. Hernâni Monteiro
Porto
4200 - 319
Portugal
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Effect of order communication system optimization in the prescription of unnecessary laboratory tests: a randomised controlled trial |
Study objectives | Will the optimization of the ordering communication system, by changing a shortcut menu and adding a clinical decision support system based on the integration of the United States Preventive Services Task Force recommendations, improve the profile of laboratory tests prescription and reduce the prescription of unnecessary laboratory tests? |
Ethics approval(s) | Northern Regional Health Administration Medical Ethics Committee, 17/06/2011, ref: 56/201 |
Health condition(s) or problem(s) studied | Laboratory tests prescription |
Intervention | The control group continued to use the usual version of the EHR software (SAM). The intervention group used a modified version of the software (SAM modified) installed in each server. The modification of the SAM consisted of two principal changes: 1. Basic shortcut menu changes, including changes to the composition of the basic menu set of diagnostic laboratory tests, with withdrawals (uric acid, serum protein electrophoresis, sedimentation rate, and electrocardiogram and lung X-ray tests) and additions (HDL cholesterol, faecal occult blood test, triglycerides, Pap smear and mammography tests) 2. Addition of an evidence-based decision support We added traffic light based coloured dots according to the USPSTF recommendations, and an additional information box containing the summary of the USPSTF recommendation and a link to the integral recommendation at the USPSTF website. |
Intervention type | Other |
Primary outcome measure | Primary outcomes were chosen to assess the impact of our intervention in the number of diagnostic and laboratory tests prescribed by physicians including four different perspectives: 1. Impact on the number of the prescriptions of diagnostic and laboratory tests that were withdrawn from the basic menu 2. Impact on the number of the prescriptions of diagnostic and laboratory tests that were added to the basic menu 3. Impact on the number of the prescriptions of diagnostic and laboratory tests that were marked with green dots (USPSTF recommendations grade A and B) 4. Impact on the number of prescriptions of diagnostic and laboratory tests that were marked with red dots (USPSTF recommendations grade D) Prospective monthly monitoring and data collection occurred until 31/01/2013. To allow a pre-post analysis in both groups, a retrospective monthly data collection of both control and intervention groups was also performed between 01/12/2011 and 31/05/2012. |
Secondary outcome measures | 1. Monthly number of family physicians prescribing 2. Monthly number of face-to-face consultations made 3. Monthly number of each diagnostic 4. Laboratory test prescribed Prospective monthly monitoring and data collection occurred until 31/01/2013. To allow a pre-post analysis in both groups, a retrospective monthly data collection of both control and intervention groups was also performed between 01/12/2011 and 31/05/2012. |
Overall study start date | 01/01/2012 |
Completion date | 30/09/2012 |
Eligibility
Participant type(s) | Health professional |
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Age group | Adult |
Sex | Both |
Target number of participants | 9 computer servers, 14 health centers, 117 family physicians |
Key inclusion criteria | All family physicians working and prescribing diagnostic and laboratory tests in the Western Oporto group of health centers (except those where the authors worked) |
Key exclusion criteria | Family physicians working in the same health center as the researchers |
Date of first enrolment | 01/01/2012 |
Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Portugal
Study participating centre
4200 - 319
Portugal
Sponsor information
Charity
AstraZeneca Produtos Farmacêuticos, Lda
Rua Humberto Madeira, 7
Queluz-de-Baixo
Barcarena
2730-097
Portugal
CorporateAffairs.Portugal@astrazeneca.com | |
https://ror.org/05mt63e64 |
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 20/02/2017 | Yes | No |
Editorial Notes
22/02/2017: Publication reference added.