Laboratory tests order communication system optimization: a randomised controlled trial

ISRCTN ISRCTN45427977
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Carlos Martins
Scientific

Faculdade de Medicina da Universidade do Porto
Al. Prof. Hernâni Monteiro
Porto
4200 - 319
Portugal

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffect of order communication system optimization in the prescription of unnecessary laboratory tests: a randomised controlled trial
Study objectivesWill 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) studiedLaboratory tests prescription
InterventionThe 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 typeOther
Primary outcome measurePrimary 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 measures1. 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 date01/01/2012
Completion date30/09/2012

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants9 computer servers, 14 health centers, 117 family physicians
Key inclusion criteriaAll 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 criteriaFamily physicians working in the same health center as the researchers
Date of first enrolment01/01/2012
Date of final enrolment30/09/2012

Locations

Countries of recruitment

  • Portugal

Study participating centre

Faculdade de Medicina da Universidade do Porto
Porto
4200 - 319
Portugal

Sponsor information

AstraZeneca HealthCare Foundation (Portugal)
Charity

AstraZeneca Produtos Farmacêuticos, Lda
Rua Humberto Madeira, 7
Queluz-de-Baixo
Barcarena
2730-097
Portugal

Email CorporateAffairs.Portugal@astrazeneca.com
ROR logo "ROR" https://ror.org/05mt63e64

Funders

Funder type

Charity

AstraZeneca HealthCare Foundation (Portugal)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.