Condition category
Not Applicable
Date applied
15/04/2014
Date assigned
01/05/2014
Last edited
01/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlos Martins

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of order communication system optimization in the prescription of unnecessary laboratory tests: a randomised controlled trial

Acronym

Study hypothesis

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

Northern Regional Health Administration Medical Ethics Committee, 17/06/2011, 56/201

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2012

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

9 computer servers, 14 health centers, 117 family physicians

Participant exclusion criteria

Family physicians working in the same health center as the researchers

Recruitment start date

01/01/2012

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Portugal

Trial participating centre

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

Sponsor information

Organisation

AstraZeneca HealthCare Foundation (Portugal)

Sponsor details

AstraZeneca Produtos Farmacêuticos
Lda
Rua Humberto Madeira
7
Queluz-de-Baixo
Barcarena
2730-097
Portugal
CorporateAffairs.Portugal@astrazeneca.com

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

AstraZeneca HealthCare Foundation (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes