Colorectal NeoplasmsCOLO-ALERTNCT01877018
Colorectal Cancer Screening in Primary Care
A study testing electronic reminder in people with Colorectal Neoplasms, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
Trial summary
The implementation of screening programs for colorectal cancer by screening for fecal occult blood has proven effective in reducing the incidence and mortality from this type of neoplasms. However, to ensure the efficiency of the programs require population participation rates of at least 50%. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- electronic reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41,042 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Men and women, aged between 50-69, with an average risk of developing CRC, involved to participate in the first round of a population-based CRC screening program (N=57.020)
- To be registered with a primary care physician (PCP) at one of the centers participating.
- Health care professionals: All the physicians and nurses working at every center voluntarily participating (N=280).
Who cannot join
- Patients: Refusal to participate.
- Health care professionals: Refusal to participate by the center where they work.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Jordi Gol Foundation
Barcelona, Catalonia, 08007
Jordi Gol Gurina Foundation
Barcelona, Catalonia, 08007
About this study
Official title: Effectiveness of an Electronic Alert Into the Primary Care Medical Health Record to Increase Participation in a Population Colorectal Cancer Screening Program.
The implementation of screening programs for colorectal cancer by screening for fecal occult blood has proven effective in reducing the incidence and mortality from this type of neoplasms. However, to ensure the efficiency of the programs require population participation rates of at least 50%. Experiences in our country show that the population participation is far from this recommended minimum number.
Interventions to promote preventive activities in primary care are well received by the population; in the case of colorectal cancer, direct recommendation of primary care professionals to carry out the screening is one of the factors with greatest impact on increasing population participation in such programs. Care overload, circuit design for screening without the direct intervention of primary care professionals and the multiplicity of tasks that they must face, are elements that influence the low recommendation for screening in the target population who consults for any other reason.
The introduction of specific reminders in electronic medical record (in widespread use in primary care), as a tool to facilitate and encourage direct referral by physicians and nurse practitioners to perform colorectal cancer screening will mean an increase of at least 10% in participation of the target population, increasing the efficiency of screening programs. The introduction of this new software tool will have good acceptance and increase compliance with recommendations from health professionals.
Read the detailed description
Background:
Colorectal cancer (CRC) is an important public health problem in our country. Over the last decade, several autonomous regions in Spain have carried out screening programs, but population participation rates remain below recommended European targets.
Reminders on electronic medical record (EMR) have been identified as a low-cost and high-reach strategy to increase participation. The population-based colorectal cancer screening program in the city of Barcelona is aimed at men and women between ages 50 and 69 involving immunochemical fecal occult blood test (iFOBT) every 2 years. Community pharmacies participating in the program are in charge of delivery and collection of iFOBT.
Aims:
Main: To asses the effectiveness of an intervention in primary care, by using reminder systems applied to the electronic medical records to promote the population's participation in a Public CRC Screening Program.
Secondary:
- To know the population's reasons for refusing to take part in the screening program.
- To know the health professionals' opinion on the official program implementation.
- To know the health professionals' opinion on the implementation of the new computerized tool.
Methods:
Design: Randomized controlled trial and a cross-sectional second phase. Setting: 11 primary care centers
Subjects:
Inclusion criteria Patients
- Men and women, aged between 50-69, with an average risk of developing CRC, involved to participate in the first round of a population-based CRC screening program (N 57.020).
- To be registered with a primary care physician (PCP) at one of the centers participating.
Health care professionals:
- All the physicians and nurses working at every center voluntarily participating (N 280).
Exclusion criteria Patients: Refusal to participate. Health care professionals: Refusal to participate by the center where they work.
Intervention It consists of entering a reminder in the EMR of patients (e-cap program), in the form of a specific icon, in the medical scheduler, which identifies subjects who had been invited to take part in the CRC screening program. The alert is addressed to physicians and nurses, in order to promote CRC screening, through some brief advice and asking the patient to fill in a data collection sheet specifically designed for this study and also included in the EMR. Health care professionals in the intervention group will have had a training session on the intervention's characteristics and development.
Sample size: The target population registered with the centers involved in the study is about 60.000 people. It is estimated that 90% of them will be invited to participate in the screening program. In case of low participation (30%), the resulting sample could identify a difference of at least 10% between the control group and the intervention group, with an alpha error of 5% and a statistical power of 95%, and an estimated loss to follow up rate at 20 %.
Randomization:The randomization unit is the PCP. The allocation of the participant PCPs to the control or intervention groups is carried out through a stratified random sampling by center, allocating 50% of the physicians to the control or intervention group, respectively.
The nurses are allocated to the intervention/control group according to the study group of the PCP that they share patients care with. Patients are allocated to the intervention/control group according to the study group of their PCP.
Masking: Given the nature of the intervention, there's no masking of the health professionals or of the statistician responsible for the statistical analysis, but due to the objectivity of the final outcome we don't think the result could be influenced by this fact. Moreover the data manager for the CRC screening program, responsible for the data management of the participation outcome, does not know what study group the invited population was allocated to. Patients are also unaware of study group that they have been assigned to, and they have no access to the EMR.
Outcomes:
Primary outcome: CRC screening status (Update, not update, exclusion)
Secondary outcomes:
- Patient's characteristics: age, gender, socioeconomic deprivation index, risk factor for colorectal cancer, clinical risk group, number of visits.
- Health professionals characteristics: age, gender, knowledge about CRC screening.
- Reminder: date when the sheet was filled in, previous participation in the CRC screening program (yes, no and barriers), exclusion criteria (normal colonoscopy within the previous five years, high CRC risk for personal or family history, symptoms of CRC), intention to participate (yes, no and barriers).
- Health Professionals Opinion questionnaire on:
Population-based CRC screening program: Information given, process operation, primary care professionals implication.
Electronic reminder: usefulness, usage, operation.
Data collection: Data obtained from population based CRC screening program, the EMR and two questionnaires for the cross-sectional second phase.
Statistical analysis: Data will be analyzed using Stata, version 12.1, statistical software package and an intention-to-treat approach will be applied. Analyses will include standard descriptive statistics, Student's t tests, correlation and regression, to examine differences between groups. All tests will be two-tailed and an alpha level of 0.05 will be applied as the criterion for statistical significance.
Limits:
Given the nature of the intervention and the great social, economic and demographical differences of the population registered with the centers participating in this study, we take the physicians as a unit of randomization, instead of the centers or the patients.
External validity: This is an urban population study, but as the EMR is universally used in Catalonia's primary care centers, we don't expect differences due to the area of work.
Ethical aspects:
The investigators are committed to complying with the prevailing norms of Good Clinical Practice, as well as with the requirements of the Declaration of Helsinki and the clauses of general and particular ethical conditions related to the right to privacy, anonymity and confidentiality. Neither the first name nor the surnames or any other type of data indicating the identity of the subjects will be registered. Therefore, identification will be made by numerical codes. Since this type of study is developed in the usual clinical setting, authorization and support must be and has already been granted by the representatives and authorities of the groups involved and thus, individual informed consent is not necessary. However, the consent of target population attending a primary care appointment will be registered in the EMR. The protocol has been approved by the Clinical Investigation Ethics Committee of the Jordi Gol i Gurina Foundation (protocol number P10/31).
- Conditions
- Colorectal Neoplasms
- Being tested
- electronic reminder
- Keywords
- Comparative Effectiveness Research, Reminder Systems, Patient Participation, Primary Health Care, Early Detection of Cancer, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic reminderBehavioural
Electronic reminder introduced into primary care medical health record, identifying invited people to the population-based colorectal cancer screening program, to promote their participation.
| Study group | Role | What they receive |
|---|---|---|
| electronic reminder | Experimental | Electronic reminder introduced into primary care medical health record. Receives: Behavioral: electronic reminder |
| Usual care | No intervention | Usual care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's status participation to colorectal cancer screening program
Status of participation at the end of the intervention (1 year):
- Update: completion of faecal occult blood test by invitation from the colorectal cancer screening program within the duration of the study.
- Exclusion: exclusion criteria identified through the screening process by colorectal cancer screening program.
- Not update: No completion of faecal occult blood test.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Carolina Guiriguet, Principal investigator, Catalan Health Institute. IDIAP Jordi GolLaura Muñoz, Study chair, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaIrene Rivero, Study chair, Catalan Institute of HealthCarme Vela, Study chair, Catalan Institute of HealthMercedes Vilarrubí, Study chair, Catalan Institute of HealthMiquel Torres, Study chair, Hospital Esperit SantJaume Grau, Study chair, Hospital Clínic ProvincialAndrea Buron, Study chair, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877018
- Sponsor's protocol ID
- PI10/01994
- Acronym
- COLO-ALERT
- Status last verified
- Aug 2016
- First submitted
- 2 Jun 2013
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Guiriguet-Capdevila C, Munoz-Ortiz L, Rivero-Franco I, Vela-Vallespin C, Vilarrubi-Estrella M, Torres-Salinas M, Grau-Cano J, Buron-Pust A, Hernandez-Rodriguez C, Fuentes-Pelaez A, Reina-Rodriguez D, De Leon-Gallo R, Mendez-Boo L, Toran-Monserrat P. Can an alert in primary care electronic medical records increase participation in a population-based screening programme for colorectal cancer? COLO-ALERT, a randomised clinical trial. BMC Cancer. 2014 Mar 31;14:232. doi: 10.1186/1471-2407-14-232.
PubMed 24685117
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Electronic Alert Into the Primary Care Medical Health Record to Increase Participation in a Population Colorectal Cancer Screening Program.
- ClinicalTrials.gov ID
- NCT01877018
- Acronym / sponsor ID
- COLO-ALERT / PI10/01994
- Conditions
- Colorectal Neoplasms
- Keywords
- Comparative Effectiveness Research, Reminder Systems, Patient Participation, Primary Health Care, Early Detection of Cancer, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41,042 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The implementation of screening programs for colorectal cancer by screening for fecal occult blood has proven effective in reducing the incidence and mortality from this type of neoplasms. However, to ensure the efficiency of the programs require population participation rates of at least 50%. Experiences in our country show that the population participation is far from this recommended minimum number.
Interventions to promote preventive activities in primary care are well received by the population; in the case of colorectal cancer, direct recommendation of primary care professionals to carry out the screening is one of the factors with greatest impact on increasing population participation in such programs. Care overload, circuit design for screening without the direct intervention of primary care professionals and the multiplicity of tasks that they must face, are elements that influence the low recommendation for screening in the target population who consults for any other reason.
The introduction of specific reminders in electronic medical record (in widespread use in primary care), as a tool to facilitate and encourage direct referral by physicians and nurse practitioners to perform colorectal cancer screening will mean an increase of at least 10% in participation of the target population, increasing the efficiency of screening programs. The introduction of this new software tool will have good acceptance and increase compliance with recommendations from health professionals.
Detailed description
Background:
Colorectal cancer (CRC) is an important public health problem in our country. Over the last decade, several autonomous regions in Spain have carried out screening programs, but population participation rates remain below recommended European targets.
Reminders on electronic medical record (EMR) have been identified as a low-cost and high-reach strategy to increase participation. The population-based colorectal cancer screening program in the city of Barcelona is aimed at men and women between ages 50 and 69 involving immunochemical fecal occult blood test (iFOBT) every 2 years. Community pharmacies participating in the program are in charge of delivery and collection of iFOBT.
Aims:
Main: To asses the effectiveness of an intervention in primary care, by using reminder systems applied to the electronic medical records to promote the population's participation in a Public CRC Screening Program.
Secondary:
- To know the population's reasons for refusing to take part in the screening program.
- To know the health professionals' opinion on the official program implementation.
- To know the health professionals' opinion on the implementation of the new computerized tool.
Methods:
Design: Randomized controlled trial and a cross-sectional second phase. Setting: 11 primary care centers
Subjects:
Inclusion criteria Patients
- Men and women, aged between 50-69, with an average risk of developing CRC, involved to participate in the first round of a population-based CRC screening program (N 57.020).
- To be registered with a primary care physician (PCP) at one of the centers participating.
Health care professionals:
- All the physicians and nurses working at every center voluntarily participating (N 280).
Exclusion criteria Patients: Refusal to participate. Health care professionals: Refusal to participate by the center where they work.
Intervention It consists of entering a reminder in the EMR of patients (e-cap program), in the form of a specific icon, in the medical scheduler, which identifies subjects who had been invited to take part in the CRC screening program. The alert is addressed to physicians and nurses, in order to promote CRC screening, through some brief advice and asking the patient to fill in a data collection sheet specifically designed for this study and also included in the EMR. Health care professionals in the intervention group will have had a training session on the intervention's characteristics and development.
Sample size: The target population registered with the centers involved in the study is about 60.000 people. It is estimated that 90% of them will be invited to participate in the screening program. In case of low participation (30%), the resulting sample could identify a difference of at least 10% between the control group and the intervention group, with an alpha error of 5% and a statistical power of 95%, and an estimated loss to follow up rate at 20 %.
Randomization:The randomization unit is the PCP. The allocation of the participant PCPs to the control or intervention groups is carried out through a stratified random sampling by center, allocating 50% of the physicians to the control or intervention group, respectively.
The nurses are allocated to the intervention/control group according to the study group of the PCP that they share patients care with. Patients are allocated to the intervention/control group according to the study group of their PCP.
Masking: Given the nature of the intervention, there's no masking of the health professionals or of the statistician responsible for the statistical analysis, but due to the objectivity of the final outcome we don't think the result could be influenced by this fact. Moreover the data manager for the CRC screening program, responsible for the data management of the participation outcome, does not know what study group the invited population was allocated to. Patients are also unaware of study group that they have been assigned to, and they have no access to the EMR.
Outcomes:
Primary outcome: CRC screening status (Update, not update, exclusion)
Secondary outcomes:
- Patient's characteristics: age, gender, socioeconomic deprivation index, risk factor for colorectal cancer, clinical risk group, number of visits.
- Health professionals characteristics: age, gender, knowledge about CRC screening.
- Reminder: date when the sheet was filled in, previous participation in the CRC screening program (yes, no and barriers), exclusion criteria (normal colonoscopy within the previous five years, high CRC risk for personal or family history, symptoms of CRC), intention to participate (yes, no and barriers).
- Health Professionals Opinion questionnaire on:
Population-based CRC screening program: Information given, process operation, primary care professionals implication.
Electronic reminder: usefulness, usage, operation.
Data collection: Data obtained from population based CRC screening program, the EMR and two questionnaires for the cross-sectional second phase.
Statistical analysis: Data will be analyzed using Stata, version 12.1, statistical software package and an intention-to-treat approach will be applied. Analyses will include standard descriptive statistics, Student's t tests, correlation and regression, to examine differences between groups. All tests will be two-tailed and an alpha level of 0.05 will be applied as the criterion for statistical significance.
Limits:
Given the nature of the intervention and the great social, economic and demographical differences of the population registered with the centers participating in this study, we take the physicians as a unit of randomization, instead of the centers or the patients.
External validity: This is an urban population study, but as the EMR is universally used in Catalonia's primary care centers, we don't expect differences due to the area of work.
Ethical aspects:
The investigators are committed to complying with the prevailing norms of Good Clinical Practice, as well as with the requirements of the Declaration of Helsinki and the clauses of general and particular ethical conditions related to the right to privacy, anonymity and confidentiality. Neither the first name nor the surnames or any other type of data indicating the identity of the subjects will be registered. Therefore, identification will be made by numerical codes. Since this type of study is developed in the usual clinical setting, authorization and support must be and has already been granted by the representatives and authorities of the groups involved and thus, individual informed consent is not necessary. However, the consent of target population attending a primary care appointment will be registered in the EMR. The protocol has been approved by the Clinical Investigation Ethics Committee of the Jordi Gol i Gurina Foundation (protocol number P10/31).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electronic reminder | Experimental | Behavioral: electronic reminderElectronic reminder introduced into primary care medical health record. |
| Usual care | No intervention | –Usual care control group |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients:
- Health care professionals: All the physicians and nurses working at every center voluntarily participating (N=280).
Key exclusion criteria (2 listed)
- Patients: Refusal to participate.
- Health care professionals: Refusal to participate by the center where they work.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic reminderElectronic reminder introduced into primary care medical health record, identifying invited people to the population-based colorectal cancer screening program, to promote their participation. | Behavioural | electronic reminder |
Primary outcome
Patient's status participation to colorectal cancer screening program
Time frame: one year
Status of participation at the end of the intervention (1 year): 1. Update: completion of faecal occult blood test by invitation from the colorectal cancer screening program within the duration of the study. 2. Exclusion: exclusion criteria identified through the screening process by colorectal cancer screening program. 3. Not update: No completion of faecal occult blood test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 24685117Guiriguet-Capdevila C, Munoz-Ortiz L, Rivero-Franco I, Vela-Vallespin C, Vilarrubi-Estrella M, Torres-Salinas M, Grau-Cano J, Buron-Pust A, Hernandez-Rodriguez C, Fuentes-Pelaez A, Reina-Rodriguez D, De Leon-Gallo R, Mendez-Boo L, Toran-Monserrat P. Can an alert in primary care electronic medical records increase participation in a population-based screening programme for colorectal cancer? COLO-ALERT, a randomised clinical trial. BMC Cancer. 2014 Mar 31;14:232. doi: 10.1186/1471-2407-14-232.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Guiriguet principal investigator
Catalan Health Institute. IDIAP Jordi Gol
Laura Muñoz study chair
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Irene Rivero study chair
Catalan Institute of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic reminder in people with Colorectal Neoplasms, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's status participation to colorectal cancer screening program (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.