NCT01877018

Brief 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%. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41,042

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

June 2, 2013

Last Update Submit

August 29, 2016

Conditions

Keywords

Comparative Effectiveness ResearchReminder SystemsPatient ParticipationPrimary Health CareEarly Detection of CancerColorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Patient's status participation to colorectal cancer screening program

    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.

    one year

Study Arms (2)

electronic reminder

EXPERIMENTAL

Electronic reminder introduced into primary care medical health record.

Behavioral: electronic reminder

Usual care

NO INTERVENTION

Usual care control group

Interventions

Electronic reminder introduced into primary care medical health record, identifying invited people to the population-based colorectal cancer screening program, to promote their participation.

electronic reminder

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patients: Refusal to participate.
  • Health care professionals: Refusal to participate by the center where they work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jordi Gol Foundation

Barcelona, Catalonia, 08007, Spain

Location

Jordi Gol Gurina Foundation

Barcelona, Catalonia, 08007, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Participation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Carolina Guiriguet

    Catalan Health Institute. IDIAP Jordi Gol

    PRINCIPAL INVESTIGATOR
  • Laura Muñoz

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    STUDY CHAIR
  • Irene Rivero

    Catalan Institute of Health

    STUDY CHAIR
  • Carme Vela

    Catalan Institute of Health

    STUDY CHAIR
  • Mercedes Vilarrubí

    Catalan Institute of Health

    STUDY CHAIR
  • Miquel Torres

    Hospital Esperit Sant

    STUDY CHAIR
  • Jaume Grau

    Hospital Clínic Provincial

    STUDY CHAIR
  • Andrea Buron

    Hospital del Mar

    STUDY CHAIR
  • Cristina Hernández

    Hospital del Mar

    STUDY CHAIR
  • Antonio Fuentes

    Catalan Institute of Health

    STUDY CHAIR
  • Dolores Reina

    Catalan Institute of Health

    STUDY CHAIR
  • Rosa De León

    Catalan Institute of Health

    STUDY CHAIR
  • Leonardo Mendez

    Catalan Health Institute. IDIAP Jordi Gol

    STUDY CHAIR
  • Pere Toran

    Catalan Health Institute. IDIAP Jordi Gol

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2013

First Posted

June 13, 2013

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations