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出境医 / 临床实验 / Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening (FORCEPS)

Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening (FORCEPS)

Study Description
Brief Summary:

Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.

Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention Intervention ; six hour educational training either in person or through e-learning The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories.


Condition or disease Intervention/treatment
Colorectal Cancer Other: Training

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Study Design
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Study Type : Observational
Actual Enrollment : 274 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Other: Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Other Name: The patient-centered approach

Control
General Practitioners not using the patient-centered approach
Outcome Measures
Primary Outcome Measures :
  1. number of patients screened positive using the patient-centered approach after training of face to face training or e-learning [ Time Frame: 1 year ]
    Evaluate the effectiveness of face to face training or e-learning training to use the patient-centered approach


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
Criteria

Inclusion Criteria:

  • Patients aged 50 to 74,
  • Residing in the regions of Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrenees, Poitou-Charentes, and Provence-Alpes-Côte-D'azur,
  • Registered on the AMELI file of general practitioners participating in beginning of the study, before the training (ie the patients who have declared as a doctor one of the participating general practitioners).
  • Affiliation to the general social security scheme

Exclusion Criteria:

  • Patients excluded from screening for medical reasons (colorectal cancer or symptoms such as presence of red or black blood in the stool, other pathologies in non-priority treatment and screening)
  • Patient having performed a Hemoccult® test / test immunological test for less than 2 years or had colonoscopy for less than 5 years.
  • Patient who has declared as a treating physician one of the participating physicians for the duration of the study.
  • Patient who did not consult for the duration of the study
Contacts and Locations

Locations
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France
Département de Médecine Générale
Paris, Idf, France, 75018
Sponsors and Collaborators
Collège de la Médecine Générale, France
National Cancer Institute, France
Investigators
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Principal Investigator: AUBIN-AUGER M ISABELLE, MD, Pr COLLEGE DE LA MEDECINE GENERALE
Tracking Information
First Submitted Date April 25, 2019
First Posted Date May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date January 24, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
number of patients screened positive using the patient-centered approach after training of face to face training or e-learning [ Time Frame: 1 year ]
Evaluate the effectiveness of face to face training or e-learning training to use the patient-centered approach
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening
Official Title Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening
Brief Summary

Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.

Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention Intervention ; six hour educational training either in person or through e-learning The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories.

Detailed Description

Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.

Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention .Given that the type of educational intervention modifies the global organization and medical practices of the participating centers, the randomization will be done at the level of GP's practice as a cluster unit in order to avoid contamination bias.

Population : All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.

212 centers are expected with 318 investigating doctors (an average of 1,5 doctors per center) and 42 358 total patients (21 179 patients in each arm) Intervention ; will be an educational training either in person or through e-learning GPs from practices in the control group were asked to continue their usual care, as if they were not participating in this trial. The whole procedure is the same all over the country i.e. all adults aged 50 to 74 of each GP's target population receive a letter every two years from the local cancer prevention association encouraging them to visit their GP and ask for the test. Patients must then send the test and a completed identity form, contained in an envelope to a central laboratory.

In the intervention group, participating GPs will receive a six-hour training course focusing on patient-centered care either in person or through e-learning . Two different scenarios for a video aiming to improve communication with patients were developed: one for a compliant patient, another for a non-compliant patient based on the four components of the patient centered clinical method

Objectives :

The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories The Secondary objectives are ;

  • Assess the effectiveness of this training on moderate-risk patient participation in organized CRC screening
  • Assess the effectiveness of this training on high-risk patient participation in targeted CRC screening
  • Compare the effectiveness of in-person training versus e-learning
  • Assess the effect of the training on whether the sequence of tests completed by patients is appropriate for their risk category (carrying out a test that was given to them, immediate refusal of the test, carrying out a colonoscopy if the test is positive) Assess the effectiveness of this training on reducing social inequalities in CRC screening participation Evaluation criteria : the primary endpoint is patient participation in the appropriate CRC screening for their level of risk (i.e. completing the Fecal Occult Blood Test [FOBT] if at moderate risk or a colonoscopy if at high risk) within 12 months of randomization. The secondary endpoints are: completing the FOBT for moderate risk patients, completing a colonoscopy for higher risk patients, proportion of dispensed tests that were completed , proportion of tests refused among those proposed, proportion of colonoscopies performed among those whose FOBT is positive, patient screening participation rate according to socio-economic level, proportion of tests that could not be interpreted
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
Condition Colorectal Cancer
Intervention Other: Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Other Name: The patient-centered approach
Study Groups/Cohorts
  • Training
    Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
    Intervention: Other: Training
  • Control
    General Practitioners not using the patient-centered approach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 2, 2019)
274
Original Actual Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 50 to 74,
  • Residing in the regions of Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrenees, Poitou-Charentes, and Provence-Alpes-Côte-D'azur,
  • Registered on the AMELI file of general practitioners participating in beginning of the study, before the training (ie the patients who have declared as a doctor one of the participating general practitioners).
  • Affiliation to the general social security scheme

Exclusion Criteria:

  • Patients excluded from screening for medical reasons (colorectal cancer or symptoms such as presence of red or black blood in the stool, other pathologies in non-priority treatment and screening)
  • Patient having performed a Hemoccult® test / test immunological test for less than 2 years or had colonoscopy for less than 5 years.
  • Patient who has declared as a treating physician one of the participating physicians for the duration of the study.
  • Patient who did not consult for the duration of the study
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03938623
Other Study ID Numbers 2016IAN913
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Collège de la Médecine Générale, France
Study Sponsor Collège de la Médecine Générale, France
Collaborators National Cancer Institute, France
Investigators
Principal Investigator: AUBIN-AUGER M ISABELLE, MD, Pr COLLEGE DE LA MEDECINE GENERALE
PRS Account Collège de la Médecine Générale, France
Verification Date April 2019

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