Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00728442
First received: July 31, 2008
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

The objective of the study is to evaluate how the use of OncoDoc2, a computerized guideline-based decision support system, could improve the compliance of multidisciplinary staff meeting decisions with local clinical practice guidelines in the management of non-metastatic breast cancer.


Condition Intervention
Breast Cancer
Device: ONCODOC LOGICIEL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of the OncoDoc2 Decision Support System on Compliance of Multidisciplinary Staff Meeting Decisions With Clinical Practice Guidelines in the Management of Non-metastatic Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Compliance of multidisciplinary staff meeting (MSM) decisions with OncoDoc2 guideline-based recommendations at one year : MSM decisions are recorded on a weekly basis. [ Time Frame: Every week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance of actually administered treatments with OncoDoc2 recommendations at 18 months (treatments administration may last until 8 months after the therapeutic decision has been taken by MSMs) [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • typology of non-compliant reasons for both MSM decisions and treatments administration [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
  • patient profiles associated with non-guideline-compliant therapeutic decisions. [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Enrollment: 816
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
medical decision based on computerized guideline-based decision support system
Device: ONCODOC LOGICIEL
Introduction of a computer-based decision support system in the medical decision process
Other Name: ONCODOC LOGICIEL
No Intervention: 2

Detailed Description:

In France, to promote the quality of cancer care, decisions have currently to be made according to clinical practice guidelines (CPGs) during regularly organized multidisciplinary staff meetings (MSMs). Dissemination of textual CPGs has a poor impact on clinical practice as opposed to the use of clinical decision support systems (CDSSs) known to improve compliance with CPGs. OncoDoc2 is a CDSS providing patient-specific recommendations based on CPGs for non-metastatic female breast cancer management elaborated by the CancerEst INTERMEDICAL collaboration.The main goal of the study is to evaluate the effect of the routine use of OncoDoc2 during MSMs on compliance of MSM decisions with local CPGs. Impact will be measured by the compliance rate of MSM decisions with OncoDoc2 recommendations. The design of the study relies on a cluster randomized controlled trial. Under the assumption of a baseline compliance rate of 70% without intervention, an expected compliance rate of 90% in the intervention group (α = 5%, β = 20%), an inter-cluster variability of 5%, and 59 decisions per center, the required number of centers is 3 in each group, or 177 decisions in each arm. The study will be conducted in cancer care centers (public and private) from Paris area, France.This prospective trial will be conducted in two steps. First, baseline compliance rates will be measured in each center. Then, the 6 centers will be randomized into 2 arms. In the intervention arm, OncoDoc2 will be used during MSMs at decision time. Every case of non-adherence with system recommendations will have to be justified by clinicians. In both arms and after each MSM, MSM decisions will be recorded as well as patient characteristics and OncoDoc2 will be used for each patient case to get system recommendations. In the intervention arm, OncoDoc2 recommendations obtained by MSM will also be recorded, as well as the reason for non following recommendations in case MSM decision does not comply with guidelines.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non metastatic, including invasive and in situ, breast cancers as well as axillary cancer without breast tumor.
  • At least one therapeutic MSM decision.

Exclusion Criteria:

  • Breast disease without cancer
  • Metastatic breast cancer
  • Male breast cancer
  • Breast cancer cases when medical records are not accessible to investigators
  • Management but not therapeutic breast cancer decisions (diagnostic investigations, treatment follow-up, delayed decisions…)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728442

Locations
France
Service de gynecologie obstetrique, Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Serge UZAN, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00728442     History of Changes
Other Study ID Numbers: K 070603
Study First Received: July 31, 2008
Last Updated: September 2, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Clinical practice guidelines
Guideline adherence
Clinical decision support systems
Randomized controlled trial
Intervention study

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014