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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03350776
Other study ID # CHUBX 2016/31
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2018
Est. completion date October 30, 2019

Study information

Verified date June 2020
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several stakeholders are implied in cancer care pathways and there is a need for coordinating their actions. New occupations of care coordination have thus emerged. However, the conditions of their efficiency have been too few reported and included discrepancies between reports. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes to professionals, patients and caregivers representations.


Description:

Several stakeholders are implied in cancer care pathways and there is a need to coordinate their actions. New occupations of care coordination have thus emerged, such as nurse coordinator in France (IDEC: Infirmière de Coordination). However, the conditions of their efficiency are not well known. Moreover, several other complementary approaches and nurse occupations have to be identified because of their contribution to care coordination (IDE TAS, IPO, IDE AMA, IDE-CO, IDE HAD-CAD, IDE ETP)*. Finally, all together, these interventions of care coordination appeared as complex and asked for a theoretical model. Because of this high variability of the practices, without an underlying model, the impact of care coordination on patient quality of life, safety and efficiency of care is difficult to assess. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations.

The pilot observational study is based on three distinct stages: (1) the definition of care coordination in oncology using a literature review and a Delphi consensus study; (2) the description of practices, contexts, perceptions and attitudes related to care coordination occupations in oncology using a qualitative and a cross-sectional quantitative survey; (3) the comparison of the practices to the theoretical model to propose a modeling of care coordination occupations in oncology.


Recruitment information / eligibility

Status Completed
Enrollment 960
Est. completion date October 30, 2019
Est. primary completion date October 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For health institutions: public or private institutions in which nurses contributing to care coordination. Each institution will be associated with one type of coordination occupation, even if other healthcare workers contribute to care coordination in the same institution.

- For professionals of care coordination: nurses contributing to care coordination in oncology (IDEC , IDE TAS, IPO, IDE AMA, IDE-CO, IDE HAD-CAD or IDE ETP)

- For professionals working with professionals of care coordination:

- Medical and non-medical healthcare professionals (oncologist, surgeon, nurses…), administrative professionals (secretary…), professionals of supportive care (psychologists, social workers…) and volunteers in patient organizations.

- Private practitioners: general practitioner, private nurses, pharmacist

- For the patients : adults under supervision of the selected professionals of care coordination for at least four weeks and able to express themselves

- For the caregivers: family caregivers of the selected patients.

Exclusion Criteria:

- For health institutions: private healthcare networks, territorial support platforms, home-based care providers, healthcare houses

- For professionals of care coordination: coordinating medical doctors of care networks, coordinating medical doctors of hospital care at home, practitioners of regional cancer networks.

- For the patients: <18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Care coordination
Care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations

Locations

Country Name City State
France Institut Sainte Catherine Avignon
France CHU de Bordeaux Bordeaux
France Clinique Tiivoli Ducos Bordeaux
France CH Sud Gironde Langon
France CH de Libourne Libourne
France Institut Curie Paris
France Institut de Cancérologie de la Loire Saint-Priest
France HAD Bagatelle Talence
France CHU de Toulouse Toulouse
France Institut Claudius Regaud Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modeling of care coordination in Oncology in France Constitutive elements of modelling of care coordination in oncology in France (qualitative analysis) During the whole period (36 months: from Month 1 to Month 36)
Secondary Care coordination profesionals quality of life Three scores : perceived organizational support, role conflict and commitment to the organization Quantitative cross sectional survey (from Month 10 to Month 29)
Secondary Satisfaction with care coordination for profes professionals working with professionals of care coordination Score of satisfaction Quantitative cross sectional survey (from Month 10 to Month 29)
Secondary Patients quality of life and satisfaction with care coordination Score of satisfaction and score of quality of life (measured with the European Organization for Research and Treatment (EORTC) quality of life questionnaire) Quantitative cross sectional survey (from Month 10 to Month 29)
Secondary Caregivers burden with care coordination Score of burdean (Zarit Burden Interview) with care coordination Quantitative cross sectional survey (from Month 10 to Month 29)
Secondary Caregivers satisfaction with care coordination Score of satisfaction with care coordination Quantitative cross sectional survey (from Month 10 to Month 29)