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Screening for COPD in Primary Care: a Synergistic Approach - Dentists - Pharmacists -Physiotherapists - Nurses - Physicians (UNANIME)

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ClinicalTrials.gov Identifier: NCT03104348
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

A recent French study conducted in the general population in the north, using more than 12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. If we consider the Finistère situation, the mortality data are unfavorable, with an excess of COPD mortality compared to the French average.

Compared to other frequent chronic conditions, such as high blood pressure or diabetes, the management of COPD may appear complex for at least two reasons:

  • Screening is difficult because of the banality of symptoms and the need for spirometry to confirm the diagnosis;
  • Comorbidities are masking the respiratory pathology; It is on this first point concerning the difficulty of screening that this project focuses.

It is true that the development of screening strategies for COPD has been the subject of numerous studies, the results of which are controversial. The target population of smokers over the age of 40, who are readily selected, is difficult to achieve as a whole because the use of care is far from homogeneous. Many people do not have a general practitioner.

Recent reviews of COPD screening do not recommend systematic screening for COPD in adults. However, they emphasize the feasibility of screening by questionnaire and / or portable spirometry. A selection of patients suspected of exacerbations (patients with at least one episode labeled "bronchitis") could increase the cost-effectiveness of screening by focusing on the most severe cases.

In France, the High Authority for Health (HAS), inspired by the work of the WHO (GOLD programs), offers a simple five-question questionnaire available online for all healthcare professionals in order to facilitate an indication of screening spirometry, where the proposed approach combines symptom identification with active smoking. General practitioners are in this first line of approach for the diagnosis: in fact, the HAS, in its guide of the "pathway of care of the patient COPD", recommends that the general practitioner can carry out the spirometric screening. The corresponding pulmonologist intervenes in this course by completing the explorations and optimizing the management, especially in patients with frequent exacerbations. This ideal scheme is hampered by the present practical organization, a minority of general practitioners (10%) practicing in multidisciplinary health centers, places where the organization of a functional respiratory measurement can be easier.

The current recommendations for smoking cessation allow the coding of this management. It is global, applicable in primary care. It proposes as a starting point the minimal advice, then associates medicines of assistance with the stop, cognitive-behavioral therapies and a prolonged follow-up of the patients after weaning. However, although these comprehensive management techniques are effective for smoking cessation, it is shown that they are underutilized in routine practice by health professionals with low patient participation rates. This is noticed, whereas the application of the minimum board alone would allow about 200 000 people to have access to weaning every year.

In a complementary way, the performance of a functional respiratory test in the active smoking patient has been proposed as a full-fledged tool for the weaning assistance process. Analysis of the literature, however, yields discordant results. Two recent studies have revived the debate: they highlight the potential of spirometry as a communication medium in the context of smoking cessation (using pulmonary age) by confronting patients with the discovery and understanding of their ventilatory disorder obstructive.

Finally, if other health care providers are invited to participate actively in screening, including pharmacists, their place in this screening strategy has been less valued. In particular, pharmacists and dentists are required to provide care to patients with little or no use of the general practitioner: screening for COPD among these patients deserves consideration. Similarly, nurses occupy a special place, being called in particular to carry out regular care of patients, both in their office and at home. The administration of injectable antibiotics in a context of exacerbation of unlikely COPD is a frequent care opportunity, which may include this more comprehensive approach. Finally, physiotherapists, who are increasingly trained in the concept of respiratory rehabilitation, are taking charge of other potentially COPD smokers for other pathologies.

Based on the willingness of Finnish actors to work on a COPD pathway with the help of the regional health agency, the investigators propose to question the respective place of health care professionals involved in primary care among potentially COPD patients: Dentists, nurses, general practitioners, physiotherapists and pharmacists


Condition or disease Intervention/treatment Phase
COPD Diagnostic Test: COPD screening Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for COPD in Primary Care: a Synergistic Approach - Dentists - Pharmacists -Physiotherapists - Nurses - Physicians
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : October 7, 2018
Estimated Study Completion Date : December 7, 2018

Arm Intervention/treatment
COPD screening Diagnostic Test: COPD screening
Self-questionnaire with 5 questions Fagerström's test Spirometry




Primary Outcome Measures :
  1. Effectiveness of a COPD screening procedure on primary care with a questionnaire and a measure with a micro-spirometer [ Time Frame: 2 months ]
    Evaluate the effectiveness of a COPD screening procedure in primary care with a questionnaire and an estimate of the FEV1 / FVC ratio by a micro-spirometer, in primary gare



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 40 years,
  • Smoking greater than 10 packs / year, active.
  • No previous diagnosis of COPD
  • Signature of informed consent

Exclusion Criteria:

  • Patients under 40 years of age
  • Previous of COPD diagnosis
  • Refusing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104348


Contacts
Contact: Christophe LEROYER, MD 298145008 ext +33 christophe.leroyer@chu-brest.fr
Contact: Christophe GUT-GOBERT, MD 298145008 ext +33 christophe.gut-gobert@chu-brest.fr

Locations
France
Charles Yannick Recruiting
Brest, France, 29200
Morvan Pierre-Yves Recruiting
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03104348     History of Changes
Other Study ID Numbers: 29BRC17.0022 UNANIME
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
COPD
Primary care