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

November 19, 2018 updated by: University Hospital, Brest

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29200
        • Charles Yannick
      • Brest, France, 29200
        • Morvan Pierre-Yves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: COPD screening
Self-questionnaire with 5 questions Fagerström's test Spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2017

Primary Completion (Actual)

November 9, 2018

Study Completion (Actual)

November 9, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

April 1, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC17.0022 UNANIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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