Fact CheckerSign in

NCT07907601Not yet recruiting

Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.

Evaluation of the Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway. A Prospective Monocentric Randomized Controlled Pilot Study

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

In 2020, chronic obstructive pulmonary disease (COPD) was the 4th leading cause of death worldwide. In France, its annual cost was estimated at 4366 euros per patient, including 25% related to management of exacerbations and 33% to hospitalization. In 2014, the prevalence of COPD in France was estimated at 7.5% of the population. Projections of the epidemiological evolution of COPD systematically predict an increase in the prevalence of moderate to very severe COPD, notably due to an increase among women and subjects aged ≥ 75 years. Management of COPD patients is multi-dimensional and multi-professional. In January 2020, the French National Authority for Health (HAS) issued recommendations for comprehensive management of COPD, including smoking cessation, influenza and pneumococcal vaccinations, therapeutic training on the use of inhalation devices, and pulmonary function tests. In 2022, the French health insurance scheme also measured quality indicators to assess the care pathway for COPD patients. Among these indicators, two concerned the care of stable patients: influenza vaccination, performed on only 52.7% of patients, and PFT or annual spirometry in 34.2% of patients. Indicators concerning post-hospitalization follow-up were also deemed insufficient, with only 41.9% of patients receiving medical follow-up within 7 days of hospitalization for COPD exacerbation, and 30.9% receiving follow-up by a pulmonologist within 60 days. Recently, in 2023, an observational study was conducted at Nîmes University Hospital, and is currently under review for publication. The study aimed to assess the profile of hospitalized COPD patients, as well as compliance with HAS recommendations. Of the 85 patients included, 59 (69.5%) had a COPD-VQ-11 score ≥ 22, reflecting poor COPD-related quality of life, and 30 (35.3%) were not followed by a pulmonologist. Twenty-five patients had not stopped smoking (32.9%), and pneumococcal vaccination coverage was only 34% (10% in patients not followed by a pulmonologist).Thanks to their daily presence and expertise in care departments, hospital clinical pharmacists can do targeted interventions tailored to individual patients. For example, during a hospital stay they can identify shortcomings in the care of certain chronic diseases and, if necessary, intervene with the patient or the care team. Clinical pharmacists can also take part in day hospitalizations (DHs) by doing pharmaceutical consultations with patients. Since 2021, a respiratory insufficiency DH has been set up at Nîmes University Hospital. This DH, coordinated by an advanced practice nurse (APN), enables multi-professional reassessment of the care of COPD patients, and targeted interventions such as PFTs or stress tests, vaccination prescriptions, help with quitting smoking and training on the use of inhalation devices. Based on these findings, and using the tools and resources available at Nîmes University Hospital, the aim is to evaluate the impact of a structured, multi-disciplinary care process for hospitalized COPD patients, focusing on changes in their quality of life, a reflection of their state of health, as well as on their care pathway. The hypothesize is that this targeted intervention will improve patients' COPD-related quality of life, and reduce mortality, exacerbations, hospitalizations, cardiovascular events, emergency room visits and consultations with general practitioners. This intervention could also improve smoking cessation and vaccination coverage. Finally, the medico-economic efficiency of this process will be assessed via a cost-utility analysis. The national supply of care for certain chronic diseases is currently limited and saturated, leading to difficulties in management and medical follow-up, and resulting in an unfavorable trend in patients' state of health. This study aims to repond to that problem, focusing on COPD, to assess the feasibility and effectiveness of a structured, multidisciplinary care concept hitherto never implemented in this region. Such an approach could make it possible to detect patients suffering from chronic diseases not only like COPD, but also heart failure or diabetes, and optimize their care through interventions and the organization of a dedicated care pathway. This care would be based on the various clinical pharmacy missions carried out during the hospital stay, and the deployment of optimized DH pathways for high-performance global care. This pilot study aims to obtain the initial indicators required to set up future comparative multicenter studies with a high level of evidence on efficacy and costs.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
116 (estimated)
First submitted
26 Oct 2026
Start date
1 Nov 2026
Primary completion date
30 Nov 2027
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Diseases
COPD
NCT number
NCT07907601

What you commit to

  • Study type: Interventional
  • Planned participants: 116
  • From 1 Nov 2026 to the primary completion date, 30 Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients taking part in an interventional drug study.

Other illness

  • Cancer patients undergoing chemotherapy or palliative care.

Lab values

  • Patients with heart failure and LVEF \< 30%.

Other

  • Patients hospitalized in the Pneumology Department.
  • Patients hospitalized for COPD exacerbation.
  • WHO stage 4 patients.
  • Patients in an exclusion period determined by another study.
  • Patients under court protection, guardianship or curatorship.
  • Patients unable to give consent.
  • Patients for whom it is impossible to provide information.
  • Pregnant or breast-feeding patients.

Who the study is looking for

  • Patients with COPD. A patient will be considered to have COPD if he or she meets all the following criteria: 1) active or former smoker \> 1 packet per day for 10 years; 2) history of COPD mentioned in the medical record; 3) treated with at least one inhalation device.
  • Patient hospitalized at Nimes University Hospital (besides the Pneumology department).
  • Patients not benefiting from a regular pneumology follow-up (i.e. less than one visit per year).
  • Patients able to self-manage his/her COPD.
  • Patients with a life-expectancy of at least 12 months.
  • Affiliated person or beneficiary of a social security scheme.
  • Free, written, informed consent signed by the participant and the investigator.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nîmes University Hospital
Coordinator of this site? Confirm its status
NîmesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.