Soins intégrés BPCO (Broncho-pneumopathie Chronique Obstructive) en Valais - Mieux Vivre Avec ma BPCO (COPD Integrated Care Program Valais - Living Well With COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

COPD Integrated Care Program Valais - Living Well With COPD, a Pilot Study Assessing Feasibility, Acceptability and Effectiveness in the Canton of Valais, Switzerland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001922
• Other study ID #: COPD Integrated Care Valais
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: May 18, 2016
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: Centre Hospitalier du Centre du Valais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance.

Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais.

Design: The evaluation plan of this study will combine both quantitative (controlled before-after study design) and qualitative methods (focus groups with COPD patients and practicing healthcare professionals).

Setting: French-speaking part of the canton of Valais.

Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, non-institutionalized and residing in the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study.

Measures:

Quantitative part:

Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause hospitalizations (past 12 months)

Other outcomes:

1. Processes of care

2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument)

3. Measure of self-efficacy (intermediary outcome)

4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers

5. Healthcare utilization: unscheduled ambulatory care visits

6. Care satisfaction

7. Measures of the process of implementation of the intervention

Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals.

Description:

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance.

Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais.

Design: The evaluation plan of this study will combine both quantitative and qualitative methods. A controlled before-after study design will be considered for the quantitative part of the project, and the qualitative part will include the conduct of focus groups with COPD patients and practicing healthcare professionals.

Setting: French-speaking part of the canton of Valais.

Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, aged > 35 years, non-institutionalized and residing in the canton of Valais. Patients will be recruited by primary care and pulmonary care physicians practicing in the French-speaking part of the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients already included in the Swiss COPD cohort study.

Measures:

Quantitative part:

Primary outcomes: Generic and disease-specific health-related quality-of-life(Chronic Respiratory Questionnaire (CRQ), SF-36 and COPD Assessment Test (CAT)) and all-cause hospitalizations (past 12 months)

Other outcomes:

1. Processes of care (% patients having participated to self-management education sessions, % patients having received/used the action plan, % patients having received smoking cessation recommendations, % patients having received advices/participated to participate to pulmonary rehabilitation, % patients having received influenza immunization during the past 12 months, % patients receiving appropriate treatment, nb of consultations with primary care physician/pulmonary care physician/other, nb of contacts with the hotline)

2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument)

3. Measure of self-efficacy (intermediary outcome)

4. Health behaviors, symptoms and physical activity measures: 6-minutes walking test, nb of COPD exacerbations during past (past 12 months), % of current smokers

5. Healthcare utilization: unscheduled ambulatory care visits

6. Care satisfaction

7. Measures of the process of implementation of the intervention (nb of recruiting practices and physicians, nb of participating practices and physicians, nb of and patients, of drop-outs, satisfaction of healthcare professionals towards COPD program)

Qualitative part: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals, 12 months after the start of the recruitment.

Development and implementation of the intervention:

The development of the current COPD program in Valais is being implemented in collaboration with physicians working in private practices (family physicians and specialists), physiotherapists, pharmacists and nurse specialists. It will involve academic and public institutions, as well as practitioners. The program has been launched in March 2013, after a preliminary phase involving the conduct of focus groups. Their aims were to explore the needs and barriers to better care, as well as the shape of the targeted CDM elements for better implementation in real life, from the point of view of COPD patients and healthcare professionals.

The CDM intervention considered in the "Soins intégrés BPCO en Valais - Mieux vivre avec ma BPCO" program is based on the " Living well with COPD programme " developed by Prof. Bourbeau & al at McGill University, Montreal, Canada. The "Soins intégrés BPCO en Valais - Mieux vivre avec ma BPCO" program will include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, and promotion of pulmonary rehabilitation, physical activity as well as smoking cessation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD (GOLD stage 1-symptomatic to 4)

• Age >= 35 years

• Residing in the canton of Valais Switzerland, non-institutionalized

• Informed consent

Exclusion Criteria:

• Hospitalization during previous 4 weeks

• Pulmonary rehabilitation during past 18 months

• Estimated life expectancy < 12 months

• Obvious cognitive impairment

• Not speaking or understanding French well enough

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• COPD integrated care
The intervention will target COPD integrated care, and include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, promotion of pulmonary rehabilitation, physical activity and smoking cessation.

Locations

Country	Name	City	State
Switzerland	Centre Valaisan de Pneumologie, Centre Hospitalier du Centre du Valais	Crans Montana	Valais

Sponsors (8)

Lead Sponsor	Collaborator
Centre Hospitalier du Centre du Valais	Association des médecins de famille du Valais, Fondation Bangarter, Ligue pulmonaire valaisanne, Promotion santé Valais, Swiss National Science Foundation, Swiss School of Public Health (personal grant to Isabelle Peytremann-Bridevaux), University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy		12 months	No
Other	Healthcare utilization		12 months	No
Other	Care satisfaction		12 months	No
Other	Process of implementation of the intervention		12 months	No
Primary	Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))		12 months	No
Primary	All-cause hospitalizations (past 12 months)		12 months	No
Secondary	Processes of care, patient assessment of chronic illness care (PACIC)		12 months	No
Secondary	6-minutes walking test		12 months	No
Secondary	COPD exacerbations		12 months	No
Secondary	% smokers		12 months	No