A pragmatic stepped intervention cluster randomized trial

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A pragmatic stepped intervention cluster randomized trial V-CAPS Vietnam COPD, Asthma and Prevention of Smoking An integrated health-sector strategy to combat COPD and asthma in Vietnam A pragmatic stepped intervention cluster randomized trial https://www.vcaps-study.com

Aim Objectives Aim & objectives Current status Milestones Challenges Aim Improve management of chronic lung disease and reduce smoking rates among patients and healthcare workers within government health facilities Objectives Evaluate the effectiveness of a COPD/asthma management intervention upon reducing exacerbations of COPD or asthma Evaluate the effect of a health system smoking cessation intervention upon the rate of sustained abstinence among smokers V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Baseline data collection finished Current status Aim & objectives Milestones Challenges Evaluates the clinical characteristics of patients with chronic lung disease and smoking, and current practices within the health system to manage these conditions Baseline data collection finished and two cohorts expected to complete follow-up in December 2019 V-CAPS1 Phase 2 planning workshop Inaugural meeting V-CAPS3 V-CAPS4 V-CAPS2 Characterising the current practices and attitudes regarding disease management and tobacco control, which includes both qualitative interviews of stakeholders and a health facility-wide assessment of tobacco control practices Baseline data collection finished V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Current status V-CAPS1 V-CAPS3 V-CAPS4 V-CAPS2 Phase 2 planning Aim & objectives Milestones Challenges Pilot study to test the feasibility of COPD/asthma management intervention and health system smoking cessation intervention The study will start shortly at 3 district hospitals in Hanoi V-CAPS1 Phase 2 planning workshop Inaugural meeting V-CAPS3 V-CAPS4 V-CAPS2 2*2 factorial cluster randomized controlled trial to assess the effectiveness of the two interventions The study will commence mid 2019 in 4 provinces V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones V-CAPS1 1,404 patients in baseline full survey (Men: 76.2%) Aim & objectives Current status Challenges V-CAPS1 V-CAPS2 V-CAPS3 V-CAPS4 Baseline data: COPD/Asthma among patients presenting to health facilities 1,404 patients in baseline full survey (Men: 76.2%) 974 with respiratory symptoms (Men: 65.7%) V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones Aim & objectives Current status Challenges V-CAPS1 V-CAPS2 V-CAPS3 V-CAPS4 Baseline data: COPD/Asthma among patients presenting to health facilities V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones V-CAPS1 7,954 patients aged ≥ 15 enumerated (Men: 48.7%) Aim & objectives Current status Challenges V-CAPS1 V-CAPS2 V-CAPS3 V-CAPS4 Baseline data: smoking behaviours among patients presenting to health facilities 7,954 patients aged ≥ 15 enumerated (Men: 48.7%) 1,404 participated in baseline full survey (Men: 76.2%) V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones Aim & objectives Current status Challenges V-CAPS1 V-CAPS2 V-CAPS3 V-CAPS4 Baseline data: smoking behaviours among patients presenting to health facilities V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones Aim & objectives Current status Challenges V-CAPS2 V-CAPS1 V-CAPS3 V-CAPS4 Baseline data: attitudes and health-seeking behaviour Baseline data: among patients who have a diagnosis of COPD or asthma Patients came to various healthcare facilities, back and forth, before diagnosed with COPD/asthma at provincial or national level Lack of following up after the acute treatment at the facilities without COPD program Lack of awareness of the medicines prescribed Inconsistent referral mechanism among the facilities Lack of affordability of outpatients with health insurance V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones Aim & objectives Current status Challenges V-CAPS2 V-CAPS1 V-CAPS3 V-CAPS4 Baseline data: smoking behaviours among healthcare workers (n = 2,757) V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones V-CAPS3 Pilot study to test the feasibility of Aim & objectives Current status Challenges V-CAPS3 V-CAPS1 V-CAPS2 V-CAPS4 Pilot study to test the feasibility of (a) COPD/asthma management intervention (b) Health system smoking cessation intervention 3 district clinics in rural Hanoi Under development and ethics approval Expected to implement soon V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones Aim & objectives Current status Challenges V-CAPS4 V-CAPS1 V-CAPS2 V-CAPS3 2*2 factorial cluster randomized controlled trial to assess the effectiveness of (a) COPD/asthma management intervention (b) Health system smoking cessation intervention 40 district clinics in 4 provinces Hanoi, Thanh Hoa, Ho Chi Minh City, and Ca Mau Expected to commence in mid 2019 V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Patients recruited for COPD/asthma management intervention Milestones Aim & objectives Current status Challenges V-CAPS3 V-CAPS4 V-CAPS1 V-CAPS2 Proposed COPD/asthma management intervention Patients recruited for COPD/asthma management intervention Step 1. (a) As-needed budesonide/formoterol (b) Respiratory disease management plan Poor control at follow-up OR Acute exacerbation Step 2. Maintenance budesonide/formoterol As-needed budesonide/formoterol (c) Respiratory disease management plan Poor control at follow-up OR Acute exacerbation Step 3. Refer to specialist care for further assessment V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Milestones V-CAPS3 V-CAPS4 Aim & objectives Current status Challenges V-CAPS3 V-CAPS4 V-CAPS1 V-CAPS2 Proposed health system smoking cessation intervention Implementation of smoke-free hospital policy Initial brief smoking cessation advice by staff Smoking cessation materials provided at baseline Follow-up: integrating phone call and two-way text message system V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

Study approval by Ministry of Health Challenges Aim & objectives Current status Milestones Study approval by Ministry of Health The government approval through the MOH has introduced some delays. We have collaborated with key agencies to enable the MOH to proceed with this process as quickly as possible. Insurance coverage We are working with the Vietnamese government to add inhaled medications to the public health insurance subsidy list at a local level. This will be essential for the interventions to be scaled up following the study. V-CAPS Vietnam COPD, Asthma and Prevention of Smoking

A pragmatic stepped intervention cluster randomized trial V-CAPS Vietnam COPD, Asthma and Prevention of Smoking An integrated health-sector strategy to combat COPD and asthma in Vietnam A pragmatic stepped intervention cluster randomized trial https://www.vcaps-study.com