Please select the eligibility criteria that correspond to the clinical trial below.
Title: Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
Brief Summary: In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.


Options:
A: Inclusion Criteria:

Population to be studied

The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.

Inclusion Criteria:

1. Diagnosis of COPD confirmed by all of the following:

   1. FEV1/FVC \< 0.70
   2. FEV1 \< 80%
   3. Age \> 40 years
   4. A current or past history of cigarette smoking (\> 10 pack-years)
2. COPD hospitalization in the previous year
3. Receives care at participating VA medical center

   1. Enrolled in either primary care or pulmonary clinic at the VA
   2. Seen at least once in the past year in either primary care or pulmonary clinic
4. No COPD exacerbations in last 4 weeks
5. English-speaking
6. Access to telephone

Exclusion Criteria:

1. Primary clinical diagnosis of asthma
2. Medical conditions affecting the ability to participate in the study such as:

   1. Comorbid illness likely to limit life expectancy \< 1 year
   2. Decompensated heart failure
   3. Dementia
   4. Uncontrolled psychiatric illness
3. Participation in another clinical intervention trial in the previous 30 days
B: Inclusion Criteria:

One or more of the following:

* Hospital admission for COPD within the prior year
* Unscheduled visit for COPD within the prior year
* Home oxygen use for COPD
* Systemic steroid use for COPD within the prior year
* Post bronchodilator FEV1 \< 70% predicted
* Post bronchodilator FEV1/FVC \< 70% predicted

Exclusion Criteria:

* Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to \< 1 year
* Inability to contact patient by telephone
C: Inclusion Criteria:

* post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio \< 70%
* age \> 40 years
* complaints of chronic cough
* smoking history of more than 20 years or 15 pack-years
* diagnosis of COPD as major functionally limiting disease and
* current use of bronchodilator therapy.

Exclusion Criteria:

* primary diagnosis of asthma
* primary diagnosis of cardiac disease
* presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
D: Inclusion Criteria:

* Registered in one of the general practices participating in the study
* Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
* Age ≥35 years
* Willing to provide written informed consent

Exclusion Criteria:

* Very poor prognosis with regard to respiratory condition (GOLD stage IV)
* Severe co-morbid conditions with a reduced life expectancy
* Unable to communicate in the Dutch language
* Objections to one or more of the disease management modes in the study

Answer: D