Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tailored Implementation for Chronic Diseases.
Brief Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.


Options:
A: Inclusion Criteria:

* patients with diagnosed COPD via the medical records with code J44

Exclusion Criteria:

* terminal illness
* cognitive impairments
B: Inclusion:

* Aged 18 years or older
* Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
* Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) \[46\] and
* Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
* Had at least one exacerbation in the previous 12 months before study start
* With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)

Exclusion:

* Suffering from malignancies and/or other severe diseases
* Insufficient in the German language
* Pregnant or lactating
C: Diagnosis and Criteria for Inclusion:

* A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months.
* A participant must have been able to demonstrate correct use of an MDI without a counter at the Screening Visit.
* A participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week Screening Period.

Exclusion Criteria:

* Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
* Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.
D: Inclusion Criteria:

* Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
* Age 40 and older
* Speaking English or Spanish
* Plan to continue to be seen at current clinic and to not leave the area for \>2 months anytime in the next 9 months or to be absent at 9 or 15 months
* COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \<.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
* Willingness to attempt spirometry
* At least moderate COPD, defined as at least one of the following:

  * Ever Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted
  * 1 or more emergency department (ED) visit for COPD exacerbation in past 12 months
  * 1 or more hospital stays for COPD exacerbation in past 12 months
  * 1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12 months
  * Ever on home oxygen therapy
  * Ever outpatient percutaneous oxygen saturation of \</=88%
  * Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of \</=55mm Hg
  * At least 3 outpatient visits for COPD in past 12 months AND (a current COPD Assessment Test (CAT) score of \>/=10 OR an modified Medical Research Council (mMRC) score of \>/=2).
  * Currently using tiotropium inhaler or combination inhaled corticosteroid and long-acting beta agonist

Exclusion Criteria:

* Unable to participate in the study due to mental or physical impairment
* Severe or terminal illness that precludes focus on COPD
* No phone

Answer: A