Please select the arm or intervention descriptions that belong 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: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: adherence to guideline; Type: OTHER; Interventions: Other: Implementation educational programme | Intervention Type: OTHER; Name: Implementation educational programme; Assigned to Arm(s): adherence to guideline
B: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Device: Electronic Monitoring with audio reminders and additional support | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Electronic Monitoring with audio reminders and additional support; Assigned to Arm(s): Intervention group
C: Arm Label: MF/F MDI 100/10 mcg BID with dose counter; Type: EXPERIMENTAL; Interventions: Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) | Intervention Type: DRUG; Name: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ); Assigned to Arm(s): MF/F MDI 100/10 mcg BID with dose counter
D: Arm Label: Health Coaching; Type: EXPERIMENTAL; Interventions: Behavioral: Health Coaching | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Health Coaching; Assigned to Arm(s): Health Coaching

Answer: A