Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.

Proportion of patients who initiate use of COPD Action Plan including starting exacerbation medications (i.e., antibiotics and/or prednisone) within 3 days.

Patient monitoring will be done using the SmartInhaler for Advair and Ventolin on a sample of subjects.

Self-efficacy will be measured using a scale from 0-10 asking patients to rate their level of confidence, 0= not confident at all, 10=very confident, based on the "Understanding COPD questionnaire" [Wilson 2007; O'Neill 2012] and the principles of self-efficacy scale design, according to the construct proposed by Bandura.Level of confidence will be rated with respect to: taking medications as prescribed; items that are behavior-specific related to recognition and appropriate management of exacerbation including ability to identify signs of deterioration and need to initiate the prescribed action plan. CAT- The COPD Assessment Test (CAT) is a simple and quick questionnaire to give a reliable measure of health status in COPD which will complement existing approaches and will assess impact of COPD and exacerbation on the health of individual patients [Jones P 2009; Jones PW 2009].

The Exacerbation Questionnaire provides detailed information about contacts with health care providers for both respiratory and non-respiratory problems including unplanned physician visits, Emergency Department, use and hospitalizations since the previous call. Program resources: Practice staff who assist with patient identification and chart review will be paid for their time on an hourly basis. Nurse case managers will keep records of all contact with patients (content, time spent); information on interaction between the nurse case manager and other providers (physicians, pharmacists, etc.) including type of call, who is making the call, duration and reason will be recorded.

We will closely monitor use (according to symptom changes from the daily diary), record all feedback related to utilization (patients' responses using keypad vs. question verified when case manager call back the patient) and algorithm with corresponding status (Well, Worse, Alarm).

Qualitative research is the most appropriate method to explore experiences of health care providers, practice staff, study staff and patients.39 We will conduct group and individual interviews with the case manager, physicians, nurses and staff at each site. We will also interview a random sample of patients.

Information on age, sex, education, employment, marital status, living alone, BMI, weight/height, exacerbations, co-morbidities, and health resource utilization will be gathered from a questionnaire that patients complete at baseline. Smoking status will be queried and smokers will be classified as current, ex or never smoker as well and cumulative pack-years will be estimated.

The Charlson index40;41 a widely used indicator of comorbid conditions, will be calculated for each participant. A complete list of comorbidities will be extracted by study staff at baseline from the patient's medical chart, as well as from patient recall at the baseline visit. The global score ranges from 0 to 33, highest scores indicating more comorbidities, and was shown predictive of mortality in COPD.

Dyspnea will be evaluated using a 5-grade Medical Research Council (MRC) dyspnea scale.

will be done according to stringent standards. Disease severity is categorized according to the GOLD classification. Measures will be obtained at baseline and end of treatment by the research coordinator.

The Patient Health Questionnaire-9 (PHQ-9) [Kroenke K, J Gen Intern Med 2001] will be used to assess and monitor depression, together with the Generalized Anxiety Disorder (GAD-7), a 7-item scale. The GAD-7 has also proved to have good sensitivity/specificity to screen for panic, social anxiety and post-traumatic stress disorder [Spitzer RL, Arch Intern Med 2006].