Table 1 Description of study outcomes and corresponding hypotheses evaluated by the clinical trial

Primary outcome

(outcome 1)

Prescription appropriateness

The clinician prescription will be considered concordant if it is the same as the prescription based on the ACCEPT recommendation (or if ACCEPT suggests more than one eligible prescription, the clinician prescription is one of them); otherwise, it will be considered discordant

Reduction in under- and overtreatment

Reclassifying individuals from high to low risk will avoid expensive therapies in patients who will not benefit from them, while reclassification from low to high risk will result in more intense therapies that will reduce exacerbation risk

Outcome 2

Medication adherence

Medication adherence will be assessed in two ways: (a) using the medication possession ratio and (b) self-reported medication adherence. (a) Medication possession ratio is defined as the ratio of the total days’ supply dispensed to the total days’ supply prescribed during the study period. (b) Self-reported adherence will be assessed using the COPD-specific beliefs about Medicines Questionnaire (BMQ) [31]. The COPD BMQ is a 15-item scale with 2 subscales assessing patients’ perceptions of their need for medicine and concerns regarding medicine

Higher adherence of patients to treatment recommendations

We hypothesize that accurate risk communication will improve the adherence of patients to the recommended treatment [32, 33]

Outcome 3

Rate of moderate/severe exacerbations

Moderate exacerbations: Any outpatient physician visit for COPD followed by filling prescriptions for antibiotic or oral corticosteroids

Severe exacerbations: A hospital admission with the main discharge code of COPD

Change in rate of moderate/severe exacerbations

The departure from guideline-base care is a mixture of over- and undertreatment, and the proposed intervention is likely to reduce such departure from guidelines. Correcting undertreatment will reduce exacerbation rate, while correcting overtreatment will not materially change the rate, resulting in a net-reducing effect. In addition, improving adherence will further reduce exacerbations

Outcome 5

Impact of COPD on health status

Measured by the COPD Assessment Test (CAT) [34]. The CAT includes 8 questions scored from 0 to 5, with higher scores indicating more severe impact of COPD

Improved health status

Patient-reported outcomes are likely to be affected by a quality-improvement intervention that involves addressing low health literacy and inaccurate medication beliefs [35]

Outcome 6

Quality of life

Euro Quality of Life-5 Dimensions (EQ5D). The EQ5D is a standardized questionnaires that assess 5 dimensions of health status, each at 3 distinct levels [36]. These data will be used to track changes in patient-report quality of life over the duration of the study

Improved quality of life

Patient-reported outcomes are likely to be affected by a quality-improvement intervention that involves addressing low health literacy and inaccurate medication beliefs [35]

Outcome 7

Smoking cessation

Measured by the following questions

1. Smoking status will be assessed by asking, “Do you currently smoke cigarettes” (yes/no)?

2. Motivation to quit will be assessed using the motivation to stop smoking (MTSS) scale [37]. Participants will be asked to classify themselves into one of the following six stages: (a) I do not want to quit smoking, (b) I think I should stop smoking but do not really want to, (c) I want to stop smoking but have not thought about when, (d) I REALLY want to stop smoking and intend to in the next 3 months; (e) I want to stop smoking and hope to soon, (f) I REALLY want to stop smoking and I hope to in the next month

3. Nicotine dependence will be assessed using the Fagerström test [38]—a questionnaire made up of 7 questions, the first scored as 0 and 1 (yes/no), and the remaining 6 multiple-choice questions scored from 0 to 3. The total test score ranges from 0 to 10, with higher scores indicating more intense physical dependence on nicotine

4. Cessation methods will be assessed by asking: Which of the following methods have you tried in the last 6 months (check all that apply): (a) nicotine replacement therapy, (b) cold turkey, (c) Champix®, (d) bupropion (Wellbutrin or Zyban), and or (e) behavioral support (e.g., smokers help line, cessation support group, cessation website, smartphone app)

Improved lifestyle behaviors

While smoking cessation is recommended for all current smokers with COPD, very few are offered such an intervention. Studies have suggested that even a brief intervention can be effective on reducing exacerbation rates [39]