Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #560 - Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (BREATH)
Brief Summary: EXECUTIVE SUMMARY:

Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.

Hypotheses:

Primary Hypothesis:

Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.

Primary Objective:

In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.

Secondary Hypotheses:

Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.

Secondary Objectives:

To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:

A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures

1. Mortality
2. Health-related quality of life measured by generic and COPD-specific measures
3. Patient satisfaction
4. Medication adherence
5. Disease knowledge, skill acquisition and self-efficacy

In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.

The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.


Options:
A: Inclusion Criteria:

* 18 years of age or older
* Utilize a pharmacy in Durham, Robeson, Person, Granville, or Vance County, NC
* Have coronary artery disease (CAD) documented in the medical record by one of the following:

  1. A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)
  2. A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)
  3. Prior angioplasty
  4. Prior coronary artery stent
  5. Prior coronary artery bypass graft surgery (CABG)
* Plan to have their prescription medications filled and refilled by one of the participating pharmacies
* Prescribed aspirin or another antiplatelet, a beta-blocker and statin agent (referred to as triple therapy for this study) at discharge. If a patient has a true contraindication to any of the three medication groups in triple therapy, they will still be eligible for the study

Exclusion Criteria:

* Providers predict an anticipated hospital stay of less than 48 hours
* Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC
* Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
* Patient transferred to Cardiothoracic Surgery service for CABG
* Patient has terminal condition and may not survive until 6-month follow-up
* Patient lives in a correctional or long-term care facility
* Patient will be unable to participate in follow-up phone call (hearing impaired without caregiver who can help or does not have a phone)
* Patient is a known participant in the Duke Heart Failure Program
* Patient does not agree to use only the one Durham, Robeson, Person, Granville, or Vance County pharmacy throughout the study period
B: Inclusion Criteria:

* People 70 years of age or older
* Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification of Diseases (ICD-10) codes with an estimated duration of 6 months or more or based on a clinical decision
* Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days.
* In inpatient: Estimated minimal length of stay within the cluster is sufficient to apply the intervention
* If outpatient: prescribing physician has GP function and has a planned appointment to conduct intervention

Exclusion Criteria:

* Inability to provide informed consent or to obtain informed consent from a proxy for patients with cognitive impairment
* Direct admission to palliative care (\< 24h after admission)
* Has passed or will pass a systematic structured drug review during this hospitalisation or within the last two months
C: 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
D: Inclusion Criteria:

* Primary care provider is participating in trial
* Are an adult (≥ 18 years) with type 2 diabetes
* English speaking
* Recognize their primary care provider as their main diabetes care provider
* Declare being available for follow-up for six months after treatment decision

Exclusion Criteria:

- Have major barriers to provide written informed consent and to participate in shared decision making (i.e., severe vision or hearing impairment, cognitive impairment, non-English speaking)

Additional Inclusion Criteria for Diabetes Medication:

* Have a clinical diagnosis of type 2 diabetes for one year or more (c-peptide test is not required)
* Use 0, 1, or 2 oral hypoglycemic agents at maximum doses
* Have stable but inadequate glycemic control or worsening glycemic control as identified by their most recent HbA1c measure (within 12 months of the time of eligibility over 7.3%
* Be identified by provider as a medically-appropriate candidate for diabetes medications, (i.e., have not contraindications to taking the medications, e.g., allergy).

Additional Exclusion Criteria for Diabetes Medication:

- Use insulin therapy.

Additional Inclusion Criteria for Cardiovascular Medication:

* Have a clinical diagnosis of type 2 diabetes for any duration (c-peptide test is not required).
* Be identified by provider as a medically-appropriate candidate for statins, (i.e., have not contraindications to taking the medications, e.g., allergy).

Additional Exclusion Criteria for Cardiovascular Medication:

- Use a statin currently.

Answer: C