NIV for COPD: Hospital to Home
NIV for COPD: Hospital to Home
This is a pilot study to evaluate the impact of providing patients admitted with acute
 exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to
 discharge on hospital readmission rates and other secondary outcomes.

 Aim 1 To test whether continuation of NIV at home after being initiated during
 hospitalization for AECOPD improves subsequent admission-free survival in patients with
 chronic hypercapnic respiratory failure secondary to COPD

 Hypothesis 1: The use of targeted NIV during hospitalization with continuation upon discharge
 to home will improve one-year all-cause mortality as compared to published mortality in the
 current literature.

 Hypothesis 2: The use of targeted NIV during hospitalization with continuation upon discharge
 to home will reduce readmission rates for AECOPD within-institution historical data.

 Aim 2 To evaluate the feasibility of a larger multisite randomized controlled trial in
 veterans using inclusion and exclusion criteria specified in this pilot.

 Outcomes

 Primary: Event-free survival (re-hospitalization for AECOPD, time to readmission for AECOPD,
 and all-cause mortality)

 Secondary:

 1. Unplanned readmission rates (all complications)

 2. Time to readmissions for admissions other than AECOPD.

 3. Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at
 Baseline, 6 and 12 months

 4. Pulmonary function (handheld spirometer or in-laboratory based on specific institution
 resources) at Baseline, 6, and 12 months 5.6 minute walk test at Baseline, 6,and 12
 months

 6.Health related quality of life (HRQOL) measured by the St. Georges respiratory
 questionnaires (SGRQ) at Baseline, 1,3,6,9 and 12 months 7.Adherence to NIV at Week 1-2,
 Months 1,3,6,9 and 12 8.Sleep assessed by type 3 portable monitors 9.Sleep assessed by
 questionnaires: Insomnia severity index (ISI), Epworth Sleepiness Scale (ESS), Pittsburgh
 Sleep Quality Index (PSQI), Functional Outcomes of Sleep Short Form (FOSQ-10) at Baseline,
 1,3,6,9 and 12 months 11.Utilization of healthcare services (number of visits to outpatient
 clinics and emergency services, number of inpatient admissions)
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality
 worldwide, with the economic and social burden of disease anticipated to increase annually.
 Acute exacerbations of COPD (AECOPD) are associated with significant in-hospital mortality
 (6-8%), high readmission rates (60-80%), and even more dramatic 1-year mortality (23-49%).

 The use of non-invasive ventilation (NIV) has been extensively evaluated in both patients
 with stable disease in the home setting and in AECOPD during hospitalization. It is widely
 accepted that NIV used during AECOPD in the inpatient setting reduces rates of endotracheal
 intubation, as well as length of ICU and hospital stay. Long-term use of NIV, particularly at
 higher pressures, in the home setting in COPD patients with evidence of chronic compensated
 respiratory acidosis (PaCO2 >45mmHg) decreases elevated PaCo2 and serum bicarbonate levels,
 improves pulmonary function, and improves quality of life. Little is known about whether
 patients initiated on NIV during an AECOPD and subsequently transitioned to long-term home
 NIV on discharge demonstrate reduced AECOPD rates, readmission rates, or differences in
 morbidity and mortality. The few existing randomized trials aimed at this patient population
 suffer from criticisms of lack of power, varying degrees of patient symptoms, conflicting
 results, and inconsistent approaches in NIV strategies. Nonetheless, this is an important
 population to address, as AECOPD frequently leads to accelerated loss of lung function
 (pre-AECOPD function not recovered), decreased quality of life (QOL), more frequent
 exacerbations, and higher overall mortality. If NIV can minimize the loss of lung function
 during the transition period following AECOPD, QOL, physical activity tolerance, readmission
 rates and overall mortality may improve.

 Economic analyses of the use of NIV in patients with AECOPD transitioning from the inpatient
 to home setting are also sparse, but of high value as healthcare transitions toward bundled
 payments and penalties for readmissions. This pilot study seeks to better inform the
 literature on the role of NIV initiated during inpatient AECOPD and continued long-term
 following discharge home in patients with chronic hypercapnic respiratory failure due to
 COPD. The investigators hypothesize that the use of NIV during acute inpatient treatment of
 AECOPD followed by continuation of NIV therapy long-term at home will improve admission free
 survival, improve quality of life, reduce 1-year exacerbation rates, and reduce 30d
 readmissions.

 This is a prospective 1-year interventional pilot study that will occur at 4 Veterans Affairs
 (VA) hospitals (Sacramento, Durham, Pittsburgh, and San Francisco).

 The total enrollment goal across all sites is 50. Total study period expected includes an
 enrollment period of approximately 10-12 months and follow-up period of 12 months for a total
 study duration of approximately 2 years.
Inclusion Criteria:

 1. Admission for acute hypercapnic respiratory failure requiring mechanical ventilation
 or NIV

 2. Resolution of acute respiratory failure reflected by normalization of pH and downgrade
 of clinical status to ward or floor status.

 3. Severe COPD defined by GOLD stage 3 (FEV1 30-50%) or 4 (FEV1 < 30%) OR GOLD C or D.
 Pulmonary function tests (PFTs) done within 3 years preceding admission are acceptable
 to document an obstructive ventilatory defect and decrease diffusion capacity
 consistent with emphysema and COPD. If no PFTs are available, bedside spirometry will
 be performed to confirm COPD.

 4. Chronic compensated respiratory acidosis based on PaCO2 >52 adjusted for pH 7.40, on
 pre-admission laboratory values or after resolution of acute respiratory failure.

 5. Able to consent without surrogate and complete all required study visits.

 Exclusion Criteria:

 1. Moderate or severe obstructive sleep apnea (OSA), apnea-hypopnea index (AHI) >15/h.
 Sleep testing done within the prior 3 years with no increase in body mass index (BMI)
 >2kg/m2 or major change in cardiopulmonary conditions (new reduced ejection heart
 failure [HFrEF], atrial fibrillation [AFib], opioid use with morphine dose equivalent
 (MDDE) >120mg, or cardiothoracic surgery for lung resection or coronary artery bypass
 grafting) will be accepted for AHI severity.

 2. BMI>35 kg/m2

 3. Congestive heart failure (HFrEF, EF< 45%)

 4. Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal
 cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis,
 chest wall restrictive ventilatory defect

 5. Lack of stable housing, homelessness, or unreliable electricity source in home
 environment.

 6. Use of NIV at home within past three months

 7. Failure to tolerate NIV during initial hospitalization

 8. Unable or unwilling to comply with the protocol

 9. Age <18 years

 10. Inability to consent due to limited cognitive capacity

 11. Pregnancy