Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

Pennsylvania Study of Chronic Obstructive Pulmonary Exacerbations (PA-SCOPE)

The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

• Overall objective: To determine why African American and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for COPD-and to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention--access to a 1-800 Temple Call Center phone number where patients can get immediate customized advice on managing COPD exacerbations in their early stages.
• Phase 1: To compare and contrast the influence of race and geographic location in COPD exacerbation in relation to severity, comorbidities, treatment patterns, infection rate. To identify potential risk factors for COPD exacerbations leading to hospitalization.
• Phase 2: To reduce hospitalizations and deaths due to COPD exacerbations and to improve patient quality of life, lung function, and everyday activity levels

• Study Type: Observational
• Enrollment (Actual): 1066

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Phase 1: inpatients hospitalized for COPD exacerbations Phase 2: Moderate to severe COPD

Description

Inclusion Criteria:

• Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation

• Phase 1 & 2: COPD & ONE of the following criteria:

  1. History of hospitalization for COPD exacerbation, OR
  2. Currently on supplemental oxygen, OR
  3. History of evaluation for lung transplant or LVRS, OR
  4. >/= 6 months post-LVRS

• Phase 1 or 2:

  1. Current or former smoker, >/= 20 pack-yr. smoking history
  2. FEV1 </= 70%; FEV1/FVC </= 70%
  3. Life expectancy of > 6 months

Exclusion Criteria:

• < 20 pack-yr. smoking history
• Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass
• Asthma
• FEV1 > 70% or FEV1/FVC >70%

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
1; Phase 1 & Gene Expression:Hospitalized COPD exacerbators
2; Phase 2: COPD group
3; Genetic Association Studies: COPD and Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase 1 identifies the demographic & genetic factors affecting inpatient hospitalization for COPD exacerbation.Phase 2 documents the number of physician & ER visits, hospitalizations & death related to exacerbations.	Phase 1 is up to 10 weeks. Phase 2 is up to 2 years.

Secondary Outcome Measures

Outcome Measure	Time Frame
Phase 2 also documents the number, severity, & subject reporting of exacerbations, spirometry changes,& quality of life.	2 years

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Pennsylvania Department of Health

Publications and helpful links

General Publications

• Busch R, Qiu W, Lasky-Su J, Morrow J, Criner G, DeMeo D. Differential DNA methylation marks and gene comethylation of COPD in African-Americans with COPD exacerbations. Respir Res. 2016 Nov 5;17(1):143. doi: 10.1186/s12931-016-0459-8.

Helpful Links

• Publication of results: PMID: 26259074

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Emphysema; COPD Exacerbation; Genetic markers COPD; Gene expression in COPD exacerbations; COPD Exacerbation Symptom Reporting; COPD Exacerbation Disease Management; COPD Treatment; Breathing disorders; COPD with Healthy Control comparators for genetic association studies.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PA DOH RFA-02-07-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No