Understanding Patient Management of COPD Exacerbations

NCT02725294 | Unknown

• 1 other identifier: 00874
• Study Type: observational
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

exacerbation; access to care; telemedicine

Outcome Measures

Primary Outcomes (1)

• Decision to seek care

  All participants with at least one exacerbation will be included in this analysis. Individuals could have both treated or untreated exacerbations and the unit of analysis will be each patient-exacerbation event. The outcome will be whether the patient sought treatment (yes/no) for their COPD exacerbation.

  Determined for each exacerbation event during the 1-year follow-up period

Secondary Outcomes (1)

• Treatment delay

  Determined for each treated exacerbation event during the 1-year follow-up period

Study Arms (2)

COPD patients

Veterans with COPD who are cared for at VA Puget Sound Health Care System (Seattle, WA) or VA Eastern Colorado (Denver, CO) who are at high risk for a COPD exacerbation based on an exacerbation treated with prednisone or antibiotics in the year preceding enrollment.

Other: This is an observational study without an intervention

Informal Caregiver for COPD patients

Informal caregiver (ie. family member, friend, etc.) for the patient with COPD who is participating in the COPD patients cohort.

Other: This is an observational study without an intervention

Interventions

This is an observational study without an intervention OTHER

Not applicable. This is an observational study without an intervention.

COPD patients; Informal Caregiver for COPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease (COPD) who receive care at the VA Puget Sound Health Care System in Seattle, WA or the VA Eastern Colorado Health Care System in Denver, CO. Informal caregivers (ie. family member or friend) to the Veteran subject will also be included

You may qualify if:

• COPD diagnosis
• Spirometry showing FEV1/VC\<0.70
• COPD exacerbation treated with prednisone and/or antibiotics, or that resulted in a visit to the emergency department or hospitalization in the previous 12 months
• English speaking
• Access to telephone

You may not qualify if:

• nursing home resident
• institutionalized, imprisoned
• life expectancy \< 1 year
• Informal Caregiver Cohort:
• Identified by Veteran patient as informal caregiver
• English speaking
• Access to telephone
• \>=18 years old

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead
• VA Eastern Colorado Health Care System: collaborator
• VA Palo Alto Health Care System: collaborator

Related Publications (2)

• Locke ER, Thomas RM, Simpson TL, Fortney JC, Battaglia C, Trivedi RB, Gylys-Colwell J, Swenson ER, Edelman JD, Fan VS. Cognitive and Emotional Responses to Chronic Obstructive Pulmonary Disease Exacerbations and Patterns of Care Seeking. Ann Am Thorac Soc. 2024 Apr;21(4):559-567. doi: 10.1513/AnnalsATS.202303-287OC.

  PMID: 37966313 DERIVED

• Locke ER, Young JP, Battaglia C, Simpson TL, Trivedi R, Simons C, Fortney JC, Hebert P, Swenson ER, Edelman J, Fan VS. Care-seeking and delay of care during COPD exacerbations. NPJ Prim Care Respir Med. 2022 Feb 15;32(1):7. doi: 10.1038/s41533-022-00269-9.

  PMID: 35169140 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: March 31, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2022
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share