Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)

University of Illinois

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Behavioral: PELICAN-Reactive; Behavioral: PELICAN-Proactive; Behavioral: Written education material (basic); Behavioral: Additional education material

Study type: Interventional

Funder types: Other

Identifiers

NCT02098369

PCORI-CE 1304-6490

Details and patient eligibility

About

About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using O2 can prolong life and increase quality of life. Patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (COPD).

Full description

The COPD Foundation operates a peer-led telephone-based information line, but its effectiveness in promoting adherence to O2 therapy and patient-centered outcomes is unknown. Our overall hypothesis is that a patient-centered Peer-Led O2 InfoLine for patients and CAregivers (PELICAN) will increase adherence and improve health. We have developed a broad-based collaboration with patients/caregivers, advocacy groups, a national O2 supplier, and others to conduct a 3-arm pragmatic clinical trial, to evaluate the comparative effectiveness of proactive vs. reactive PELICAN interventions vs. usual care on adherence to O2 (primary outcome) and on other patient-centered outcomes (secondary outcomes).

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older.
2. Physician diagnosis of COPD
3. Physician prescription for home O2 for 24hrs/day, 7 days/week
4. Willing to use home O2.
5. Working telephone number.

Exclusion criteria

1. Unable to read and speak English.
2. Discharge to home hospice or expected survival less than 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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444 participants in 3 patient groups

Usual care

Other group

Description:

Written education material (basic)

Treatment:

Behavioral: Written education material (basic)

Proactive

Experimental group

Description:

Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\]

Treatment:

Behavioral: Written education material (basic)

Behavioral: PELICAN-Proactive

Behavioral: Additional education material

Reactive

Experimental group

Description:

Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\]

Treatment:

Behavioral: Written education material (basic)

Behavioral: PELICAN-Reactive

Behavioral: Additional education material