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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Written education material (basic); Behavioral: Additional education material; Behavioral: PELICAN-Proactive; Behavioral: PELICAN-Reactive

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 444
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Apria Healthcare
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Miami, Florida, United States, 33134
      • COPD Foundation
    • Miami, Florida, United States, 33134
      • AlphaNet
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; Written education material (basic)	Behavioral: Written education material (basic); Education material on COPD distributed to all participants.
Experimental: Proactive; 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)]	Behavioral: Written education material (basic); Education material on COPD distributed to all participants.; Behavioral: Additional education material; Additional education material sent to participants in the proactive and reactive arms.; Behavioral: PELICAN-Proactive; In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy.
Experimental: Reactive; 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)]	Behavioral: Written education material (basic); Education material on COPD distributed to all participants.; Behavioral: Additional education material; Additional education material sent to participants in the proactive and reactive arms.; Behavioral: PELICAN-Reactive; Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Supplemental O2 Prescription	Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS - Physical Function	Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)	60 days
PROMIS - Fatigue	Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)	60 days
PROMIS - Emotional Distress - Anxiety	Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)	60 days
PROMIS - Sleep Disturbance	Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)	60 days
PROMIS - Emotional Distress - Depression	Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)	60 days
PROMIS - Satisfaction With Social Roles and Activities	Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)	60 days
PROMIS - Ability to Participate in Social Roles and Activities	Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)	60 days

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Patient-Centered Outcomes Research Institute; National Jewish Health; COPD Foundation; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; American Association for Respiratory Care; AlphaNet; Apria Healthcare
• Investigators: Principal Investigator: Jerry A Krishnan, MD, PhD, University of Illinois at Chicago

Publications and helpful links

Helpful Links

• Patient-Centered Outcomes Research Institute (PCORI): Funding Award details

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Adherence; Chronic obstructive pulmonary disease (COPD); Supplemental oxygen; Peer coaching; Telephonic education
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PCORI-CE 1304-6490