RELIANCE

Community Research Partners

A Community Research Partner is a practicing clinician (MD, PA, NP) who treats people with COPD.

To be eligible to be a community partner, the clinicians underwent an onboarding process with the RELIANCE study team. Community Research Partners are not Investigators in the RELIANCE consortium.

RELIANCE enrolled 1,032 people across the country. It is now closed for enrollment.

RELIANCE supported hospital efforts to reduce the risk of all-cause hospitalization and premature deaths in individuals with COPD.

Both roflumilast and azithromycin have been shown to reduce the risk of COPD exacerbations compared to placebo.

However, there have not been a head-to-head comparison of the two medications.

RELIANCE (Roflumilast or Azithromycin to Prevent Exacerbations) was a U.S.-based pragmatic, comparative effectiveness trial funded by PCORI (the Patient-Centered Outcomes Research Institute) to compare long-term use of roflumilast vs. azithromycin.

What were the benefits for clinicians?

Community Partners had a clinic flow that supported at least 1 eligible patient referral per month.
The data showed that about 50% of referrals resulted in enrollments.

Budget:

Costs supported 20 enrolled patients in 1 year

RELIANCE's IRB did not require any additional submissions from Clinicians.

Single IRB (CHAIRb). Referring clinicians did not require individual regulatory approval from sIRB.

Participating clinicians collaborated and attended webinars with leaders in COPD treatment, readmission prevention, & pulmonary care.

The Steps:

Community Research Partner Role

Identify potentially eligible patients during routine care (in-person or telehealth).

Hospitalized for COPD exacerbation or respiratory complications of COVID-19 in the last 12 months;
Have severe COPD with associated chronic bronchitis;
Currently take a LAMA, ICS/LABA, or LAMA/LABA;
May need treatment escalation with either roflumilast or azithromycin (and you have no preference).

Introduce the RELIANCE study.

RELIANCE provides materials to help introduce the study.
If a patient expresses interest, you confirm eligibility and hand them an envelope of RELIANCE materials to support enrollment by the RELIANCE call center.

Submit a 3-minute online referral form. RELIANCE takes it from there!

The RELIANCE call center confirms interest and eligibility.
A central study MD writes the first Rx and sends it to your patient’s pharmacy.

Overview of RELIANCE Trial Design

1. Up to 1,250 people with COPD associated with chronic bronchitis hospitalized for COPD exacerbation in the past 12 months

2. Evaluate guideline-recommended options for preventative care with established efficacy compared with placebo. Chronic azithromycin vs. roflumilast as used in routine care, with randomization to select initial therapy

3. COPD Foundation PPRN-led non-inferiority comparative effectiveness trial, stratified by site and current/past smoking status, followed at least 6 months

Primary outcome: All-cause hospitalization or death (self-report via call center, EHR, claims, Medicare data in subset)

4. Secondary outcomes:

All-cause individual events: hospitalization, emergency department visit, urgent care visit, and death (EHR, claims, self-report, NDI)

Single-item PROMIS measures (physical function, sleep disturbance, fatigue, anxiety, depression; self-report)

Adverse events (self-report, EHR)

Medication adherence (self-report, Medicare data in subset); Crossover (self-report, Medicare data in subset, EHR); Treatment discontinuation (self-report, Medicare data in subset, EHR); Out-of-pocket costs (self-report), Weight (self-report)

A pragmatic study - fitting COPD care to real world patient and clinician practices

RELIANCE assessed the combined effects of “real-world” patient and clinician practices plus pharmacologic efficacy in individual patients.

RELIANCE was an effectiveness trial, it was inclusive of adverse effects, out-of-pocket costs of medications, co-morbid conditions and other factors that contributed to patient/clinician practices, including dosing, dose-titrations, adherence and treatment discontinuations, cross-overs, and use of co-therapies.

Medications were not provided to patients. Clinicians asked the patients to fill the prescription as per usual practice.

Clinicians retained the flexibility to select alternate regimens (e.g., starting at a lower dose and titrating up), discontinuing therapy, crossing-over to the alternate treatment, or combining both treatments at any time, as clinically indicated.

No additional visits were required for RELIANCE participants.

Susan Bleasdale, MD
Chief Quality Officer

Laura Bullock, PharmD
Pharmacy

Judy Corn
American Thoracic Society

Marilyn Hyatt
Caregiver

Patricia Jellen, RN, MSN
Nurse Administrator

John Linnell
Patient

Elisha Malanga
COPD Foundation

Daniel Ouellette, MD
ACCP Guidelines

With special contributions by
Jan Cotton

Susan Rappaport, PhD
American Lung Association

Stephanie Williams, RRT
Respiratory Therapy

Bob Wise, Janet Holbrook, Elizabeth Sugar
Data Coordinating Center (Johns Hopkins University)

Richard Albert, Stephen Rennard
Medication Experts

Richard Mularski, Elisha Malanga, David Mannino, Jean Rommes
COPD Foundation

Jerry Krishnan
Clinical Coordinating Center & Sponsor (University of Illinois Chicago)

Marie Bradley, Bradley Hammill, Candace Fuller, Darren Toh
FDA Sentinel Operations Center