Facilitating a National Institute on Aging-Funded Randomized Control Trial in Largest Federally Qualified Health Center in the Country

The Problem

University of Southern California (USC) launched a National Institute on Aging funded randomized controlled trial to address inappropriate and over-prescribing of antibiotics for acute upper respiratory infections. These behaviors have led to the spread of antibiotic-resistant bacteria, a public health problem that contributed to over 18,000 deaths in the U.S. in 2005 . The initiative aimed to assess three methods of improving provider decisions concerning treatment of acute respiratory infections: 1) suggesting alternative, more appropriate prescription options, 2) requiring providers to explain their prescription of antibiotics for diagnoses for which antibiotics are not usually indicated, and 3) providing updates to providers comparing them to the best performing providers in their region. The study required recruitment and screening of several hundred physicians and advanced practice nurses. Implementation required ongoing project and data management, technical support, clinical expertise and effective communication between investigators and participating clinics.

The Solution

Engaging clinic partners
As a grant sub-awardee of USC, COPE Health Solutions reached out to their partner clinics in Los Angeles to engage primary care providers (PCPs) as participants. Several large clinic systems were engaged in the trial, including QueensCare Health Centers (6 clinic sites), The Children’s Clinic (8 sites), and AltaMed Health Services Corporation (27 clinic sites in Los Angeles and Orange County). AltaMed is the largest of these and in 2009 experienced 190,999 clinic visits in LA primary care clinics, and 109,963 clinic visits in Orange County primary care clinics. COPE Health Solutions’ long-standing relationship with these organizations resulted in successful completion of a detailed negotiation and contract phase of the initiative.

Recruiting and enrolling physicians
The team engaged several hundred potential PCP participants, and was able to successfully enroll the target number of subjects into the study. To facilitate the study launch, the COPE Health Solutions team collected vital data on providers’ prior prescribing behaviors and individual characteristics in the form of a 30 minute pre-investigation survey and orientation to the study.

Technical support, clinical expertise, and data management
During the three-year study period, COPE Health Solutions’ project managers conducted regular testing of the intervention, which was launched primarily within the clinics’ electronic health record systems. This technical support was essential to ensure that the provider interface was functioning properly. COPE Health Solutions’ clinical experts reviewed diagnostic codes and other clinical data for appropriateness to improve intervention algorithms used in generating provider reports (part 3 of the intervention). Communication and coordination between USC principal investigators and clinic leadership was critical, as provider compliance and active participation was essential to study outcomes. Communication was also key, as the team interacted and worked closely with other site management teams around the country. The COPE Health Solutions team prioritized positive participant experience as a primary goal in facilitating the study, and regularly conversed with clinic leadership regarding study activities and challenges, subsequently involving participants in developing solutions. Project managers held weekly implementation meetings with clinic leadership and study investigators to maintain open communication and address issues as needed. The team also managed databases of provider intervention assignments, personal characteristics, and EHR functionality reports.

Personalized strategy and service
COPE Health Solutions developed a strategy for facilitating exit-surveys with the participating providers upon study completion. Project managers engaged clinic leadership early in the process to ensure a simple and positive experience for providers, many of whom have full schedules and a myriad of other commitments. When challenges arose in the deployment of an online survey tool, the COPE Health Solutions team transitioned to utilizing tablets during in-person visits to clinics, and was successful in reaching providers between patient visits to complete the exit-survey and provide feedback.

Outcomes

• Participating clinics: 29
• Providers enrolled: 119
• Passed intensive patient safety audits and reviews
• Exit-survey completion rate: *92.1%
• Positive early results published in JAMA:
  “Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial”Daniella Meeker, PhD; Tara K. Knight, PhD; Mark W. Friedberg, MD, MPP; Jeffrey A. Linder, MD, MPH; Noah J. Goldstein, PhD; Craig R. Fox, PhD; Alan Rothfeld, MD; Guillermo Diaz, MD; Jason N. Doctor, PhDJAMA Intern Med. 2014;174(3):425-431
• Published in BMC Infectious Diseases:
  “Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]–study protocol and baseline practice and provider characteristics.”Persell SD1, Friedberg MW, Meeker D, Linder JA, Fox CR, Goldstein NJ, Shah PD, Knight TK, Doctor JN.BMC Infect Dis. 2013 Jun 27;13:290.
• Full results will be published in medical journals in near future

*Includes all providers who remained employed with the clinic through intervention period

For more information, please contact the COPE Health Solutions project principals:

Rebekah Dell, MPH
Senior Consultant
rdell@copehealthsolutions.org

Alan F. Rothfeld, MD
Chief Medical Officer
arothfeld@copehealthsolutions.org