|This PCORI Implementation Funding Announcement will open on Thursday, January 3, 2019.|
Notice of Upcoming PCORI Implementation Funding Announcement
This advance notice informs applicants of the eligibility requirements for projects proposed in response to this PCORI Funding Announcement (PFA).
This PFA seeks to fund meaningful implementation projects that promote the uptake of peer-reviewed findings from specific, high-priority PCORI initiatives—in the context of the body of related evidence—and make these findings more actionable and accessible to patients, clinicians, or other targeted decision makers and healthcare stakeholders at the point of care or in other decision settings.
Projects to be Funded under this PFA
All proposed implementation projects are expected to:
- Incorporate active, multi-component strategies that will lead to uptake and integration of PCORI evidence into real world practice settings. Activities may include, but should not focus on, development of tools and materials as part of these strategies.
- Target specific end-users who have a clear interest in, and would be able to benefit from, using the evidence.
- Adapt findings as needed to facilitate uptake in the proposed settings, and accomplish scale-up (to reach larger numbers) and/or scale-out (to reach broader audiences, including diverse populations and settings), as applicable.
- Demonstrate commitment and buy-in from proposed implementation sites–including frontline staff critical to the success of the project as well as leadership—to provide a supportive context and culture for undertaking the proposed project. In addition, projects should involve regional and national stakeholder organizations positioned to extend impact to broader venues.
- Be guided by an established conceptual model or framework, and where possible, by evidence regarding effective strategies for implementing evidence-based practices and interventions.
- Include a rigorous evaluation plan that documents:
- Successful execution of the implementation strategy
- Impact of the implementation project on healthcare and health outcomes as feasible and appropriate within the project scope.
Evidence Eligible as the Focus of Implementation under this PFA
Each release of this PFA will identify selected published, peer-reviewed patient-centered comparative clinical effectiveness research (CER) evidence as the focus for implementation. We anticipate that selected findings will emerge regularly from PCORI’s targeted funding initiatives and Pragmatic Clinical Studies, which address topics that have been identified as priority areas for PCORI research funding. In addition, PCORI may identify findings from PCORnet Demonstration Studies or from other selected PCORI-funded studies as the focus of implementation efforts under this PFA.
For the Cycle 1 2019 PFA, PCORI has identified two areas of eligible evidence, each of which is the focus of an important PCORI-funded study. The goal of the proposed implementation projects under this PFA is to further awareness of this evidence and its use in practice.
- The use of narrow-spectrum versus broad-spectrum antibiotics to treat children’s acute respiratory tract infections (ARTIs).
Current guidelines generally recommend the use of narrow-spectrum antibiotics, such as amoxicillin, as first-line treatment for ARTIs in children, subject to local conditions with respect to antibiotic resistance.[i],[ii] A recently published PCORI-funded study led by Jeffrey Gerber, MD, PhD, highlights the benefits of using narrow-spectrum antibiotics when possible. Gerber and colleagues looked at records for more than 30,000 children ages 6 months to 12 years taking narrow- or broad-spectrum antibiotics for ear, nose, or throat infections in 31 pediatric primary care practices in New Jersey and Pennsylvania. Their analysis found no difference in symptom resolution or treatment failure between children taking narrow versus those taking broad-spectrum antibiotics. However, the risk of side effects, including diarrhea, candidiasis, allergic reaction, and vomiting, was significantly lower for children taking narrow-spectrum antibiotics.[iii]
Available evidence suggests that approximately 80 percent of children’s diagnoses for common ARTIs should be treated with narrow-spectrum antibiotics, yet roughly 50 percent of children are still prescribed broad-spectrum antibiotics as first-line treatment.[iv],[v] In addition, studies have shown that there is significant variation in antibiotic prescribing behavior. For example, one study found that children seen at a high antibiotic use practice were four times as likely to receive a broad-spectrum antibiotic than a child visiting a low antibiotic use practice, as well as twice as likely to receive antibiotics overall.[vi]
Consistent prescription of narrow-spectrum antibiotics as first-line treatment has the potential to improve the quality of life for children, lowering the incidence of treatment-associated side effects, and for their caregivers. Inappropriate prescribing of broad-spectrum antibiotics can also contribute to antibiotic resistance, a growing problem that contributes to at least 2 million antibiotic-resistant infections each year. The problem of antibiotic resistance, as well as the larger goal of improving appropriate use of antibiotics, has been highlighted by the Centers for Disease Control and Prevention as an important priority for improving patient safety and public health.[vii]
PCORI-funded study: Comparing Broad- and Narrow-Spectrum Antibiotics for Children with Ear, Sinus, and Throat Infections
Publication: Association of Broad- vs Narrow-Spectrum Antibiotics with Treatment Failure, Adverse Events, and Quality of Life in Children with Acute Respiratory Tract Infections. Gerber, J.S. et al. JAMA, 2017; 318(23): p. 2325-2336.
- Daily self-monitoring of blood glucose has not been shown to improve health outcomes for non-insulin dependent patients with type 2 diabetes.
According to the Centers for Disease Control and Prevention, there are approximately 30 million adults with non-insulin treated type 2 diabetes.[viii] Many of these patients monitor their blood sugar level daily using testing strips and glucose meters, as prescribed by their clinicians. However, research has not established benefit from self-monitoring of blood glucose (SMBG). Some studies have reported that daily SMBG improves glycemic control in certain populations,[ix] but most have found no benefit, or benefit that was not clinically meaningful or limited to the first six months of monitoring.[x],[xi],[xii],[xiii],[xiv]
A recently published PCORI-funded study led by Katrina Donahue, MD, MPH, adds to the evidence on this topic from a relatively large pragmatic trial. Donahue and colleagues looked at 450 people with non-insulin treated type 2 diabetes in 15 community-based primary care practices in central North Carolina. The study compared people who did once-daily SMBG with those who didn’t test every day. After one year, researchers found no differences in blood sugar control or health-related quality of life between the groups. The lack of effect held true even for a subgroup of people who received real-time text messages explaining their testing results.[xv]
Proponents of SMBG have argued that testing keeps patients engaged and promotes better awareness of blood sugar levels, leading to improvements in diet and lifestyle. Others say that testing supplies are costly, that testing may be inconvenient and cause discomfort, and that patients’ attention to blood sugar levels could be more productively focused on diet and lifestyle changes that have a demonstrable impact on health. At a minimum, it is clear that patients need support as well as accurate information about SMBG in order to make informed decisions on whether SMBG is right for them. Further, clinicians and diabetes educators require adequate preparation to meaningfully engage their patients–including those who currently perform SMBG as well as new patients initiating management of their type 2 diabetes–in discussions about SMBG.
PCORI-funded study: Does Daily Self-Monitoring of Blood Sugar Levels Improve Blood Sugar Control and Quality of Life for Patients with Type 2 Diabetes Who Do Not Use Insulin
Publication: Glucose Self-Monitoring in Non-Insulin Treated Patients with Type 2 Diabetes in Primary Care Settings. Young, L.A., et al. JAMA Intern Med, 2017. 177(7): p. 920-929.
This is an Open Competition funding opportunity that seeks to draw on the expertise, creativity, and capacity of a broad applicant pool, including implementation experts and diverse stakeholder partners. As such, PCORI does not require applicants to have been associated with the PCORI-funded studies described above, nor need they have received any previous PCORI funding.
Organizations: Private-sector research organizations, including any nonprofit or for-profit organization; public-sector research organizations, including any university or college hospital or healthcare system; any laboratory or manufacturer; or any unit of local, state, or federal government may submit applications. The Internal Revenue Service must recognize all US applicant organizations. Nondomestic components of organizations based in the US and foreign organizations may apply, as long as there is demonstrable benefit to the US healthcare system and US efforts in the area of patient-centered research. Organizations may submit multiple funding applications. Individuals may not apply.
[i] Wald ER, Applegate KE, Bordley C, Darrow DH, Glode MP, Marcy SM, Nelson CE, Rosenfeld RM, Shaikh N, Smith MJ, Williams PV, Weinberg ST. Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years. Pediatrics. 2013; 132:e262-280
[ii] https://www.cdc.gov/antibiotic-use/community/for-hcp/outpatient-hcp/pediatric-treatment-rec.html. Last retrieved October 18, 2018.
[iii] Gerber JS, Ross RK, Bryan M, Localio AR, Szymczak JE, Wasserman R, Barkman D, Odeniyi F, Conaboy K, Bell L, Zaoutis TE, Fiks AG. Association of Broad-vs Narrow-Spectrum Antibiotics with Treatment Failure, Adverse Events, and Quality of Life in Children with Acute Respiratory Tract Infections. JAMA. 2017; 318(23), 2325-2336
[iv] Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic Prescribing in Ambulatory Pediatrics in the United States. Pediatrics. 2011; 128(6):1053-1061
[v] Hersh AL, Fleming-Dutra KE, Shapiro DJ, Hyun DY, Hicks LA. Frequency of First-line Antibiotic Selection Among US Ambulatory Care Visits for Otitis Media, Sinusitis, and Pharyngitis. JAMA Intern Med. 2016;176(12):1870–1872
[vi] Gerber JS, Prasad PA, Localio AR, Fiks AG, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Variation in Antibiotic Prescribing Across a Pediatric Primary Care Network. Journal of the Pediatric Infectious Disease Society. 2015; 4(4):297-304
[vii] https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements.html. Last retrieved October 18, 2018.
[ix] Poolsup N, Suksomboon N, and Rattanasookchit S. Meta-analysis of the benefits of self-monitoring of blood glucose on glycemic control in type 2 diabetes patients: an update. Diabetes Technol Ther. 2009; 11(12):775-84
[x] Malanda UL, Welschen LM, Riphagen II, Dekker JM, Nijpels G, Bot SD. Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database Syst Rev. 2012; 1: CD005060
[xi] Farmer AJ, Perera R, Ward A, Heneghan C, Oke J, Barnett AH, Davidson MY, Guerci B, Coates V, Schwedes U, and O’Malley S. Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ. 2012; 344:e486
[xii] Clar C, Barnard K, Cummins E, Royle P, Waugh N, Aberdeen Technology Assessment Group. Self-monitoring of blood glucose in type 2 diabetes: systematic review. Health Technol Assess. 2010; 14(12):1-140
[xiii] Stockholm: Swedish Council on Health Technology Assessment. Self-Monitoring of Blood Glucose in Noninsulin-Treated Diabetes: A Systematic Review. SBU Systematic Review Summaries. 2009; SBU Yellow Report No. 194
[xiv] Towfigh A, Romanova M, Weinreb JE, Munjas B, Suttorp MJ, Zhou A, Shekelle PG. Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis. Am J Manag Care. 2008; 14(7):468-75
[xv] Young LA, Buse JB, Weaver MA, Maihan BV, Mitchell Cm, Blakeney T, Grimm K, Rees J, CPF, Niblock F, Donahue KE. Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial. JAMA Intern Med. 2017; 177(7):920-929