PCORI funds implementation projects to increase awareness and promote the use of PCORI-funded research findings to improve health care practices and health outcomes. This project is proposing to conduct implementation activities for the results of the research project: Comparing Asthma Treatments: A Study Focusing on African-American, Hispanic, and Latino Adults -- The PREPARE Study for PeRson EmPowered Asthma Relief

1. What were the results from the original PCORI-funded research study? 

PREPARE was a pragmatic, open-label randomized study of 1,201 African-American/Black and Hispanic/Latino/a adults with moderate to severe asthma. The study tested Patient-Activated Reliever-Triggered Inhaled Corticosteroids (PARTICS) in which patients with asthma used an inhaled corticosteroid (ICS) each time they used their reliever medication (1:1 puff of each). Participants were randomized to PARTICS plus Usual Care (UC) (PARTICS+UC), in which they received an ICS canister and PARTICS instruction, or to continue UC. PARTICS+UC reduced the annualized rate of severe asthma exacerbations from 0.82 exacerbations per year to 0.69, HR 0.846 (p=0.048). Compared to UC, PARTICS+UC improved asthma control (measured by the Asthma Control Test, minimally important difference = three points) by 3.4 points vs. 2.5 points (p<.0001). Furthermore, the annualized rate of missed days from work/school/usual activities was 13.4 in the intervention group and 16.8 in the usual-care group (p=0.0126). This was noted by patient partners as an important improvement. Importantly, self-reported refills of beta-agonist metered-dose inhalers (the use of which is associated with increased asthma mortality) was reduced by 18 percent (4.6 versus 5.6 reported inhaler refills) and nebulizer use by 33 percent (3.6 versus 5.4 months of reported nebulizer use). Overall, the PARTICS approach presents, as stated by partners, a patient-centered and patient-empowering approach to improving meaningful outcomes among patients with moderate to severe asthma.

2. Why is this research finding important? 

PARTICS is a new way for patients with moderate to severe asthma to improve control, reduce exacerbations and miss fewer days of work or school. While somewhat similar to currently recommended SMART (Single Maintenance And Reliever Therapy), patients using PARTICS use fewer extra canisters of controller medication. PARTICS is likely more broadly applicable; studies of SMART excluded patients who use nebulizers as relievers and did not include disadvantaged patient populations. In the PREPARE study, 67 percent of participants used a nebulizer for asthma quick-reliever therapy and 45 percent of participants reported using ≥1 nebulizer treatment/week. Furthermore, there are additional barriers to SMART implementation which include a requirement to change the underlying therapy to ICS/formoterol, an FDA caution against as-needed use of ICS/formoterol and variable insurance coverage. In contrast, PARTICS requires no change in underlying therapy, would be covered by insurance and has been shown to reduce exacerbations to a degree similar to SMART. Thus, PARTICS is an important patient-centered approach to asthma care.

3. What is the goal of this project? 

The primary objective is to implement the PARTICS intervention in four diverse medical systems—sites—and to evaluate the adoption, feasibility and acceptability of the intervention to the system, providers and patients. Each site will use input from their patient stakeholders, clinicians and information technology management leaders to use existing infrastructure and previously successful methods to educate providers and communicate to eligible patients what PARTICS is and its advantages. Modifications to each electronic health record (EHR) will identify “eligible” patients and remind providers at a point of contact that the patient may benefit from PARTICS. The EHR prescribing modules will incorporate prescriptions templates to facilitate prescribing for PARTICS. Patient education materials that were successfully used in PREPARE will be incorporated into the after-visit summary, including QR codes and videos that patient stakeholders have told the project team will be useful to reinforce and clarify their providers’ instructions.

4. What is the project team doing? 

The project will be guided by two implementation models. At the macro level the project team will follow the Promoting Action on Research Implementation in Health Services Framework (PARIHS); a second framework, TRANSLATE, will be used to complement PARIHS. This project will be a contextualized implementation. The project team will develop and define the approach through engagement with organizational leaders, system and clinic managers, data informatics managers, providers and patients to determine the specific organizational characteristics that may require adaptation of the approach. Providers, practice managers, EHR managers and patients will be part of the implementation design.

Broadly, COMMUNICATION & EDUCATION will inform providers and patients of the PARTICS option and its benefits. To do this for providers the project team plans to use available practice educational and communication avenues to explain PARTICS and its benefits and the limited sets of instructions that patients would require to implement the strategy. For patients, with system and practice approval, the project team plans to communicate using existing infrastructure (e.g., patient portals and/or text messages, emails or letters). 

EHR “POP-UPS” will prompt providers about eligible patients; modification to the EHR prescription modules will allow facile prescribing of PARTICS. The project team will incorporate PATIENT INSTRUCTION MODULES into the EHR that can be provided to the patient during or after a visit. ADAPTATION will occur when, one third of the way through the project, the project team will perform qualitative (and possibly limited quantitative) assessments of the implementation amongst providers, patients and organizational stakeholders. Adaptive modifications will be considered with their input.

The project team has a robust commitment from leaders of 1) Sutter Health, which covers over 2 million lives in 100 centers across Northern California; 2) Cherokee Health, a medium sized Federally Qualified Health Center in Tennessee which operates 24 rural and urban clinics covering 70,000 lives and has served approximately 7,000 individuals with asthma on an ICS; 3)MetroHealth, a safety net system in Ohio covering more than 300,000 patients across their 65 sites and serving 9,500 with asthma and 4) Denver Health, a safety-net system in Denver serving 160,000 adults with 7,737 people with asthma on ICS. At the practice level the participants will be adult patients and the providers who care for patients who, as identified by the EHR, have a diagnosis of asthma and who have received a prescription for a controller and a reliever in the prior 12 months.

PARTICS should benefit all patients with moderate to severe asthma who remain poorly controlled or at risk for exacerbations. They will benefit from a patient-empowering approach generally covered by insurance that does not require a change in their underlying therapy and improves outcomes important to them. Providers will benefit from an easy to implement effective intervention that is applicable to a broad group of patients and does not require changing underlying medication. Health systems benefit from improved outcomes, reduced time for staff dealing with insurance denials and reduced burden to providers and medication cost compared with SMART.

5. How is the team evaluating this project?

The evaluation will be guided by the PRISM framework as follows.

Reach:

Use of PARTICS (percentage of eligible individuals started on PARTICS)

Response to clinical data system (CDS) alerts (percentage acted upon).

Effectiveness:

Asthma exacerbation rates from EHR and claims data.

Practice Level Adoption:

Percentage of clinicians receiving a CDS Alert that started at least one individual on PARTICS at the system level

Practice/staff interest (interviews, surveys)

System Implementation:

Use of PARTICS as intended (percentage of practices with clinicians prescribing PARTICS)

Costs, barriers and support needs (project implementation plans/notes/self-reported surveys/ interviews)

Adaptations made during implementation

Cost to implement

Clinician Implementation:

Fidelity to PARTICS:

Percentage of practices where greater than 50 percent of clinicians prescribed PARTICS

Clinician comfort with prescribing PARTICS

Percentage of CDS Alerts acted upon.

Participant Implementation:

Percent of patients prescribed PARTICS that filled at least one prescription

Possession ratio ICS doses/short-acting beta agonists (SABA) doses (claims)

Reasons for filling/not filling

Organization Implementation:

Cost to implement

Organization Maintenance:

Ongoing/expanded use

Expectations

Satisfaction

Participant maintenance

Percentage of individuals with at least 70 percent of SABA doses covered by filled ICS doses (claims)

Percentage of individuals with prescription refill in EHR after 12 months

Characteristics of participants who stopped versus continued use

Barriers to use (interviews)

6. How is the team involving patients and others in making sure the findings reach people who can use them?

The project team will rely on patients with asthma and partners from professional and patient advocacy groups. Patient partners will be involved in reviewing and advising on proposed implementation strategies, evaluation metrics, adaptations and review of the results. Stakeholder organizations include American Academy of Allergy, Asthma and Immunology; Primary Care Arm of the American Osteopathic Association and the American Academy of Family Physicians. Patient advocacy groups include the American Lung Association, the Asthma and Allergy Foundation of America and the Asthma and Allergy Network. The project team has organized regular meetings among the stakeholder groups. Representatives of each stakeholder group will serve on the executive committee, which is ultimately tasked with guiding the project and decision making.

7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?

All four sites have committed to continuation of the system, which should require very few resources since the project will handle the EHR changes and the patient identification systems. Learnings, adaptations and site-specific variations will serve as models for successful scaleup in health systems with varied populations and organizational structures. The project team will post all of the materials on the existing PREPARE website, including the educational presentations to providers; where permitted, the EHR scripts for the pop-ups and the prescriptions; queries and code for identifying patients who might benefit; videos and patient instructions and text of letters to patients about benefits of PARTICS. Additionally, the project team will publish findings and present them at meetings of providers and organizational and professional stakeholders.