PDSA LUPUS DRIVE LIBRARY
IdentificationofClinicalTrialsand PatientsWhoMayParticipate
Goal Rationale Time line QI Team
Identify relevant Lupus clinical trials in your community
Clinical research may provide better outcomes for your patients with Lupus and enhance knowledge about the disease
2 weeks
A lead clinician and staff member who has the skills to investigate communitybased research opportunities
Characterize the research opportunities in your community
Identify patients who may benefit from the clinical trials identified in the community
Clinical trials have inclusion and exclusion criteria which are important to understand before referring patients
4 weeks
A lead clinician working with a nurse or patient navigator
Clinical research projects typically have very specific inclusion and exclusion criteria. Before referring your patients to a clinical trial it is important to understand if it is applicable
4-8 weeks
Clinical leader, nurse, IT support
IdentificationofClinicalTrialsand PatientsWhoMayParticipate
Population Measurement
Research institutions in your community
Research protocol populations
Strategy: Conduct research to identify relevant Lupus research projects in your community
Measures: # of clinical research projects identified
Additional Notes
In addition to clinicaltrials gov, you can contact your health system, the research office of local research institutions, or Lupus Therapeutics
(https://lupustherapeutics. org/research/)
Patients with Lupus
Strategy: Obtain information from identified research sites and characterize the populations included and the intervention
Measures: Spreadsheet of research projects with project summaries, inclusion and exclusion criteria, timeline, and contact
Strategy: Run EMR report to identify patients with Lupus, including the treatments they are receiving, age, and comorbidities, comparing it to the criteria identified in review of clinical trials in the community
Measures: # of patients with Lupus, # of patients eligible for clinical trials identified
Information about clinical research often can be found on clinicaltrials.gov and other online resources; direct outreach to the research team is another strategy, which is a good first step in building a relationship
In addition to identifying your patients with Lupus, you will want to consider how well current therapies are working for them
Education
Goal Rationale Time line QI Team
Educate patients about clinical research
Many patients do not know what clinical research is or they have harbor fears or mistrust, especially people of color. Helping patients understand the research process, potential benefits and risks, and protections is vital.
Ongoing
Patient navigator, nurse, practice manager
Educate your staff about clinical research
Many clinic staff persons are not familiar with clinical research processes.
Annually
Clinician lead, patient navigator, nurse
Education
Population Measurement
Additional Notes
Strategy: Identify posters, videos, and patient hand-outs with information about clinical research that can be posted in the waiting/exam room
Patients at the clinic
Measures:Items distributed or posted; one or two question patient survey on interest/views of clinical research
Providing posters, videos, or hand-outs in the waiting or exam room can be an effective method for raising awareness; the DRIVE toolkit has links to various resources
Clinic Staff
Strategy: Provide a brief presentation to staff at a regularly scheduled meeting or over lunch about clinical research and how you are moving forward to participate
Measures:Presentation given; preand post-brief survey
Staff views and knowledge of clinical research can shape patient views and providing the staff with education can help them feel confident in answering questions.
Education
Goal Rationale Time line QI Team
Educate the community about clinical research
Churches, salons, barbershops, and other community organizations are the trusted source for information in communities of color but may require education about clinical research
8 weeks for one educatio nal event
Clinician lead, patient navigator, nurse, practice manager or administrative person, and community leader/ partners
Education
Population Measurement
Additional Notes
Minoritized members of the community
Strategy: Reach out to community leaders to consider their educational needs and how you can work together to provide that education, in a virtual or in-person town hall or meeting.
Measures:Number of presentations; reach of the education; survey of knowledge/attitudes change among community members
It will be important to include the community in planning an event as well as providing an opportunity for community members to provide feedback on their views.
Implement Clinical Research Referral
Goal Rationale
Time line
QI Team
Gather resources and information about clinical trials that are relevant to some of your patients
In preparation for conversations with your patients about clinical trial opportunities, it will be important to have information to share with them
2 to 3 weeks
Patient navigator and/or nurse or staff person connecting with the clinical trial site
Clarify your role in the ongoing care of your patients who are referred to and enrolls in a clinical trial
Patient-provider relationships are important, especially when referring patients with Lupus to clinical trials. Patients want to be reassured they will have access to follow-up care, will not have to stop therapies that have helped and won’t be left to navigate the clinical trial process alone
Work with clinical trialists to outline responsibilities.
4 to 6 weeks
Clinical lead, nurse/patient navigator
Share information with referred patients
Implement Clinical Research Referral
Population Measurement
Additional Notes
Qualifying patients with lupus
Strategy: Request resources from the clinical trialist describing the program that can be shared with the patient
Measures: # of resources gathered
In addition to information about the clinical trial itself, the process used to enroll patients will be important for patients, as well as ongoing treatment issues, cost and other concerns. This can be a great first step in connecting to the clinical trial site as well.
All clinical staff who will be involved with referring a patient to a clinical trial
Strategy: Arrange a telephone call or meeting with a lead at the clinical trial site to review respective roles and responsibilities, and how communications will be maintained
Measures: Documented role of referring clinician
If there is a shared EMR system, updates and notes can be more easily shared
Implement Clinical Research Referral
Goal Rationale Time line QI Team
Engage a patient navigator to assist with the referral process
People of color are less likely to be recruited and enroll in clinical trials Patient navigators can help patients with Lupus understand the clinical trial process, provide education and resources on effective treatment, as well help promote patient activation and effective selfmanagement
2 months
Lupus patient navigators, clinical staff
Discuss clinical research opportunities with patients who may likely qualify and benefit from clinical trial participation
Referral to a clinical trial should occur in the context of a conversation in which the patient can make an informed decision.
3 months
Clinician lead, staff lead, patient navigator, administrative staff lead
Implement Clinical Research Referral
Population Measurement
Strategy: Create a workflow for a patient navigator to assist patients referred to a clinical trial
Additional Notes
Patients referred to a clinical research study
Measures: # of patient/clinical research navigators; # of patients supported by the patient navigator; # of patients supported by the patient navigator who successfully participate in a clinical trial
Your health system may have resources to navigate patients to relevant resources
Patients with Lupus who seem to qualify for and may benefit from a local clinical trial
Strategies: Provide patients identified as potential study participants print materials in the appropriate language and health literacy level as well as a conversation with the lead clinician and patient navigator or nurse.
Measures: # of patients with whom a clinical trial referral has been discussed; # of patients who have been referred to a clinical trial; # of patients who enroll in the clinical trial
The lead clinician can provide information about the medical science and treatment implications of the clinical trial; the patient navigator or nurse lead can discuss the logistics of referral and enrollment and help set up the appointment
Implement Clinical Research Referral
Identify barriers your patients may face to enrolling in a given trial, such as SDOH, comorbidities, etc.
Patients of color can face many barriers to care, including SDOH needs such as transportation, financial resources, and healthy food access.
3 months
Clinical staff, patient navigator, administrative staff
Goal Rationale Time line QI Team
Implement Clinical Research Referral
Population Measurement Additional Notes
Strategy: Apply SDOH screening tool in EMR or at National Association of Community Health Centers PRAPARE Tool
All patients who are being referred to a clinical trial
(https://www.nachc.org/researchand-
data/prapare/prapare one pager s ept 2016-2/); implement during inperson or telehealth visits.
Measures: # of surveys administered and completed; results of survey
By understanding barriers that patients may face you can help develop strategies for overcoming them.
NOTES
Multi-stepPDSAscouldbedonewithcycle1being assessingbaseline;cycle2pilotimplementationofan improvementstrategy;cycle3broadening implementationoftheimprovementacrossthepractice; anothercyclethatmaybeincludedistheimprovement ofmedicalrecorddocumentation.Improvementgoals shouldbespecifiedwitheachcycle.
ResultsfromthePDSAsshouldbereviewedbythe champion/QIleaders;sharedwithstaffatregularly scheduledmeetings;postedinstaffcommonareas,and broughttotheattentionofleadershipsoastoshare identifiedneedsandimprovements.
Allpatienteducationresourcesshouldbeinthelanguage spoken/readbythepatient.
ThedevelopmentandimplementationoftheQIprogram areledbyaphysicianoradvancedpractitionerleadand member(s)ofthepracticewithknowledgeimportantto successfulimplementationandcommitmenttothetopic, includingdiabeteseducators,patientnavigators,practice managers,andnurses.