DRIVE Clinical Research QI Library

IdentificationofClinicalTrialsand PatientsWhoMayParticipate

Goal Rationale Time line QI Team

Identify research topics that would be most beneficial to your patients

As you begin your clinical research journey, it may be useful to identify a given clinical area or need especially important to your patient population, so as to target your exploration of research opportunities

4 weeks

Clinical leader, nurse, IT support

Identify relevant clinical trials in your community

Clinical research may provide better outcomes for your patients with and enhance knowledge about the disease

4 weeks

A lead clinician and staff member who has the skills to investigate communitybased research opportunities

Characterize the research opportunities in your community

Clinical trials have inclusion and exclusion criteria which are important to understand before referring patients

4-6 weeks

A lead clinician working with a nurse or patient navigator

IdentificationofClinicalTrialsand PatientsWhoMayParticipate

Population Measurement Additional Notes

Strategy: Review the specific or priority needs of your patient population that would benefit from research referral

Patient population

Measures: Patient population profile in terms of primary diagnoses and optimal outcomes

Begin with a particular diagnosis or intervention (e.g., vaccination) that is common among your patients or that you feel would benefit from research referral

Research institutions in your community

Strategy: Conduct research to identify relevant research projects in your community

Measures: # of clinical research projects identified

In addition to clinicaltrials gov, you can contact your health system or the research office of local research institutions

Strategy: Obtain information from identified research sites and characterize the populations included and intervention

Research protocol populations

Measures: Spreadsheet of research projects with project summaries, inclusion and exclusion criteria, timeline, and contact

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

IdentificationofClinicalTrialsand PatientsWhoMayParticipate

Goal Rationale Time line QI Team

Identify patients who may benefit from the clinical trials identified in the community

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

Survey patients about their knowledge and perceptions of clinical trials

Understanding patients’ knowledge and perceptions of clinical research help you work with them to improve outcomes and dispel any myths they may have

4 -8 weeks

Clinical leader, nurse, IT support

2-3 months

Clinical staff, administrative staff, patient coordinator

IdentificationofClinicalTrialsand PatientsWhoMayParticipate

Population Measurement Additional Notes

Patients with selected condition eligible for clinical trials

Strategy: Run EMR report to identify patients eligible for clinical trials, including the treatments they are receiving, age, and co-morbidities, comparing it to the criteria identified in review of clinical trials in the community

Measures: # of patients with given condition, # of patients eligible for clinical trials identified

In addition to identifying your patients eligible and interested in clinical trials, you will want to consider how well current therapies are working for them

Patients eligible for clinical trials, especially minoritized populations

Strategy: Survey via patient portal, EMR, or paper survey during check-in/rooming

Measures: # of eligible patients, # of completed surveys; thematic analysis on knowledge/attitudes identified

Education

Goal Rationale Time line QI Team

Educate patients about clinical research

Many patients do not know what clinical research is or they 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 processe 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

Engage patients of color who’ve successfully completed a clinical trial to educate your staff or patients

Staff and patients considering clinical trials value guidance and feedback from those who have already participated in a clinical trial

2-3 months

Clinicians, clinical staff, patient educator, patients who’ve already participated in a clinical trial

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.

Staff and patients eligible for clinical trial, especially minoritized populations

Strategy: Work with local community leaders and health system to recruit patients who’ve successfully completed a clinical trial and are willing to work with other patients considering enrolling in a clinical trial

Measures: # of patients enrolled in a clinical trial; # of patients and community members engaged

Implement Clinical Research Referral

Goal Rationale

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

Train staff on helpful resources, as well.

Patient-provider relationships are important, especially when referring patients with to clinical trials.

Time line QI Team

4 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

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

Share information with referred patients.

4 to 6 weeks

Clinical lead, nurse/patient navigator

Implement Clinical Research Referral

Population Measurement Additional Notes

Qualifying patients

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 understand the clinical trial process, provide education and resources on effective treatment, as well help promote patient activation and effective selfmanagement

2 months 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

Populati on Measurement Additional Notes

Patients referred to a clinical research study

Strategy: Create a workflow for a patient navigator to assist patients referred to a clinical trial

Measures: # of patient/clinical research navigators; # of patients supported by the patient navigator; #

Your health system may have resources to navigate patients to relevant resources

Patients 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

Goal Rationale Time line QI Team

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

Implement Clinical Research Referral

Population Measurement Additional Notes

All patients who are being referred to a clinical trial

Strategy: Apply SDOH screening tool in EMR or at National Association of Community Health Centers PRAPARE Tool; implement during in-person 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