Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Subjects assigned to this arm will receive a link to the eNav website.

Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care.

The eNav toolkit is a digital navigation toolkit that includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

eNav

Standard of care procedures for selecting their CRC screening test.

Standard of Care

Sarah Miller, PsyD

The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

This is a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit. A total of 400 participants will be from four FQHC clinics within the Institute for Family Health FQHC network. Participants will be randomly assigned to one of two groups:

1. eNav group (N=200) or
2. usual care group (N=200)

Participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment.

Those in the intervention group will receive a link to the eNav website. The digital navigation tool includes a website and text-messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

The control group will receive standard clinical care.

Then 3-4 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. The follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for CRC screening).

The impact of the eNav Toolkit on CRC screening completion at 6 months will be evaluated by checking their medical records. If a patient does not have a CRC screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.

Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening

Developing and Testing a Digital Toolkit to Improve Colorectal Cancer Screening Rates in Federally Qualified Health Centers

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

CRC, Yes/No

Medical chart review will determine whether the CRC screening was complete. If a patient does not have a CRC screening result recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.

The number of participants who complete the screening test (i.e., colonoscopy, FIT or FIT-DNA) with adequate quality. Test quality will be coded as "inadequate" if the test needs to be repeated or cannot be resulted due to inadequate quality (e.g., poor bowel prep, inadequate stool sample).

The number of participants who complete the screening test and the preparation is inadequate (e.g., poor bowel prep quality, inadequate stool sample collection).

Record if the study participant is following the colorectal cancer screening recommendations after the CRC test has been completed. Measured as:

Yes = participant completed the recommended follow up No = participant did NOT complete the recommended follow up In process = the recommended follow up does not fall within the 6-month time frame Missing = data not available in the medical chart

The assessments specifically measure the following Health Belief Model scales:

* Perceived Benefits of Stool-based Tests: min 3 - max 15
* Perceived Benefits of Colonoscopy: min 3 - max 15
* Perceived Susceptibility: min 2 - max 10
* Perceived Barriers of Stool-Based Tests: min 7 - max 35
* Perceived Barriers of Colonoscopy: min 9 - max 45
* Perceived Self-Efficacy of Stool-based Tests: min 8 - max 40
* Perceived Self-Efficacy of Colonoscopy: min 12 - max 60
* Perceive Severity: min 3 - max 15

Higher scores indicate greater benefit/barriers levels of the scale (e.g., higher scores = more barriers, more benefits, higher perceived susceptibility of CRC, higher levels of self-efficacy), there is no summed score.

The Institute for Family Health

National Cancer Institute (NCI)

Icahn School of Medicine at Mount Sinai

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

Papillomavirus Infections

Virus Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Automated, system-generated mailed or text message reminders

Parent Reminders

1. Workflow modifications to reduce missed opportunities for vaccination
2. Provider- and clinic-level audit and feedback
3. Provider \& staff training on workflow modifications and communication strategies

Multicomponent clinic-system strategies

Parent reminders and multicomponent clinic-system strategies

Combined Condition

Roshan Bastani, PhD

Beth Glenn, PhD

UCLA and Northeast Valley Health Center (NEVHC), a large, multi-site Federally Qualified Health Center (FQHC), are partnering to address underutilization of the prophylactic HPV vaccine among underserved, ethnic minority adolescents receiving care through FQHCs. We will use a cluster randomized 2x2 stepped-wedge factorial study design, implemented in seven NEVHC clinics, to compare the effectiveness of parent reminders (mailed and text), multi-component clinic system strategies, a combined intervention (parent reminders + clinic system strategies) and usual care on HPV vaccine series completion among NEVHC adolescent patients. FQHCs provide essential health care to underserved groups and have the infrastructure to sustain effective strategies to improve preventive care delivery. Therefore, study findings will be invaluable for informing future efforts to improve HPV vaccination at the population-level.

The primary aims of this study are to: 1) Examine the effects of two types of parent reminders (mailed, text) and multicomponent clinic system strategies on HPV vaccine completion compared to usual care, 2) Examine the comparative effectiveness of the reminders versus the clinic system strategies and 3) Examine whether combining parent reminders with the clinic system strategies produces larger effects compared to either type of intervention implemented alone.

Additional aims include:

* Explore the relationship between child age (12-14 years versus 15-17 years) and intervention effectiveness, due to the difference in dosing schedules for the two age groups.
* Examine parent (e.g., language preference) and provider (e.g., specialty) characteristics that may act as moderators of intervention effectiveness.
* Assess parent perspectives and experiences related to the different interventions.
* Examine the implementation process (including adaptations) for each of the interventions.
* Disseminate study findings widely to a local and national audience of relevant stakeholders.

The multicomponent clinic system strategies include workflow modifications to minimize missed opportunities for vaccination, provider- and clinic-level audit and feedback, establishment of clinic-level policies and protocols, and will also include provider and staff training regarding workflow modifications and patient communication strategies.

The study will be implemented across six study periods of 12 months each. The seven NEVHC clinics will be randomized into three groups (A, B, C). Following a 12-month start-up and observation period (Period 1), as part of a stepped wedge design, Group A will implement the parent reminders beginning in Period 2, Group B will implement the clinic-based intervention beginning in Period 3, and Group C will implement the combined condition beginning in period 4. In Period 5, Group A will crossover to the combined condition. This change from the original protocol was approved by the study funder as of Fall 2021.

Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs

We will assess completion of the HPV vaccine series based on the number and the timing of the HPV vaccine doses received according to data in NEVHC's electronic health record system. We will determine completion status based on guidelines from the CDC Advisory Committee on Immunization Practices. For adolescents who initiated the HPV vaccine series before the age of 15, completion will be defined as receiving 2 doses of the HPV vaccine a minimum of 5 months apart. For adolescents who initiated the HPV vaccine series at age 15 or older, completion will be defined as having received 3 doses with the second dose administered at least one month after the first, the third dose received at least 3 months after the second, and the first and third doses administered at least 5 months apart from each other.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluating the Efficacy of the eNav Toolkit to Improve Colorectal Cancer Screening	NCT06184594	Colorectal Canc...	eNav Standard of Car...	45 Years - 75 Years	Icahn School of Medicine at Mount Sinai
Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs	NCT03726151	Human Papilloma...	Parent Reminder... Multicomponent ... Combined Condit...	11 Years - 17 Years	University of California, Los Angeles

Spots Global Cancer Trial Database for federally qualified health centers