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Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization (CoSMMO)

torstai 9. heinäkuuta 2026 päivittänyt: University of Colorado, Denver

The goal of this interventional study is to create and test a comprehensive and low burden text message program within existing Community Health Centers (CHC) electronic records system to encourage patients to complete at home colorectal cancer (CRC) screening and to make sure they get follow-up care if their results are abnormal.

First, the investigators will learn from clinic staff and patients what their needs and preferences are in terms of use of technology. This information will be used to design the text messages program.

  • Clinic patients will participate in focus groups
  • Clinic staff will participate in interviews

Second, the investigators will test a series of different message versions in two batches (experiments):

  • Clinic patients with orders for an at-home colorectal cancer screening kit will receive the different message versions.
  • In the first batch, the messages that get the most engagement from patients will be selected to be used in the second experiment.
  • In the second batch, the investigators will test which messages lead to the most colorectal cancer screening completion.
  • This will be rolled-out within the clinics existing electronic record system. The study team will not receive any information that will identify individual patients.

Lastly, the investigators will check again with clinic staff to learn how the program performed, and what would be needed to continue using the text message program in the long run.

-Clinic staff will participate in interviews and surveys.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

This trial is studying optimization of text messages and outreach approaches by community health centers to increase patients' completion of FIT colon cancer screening tests. Text message reminders are a low cost, scalable way to deliver patient reminders that are low burden for staff. The proposed work uses a creative, community-engaged, systems-level approach to improve completion of FIT testing and abnormal follow-up and program sustainment in CHCs.

The study design includes three parts. First, the text messages will be optimized to maximize patient engagement and outreach (Aims 1 & 2). The study will enroll patients from three partnering CHCs to participate in six focus groups to inform message design. The investigators will also conduct key informant interviews with 5-15 staff per CHC regarding the logistics of ensuring seamless integration into routine clinical operations and perspectives on the intervention activities. Then, a factorial experiment will be conducted, assigning 2,000 patients who have received a stool-based screening kit to different reminder messages. Engagement will be measured as replies or use of ≥1 links, to indicate interaction with the message. The experiment will compare: (1) personalization; (2) concern or negative emotions about screening; and (3) gain framing. In the factorial design patients will not be individually enrolled, this intervention will be tested within the workflows of usual practice. All data for the factorial experiment will be de-identified.

With those tools in place, the investigators will optimize outreach strategies for CRC screening completion. In a second factorial experiment with 5,100 patients, the investigators will optimize outreach strategy for primary screening outcomes of home-based stool screening test completion and screening completion by any guideline-recommended CRC screening test. Secondary outcomes include follow-up care for abnormal stool test results. In this factorial experiment, the investigators will test the impact of three outreach conditions on screening completion: increasing patient autonomy, providing information for accessing resources for impediments to care, and provision of live support. As in the first factorial test, for the second factorial test patients will not be individually enrolled, as the intervention will be tested within the workflows of usual practice. All data will be de-identified.

Finally, the study will assess implementation outcomes and sustainment of intervention components and effects. The investigators will conduct staff interviews and surveys to assess organizational capacity for sustaining the intervention elements being tested as well as the acceptability and feasibility of the text messages and screening tools. Sustainment of the text message outreach intervention elements will be assessed at post intervention and two 6-month intervals post-intervention.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

7220

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02114
        • Massachusetts General Hospital
        • Ottaa yhteyttä:
        • Alatutkija:
          • Adjoa Anyane-Yeboa, MD, MPH
      • Boston, Massachusetts, Yhdysvallat, 02215
        • Dana Farber Cancer Institute
        • Ottaa yhteyttä:
        • Alatutkija:
          • Kasisomayajula Viswanath, PhD
      • Boston, Massachusetts, Yhdysvallat, 02108
        • The Massachusetts League of Community Health Center, Inc.
        • Ottaa yhteyttä:
        • Päätutkija:
          • Susan Dargon-Hart
    • Texas
      • Dallas, Texas, Yhdysvallat, 75390
        • University of Texas Southwestern Medical Center
        • Ottaa yhteyttä:
        • Alatutkija:
          • Lynn Ibekwe-Agunanna, MPH, PhD

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

Eligibility Criteria for CHC Patients Cohorts

Inclusion Criteria (CHC Patients):

  • Adults 45-75 years old
  • Receive care in partner CHCs
  • Are of average risk for colorectal cancer
  • Received a stool-based testing order at their CHC
  • Have a mobile phone and can receive text messages (Aim 1 quantitative cohort only)
  • Fluent in English, Spanish, or another predominant language to be identified by the PI (applicable to patients focus groups cohort only)

Exclusion Criteria (CHC Patients):

  • Personal or family history of CRC or colorectal polyps
  • History of inflammatory bowel disease
  • Heritable conditions that put them at above average risk for colorectal cancer (e.g., familial adenomatous polyposis)

Eligibility Criteria for CHC Staff Cohorts Inclusion Criteria (CHC Staff)

  • Adult employees of participating CHCs
  • Job responsibilities include activities related to CRC screening

Exclusion Criteria (CHC Staff)

  • None

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
  • Jako: Satunnaistettu
  • Inventiomalli: Tehtävätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Standard Message - Gain Frame
No personalization, no concerns/negative emotion, gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Kokeellinen: Concern Message - Gain Frame
No personalization, screening concerns/negative emotions, gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
Kokeellinen: Concern Message - No Gain Frame
No personalization, screening concerns/negative emotions, no gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
Kokeellinen: Standard Message - No Gain Frame
No personalization, no screening concerns/negative emotions, no gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Kokeellinen: Personalized Message - Gain Frame
Personalization included, no screening concerns/negative emotions, gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Message includes personalized content.
Kokeellinen: Personalized Message - No Gain Frame
Personalization included, no screening concerns/negative emotions, no gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Message includes personalized content.
Kokeellinen: Personalized - Concern Message - Gain Frame
Personalization and screening concerns/negative emotions, gain framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
Kokeellinen: Personalized - Concern Message - No Gain Frame
Personalization and screening concerns/negative emotions, no gain-framed message.
Use gain-framed language to influence motivation.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Emotional concerns or barriers related to CRC screening.
Kokeellinen: Basic Outreach Only
No autonomy support, no impediments support, no live support.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Kokeellinen: Outreach + Impediments Support
No autonomy support, no live support. Impediment support.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Include information or resources to help overcome barriers to care.
Kokeellinen: Outreach + Impediments + Live Support
No autonomy support. Impediment support and live support included.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Include information or resources to help overcome barriers to care.
Kokeellinen: Outreach + Live Support
Live support included. No autonomy or impediments support.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Kokeellinen: Autonomy Outreach Support
Autonomy support included, no impediments or live support.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Provide patients with choices or options to increase sense of control.
Kokeellinen: Autonomy + Live Support
Autonomy and live support with impediments support.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Provide patients with choices or options to increase sense of control.
Kokeellinen: Autonomy + Impediments Support
Autonomy and impediments support included. No live support included.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Include information or resources to help overcome barriers to care.
Provide patients with choices or options to increase sense of control.
Kokeellinen: Autonomy + Impediments + Live Support
Autonomy, impediments, and live support included.
Electronic alerts, dashboards, and tracking systems used to identify and follow up with patients due for CRC screening or abnormal results.
Offer access to live assistance.
Include information or resources to help overcome barriers to care.
Provide patients with choices or options to increase sense of control.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Text message engagement
Aikaikkuna: 14 days after reminder message delivery
Proportion of message recipients who interact with CRC screening reminder messages by reply
14 days after reminder message delivery
Stool-based CRC screening completion
Aikaikkuna: 3 months after reminder message delivery
Proportion of message recipients with stool-based CRC screening tests resulted in electronic health record
3 months after reminder message delivery

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to follow-up care after abnormal stool-based screening test
Aikaikkuna: 3 months after date of abnormal result
Time (days) to follow-up care after abnormal stool-based screening test
3 months after date of abnormal result
Invalid test results
Aikaikkuna: 3 months after reminder message delivery
Proportion of message recipients with invalid stool-based screening test result
3 months after reminder message delivery

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Tiistai 1. joulukuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Keskiviikko 1. lokakuuta 2031

Opintojen valmistuminen (Arvioitu)

Torstai 1. tammikuuta 2032

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 29. huhtikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 29. huhtikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 6. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 10. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 9. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

All EHR derived data or data on text message intervention interactions, and any descriptive quality improvement data that we receive from the CHCs are de-identified. If qualitative data is shared, transcripts would be stripped of all identifiers.

IPD-jaon aikakehys

The data will be available when the project is complete. The data will be maintained for 7 years on our servers, per our standard practice.

IPD-jaon käyttöoikeuskriteerit

The primary restriction will be approval of data use requests by the participating community health centers' leadership. We will share the data with potential users who have a legitimate and appropriate use for data of this nature. Because the data is owned by the participating health centers, data use requests will be reviewed and approved by the health centers' leadership committee. Since the data is owned by the participating community health centers, a data use agreement will be created to allow for use and analysis by the collaborating researchers. All data use requests will be made to Dr. Kruse, who will discuss them with the study team and with CHC leadership, before any data use agreements are made and data is released.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA

Lääke- ja laitetiedot, tutkimusasiakirjat

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Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

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