Increasing CRC Screening in Community Health Centers Through Mobile Messaging Optimization (CoSMMO)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Gedragsmatig: Message Framing Text Message
- Ander: Data Reporting and Visualization System Tools
- Gedragsmatig: Screening Concerns Text Message
- Gedragsmatig: Personalized Text Message
- Gedragsmatig: Live Support Outreach
- Gedragsmatig: Impediments Support Outreach
- Gedragsmatig: Autonomy Support Outreach
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Yamila Sierra
- Telefoonnummer: 303-724-4811
- E-mail: yamila.sierra@cuanschutz.edu
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General Hospital
-
Contact:
- Stephanie Martinez, MPH
- Telefoonnummer: 617-643-4995
- E-mail: smartinez7@mgb.org
-
Onderonderzoeker:
- Adjoa Anyane-Yeboa, MD, MPH
-
Boston, Massachusetts, Verenigde Staten, 02215
- Dana Farber Cancer Institute
-
Contact:
- Soumya Mohanty, MBBS, MD, MPH
- Telefoonnummer: 857-263-9746
- E-mail: soumya_mohanty@dfci.harvard.edu
-
Onderonderzoeker:
- Kasisomayajula Viswanath, PhD
-
Boston, Massachusetts, Verenigde Staten, 02108
- The Massachusetts League of Community Health Center, Inc.
-
Contact:
- Susan Dargon-Hart, LICSW
- Telefoonnummer: 617-877-6535
- E-mail: sdargonhart@massleague.org
-
Hoofdonderzoeker:
- Susan Dargon-Hart
-
-
Texas
-
Dallas, Texas, Verenigde Staten, 75390
- University of Texas Southwestern Medical Center
-
Contact:
- Lynn N Ibekwe-Agunanna, PhD, MPH
- Telefoonnummer: 214-645-2532
- E-mail: Lynn.Ibekwe-Agunanna@utsouthwestern.edu
-
Onderonderzoeker:
- Lynn Ibekwe-Agunanna, MPH, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Text message engagement
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to follow-up care after abnormal stool-based screening test
Tijdsspanne: 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
Tijdsspanne: 3 months after reminder message delivery
|
Proportion of message recipients with invalid stool-based screening test result
|
3 months after reminder message delivery
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Gina Kruse, MD, University of Colorado, Denver
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Darmziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Intestinale neoplasmata
- Rectale ziekten
- Colon Ziekten
- Colorectale neoplasmata
- Onderzoekstechnieken
- Methoden
- Research Design
Andere studie-ID-nummers
- 25-1144.cc
- R01CA293501 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
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