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CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers

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ClinicalTrials.gov Identifier: NCT02355262
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
Kaiser Permanente
National Cancer Institute (NCI)
Oregon Community Health Information Network
Oregon Health and Science University
Information provided by (Responsible Party):
Jennifer Devoe, MD, OHSU Knight Cancer Institute

Brief Summary:
This randomized research trial studies the Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP) intervention in increasing cancer screening and prevention care in uninsured patients at community health centers. The CATCH-UP intervention may contribute to increased rates of insurance coverage, leading to improved cancer screening and prevention rates in community health care settings, and general recommended preventive care.

Condition or disease Intervention/treatment
Breast Carcinoma Cervical Carcinoma Colorectal Carcinoma Health Status Unknown Human Papillomavirus Infection Malignant Neoplasm Other: Informational Intervention

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate the effect of the CATCH-UP intervention on up-to-date status of cancer screening and preventive care received by patients.

II. Evaluate the effect of the CATCH-UP intervention on patients? insurance coverage rates.

III. Evaluate the intervention implementation process, patient and community health center (CHC) staff acceptance and use of the CATCH-UP tools, and the patient-, provider-, and system-level factors associated with successful implementation and sustainability of the tools, using mixed methods.

OUTLINE: CHC clinics are randomized to 1 of 2 groups. We compare between groups and with a matched-comparison group.

GROUP I (INTERVENTION ARM 1): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.

GROUP II (INTERVENTION ARM 2): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.

Matched-comparison group: A clinic-level matched comparison group will be derived from the OCHIN membership by using propensity score matching techniques. Comparison group clinics will not participate actively in any study activities but, as part of their member business associate agreement with OCHIN, have already agreed to provide data through OCHIN for pre- and post-implementation analysis in the study.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Community-Based HIT Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP)
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Arm I (Independent Tool Implementation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
Other: Informational Intervention
Receive CATCH-UP intervention

Arm II (Tool Implementation with Interactive Facilitation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
Other: Informational Intervention
Receive CATCH-UP intervention




Primary Outcome Measures :
  1. Changes in the proportion of clinic patients who receive age- and gender-appropriate recommended cancer screening and preventive care (clinic-level) [ Time Frame: Baseline to up to 6 years ]
    Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis). Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.

  2. Changes in the proportion of clinic patients with insurance continuity [ Time Frame: Baseline to up to 6 years ]
    Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis). Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates. Serial and intra-clinic correlations will be modeled as random effects.

  3. Total number of months uninsured (total gap months) [ Time Frame: Up to 6 years ]
    The Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion tool?s impact on total number of months uninsured (total gap months) will be evaluated. The distribution of total gap months will be examined before selecting a specific model to use for the analysis. Analytic models will be refined through an iterative process, guided by the hypotheses and preliminary analyses.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with at least one encounter at a CHC in the OCHIN network since January 1, 2012
Criteria

Inclusion Criteria:

  • Established patients at CHC sites
  • Low-income
  • Ethnically diverse populations with lower rates of cancer screening compared to national rates
  • Uninsured patients
  • Patients 18 to 64 years of age
  • Clinics must be primary care sites, with greater than 1,000 adult patients in the past year, be located in a state that expanded Medicaid, and have implemented the OCHIN EHR prior to January 1, 2012

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355262


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Kaiser Permanente
National Cancer Institute (NCI)
Oregon Community Health Information Network
Oregon Health and Science University
Investigators
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Principal Investigator: Jennifer DeVoe OHSU Knight Cancer Institute
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Devoe, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02355262    
Other Study ID Numbers: IRB00009862
NCI-2014-02326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CR00024554
5219
MR00042926
MR00044877
IRB00009862 ( Other Identifier: OHSU Knight Cancer Institute )
R01CA181452 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Keywords provided by Jennifer Devoe, MD, OHSU Knight Cancer Institute:
Insurance Coverage
Insurance Continuity
Additional relevant MeSH terms:
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Papillomavirus Infections
Carcinoma
Breast Neoplasms
Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections