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NCT Number: NCT02355262

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Cervical Carcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Health Status Unknown Human Papillomavirus Infection Infections Intestinal Diseases Intestinal Neoplasms Malignant Neoplasm Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive CATCH-UP intervention

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Kaiser Permanente
  • National Cancer Institute (NCI)
  • Oregon Community Health Information Network
  • Oregon Health and Science University

Registry information

Official study title

Community-Based HIT Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP)

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2015
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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