Oregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were randomly chosen to apply for insurance coverage via the Oregon Experiment

Oregon OCHIN patients that put their names on the reservation list for the Oregon Experiment and were not chosen to apply for insurance coverage via the Oregon Experiment

Random selection to apply for Medicaid coverage through Oregon Experiment drawings held between March and October 2008

Insurance Intervention

Jennifer E DeVoe, MD, DPhil

Heather Angier, MPH

This study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (EHR) data.

In 2008, the Oregon Medicaid program used a "lottery" (Oregon Experiment) to allocate limited insurance resources to low income adults who did not categorically qualify for traditional Medicaid coverage. Thousands were randomly selected to apply for Medicaid; many others were not selected. This "natural policy experiment" is the first population-level randomization of insurance coverage since Rand's 1971-1982 experiment. We will use data from safety net clinics that share a common electronic health record (EHR) operated by OCHIN, a non-profit organization in Portland, Oregon. As one of the nation's largest linked community health center networks, the OCHIN EHR database records nearly all visits to safety net clinics in Oregon with one patient chart linked across \>100 community health centers. We will link Medicaid claims data and the OCHIN database to determine patients that had applied to participate in the Oregon Experiment, as well as to determine those that gained insurance via this experiment. We will test the hypothesis that public insurance coverage is associated with higher rates of receiving preventive care services and increased healthcare utilization among persons with a usual source of primary care. To that end, we will analyze preventive care and utilization patterns among the OCHIN clinic patients affected by Oregon's Medicaid Experiment. This study capitalizes on two unique opportunities: an EHR database linking \>100 community health centers, and the quasi-experimental design of Oregon's randomized Medicaid experiment.

The specific aims related to the Oregon Experiment are:

1) To compare post-intervention rates of preventive services receipt among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group); and 3) To compare post-intervention rates of ambulatory healthcare utilization among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group).

Assessing a Medicaid Randomized Insurance Experiment Within Community Clinics

Number of patients with receipt of the following preventive services in the post-period (each outcome assessed individually by whether person met age, gender, and diagnosis criteria (if applicable): body mass index, blood pressure, smoking, pap test, mammography, colorectal cancer screening, chlamydia screening, lipid test, flu vaccination, pneumococcal vaccination, HbA1c test, glucose test) using ICD-9-CM diagnosis and procedure codes, CPT and HCPCS codes, LOINC codes, medication codes, relevant code groupings and codes specific to the OCHIN EHR.

Number of visits in the post-period for the following services: total primary care office visits, total behavioral/mental health visits, labs, referrals, immunizations, imaging)

Kaiser Foundation Hospitals, Center for Health Research

OCHIN, Inc.

National Heart, Lung, and Blood Institute (NHLBI)

Oregon Health and Science University

Associate Professor

Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Access to systems-level interventions to increase colorectal cancer screening.

Practices will receive access to intervention components after outcomes data collection is complete.

Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.

Systems-level intervention to promote colon cancer screening

Aimee S James, PhD, MPH

Colorectal cancer is the second leading cause of cancer death and one of the most commonly diagnosed malignancies. Screening is effective at reducing incidence and mortality from colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes in community health centers that facilitate screening.

Colorectal cancer (CRC) is one of the cancers that our community partners have identified as a priority. It is the second leading cause of cancer death in the United States, and one with significant disparities in screening, stage of diagnosis, and survival. Underinsured and uninsured adults are less likely to be screened, more likely to have their cancer diagnosed at a late stage, and less likely to survive CRC. In this project we will work with "safety-net" health centers serving Medicaid and uninsured patients in St. Louis City and St. Louis County in Missouri, and in East St. Louis/St. Clair County in Illinois. Working with our Colorectal Cancer Community Partnership we planned a cluster-randomized delayed start trial to test the effectiveness of offering community health centers a "Menu" of evidence-based systems interventions for increasing rates of CRC screening. The strategies included in the Menu will be drawn from evidence-based interventions. The control condition will be usual care, but in concordance with our partners' wishes, we will offer all participating health centers access to state-of-the-art evidence-based patient education materials. The primary outcome will be CRC screening adherence as measured by self-report surveys of a random sample of health center patients. Our evaluation will also be informed by a chart audit to assess screening referral and completion, surveys of physicians and staff at intervention sites to assess implementation outcomes, and exit interviews with administration of intervention health centers to assess maintenance of the intervention strategies. We developed and will conduct our study adhering to the principles of community-based participatory research (CBPR). The specific aims are: (1) Working with community partners, we will select and refine the evidence-based intervention strategies for the trial; (2) Using a CBPR approach, we will collaborate with our partners to implement and evaluate the systems-level intervention for its effectiveness in increasing CRC screening rates. (3) Using the RE-AIM framework, we will work with our partners to evaluate implementation and maintenance of systems changes by intervention health centers and adoption of the changes by control centers. Compared to traditional clinics and healthcare providers, safety-net health centers face additional challenges in implementing evidence-based strategies for increase screening uptake; yet rigorously testing such strategies in this context is novel. Allowing health centers to select from a menu of strategies will provide a practical test of effectiveness, and will increase buy-in and representativeness of participating health centers. As a practical clinical trial with good external validity, this project has the potential for significant impact on CRC screening rates with promise for substantial impact on disparities in CRC burden. This study is responsive to community concerns about CRC and about no-intervention control groups, and is responsive to the RFA by proposing a CBPR randomized controlled trial to increase access to and utilization of CRC screening procedures.

Systems Intervention to Promote Colorectal Cancer (CRC) Screening

Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities

Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.

National Cancer Institute (NCI)

Washington University School of Medicine

Infections

Virus Diseases

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Vaccines

Initial group of community health centers to receive intervention

Second group of community health centers to receive intervention

The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) provider-level intervention for all clinical staff (e.g., physicians, nurses, medical assistants) includes a 1-hour online training session on the Announcement Approach (i.e., presumptive recommendation) to recommend adolescent vaccinations.

HPV MISTICS -Provider Level

The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) parent-level intervention includes a low literacy pre-visit HPV vaccine notification post card in the parent's preferred language.

HPV MISTICS - Parent Level

The HPV MISTICS (Multilevel Intervention Strategies Targeting Immunization in Community Settings) system-level intervention involves training an HPV Vaccine Champion at each FQHC on the provider and parent EBIs to monitor and share clinic HPV initiation and completion rates with providers, and to implement reminder/recall systems for subsequent vaccine doses

HPV MISTICS- HPV Vaccine Champion Level

Lindsay Fuzzell

Susan T Vadaparampil, PhD, MPH

Shannon Christy, PhD

Kea Turner, PhD, MPH, MA

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.

The goals of this multi-level intervention study are to: 1) test whether HPV MISTICS intervention increases human papillomavirus (HPV) vaccine initiation and completion rates among 11-17-year-old adolescents in 8 Health Choice Network-affiliated community health centers in Florida. 2) Explore other factors related to the intervention effect. 3) Explore implementation outcomes (i.e., reach, adoption, implementation, maintenance, and sustainability) and identify implementation barriers and facilitators with a focus on equity. The study will use parent-, provider-, and health center-level strategies to promote HPV vaccination.

Hybrid Type 1 implementation design which will allow the team to examine both effectiveness of HPV MISTICS and implementation outcomes in a single study. Implementation outcomes will be evaluated using the RE-AIM Qualitative Evaluation for Systematic Translation (RE-AIM QuEST) framework, a mixed-methods framework to identify implementation barriers and facilitators while assessing implementation outcomes (e.g., reach, adoption, implementation, maintenance/sustainability) with a focus on evaluating equity across these outcomes.

HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)

HPV vaccine series initiation (1st dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.

HPV vaccine series completion (2nd and 3rd dose) rates among adolescents ages 11-17 will be determined on a monthly basis as well as annually. Providers' vaccination rate data for their patient panel (using Florida SHOTS - a free, statewide centralized online immunization information system) will be compared to the National Immunization Survey-Teen (NIS-TEEN) data for the state of Florida.

The intervention's implementation will be evaluated for reach - proportion of eligible patients that receive the intervention.

The intervention's implementation will be evaluated for reach - demographics of patients reached.

The proportion of health care providers who participate in the intervention, measured by contact log data.

The proportion of health care providers in rural vs urban Federally Qualified Health Centers in network that participate.

The proportion of participating health care providers and staff who complete training per site will be measured using the training attendance log

Long term intervention effects and use over time will be determined semi-structured interviews of providers

Long term intervention effects and use over time will be determined semi-structured interviews of health care staff.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing a Medicaid Randomized Insurance Experiment Within Community Clinics	NCT02355132	Cardiovascular ... Cancer	Insurance Inter...	19 Years - 64 Years	Oregon Health and Science University
Systems Intervention to Promote Colorectal Cancer (CRC) Screening	NCT01299493	Carcinoma	Systems-level i...	-	Washington University School of Medicine
Systems Intervention to Promote Colorectal Cancer (CRC) Screening	NCT01299493	Carcinoma	Systems-level i...	-	Washington University School of Medicine
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)	NCT05677360	Human Papilloma...	HPV MISTICS -Pr... HPV MISTICS - P... HPV MISTICS- HP...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for community health centers