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Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved

Primary Purpose

Breast Cancer in Situ

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BSPAN
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer in Situ

Eligibility Criteria

40 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for patient participants include:

  • adult females age 40-64,
  • able to read, speak and comprehend English or Spanish,
  • the capacity to comprehend study information, and
  • ability to communicate with voice (to participate in interviews).

Inclusion criteria for key county actors include:

  • involved in facilitation of mammography screening services in the counties served by the BSPAN program.
  • Both women and men will be eligible to participate.
  • No racial or ethnic group will be excluded from participation.

Exclusion Criteria:

Exclusion criteria for patient participants:

  • Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will be excluded from participation (in interviews).

Exclusion criteria for key county actors:

  • individuals not involved in the facilitation of mammography screening services in one of the counties served by the BSPAN program will be excluded from participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    BSPAN Expansion

    Arm Description

    We will expand BSPAN's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/UTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. We will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPAN tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties (BSPAN2 total= 17 counties). Findings will be used to develop a model by which BSPAN benefits can be brought to rural communities across the country.

    Outcomes

    Primary Outcome Measures

    Survey items measuring delivery of comprehensive mammography services and appropriate follow-up for women in rural and underserved counties.
    We will use NVivo 9.0 (QSR International, Melbourne AUS) to collate and analyze data from site visits notes, semi-structured interviews, and document analysis. NVivo, a well-respected qualitative data analysis software program, makes the analysis process transparent so that investigators can track their evolving analysis. Led by Drs. Lee and Inrig, the evaluation team and their staff will organize these codes into a codebook that relates data to behavioral and organizational theory. Regular meetings will enable the BSPAN evaluation team to test emergent themes and interpretation against the knowledge base of experts in clinical medicine (e.g. Argenbright), organizational behavior (Inrig, Lee), and screening behavior (Tiro). Cross-analysis of data from all sources will allow us to conduct an integrated analysis across BSPAN components to assess key steps and interface of mammography screening and appropriate follow-up.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2017
    Last Updated
    April 20, 2018
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03052907
    Brief Title
    Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved
    Official Title
    Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators will expand BSPan's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/uTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. The investigators will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPan tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties. Findings will be used to develop a model by which BSPan benefits can be brought to rural communities across the country. The investigators will use a readiness assessment criteria (RaC) to gauge county capacity and readiness for BSPan program implementation. The goal of our evaluation is to demonstrate whether a regional decentralized delivery (hub-and-spoke) model can be sustained and increase program reach to underserved rural women. The RaC tool serves two purposes: 1) to determine county capacity and 2) harness program data to facilitate communication during operations between a central BSPan hub and each county partner (spokes). Our evaluation will analyze county training and implementation of BSPan program components, and comprehensive screening processes of the hub and spoke model. The investigators will use county site visits and selected interviews of participants and staff to gain insight into factors at the participant and county levels that facilitate adoption and implementation of comprehensive screening processes, in conjunction with key quantitative metrics and process outcomes. The investigators will apply the Glasgow Re-aiM model to guide our evaluation of BSPan program component implementation in each county. Re-aiM specifies dimensions at the participant and organizational levels. Dimensions are defined as the intervention's: 1) Reach into the target population, 2) effectiveness in modifying risk, 3) adoption by target settings, 4) consistent implementation, and 5) Maintenance of its effects among participants and target settings. our mixed-methods approach will enable focus at both the individual and organizational levels and has been successfully used to assess other similar screening and health promotion programs.
    Detailed Description
    Specific aims are to: Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. Through a mixed-method analysis, using qualitative and quantitative techniques, we will define essential factors in leadership, infrastructure and local resources across the five counties of the initial BSPAN network. Using the RAC (defined in Aim 1), we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach & Health Promotion and Delivery & Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach & Health Promotion component (Medium Capacity). We will monitor the performance of two High Capacity and one Medium Capacity counties to increase program responsibility, adjust BSPAN support as needed, and calibrate the sensitivity of our RAC tool. Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up. Using the RAC (defined in Aim 1), we will characterize the capacity in each of the 12 new counties to implement components of the BSPAN program (High, Medium, and Low Capacity). We will monitor process measures and outcomes in each county at regular intervals. Results of BSPAN2 will demonstrate a sustainable hub-and-spoke model of service delivery that capitalizes on local community strengths to care for their own residents. This expansion will enable 12 new county partners to increase screening access, improve time to diagnostic resolution, and facilitate timely referral to local treatment services, while maintaining services levels in the original five counties. BSPAN2 will also produce an assessment tool and internet-based patient tracking application that can be used to disseminate a hub-and-spoke model for delivery of mammography services to rural communities across the country.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer in Situ

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18540 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BSPAN Expansion
    Arm Type
    Other
    Arm Description
    We will expand BSPAN's reach and sustainability by systematizing how to enable counties to assume responsibility for one or two of the components while Moncrief/UTSW continues to provide centralized financial review and reimbursement as the Texas BCCS contractor. We will prospectively identify which counties have the necessary program capacity, then test whether implementation of BSPAN tailored to a county's capacity and local needs can lead to equivalent program success in an additional 12 rural counties (BSPAN2 total= 17 counties). Findings will be used to develop a model by which BSPAN benefits can be brought to rural communities across the country.
    Intervention Type
    Behavioral
    Intervention Name(s)
    BSPAN
    Intervention Description
    Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services. Using the RAC, we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach & Health Promotion and Delivery & Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach & Health Promotion component (Medium Capacity). Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up.
    Primary Outcome Measure Information:
    Title
    Survey items measuring delivery of comprehensive mammography services and appropriate follow-up for women in rural and underserved counties.
    Description
    We will use NVivo 9.0 (QSR International, Melbourne AUS) to collate and analyze data from site visits notes, semi-structured interviews, and document analysis. NVivo, a well-respected qualitative data analysis software program, makes the analysis process transparent so that investigators can track their evolving analysis. Led by Drs. Lee and Inrig, the evaluation team and their staff will organize these codes into a codebook that relates data to behavioral and organizational theory. Regular meetings will enable the BSPAN evaluation team to test emergent themes and interpretation against the knowledge base of experts in clinical medicine (e.g. Argenbright), organizational behavior (Inrig, Lee), and screening behavior (Tiro). Cross-analysis of data from all sources will allow us to conduct an integrated analysis across BSPAN components to assess key steps and interface of mammography screening and appropriate follow-up.
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria for patient participants include: adult females age 40-64, able to read, speak and comprehend English or Spanish, the capacity to comprehend study information, and ability to communicate with voice (to participate in interviews). Inclusion criteria for key county actors include: involved in facilitation of mammography screening services in the counties served by the BSPAN program. Both women and men will be eligible to participate. No racial or ethnic group will be excluded from participation. Exclusion Criteria: Exclusion criteria for patient participants: Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will be excluded from participation (in interviews). Exclusion criteria for key county actors: individuals not involved in the facilitation of mammography screening services in one of the counties served by the BSPAN program will be excluded from participation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon Lee, PhD
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Breast Screening & Patient Navigation (BSPAN2): Evaluating a De-Centralized Regional Delivery System for Rural Underserved

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