Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

Information

  • Research Project
  • 10474768
  • ApplicationId
    10474768
  • Core Project Number
    R56HL159216
  • Full Project Number
    1R56HL159216-01
  • Serial Number
    159216
  • FOA Number
    PAR-19-274
  • Sub Project Id
  • Project Start Date
    9/15/2021 - 2 years ago
  • Project End Date
    8/31/2022 - a year ago
  • Program Officer Name
    DONZE, LAURIE FRIEDMAN
  • Budget Start Date
    9/15/2021 - 2 years ago
  • Budget End Date
    8/31/2022 - a year ago
  • Fiscal Year
    2021
  • Support Year
    01
  • Suffix
  • Award Notice Date
    9/10/2021 - 2 years ago
Organizations

Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

ABSTRACT Standardized protocols can reduce the impact of implicit bias but are underused. Since the Institute of Medicine?s report, ?Unequal Treatment?, multiple studies have confirmed that standardization of decision- making processes reduces bias, but bias in the allocation of advanced therapies has not been addressed. Using an evidence-based framework for behavior change [Capability, Opportunity, and Motivation for Behavior Change/Behavior Change Wheel (COM-B/BCW)], we developed a standardized protocol strategy, Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF), that addresses significant barriers to equity in advanced therapies: 1) bias, 2) subjectivity in evaluation of social support and adherence, and 3) poor group dynamics. Thus, SOCIAL HF includes: 1) evidence-based bias training tailored for HF, 2) restriction to objective evaluations of social support and adherence, and 3) environmental restructuring and modeling of meeting settings to include anonymous electronic voting and equitable seating arrangement. In complex decision-making that includes individuals and groups, our standardized protocol strategy, SOCIAL HF, has the greatest likelihood of achieving health equity in advanced HF. Our goal is to assess real-world effectiveness (Aim 1) and implementation (Aim 2) of SOCIAL HF for allocation of advanced HF therapies, heart transplant and ventricular assist device implantation. We will use a cluster randomized design to test the effectiveness of SOCIAL HF strategy. We will evaluate implementation of SOCIAL HF across study sites using mixed-methods in order to learn optimal implementation strategies to achieve equity. We will use normalization process theory to evaluate how SOCIAL HF affects processes and outcomes important to advanced HF centers (e.g. fidelity/variation). We will use RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate factors that promote reach and adoption and resources needed for implementation. We have the relationships, infrastructure, and expertise to execute this project; our multidisciplinary team includes experts in HF, evidence-based bias reduction training, clinical trials, mixed-methods, and implementation science.

IC Name
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
  • Activity
    R56
  • Administering IC
    HL
  • Application Type
    1
  • Direct Cost Amount
    595788
  • Indirect Cost Amount
    310193
  • Total Cost
    905981
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    837
  • Ed Inst. Type
  • Funding ICs
    NHLBI:905981\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    HHD
  • Study Section Name
    Healthcare and Health Disparities Study Section
  • Organization Name
    UNIVERSITY OF ARIZONA
  • Organization Department
  • Organization DUNS
    806345617
  • Organization City
    TUCSON
  • Organization State
    AZ
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    857210158
  • Organization District
    UNITED STATES