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Clinical Trials/NCT06412029
NCT06412029
Enrolling By Invitation
Not Applicable

Understanding and Enhancing Health-Related Social Needs (HRSN) Screening Among Community Oncology Practices

Wake Forest University Health Sciences71 sites in 2 countries144 target enrollmentNovember 20, 2024
ConditionsCancer
InterventionsNon-Interventional

Overview

Phase
Not Applicable
Intervention
Non-Interventional
Conditions
Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
144
Locations
71
Primary Endpoint
HRSN screening reach (Part 1)
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

Brief Summary

This study evaluates health related social needs screening processes in community oncology clinics.

Detailed Description

The primary objective of this study is to assess current processes around health related social needs (HRSN) screening among NCORP clinics and categorize clinics based on their implementation of HRSN screening. The primary endpoint will be a detailed understanding of current processes, with attention to variability by key clinic characteristics. There are 3 parts of the study in which participants can participate in one or all parts (3 total). Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study. Part 2: Identified clinic staff will be interviewed to discuss factors that influence HRSN screening at their clinic and help develop generalized guidance. Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.

Registry
clinicaltrials.gov
Start Date
November 20, 2024
End Date
November 1, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • NCORP PRACTICES:
  • Must be an affiliate or sub-affiliate of an NCORP Community or Minority Underserved Community site
  • Must provide outpatient oncology care
  • Must be a NCORP practice (defined as one or more NCORP affiliates/sub-affiliates, that have a common administrative structure and share providers and/or patients)
  • Must have identified two or more Practice Staff that are available and willing to participate on the Practice Interest Form
  • Must have identified at least 1-3 outpatient oncology clinics willing to participate on the Practice Interest Form
  • 1-3 clinics within the practice should be selected
  • Clinics may or may not be located in different physical locations
  • The investigators will encourage NCORP practices to select clinics within a practice that differ in current or potential implementation of health related social needs (HRSN) screening (e.g., different clinic workflow or staff, different screening triggers, different tools), so that heterogeneity within NCORP practices can be captured
  • Clinics must be willing to allow Practice Staff participants to observe the clinical operations in-person

Exclusion Criteria

  • PRACTICE STAFF:
  • \*\* Unable to understand, read and communicate in English, as the trainings and observations will be documented in English
  • STAFF WORKSHOP PARTICIPANT:
  • \*\* Unable to understand, read and communicate in English, as the workshop will be conducted in English
  • PATIENT WORKSHOP PARTICIPANT:
  • \*\* Unable to understand, read and communicate in English, as the workshop will be conducted in English

Arms & Interventions

Part 1

Part 1: Participants attend training, complete clinic assessments and observations and may complete an interview on study.

Intervention: Non-Interventional

Part 2

Part 2: Identified clinic staff will be interviewed to discuss factors that influence health related social needs (HRSN) screening at their clinic and help develop generalized guidance.

Intervention: Non-Interventional

Part 3

Part 3: Participants attend a co-design workshop and complete surveys on study feasibility.

Intervention: Non-Interventional

Outcomes

Primary Outcomes

HRSN screening reach (Part 1)

Time Frame: From study enrollment to approximately 4 and 16 weeks post initial study training

Determining the perception of the proportion of patients at clinics who are screened for health related social needs (HRSN).

Barriers and facilitators influencing HRSN screening implementation

Time Frame: From study enrollment to time completion of key informant interviews, approximately within 6 months

Synthesize themes to create a list of barriers and facilitators influencing HRSN screening implementation within high-implementation clinics, moderate-implementation clinics, and low-implementation clinics.

Generation of a tailored implementation plan for each participating clinic

Time Frame: Between time of clinic selection and co-design workshop completion, to be no more than 6 months

Generation (defined for each clinic as completed or not completed) of a tailored implementation plan for each participating clinic in Part 3 that includes (1) adaptations to current HRSN screening and follow-up processes, and (2) potential implementation strategies to enhance HRSN screening implementation.

Study Sites (71)

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