Promotora Navigator - Culturally Appropriate Patient Navigator

Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting

Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Screening Mammography; Community Health Worker
• Intervention / Treatment: Other: Standard of Care Mammography; Behavioral: Mammography with Community Health Worker (individual); Behavioral: Mammography with Community Health Worker (group)

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • Matthew Walker Comprehensive Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women
• Identifying as Hispanic ethnicity
• Age 40-64
• Tennessee resident

Exclusion Criteria:

• Personal history of breast cancer
• Current breast symptoms (palpable mass)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Mammography; Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.	Other: Standard of Care Mammography; Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.
Experimental: Mammography with Community Health Worker (individual); Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.	Behavioral: Mammography with Community Health Worker (individual); Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
Experimental: Mammography with Community Health Worker (group); Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.	Behavioral: Mammography with Community Health Worker (group); Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Measures From Interpersonal Processes of Care Survey	Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.	Approximately 2 weeks after consent/screening mammogram.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.	Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score.	Baseline, approximately 2 weeks after consent/screening mammogram.
Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.	Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care.	Approximately 2 weeks after consent/screening mammogram.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Lucy Spalluto, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 180276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No