Promotora Navigator - Culturally Appropriate Patient Navi... | NCT03557801

Description Module

Brief Summary

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care Mammography	Active Comparator	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
Mammography with Community Health Worker (individual)	Experimental	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)
Mammography with Community Health Worker (group)	Experimental	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mammography with Community Health Worker (individual)	Behavioral	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Name	Affiliation	Role
Lucy Spalluto, MD	Vanderbilt University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Matthew Walker Comprehensive Health Center		Nashville	Tennessee	37208	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 6, 2018

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Mammography With Community Health Worker (Group)	Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00034 BG00133 BG00233 BG003100

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Participants that completed the study.

Posted

Median

Inter-Quartile Range

score on a scale

Approximately 2 weeks after consent/screening mammogram.

ID	Title	Description
OG000	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.
OG001	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.
OG002	Mammography With Community Health Worker (Group)	Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 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.

Units	Counts
Participants	OG00032 OG00132 OG00230

Title

Denominators

Categories

Title	Measurements
	OG00073(70.5 to 79) OG00178(75 to 84) OG00277(72 to 85)

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, approximately 2 weeks after consent/screening mammogram.

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Participants that completed the study.

Posted

Mean

Standard Deviation

score on a scale

Approximately 2 weeks after consent/screening mammogram.

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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.	34	34	34
EG001	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.	33	33	33
EG002	Mammography With Community Health Worker (Group)	Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 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.	33	33	33

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003150	Community Health Workers
D044382	Population Groups

ID	Term
D000488	Allied Health Personnel
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services
D003710	Demography
D011154	Population Characteristics