With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care

Palliative Care Clinical Trial

Official title:

With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736031
• Other study ID #: E18031
• Status: Completed
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite being strongly recommended, the integration of palliative care in oncology has not been widely adopted. Very few people have access to comprehensive palliative care. Access is even lower in rural and Hispanic communities. Even in communities with access, uptake is often low due to a lack of education on the part of both patients and providers regarding palliative care. This study aims to use an innovative approach to provide quality palliative care to oncology Hispanic patients by using community health workers also known as promotoras.

Description:

Palliative care has been highly recommended to be an integral part of oncology yet very few people have access to comprehensive palliative care. Access is even lower in rural, low socio-economic and Hispanic communities. Palliative care has been shown to decrease healthcare costs. This study will use an innovative approach to provide quality palliative care to gynecology-oncology Hispanic patients by using community health workers also known as promotoras. The promotora model has been shown to be successful in several behavioral modification programs. The investigators aim to use promotoras to deliver a comprehensive and culturally sensitive educational intervention that covers self-care in the presence of cancer, advance directives, pain management, and care taker awareness. The goal of the intervention will be to decrease number of emergency department visits and hospital admissions of patients with advanced cancer, and increase the rate of completion of advanced directives, as well as improve overall quality of life (as measured by standardized scales) when comparing the intervention group vs. the control (usual care) group. The investigators will additionally assess the cost effectiveness of this intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 30, 2020
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Must be 18 years or older

• Must be a Texas Tech University Health Sciences Center El Paso (TTUHSC El Paso) or University Medical Center (UMC) El Paso patient

• Must be Hispanic

• Must have a cancer diagnosis

Exclusion Criteria:

• Under 17 years of age

• Not Hispanic

• Is not a patient of UMC or TTUHSC El Paso

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Intervention (Promotora)
If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire - 9 (PHQ-9)	Patient Health Questionnaire -9 (PHQ-9); the score can range from 0 - 27; the lower score indicates a better outcome	The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed..
Primary	Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal)	Functional Assessment Chronic Illness Therapy (FACIT)-Palliative care (Pal), score range 0-184, a higher score means a better outcome.	The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed.
Secondary	Emergency Department Visits	Frequency of visits will be analyzed as an intent-to-treat analysis	six weeks after enrollment
Secondary	Intensive Care Unit Admissions	Frequency of visits will be analyzed as an intent-to-treat analysis	six weeks after enrollment