Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03326206
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2017-10-24
Brief Title:
Evaluating the Navajo Community Outreach and Patient Empowerment COPE Program
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Evaluating the Navajo Community Outreach and Patient Empowerment COPE Program
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since 2009 a programmatic community-based strategy COPE has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions COPE Community Outreach and Patient Empowerment targets individual family and health system-level factors through four activities 1 coordination between community health representatives CHRs and Indian Health Service providers 2 CHR competency with standardized training 3 a culturally-sensitive health promotion curriculum for patients and families and 4 strong CHR supervision
COPE has been implemented throughout Navajo Nation Enrollment is programmatic in other words the decision to enroll a patient in COPE occurs independently of whether the patient is in this study Participants receive the COPE intervention in the same manner and intensity whether they are included in this observational study or not
The main goal of this observational research is to understand if COPE improves the lives of participating community members The Primary Aim is to assess the impact of the COPE Project on changes in HbA1c and other CVD risk factors Hypothesis Patients enrolled in the COPE program will experience a reduction in HbA1c compared to the control group Secondary aims are 1 To understand if COPE improves patients own self-reported outcomes Hypothesis COPE patients will report better health compared with their own baseline at 12 months 2 To Identify factors associated with increased effectiveness of the COPE Project at the individual community and health system level using a mixed-model approach 3 To understand diverse stakeholder perspectives on COPE impact and value among CHRs providers and the health care system Hypothesis Compared with baseline CHRs will report greater empowerment in their work providers will report greater confidence in CHRs
The observational cohort will be comprised of individuals with diabetes receiving care at one of the participating health facilities Cases include individuals participating in the COPE intervention controls are non-COPE participants identified within the same hospital and matched based on similar baseline characteristics Study findings will improve clinical and patient-decision making and the health of marginalized AIANs by informing policies to promote CHR interventions in rural and underserved communities
COPE has been implemented throughout Navajo Nation Enrollment is programmatic in other words the decision to enroll a patient in COPE occurs independently of whether the patient is in this study Participants receive the COPE intervention in the same manner and intensity whether they are included in this observational study or not
The main goal of this observational research is to understand if COPE improves the lives of participating community members The Primary Aim is to assess the impact of the COPE Project on changes in HbA1c and other CVD risk factors Hypothesis Patients enrolled in the COPE program will experience a reduction in HbA1c compared to the control group Secondary aims are 1 To understand if COPE improves patients own self-reported outcomes Hypothesis COPE patients will report better health compared with their own baseline at 12 months 2 To Identify factors associated with increased effectiveness of the COPE Project at the individual community and health system level using a mixed-model approach 3 To understand diverse stakeholder perspectives on COPE impact and value among CHRs providers and the health care system Hypothesis Compared with baseline CHRs will report greater empowerment in their work providers will report greater confidence in CHRs
The observational cohort will be comprised of individuals with diabetes receiving care at one of the participating health facilities Cases include individuals participating in the COPE intervention controls are non-COPE participants identified within the same hospital and matched based on similar baseline characteristics Study findings will improve clinical and patient-decision making and the health of marginalized AIANs by informing policies to promote CHR interventions in rural and underserved communities
Detailed Description:
Study population The study will take place on the Navajo Reservation and within Navajo Area IHS clinical facilities The Navajo Reservation covers over 27000 square miles in rural New Mexico and Arizona The proposed evaluation will occur at the six sites including two which are currently implementing COPE as well as four sites which will implement COPE in the next two years The health care centers included in this evaluation represent a mix of federally and tribally operated programs and together provide care for over 200000 individuals All sites use a common suite of software applications to record electronic health care data the IHS RPMS Resource Patient Management System
Study Design The research is aligned with PCORIs definition of patient-centered research by answering questions that will allow patients and other stakeholders to make informed health care decisions This will be completed by incorporating patient input at all stages comparatively assessing the benefits and weaknesses of COPE capturing the voice of stakeholders through qualitative methods choosing outcomes that have been cited as relevant to patients own priorities and decision-making and studying cross-site variation to capture individual and community factors associated with impact The study will address the following questions
1 Do clinical outcomes hemoglobin A1c blood pressure cholesterol and body mass index improve more among COPE participants compared with similar patients who do not participate in COPE
2 Do COPE patients experience improvements in self-rated overall health quality of life empowerment and satisfaction compared with similar patients who do not participate in COPE
3 As COPE is implemented in six different service units across the Navajo Nation can we identify any factors among patients CHRs and hospitals that are key ingredients for COPE to be effective
4 Does COPE benefit the health system and population served from diverse stakeholder perspectives including CHRs providers and the local health care delivery system
Study Design The research is aligned with PCORIs definition of patient-centered research by answering questions that will allow patients and other stakeholders to make informed health care decisions This will be completed by incorporating patient input at all stages comparatively assessing the benefits and weaknesses of COPE capturing the voice of stakeholders through qualitative methods choosing outcomes that have been cited as relevant to patients own priorities and decision-making and studying cross-site variation to capture individual and community factors associated with impact The study will address the following questions
1 Do clinical outcomes hemoglobin A1c blood pressure cholesterol and body mass index improve more among COPE participants compared with similar patients who do not participate in COPE
2 Do COPE patients experience improvements in self-rated overall health quality of life empowerment and satisfaction compared with similar patients who do not participate in COPE
3 As COPE is implemented in six different service units across the Navajo Nation can we identify any factors among patients CHRs and hospitals that are key ingredients for COPE to be effective
4 Does COPE benefit the health system and population served from diverse stakeholder perspectives including CHRs providers and the local health care delivery system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None