Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790604
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2021-01-13
Brief Title:
ENCOMPASS Expansion Study A RCT
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Enhancing Community Health Through Patient Navigation Advocacy and Social Support ENCOMPASS Expansion Study A A Randomized Controlled Trial With Waitlist Control
Status:
COMPLETED
Status Verified Date:
2024-05
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:
ENCOMPASS
Brief Summary:
Some patients living with multiple long-term health conditions have difficulty accessing the services they need despite available primary care and community resources Patient navigation programs may help those with complex health conditions to improve their care and outcomes Community health navigators CHNs are community members who help guide patients through the health care system CHNs are not health professionals like a doctor or nurse but they are specially trained to help patients get the most out of their health care and connect them to resources The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs To understand if the CHN program can be scaled to a provincial level the ENCOMPASS program of research is expanding to select primary care settings across Alberta This study implements and evaluates the CHN program at Edmonton Oliver Primary Care Network in Edmonton Alberta Canada
Detailed Description:
Community Health Navigators CHNs are defined as community health workers that provide patient navigation Based on evidence to date CHNs for chronic disease management are likely to beneficially impact patient experience clinical outcomes and costs however contextual evidence is lacking given that most studies to date have been conducted in the United States In Canada patient navigation programs currently exist in only a few settings primarily cancer treatment and transitional care with few navigation programs implemented in chronic disease care
The ENCOMPASS program of research was initiated in 2016 when researchers with the University of Calgarys Interdisciplinary Chronic Disease Collaboration partnered with Mosaic Primary Care Network PCN to develop implement and evaluate a community health navigation program for patients with multiple chronic conditions The program was based on a systematic literature review and refined in consultation with key stakeholders A cluster-randomized controlled trial is currently ongoing with Mosaic PCN to determine the impact of the program on acute care use patient-reported outcomes and experience and disease-specific clinical outcomes NCT03077386
Alberta Primary Care Networks PCNs are comprised of groups of family physicians and other health care professionals working together to provide comprehensive patient care to Albertans To understand if the community health navigation program can be feasibly scaled and spread to PCNs across Alberta we are expanding research to examine and evaluate community health navigation program implementation to other geographic areas and populations This study expands the ENCOMPASS program of research to Edmonton Oliver PCN which represents over 170 physician members and serves approximately 131000 patients The current study employs the RE-AIM framework reach effectiveness adoption implementation and maintenance to examine the scalability of the community health navigation program
The objectives of this study are to 1 assess the impact of the intervention on the target population and health system effectiveness 2 explore the feasibility and appropriateness of practical intervention scale-up reach adoption implementation and maintenance and 3 identify the required resources and infrastructure necessary to maintain and scale the intervention provincially
The effectiveness of the community health navigator program will be studied using a two-armed pragmatic randomized waitlist-controlled trial This study will employ patient-level block randomization with research staff blinded to block size Randomization will be concealed and computer-generated Primary outcomes will be assessed using administrative health data Secondary outcomes will be measured using a patient health survey administered by a research assistant at baseline 6 months and 12 months A concurrent qualitative study will provide contextual information on the effectiveness of the community health navigator program from patient provider and CHN perspectives Process evaluation metrics and interviews with program stakeholders will inform the feasibility and sustainability of the community health navigator program in Alberta PCNs
The ENCOMPASS program of research was initiated in 2016 when researchers with the University of Calgarys Interdisciplinary Chronic Disease Collaboration partnered with Mosaic Primary Care Network PCN to develop implement and evaluate a community health navigation program for patients with multiple chronic conditions The program was based on a systematic literature review and refined in consultation with key stakeholders A cluster-randomized controlled trial is currently ongoing with Mosaic PCN to determine the impact of the program on acute care use patient-reported outcomes and experience and disease-specific clinical outcomes NCT03077386
Alberta Primary Care Networks PCNs are comprised of groups of family physicians and other health care professionals working together to provide comprehensive patient care to Albertans To understand if the community health navigation program can be feasibly scaled and spread to PCNs across Alberta we are expanding research to examine and evaluate community health navigation program implementation to other geographic areas and populations This study expands the ENCOMPASS program of research to Edmonton Oliver PCN which represents over 170 physician members and serves approximately 131000 patients The current study employs the RE-AIM framework reach effectiveness adoption implementation and maintenance to examine the scalability of the community health navigation program
The objectives of this study are to 1 assess the impact of the intervention on the target population and health system effectiveness 2 explore the feasibility and appropriateness of practical intervention scale-up reach adoption implementation and maintenance and 3 identify the required resources and infrastructure necessary to maintain and scale the intervention provincially
The effectiveness of the community health navigator program will be studied using a two-armed pragmatic randomized waitlist-controlled trial This study will employ patient-level block randomization with research staff blinded to block size Randomization will be concealed and computer-generated Primary outcomes will be assessed using administrative health data Secondary outcomes will be measured using a patient health survey administered by a research assistant at baseline 6 months and 12 months A concurrent qualitative study will provide contextual information on the effectiveness of the community health navigator program from patient provider and CHN perspectives Process evaluation metrics and interviews with program stakeholders will inform the feasibility and sustainability of the community health navigator program in Alberta PCNs
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