Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05611125
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2022-09-27
Brief Title:
Nursing-Driven Primary Palliative Care for Urban-Dwelling African Americans With Chronic Lung Disease
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Nursing-Driven Primary Palliative Care for Urban-Dwelling African Americans With Chronic Lung Disease
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Hillman
Brief Summary:
In prior work this research team developed a telehealth primary care model TIPC designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic Researchers will test the TIPC intervention to assess palliative care PC support for patients with chronic obstructive pulmonary disease COPD among a population of urban-dwelling African American AA persons over the course of 15 months
The aims of this study are to 1 evaluate patient caregiver and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD and 2 explore the impact of TIPC intervention on knowledge and completion of advanced care planning ACP and on hospice and healthcare utilization patterns in the target population as well as on additional quality of life QOL endpoints and compare these between individuals participating in the intervention group and control group
The aims of this study are to 1 evaluate patient caregiver and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD and 2 explore the impact of TIPC intervention on knowledge and completion of advanced care planning ACP and on hospice and healthcare utilization patterns in the target population as well as on additional quality of life QOL endpoints and compare these between individuals participating in the intervention group and control group
Detailed Description:
African Americans with chronic lung disease CLD experience higher-cost lower-quality care ie more untreated symptoms poorer provider communication care inconsistent with practices lower hospice enrollment compared to their white counterparts Uptake of PC and ACP is also substantially lower amongst AAs and other underrepresented minorities URMs due to disparate access to information and mistrust in the healthcare system as generated by systemic structural racism Additionally there are existing gaps in Jeffersons own PC program as revealed by our teams preliminary research into the programs level of cultural literacy Interviews with black indigenous people of color BIPOC enrolled with Jefferson PC revealed issues of clinician color blindness an increased need for family engagement and gaps in considering race and relationship to black pain in PC delivery
This study will enroll 20 patients from Jeffersons Center City campuses Half of the participants will be given the TIPC intervention the other half will be assigned as controls who will receive their usual standard of care All participants will be assessed over 6 months to assess changes in outcomes Specifically amongst intervention patients researchers will evaluate implementation outcomes feasibility acceptability satisfaction intervention uptake of TIPC intervention at intervention start post-visit 2 and 6 months after Both intervention and control participants will be assessed for knowledge of ACP at 3 and 6 months and health-related QOL and caregiver burden at baseline 3 months and 6 months
Researchers will also measure clinical outcomes amongst both intervention and control patients advance care planning and healthcare proxy designation hospice use avoidable healthcare utilization events over 6 months
Researchers will directly reach out to several departments including Department of Medicine Division of Pulmonary Division of Hospital Medicine and Division of Internal Medicine Department of Family and Community Medicine and Department of Emergency Medicine to identify patients and as applicable their designated caregivers for recruitment
Once potential participants are identified research team members will screen for eligibility criteria using EPIC Recruitment will continue for all patients and caregivers until the anticipated enrollment goal for each group are reached 10 intervention 10 controls
Follow-up phone calls will be made to those who have not responded at approximately 3-7 day intervals
Intervention subjects will partake in 2 telehealth visits as a part of the TIPC model The first visit between patient caregiver and PC specialist will facilitate a patient-centered consultation guided by The Serious Illness Conversation Guide and involving patient completion of several PC assessments ie Palliative Performance Scale The second visit between patient caregiver PC specialist and a pulmonology cliniciannurse will involve collaborative PC plan development and management and modeling of PC skills in an MDT framework
This research team has trained staff to assess digital literacy and access barriers amongst all research participants They will guide patients through accessing MyChart creating an email if needed and perform test telehealth visits with patients prior to the scheduled clinical telehealth visits If a patient is not able to connect at the time of their scheduled telehealth visit a team member will call them via phone to again assist as needed This research team has ample experience with this having created and deployed both the Telehealth Task Force TTF in the Sidney Kimmel Cancer Center overseen by Dr Worster and the DOT Digital Onboarding Taskforce overseen by Dr Rising
Evaluation of patient outcomes of the TIPC model will be ongoing across 6 months Implementation outcomes will be measured amongst intervention patients Feasibility acceptability and satisfaction collected via self-report will be collected at TIPC implementation and post-visit 2 Intervention uptake measured via chart review for references to the patients PC plan in clinical encounters and PC plan-based referralsadoptions will be analyzed over 6 months post-intervention
Clinical outcomes will be measured for both subjects and controls Advance care planning and healthcare proxy designation will be collected over 6 months via chart review hospice use will be collected over 6 months via chart review for hospice enrollment and length of stay LOS and avoidable healthcare utilization events will be collected over 6 months via chart review for ED visits urgent care non-scheduled visits hospitalizations and LOS with chief complaints collected for each participant
Additional follow-up outcomes of knowledge of ACP will be collected at 3 and 6 months and health-related QOL and caregiver burden will be collected at baseline 3 and 6 months for both subjects and controls via self-reporting
This study will enroll 20 patients from Jeffersons Center City campuses Half of the participants will be given the TIPC intervention the other half will be assigned as controls who will receive their usual standard of care All participants will be assessed over 6 months to assess changes in outcomes Specifically amongst intervention patients researchers will evaluate implementation outcomes feasibility acceptability satisfaction intervention uptake of TIPC intervention at intervention start post-visit 2 and 6 months after Both intervention and control participants will be assessed for knowledge of ACP at 3 and 6 months and health-related QOL and caregiver burden at baseline 3 months and 6 months
Researchers will also measure clinical outcomes amongst both intervention and control patients advance care planning and healthcare proxy designation hospice use avoidable healthcare utilization events over 6 months
Researchers will directly reach out to several departments including Department of Medicine Division of Pulmonary Division of Hospital Medicine and Division of Internal Medicine Department of Family and Community Medicine and Department of Emergency Medicine to identify patients and as applicable their designated caregivers for recruitment
Once potential participants are identified research team members will screen for eligibility criteria using EPIC Recruitment will continue for all patients and caregivers until the anticipated enrollment goal for each group are reached 10 intervention 10 controls
Follow-up phone calls will be made to those who have not responded at approximately 3-7 day intervals
Intervention subjects will partake in 2 telehealth visits as a part of the TIPC model The first visit between patient caregiver and PC specialist will facilitate a patient-centered consultation guided by The Serious Illness Conversation Guide and involving patient completion of several PC assessments ie Palliative Performance Scale The second visit between patient caregiver PC specialist and a pulmonology cliniciannurse will involve collaborative PC plan development and management and modeling of PC skills in an MDT framework
This research team has trained staff to assess digital literacy and access barriers amongst all research participants They will guide patients through accessing MyChart creating an email if needed and perform test telehealth visits with patients prior to the scheduled clinical telehealth visits If a patient is not able to connect at the time of their scheduled telehealth visit a team member will call them via phone to again assist as needed This research team has ample experience with this having created and deployed both the Telehealth Task Force TTF in the Sidney Kimmel Cancer Center overseen by Dr Worster and the DOT Digital Onboarding Taskforce overseen by Dr Rising
Evaluation of patient outcomes of the TIPC model will be ongoing across 6 months Implementation outcomes will be measured amongst intervention patients Feasibility acceptability and satisfaction collected via self-report will be collected at TIPC implementation and post-visit 2 Intervention uptake measured via chart review for references to the patients PC plan in clinical encounters and PC plan-based referralsadoptions will be analyzed over 6 months post-intervention
Clinical outcomes will be measured for both subjects and controls Advance care planning and healthcare proxy designation will be collected over 6 months via chart review hospice use will be collected over 6 months via chart review for hospice enrollment and length of stay LOS and avoidable healthcare utilization events will be collected over 6 months via chart review for ED visits urgent care non-scheduled visits hospitalizations and LOS with chief complaints collected for each participant
Additional follow-up outcomes of knowledge of ACP will be collected at 3 and 6 months and health-related QOL and caregiver burden will be collected at baseline 3 and 6 months for both subjects and controls via self-reporting
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22G350 | OTHER | Jefferson Institutional Review Board | None |