Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362239
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-12
First Post:
2024-03-28
Brief Title:
Prospective Home-Based Palliative Care and Hospice Study
Sponsor:
Steven Smith
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Prospective Analysis of the Impact of Home-Based Palliative Care and Hospice Compared to Inpatient and Clinic Based Palliative Care
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care HBHPC will provide a reduction in health care utilization improve quality of life and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care PPC alone
Detailed Description:
Identify difference in outcomes between those that receive home-based hospice and palliative care HBHPC in conjunction with inpatient and clinic based palliative care compared to those who receive only inpatient and clinic based palliative care Outcomes analyzed will include hospital utilization including ICU days inpatient hospital days ED visits quality of life as defined by the individual andor primary caregivers through PEDSQL2 Family Impact Module survey and delivery of goal concordant care by individual and family
This is a prospective multi-site quasi-experimental design using an untreated comparison group with dependent pretest and posttest samples This trial is being carried out at five sites including Nationwide Childrens Hospital leadprimary site Columbus OH Akron Childrens Hospital Akron OH Texas Childrens Hospital Houston TX Nemours Hospital Wilmington DE and Medical University of South Carolina Charleston SC The experimental group consists of all participants from sites with high-access HBHPC programs and the untreated comparison group consisting of all participants from sites with low-volume HBHPC Protocols consistent across all sites are being submitted independently to the sites respective IRB for review and approval The intent is to pool deidentified data for aggregate analysis by NCH
This non-random design is selected because it is neither logistically feasible nor clinically ethical to conduct a randomized trial in which some participants would be allocated to not receive the intervention HBHPC Use of a pretest and comparison group minimizes threats to validity the lack of randomization allows the potential for selection bias However we anticipate that given the diagnostic and clinical diversity of the sample and the dearth of HBHPC access for pediatric patients that clinical acuity will naturally be matched between both cohorts
At or within the first few weeks of completing informed consent participants will complete the study surveys Study staff will recontact participants every three months to recomplete the surveys using a REDCap link or paper surveys sent and returned via participants preferred method and entered into REDCap by study staff
At or within the first few weeks of completing informed consent participants will complete the study surveys PEDSQL2 Family Impact Module Quality of Life survey and Goal Concordant Care survey Study staff will recontact participants in three month intervals for a two year period or patient death if death occurs within study period to recomplete the surveys using a REDCap link or paper surveys sent and returned or completed by phone call via participants preferred method and entered into REDCap by study staff NCH staff will create the REDCap and give the template to each site for consistency purposes Study staff will collect clinical and demographic information from the electronic medical record Study staff will securely transfer site REDCap clinical demographic and survey data to the primary site NCH for analysis Each site PI or CRC will complete their own patient follow up for survey completion Any identifiable information will be stored separately from the study data and only PIs and coordinators at each site will have access to their own access to PHI Aggregate data will be reviewed as a whole
This is a prospective multi-site quasi-experimental design using an untreated comparison group with dependent pretest and posttest samples This trial is being carried out at five sites including Nationwide Childrens Hospital leadprimary site Columbus OH Akron Childrens Hospital Akron OH Texas Childrens Hospital Houston TX Nemours Hospital Wilmington DE and Medical University of South Carolina Charleston SC The experimental group consists of all participants from sites with high-access HBHPC programs and the untreated comparison group consisting of all participants from sites with low-volume HBHPC Protocols consistent across all sites are being submitted independently to the sites respective IRB for review and approval The intent is to pool deidentified data for aggregate analysis by NCH
This non-random design is selected because it is neither logistically feasible nor clinically ethical to conduct a randomized trial in which some participants would be allocated to not receive the intervention HBHPC Use of a pretest and comparison group minimizes threats to validity the lack of randomization allows the potential for selection bias However we anticipate that given the diagnostic and clinical diversity of the sample and the dearth of HBHPC access for pediatric patients that clinical acuity will naturally be matched between both cohorts
At or within the first few weeks of completing informed consent participants will complete the study surveys Study staff will recontact participants every three months to recomplete the surveys using a REDCap link or paper surveys sent and returned via participants preferred method and entered into REDCap by study staff
At or within the first few weeks of completing informed consent participants will complete the study surveys PEDSQL2 Family Impact Module Quality of Life survey and Goal Concordant Care survey Study staff will recontact participants in three month intervals for a two year period or patient death if death occurs within study period to recomplete the surveys using a REDCap link or paper surveys sent and returned or completed by phone call via participants preferred method and entered into REDCap by study staff NCH staff will create the REDCap and give the template to each site for consistency purposes Study staff will collect clinical and demographic information from the electronic medical record Study staff will securely transfer site REDCap clinical demographic and survey data to the primary site NCH for analysis Each site PI or CRC will complete their own patient follow up for survey completion Any identifiable information will be stored separately from the study data and only PIs and coordinators at each site will have access to their own access to PHI Aggregate data will be reviewed as a whole
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