Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01933789
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2013-08-28
Brief Title:
Improving Communication About Serious Illness
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Health System Intervention to Improve Communication About End-of-Life Care for Vulnerable Patients
Status:
COMPLETED
Status Verified Date:
2019-03
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:
ICSI
Brief Summary:
The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients families and clinicians in the outpatient setting We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families To do this we created a simple short feedback form The form is designed to help clinicians understand what patients would like to talk about The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families
Detailed Description:
Four decades of research on end-of-life care indicate that people who are dying often spend their final days with a significant burden of pain and other symptoms and receive care they would not choose Patient-clinician communication about end-of-life care is an important focus for improving care for three reasons 1 when it occurs it is associated with improved quality of life reduced anxiety and fewer intensive life-sustaining therapies at the end of life 2 physicians frequently do not have discussions about end-of-life care with their patients even though most patients desire these discussions and 3 our preliminary studies suggest that a simple intervention based on each patients informational needs and preferences can increase the occurrence and quality of patient-clinician communication about end-of-life care By tailoring patient-clinician discussions to the individual patient patients will be able to make care decisions that are best for them and clinicians will be able to provide patients with the care patients desire
Our long-term goal is to ensure that patients receive the end-of-life care they desire through improved patient-clinician communication If effective this health-system intervention will improve 1 the occurrence and quality of patient-centered communication about end-of-life care for patients with chronic life-limiting illness and their families 2 the agreement between patients wishes for care and care received and 3 the burden of symptoms of anxiety and depression experienced by patients and families
We propose a randomized trial of a feedback form called a Jumpstart form provided to patients family members and clinicians specifying the individual patients communication needs and preferences concerning end-of- life care The trial will be tested with clinicians n120 who provide primary or specialty care to eligible patients at clinics of two large healthcare systems Eligible patients up to 6 per clinician goal n500 will include those with chronic life-limiting illness Family members of patients and interdisciplinary team members of primary clinicians may participate Primary clinicians will be randomized to the intervention or usual care The interventions effectiveness will be compared with usual care using validated self-report questionnaires that will be collected longitudinally baselineenrollment within 2 weeks of the target visit 3 months 6 months from patients and families Analyses include statistical approaches that take into account that there will be more than one patient for each physician and that data are collected at multiple time points
Outcomes of this study include patient assessments of 1 frequency and quality of patientclinician communication 2 agreement between care patients desire and care patients receive and 3 symptoms of anxiety and depression
We will also use qualitative data to accomplish the following goals 1 to explore subjects experiences with the studys activities 2 to understand barriers to participation and 3 to explore patient and family experiences with the intervention To obtain these goals we will contact a total of 30-40 participants selected from all subject groups to participate in one-on-one semi-structured interviews during which they will be asked to share their experiences as a study participant and their perspectives on study activities
Our long-term goal is to ensure that patients receive the end-of-life care they desire through improved patient-clinician communication If effective this health-system intervention will improve 1 the occurrence and quality of patient-centered communication about end-of-life care for patients with chronic life-limiting illness and their families 2 the agreement between patients wishes for care and care received and 3 the burden of symptoms of anxiety and depression experienced by patients and families
We propose a randomized trial of a feedback form called a Jumpstart form provided to patients family members and clinicians specifying the individual patients communication needs and preferences concerning end-of- life care The trial will be tested with clinicians n120 who provide primary or specialty care to eligible patients at clinics of two large healthcare systems Eligible patients up to 6 per clinician goal n500 will include those with chronic life-limiting illness Family members of patients and interdisciplinary team members of primary clinicians may participate Primary clinicians will be randomized to the intervention or usual care The interventions effectiveness will be compared with usual care using validated self-report questionnaires that will be collected longitudinally baselineenrollment within 2 weeks of the target visit 3 months 6 months from patients and families Analyses include statistical approaches that take into account that there will be more than one patient for each physician and that data are collected at multiple time points
Outcomes of this study include patient assessments of 1 frequency and quality of patientclinician communication 2 agreement between care patients desire and care patients receive and 3 symptoms of anxiety and depression
We will also use qualitative data to accomplish the following goals 1 to explore subjects experiences with the studys activities 2 to understand barriers to participation and 3 to explore patient and family experiences with the intervention To obtain these goals we will contact a total of 30-40 participants selected from all subject groups to participate in one-on-one semi-structured interviews during which they will be asked to share their experiences as a study participant and their perspectives on study activities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None