Ignite Creation Date:
2024-05-05 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00720200
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2008-07-18
Brief Title:
ICU Family Communication Study
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2014-09
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 improve care in the Intensive Care Unit ICU by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians
Detailed Description:
Three decades of research on end-of-life care in the United States indicate that people who are dying often spend their final days receiving care they would not choose The intensive care unit ICU is an important focus for efforts to improve end-of-life care both because death is common in this setting - approximately 20 of Americans die in or shortly after a stay in the ICU - and also because care is highly technologic and thus expensive As a result of our prior work we have developed a wealth of knowledge about how to improve communication and decision-making concerning end-of-life care in the ICU One of the important insights from this knowledge was the need for and development of a facilitator-assisted interdisciplinary communication intervention This intervention designed to improve communication and decision-making about end-of-life care in the ICU offers significant potential benefits for improving patient- and family-centered care for five reasons 1 communication is an integral component of clinician skill that affects all other aspects of end-of-life care 2 physicians and nurses in practice do not demonstrate adequate skills for communicating about end-of-life care especially in the ICU or acute care setting 3 interventions that have focused on improving communication within the ICU team and between the team and the family have been shown to reduce the prolongation of dying common in the ICU but it remains unclear how to generalize these successes to other hospitals 4 a recent randomized trial in France used an intervention based on our prior research and showed dramatic reductions in symptoms of anxiety depression and post-traumatic stress disorder PTSD among family members after the patients death but it is unclear how to translate these findings to hospitals in the US and 5 sustainable generalizable and widely available interventions that improve communication about end-of-life care are not available
The long-term objectives are 1 to demonstrate the efficacy of a generalizable facilitator-assisted interdisciplinary communication intervention in the ICU to improve family and patient outcomes and 2 to demonstrate the feasibility of making this intervention a routine part of clinical practice in the ICU setting
The study will advance Nursing science by addressing an important area of emphasis within Nursing science and a key component of the National Institute of Nursing Researchs strategic plan One fifth of deaths in America occur in intensive care units and nurses provide a key component of the care in this setting With the aging population and coincident advances in medical technology more patients are likely to die after an unsuccessful trial of intensive care Prior research suggests that interventions to improve communication about end-of-life care in the ICU may reduce the prolongation of dying that is common in the ICU setting while at the same time improving the quality of care for patients and family members Unfortunately this prior research does not provide a clear generalizable intervention that can be easily implemented in academic and community hospitals The proposed randomized trial will test a feasible and generalizable intervention to improve communication about end-of-life care and improve patient and family outcomes
The consent forms used for this study address the purpose procedures risks alternatives benefits and other information -- including emphasis on the voluntary nature of this research and assurances of confidentiality
The conceptual model for the intervention addresses three components of self-efficacy theory 1 knowledge based on this teams prior research identifying components of communication during ICU family conferences that are associated with improved patient and family outcomes 2 attitudes informed by attachment theory as applied to clinician-patient relationships and communication and 3 communication behaviors informed by principles of mediation based on identifying and resolving conflict in the healthcare setting
The intervention includes the following steps 1 in-person interviews by the facilitator with the family prior to the family conference in order to discuss the familys concerns questions needs and unique communication characteristics that will be addressed in the family conference 2 a pre-conference meeting with the facilitator physicians nurses and other clinicians in which a brief summary describing the familys concerns questions needs and unique communication characteristics is presented and discussed 3 facilitator participation in the family conference and 4 facilitator follow up with the family throughout the ICU stay Prior to the facilitators involvement both the intervention and control group will meet with the research coordinator who will obtain consent from the family and distribute baseline questionnaires the research coordinator will also contact both the intervention and control group families at the time of the follow-up questionnaires 3 and 6 months after discharge or death to notify them that questionnaires are being sent to them and ask if they have any questions The contacts through the research coordinator are expected to enhance response rates for both groups For the control group these contacts with the research coordinator will provide an attention control The research coordinator will not provide any of the other intervention components provided by the facilitator ie discussion of concerns or questions prior to the family conference brief summary to clinicians participation in the family conference follow-up contact after the family conference for duration of the ICU stay A component of the facilitators role will also include helping to identify the need for a family conference and scheduling these conferences Therefore as part of the multi-faceted intervention we anticipate that family conferences will occur earlier and more frequently in the intervention arm After the initial family conference there may be additional family conferences and the facilitator will participate in these conferences for the intervention group
The long-term objectives are 1 to demonstrate the efficacy of a generalizable facilitator-assisted interdisciplinary communication intervention in the ICU to improve family and patient outcomes and 2 to demonstrate the feasibility of making this intervention a routine part of clinical practice in the ICU setting
The study will advance Nursing science by addressing an important area of emphasis within Nursing science and a key component of the National Institute of Nursing Researchs strategic plan One fifth of deaths in America occur in intensive care units and nurses provide a key component of the care in this setting With the aging population and coincident advances in medical technology more patients are likely to die after an unsuccessful trial of intensive care Prior research suggests that interventions to improve communication about end-of-life care in the ICU may reduce the prolongation of dying that is common in the ICU setting while at the same time improving the quality of care for patients and family members Unfortunately this prior research does not provide a clear generalizable intervention that can be easily implemented in academic and community hospitals The proposed randomized trial will test a feasible and generalizable intervention to improve communication about end-of-life care and improve patient and family outcomes
The consent forms used for this study address the purpose procedures risks alternatives benefits and other information -- including emphasis on the voluntary nature of this research and assurances of confidentiality
The conceptual model for the intervention addresses three components of self-efficacy theory 1 knowledge based on this teams prior research identifying components of communication during ICU family conferences that are associated with improved patient and family outcomes 2 attitudes informed by attachment theory as applied to clinician-patient relationships and communication and 3 communication behaviors informed by principles of mediation based on identifying and resolving conflict in the healthcare setting
The intervention includes the following steps 1 in-person interviews by the facilitator with the family prior to the family conference in order to discuss the familys concerns questions needs and unique communication characteristics that will be addressed in the family conference 2 a pre-conference meeting with the facilitator physicians nurses and other clinicians in which a brief summary describing the familys concerns questions needs and unique communication characteristics is presented and discussed 3 facilitator participation in the family conference and 4 facilitator follow up with the family throughout the ICU stay Prior to the facilitators involvement both the intervention and control group will meet with the research coordinator who will obtain consent from the family and distribute baseline questionnaires the research coordinator will also contact both the intervention and control group families at the time of the follow-up questionnaires 3 and 6 months after discharge or death to notify them that questionnaires are being sent to them and ask if they have any questions The contacts through the research coordinator are expected to enhance response rates for both groups For the control group these contacts with the research coordinator will provide an attention control The research coordinator will not provide any of the other intervention components provided by the facilitator ie discussion of concerns or questions prior to the family conference brief summary to clinicians participation in the family conference follow-up contact after the family conference for duration of the ICU stay A component of the facilitators role will also include helping to identify the need for a family conference and scheduling these conferences Therefore as part of the multi-faceted intervention we anticipate that family conferences will occur earlier and more frequently in the intervention arm After the initial family conference there may be additional family conferences and the facilitator will participate in these conferences for the intervention group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01NR005226 | NIH | None | httpsreporternihgovquickSearch2R01NR005226 |