Depression Clinical Trial
Official title:
A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
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.
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 patient's death, but it
is unclear how to translate these findings to hospitals in the U.S.; 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 Research's
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 team's 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 family's concerns,
questions, needs and unique communication characteristics that will be addressed in the
family conference; 2) a pre-conference meeting with the facilitator, physician(s), nurse(s),
and other clinicians in which a brief summary describing the family's 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 facilitator's 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 (i.e., 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 facilitator's 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |