Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 11 - 18 |
| Updated: | 10/31/2018 |
| Start Date: | March 9, 2017 |
| End Date: | February 2021 |
| Contact: | Frederick P Rivara, MD |
| Email: | FPR@UW.EDU |
| Phone: | 206-884-1587 |
SPECIFIC AIMS
While post-concussive symptoms following sports-related concussion are typically transient
and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who
sustain concussion experience significant morbidity that can persist well beyond the normal
disease course.Furthermore, post-concussive symptoms commonly co-occur with affective
symptoms including depression and anxiety which when present can prolong recovery from
primary post-concussive symptoms. Together, persistent physical and psychological symptoms
confer protracted functional impairment and create a significant burden for affected youth,
their family, and school. Currently, there are no evidence-based guidelines to inform
treatment of persistent post-concussive symptoms in youth and adolescents.
In response to the dearth of evidence-based treatment approaches for youth with persistent
post-concussive symptoms, the investigators developed a novel collaborative care treatment
model that simultaneously targets post-concussive symptoms and co-occurring depression and
anxiety. Athletes and their family members receive patient navigator care management services
that bridge post-injury care across acute care, specialist and primary care health service
delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain
symptomatic after initial treatment efforts receive stepped-up care that may include
psychopharmacologic consultation. The Investigators have demonstrated feasibility of the
intervention model through a pilot randomized-control trial of 49 adolescents with persistent
post-concussive symptoms recruited from a regional children's hospital. Participants assigned
to the intervention condition demonstrated significant and clinically-meaningful reductions
in post-concussive and depressive symptoms as well as health-related quality of life as
compared to adolescents in the usual care arm of the trial.
While post-concussive symptoms following sports-related concussion are typically transient
and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who
sustain concussion experience significant morbidity that can persist well beyond the normal
disease course.Furthermore, post-concussive symptoms commonly co-occur with affective
symptoms including depression and anxiety which when present can prolong recovery from
primary post-concussive symptoms. Together, persistent physical and psychological symptoms
confer protracted functional impairment and create a significant burden for affected youth,
their family, and school. Currently, there are no evidence-based guidelines to inform
treatment of persistent post-concussive symptoms in youth and adolescents.
In response to the dearth of evidence-based treatment approaches for youth with persistent
post-concussive symptoms, the investigators developed a novel collaborative care treatment
model that simultaneously targets post-concussive symptoms and co-occurring depression and
anxiety. Athletes and their family members receive patient navigator care management services
that bridge post-injury care across acute care, specialist and primary care health service
delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain
symptomatic after initial treatment efforts receive stepped-up care that may include
psychopharmacologic consultation. The Investigators have demonstrated feasibility of the
intervention model through a pilot randomized-control trial of 49 adolescents with persistent
post-concussive symptoms recruited from a regional children's hospital. Participants assigned
to the intervention condition demonstrated significant and clinically-meaningful reductions
in post-concussive and depressive symptoms as well as health-related quality of life as
compared to adolescents in the usual care arm of the trial.
The proposed study will expand upon the pilot trial in order to further develop, implement,
and test the impact of an innovative collaborative care approach tailored to the needs of a
patient population who currently have no evidence-based options. The investigators propose a
broad reach intervention strategy that is designed to be readily implemented in acute,
specialty and primary care medical settings, as well as over the telephone. The investigators
will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,
suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related
injury. Athletes will be randomized to collaborative care (intervention) or post-sports
injury care as usual (control group) conditions. The study is designed with the following
aims:
Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in
reducing post-concussive and co-occurring psychological symptoms in youth with persistent
post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative
care intervention will demonstrate clinically and statistically significant reductions in
post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month
study, compared to usual care control group athletes Aim 2. To examine the effectiveness of
the intervention in improving function and health-related quality of life amongst youth with
persistent symptoms after sports-related concussion H2: Adolescents who receive a
collaborative care intervention will exhibit a clinically meaningful improvement in function
and health-related quality life Exploratory Aim 3. To explore differences in school
performance between groups H3: Adolescents who receive the collaborative care intervention
will receive individualized treatment and community resource linkages which will improve
their school performance as compared to adolescents receiving treatment as usual Aim 4. To
explore the heterogeneity of treatment effects in the primary and secondary outcomes by
examining the interaction of the treatment effect with group membership in distinct subgroups
of the population. H4: Three distinct subgroups are expected to emerge from the study
population: adolescents who recover from symptoms, adolescents with chronic psychosocial
problems, and adolescents whose symptoms wax and wane over time. A greater proportion of
adolescents who recover from symptoms will emerge in the treatment group, compared to
controls.
IMPACT: By broadly targeting the constellation of post-concussive physical and psychological
symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral
health providers, the collaborative care health services intervention could accelerate the
rate of recovery from persistent post-concussive symptoms and attenuate the degree and
duration of disability during adolescence, a critical period for healthy development.
Validation of this treatment through a scaled up clinical trial will serve as a foundation
for broader dissemination of this collaborative care treatment model. The multidisciplinary
sports concussion research team will simultaneously work nationally and internationally to
ensure study results are expediently translated into effective policy for youth athletes
suffering from enduring symptoms and functional impairments in the wake of sports-related
concussions.
and test the impact of an innovative collaborative care approach tailored to the needs of a
patient population who currently have no evidence-based options. The investigators propose a
broad reach intervention strategy that is designed to be readily implemented in acute,
specialty and primary care medical settings, as well as over the telephone. The investigators
will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,
suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related
injury. Athletes will be randomized to collaborative care (intervention) or post-sports
injury care as usual (control group) conditions. The study is designed with the following
aims:
Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in
reducing post-concussive and co-occurring psychological symptoms in youth with persistent
post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative
care intervention will demonstrate clinically and statistically significant reductions in
post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month
study, compared to usual care control group athletes Aim 2. To examine the effectiveness of
the intervention in improving function and health-related quality of life amongst youth with
persistent symptoms after sports-related concussion H2: Adolescents who receive a
collaborative care intervention will exhibit a clinically meaningful improvement in function
and health-related quality life Exploratory Aim 3. To explore differences in school
performance between groups H3: Adolescents who receive the collaborative care intervention
will receive individualized treatment and community resource linkages which will improve
their school performance as compared to adolescents receiving treatment as usual Aim 4. To
explore the heterogeneity of treatment effects in the primary and secondary outcomes by
examining the interaction of the treatment effect with group membership in distinct subgroups
of the population. H4: Three distinct subgroups are expected to emerge from the study
population: adolescents who recover from symptoms, adolescents with chronic psychosocial
problems, and adolescents whose symptoms wax and wane over time. A greater proportion of
adolescents who recover from symptoms will emerge in the treatment group, compared to
controls.
IMPACT: By broadly targeting the constellation of post-concussive physical and psychological
symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral
health providers, the collaborative care health services intervention could accelerate the
rate of recovery from persistent post-concussive symptoms and attenuate the degree and
duration of disability during adolescence, a critical period for healthy development.
Validation of this treatment through a scaled up clinical trial will serve as a foundation
for broader dissemination of this collaborative care treatment model. The multidisciplinary
sports concussion research team will simultaneously work nationally and internationally to
ensure study results are expediently translated into effective policy for youth athletes
suffering from enduring symptoms and functional impairments in the wake of sports-related
concussions.
Inclusion Criteria:
- English speaking male and female sports-injured adolescents
- ages 11-18
- health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured
or worsened for at least 1-month but less than 9 months since injury will be included
in the investigation.
Exclusion Criteria:
- Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be
excluded.
- Adolescents whose parents report that their child has ever had a diagnosis of
schizophrenia or psychosis will be excluded from the study.
- Adolescents whose parents report concerns about their child's ability to communicate
may be excluded from the study (pending consult with PIs).
- Adolescents who have suffered spinal cord or other severe injuries that prevent
participation will be excluded from the study.
- Adults unable to consent are not included in this research
- Adolescents and parents who do not read and speak English will not be included
- Wards of the state are not included in this research
- Pregnant women are not included in this research
- Prisoners are not included in this research
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Phone: 206-884-1489
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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