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Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.

ABSTRACT: BACKGROUND:Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown et al. JAMA Pediatr 172(11):e182853, 2018; Lumba-Brown A et al. JAMA Pediatr 172(11):e182847, 2018). We have developed a collaborative care intervention with embedded cognitive-behavioral therapy, care management, and stepped-up psychotropic medication consultation to address persistent PCS and related psychological comorbidities. The CARE4PCS-II study was designed to assess whether adolescents with persistent symptoms after sports-related concussion will demonstrate better outcomes when receiving this collaborative care intervention compared to a usual care (control) condition. METHODS/DESIGN:This investigation is a randomized comparative effectiveness trial to receive intervention (collaborative care) or control (usual care). Two hundred sports-injured male and female adolescents aged 11-18 years with three or more post-concussive symptoms that persist for at least 1?month but less than 9?months after injury will be recruited and randomized into the study. The trial focuses on the effects of the intervention on post-concussive, depressive, and anxiety symptoms measured 3, 6, and 12?months after baseline. DISCUSSION:The CARE4PCS II study is a large comparative effectiveness trial targeting symptomatic improvements in sports injured adolescents after concussion. The study is unique in its adaptation of the collaborative care model to a broad spectrum of primary care, sports medicine, and school settings. The investigation incorporates novel elements such as the delivery of CBT through HIPAA complaint video conferenceing technology and has excellent widespread dissemination potential should effectiveness be demonstrated. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03034720 . Registered on January 27, 2017.

SUBMITTER: McCarty CA

PROVIDER: S-EPMC6749638 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.

McCarty Carolyn A CA Zatzick Douglas D Hoopes Teah T Payne Katelyn K Parrish Rebecca R Rivara Frederick P FP

Trials 20190918 1

<h4>Background</h4>Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown et al. JAMA Pediatr 172(11):e182853, 2018; Lumba-Brown A et al. JAMA Pediatr 172(11):e182847, 2018). We have developed a collaborative care intervention with embedded cognitive-behavioral therapy, care management, and stepped-up psychotropic medication consultation to ad ...[more]

PMID: 31533799

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Project description:ImportanceDespite the high level of impairment for adolescents with persistent postconcussive symptoms, few studies have tested whether such problems can be remediated.ObjectiveTo examine whether collaborative care treatment is associated with improvements in postconcussive, quality of life, anxiety, and depressive symptoms over 1 year, compared with usual care.Design, setting, and participantsThe Collaborative Care Model for Treatment of Persistent Symptoms After Concussion Among Youth II Trial was a randomized clinical trial conducted from March 2017 to May 2020 with follow-up assessments at 3, 6, and 12 months. Participants were recruited from pediatric primary care, sports medicine, neurology, and rehabilitation clinics in western Washington. Adolescents aged 11 to 18 years with a diagnosed sports-related or recreational-related concussion within the past 9 months and with at least 3 symptoms persisting at least 1 month after injury were eligible. Data analysis was performed from June to September 2020.InterventionsThe collaborative care intervention included cognitive behavioral therapy and care management, delivered mostly through telehealth, throughout the 6-month treatment period, with enhanced medication consultation when warranted. The comparator group was usual care provided in specialty clinics.Main outcomes and measuresPrimary outcomes were adolescents' reports of postconcussive, quality of life, anxiety, and depressive symptoms. Secondary outcomes were parent-reported symptoms.ResultsOf the 390 eligible adolescents, 201 (51.5%) agreed to participate, and 200 were enrolled (mean [SD] age, 14.7 [1.7] years; 124 girls [62.0%]), with 96% to 98% 3- to 12-month retention. Ninety-nine participants were randomized to usual care, and 101 were randomized to collaborative care. Adolescents who received collaborative care reported significant improvements in Health Behavior Inventory scores compared with usual care at 3 months (3.4 point decrease; 95% CI, -6.6 to -0.1 point decrease) and 12 months (4.1 point decrease; 95% CI, -7.7 to -0.4 point decrease). In addition, youth-reported Pediatric Quality of Life Inventory scores at 12 months improved by a mean of 4.7 points (95% CI, 0.05 to 9.3 points) in the intervention group compared with the control group. No differences emerged by group over time for adolescent depressive or anxiety symptoms or for parent-reported outcomes.Conclusions and relevanceAlthough both groups improved over time, youth receiving the collaborative care intervention had fewer symptoms and better quality of life over 1 year. Intervention delivery through telehealth broadens the reach of this treatment.Trial registrationClinicalTrials.gov Identifier: NCT03034720.

Project description:INTRODUCTION:Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. METHODS AND ANALYSIS:This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6?weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2?weeks into the intervention period. ETHICS AND DISSEMINATION:This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. TRIAL REGISTRATION NUMBER:NCT02257749.

Project description:BackgroundPersistent concussion symptoms (PCS) negatively affects common activities of daily living including deficits in both single and dual-task (DT) gait. DT gait deficits are present post-concussion; however, task prioritization and the effects of differing cognitive challenge remain unexplored in the PCS population.Research questionThe purpose of this study was to investigate single and dual-task gait performance in individuals with persistent concussion symptoms and to identify task priorization strategies during DT trials.MethodsFifteen adults with PCS (age: 43.9+11.7 y.o.) and 23 healthy control participants (age: 42.1+10.3 y.o.) completed five trials of single task gait followed by fifteen trials of dual task gait along a 10-m walkway. The cognitive challenges consisted of five trials each of visual stroop, verbal fluency, and working memory cognitive challenges. Groups were compared on DT cost stepping characteristics with independent samples t-test or Mann-Whitney U tests.ResultsThere were significant overall gait Dual Task Cost (DTC)difference between groups for gait speed (p = 0.009, d=0.92) and step length (p = 0.023, d=0.76). Specific to each DT challenge, PCS participants were slower during Verbal Fluency (0.98 + 0.15 m/s and 1.12 + 0.12 m/s, p = 0.008; d=1.03), Visual Stroop (1.06 + 0.19 m/s and 1.20 + 0.12 m/s, p = 0.012, d=0.88), and Working Memory (1.02 + 0.15 m/s and 1.16 + 0.14 m/s, p = 0.006, d=0.96). There were significant cognitive DTC differences between groups for WM accuracy (p = 0.008, d=0.96), but not for VS accuracy (p = 0.841, d=0.061) or VF total words (p = 0.112, d=0.56).SignificanceThe PCS participants displayed a posture-second strategy whereby gait performance generally decreased in the absence of cognitive changes. However, during the Working Memory DT, PCS participants had a mutual interference response whereby both motor and cognitive performance decreased suggesting the cognitive task plays a key role in the DT gait performance of PCS patients.

Project description:Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional and faith healers are the main providers of care to affected persons. Even though frequently canvassed as desirable for improved care delivery, collaboration between these complementary alternative health providers (CAPs) and conventional health providers has yet to be rigorously tested for feasibility and effectiveness on patient outcomes.COSIMPO is a single-blind, cluster randomized controlled trial (RCT) being conducted in Nigeria and Ghana to compare the effectiveness of a collaborative shared care (CSC) intervention program implemented by CAPs and primary health care providers (PHCPs) with care as usual (CAU) at improving the outcome of patients with psychosis. The study is designed to test the hypotheses that patients receiving CSC will have a better clinical outcome and experience fewer harmful treatment practices from the CAPs than patients receiving CAU at 6 months after study entry. An estimated sample of 296 participants will be recruited from across 51 clusters, with a cluster consisting of a primary care clinic and its neighboring CAP facilities. CSC is a manualized intervention package consisting of regular and scheduled visits of PHCPs to CAP facilities to assist with the management of trial participants. Assistance includes the administration of antipsychotic medications, management of comorbid physical condition, assisting the CAP to avoid harmful treatment practices, and engaging with CAPs, caregivers and participants in planning discharge and rehabilitation. The primary outcome, assessed at 6 months following trial entry, is improvement on the Positive and Negative Symptom Scale (PANSS). Secondary outcomes, assessed at 3 and 6 months, consist of levels of disability, experience of harmful treatment practices and of victimization, and levels of perceived stigma and of caregivers' burden.Information about whether collaboration between orthodox and complementary health providers is feasible and can lead to improved outcome for patients is important to formulating policies designed to formally engage the services of traditional and faith healers within the public health system.National Institutes of Health Clinical Trial registry, ID: NCT02895269 . Registered on 30 July 2016.

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Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.

Publications

Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.

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