Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan.
Ontology highlight
ABSTRACT:
SUBMITTER: Kilbourne AM
PROVIDER: S-EPMC6522242 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
Publications
Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan.
Kilbourne Amy M AM Prenovost Katherine M KM Liebrecht Celeste C Eisenberg Daniel D Kim Hyungjin Myra HM Un Hyong H Bauer Mark S MS
Psychiatric services (Washington, D.C.) 20190103 3
<h4>Objective</h4>Few individuals with mood disorders have access to evidence-based collaborative chronic care models (CCMs) because most patients are seen in small-group practices (<20 providers) with limited capacity to deliver CCMs. In this single-blind randomized controlled trial, we determined whether a CCM delivered nationally in a U.S. health plan improved 12-month outcomes among enrollees with mood disorders compared with usual care.<h4>Methods</h4>Aetna insurance enrollees (N=238), most ...[more]
Similar Datasets
Project description:Mood disorders represent the most expensive mental disorders for employer-based commercial health plans. Collaborative care models are effective in treating chronic physical and mental illnesses at little to no net healthcare cost, but to date have primarily been implemented by larger healthcare organizations in facility-based models. The majority of practices providing commercially insured care are far too small to implement such models. Health plan-level collaborative care treatment can address this unmet need. The goal of this study is to implement at the national commercial health plan level a collaborative care model to improve outcomes for persons with mood disorders.A randomized controlled trial of a collaborative care model versus usual care will be conducted among beneficiaries of a large national health plan from across the country seen by primary care or behavioral health practices. At discharge 344 patients identified by health plan claims as hospitalized for unipolar depression or bipolar disorder will be randomized to receive collaborative care (patient phone-based self-management support, care management, and guideline dissemination to practices delivered by a plan-level care manager) or usual care from their provider. Primary outcomes are changes in mood symptoms and mental health-related quality of life at 12 months. Secondary outcomes include rehospitalization, receipt of guideline-concordant care, and work productivity.This study will determine whether a collaborative care model for mood disorders delivered at the national health plan level improves outcomes compared to usual care, and will inform a business case for collaborative care models for these settings that can reach patients wherever they receive treatment.ClinicalTrials.gov Identifier: NCT02041962; registered January 3, 2014.
| S-EPMC4266981 | biostudies-literature
Project description:ImportanceCollaborative care for depression and anxiety is superior to usual care from primary care physicians for these conditions; however, challenges limit its provision in routine practice and at scale. Advances in technology may overcome these barriers but have yet to be tested.ObjectiveTo examine the effectiveness of combining an internet support group (ISG) with an online computerized cognitive behavioral therapy (CCBT) provided via a collaborative care program for treating depression and anxiety vs CCBT alone and whether providing CCBT in this manner is more effective than usual care.Design, setting, and participantsIn this 3-arm randomized clinical trial with blinded outcome assessments, primary care physicians from 26 primary care practices in Pittsburgh, Pennsylvania, referred 2884 patients aged 18 to 75 years in response to an electronic medical record prompt from August 2012 to September 2014. Overall, 704 patients (24.4%) met all eligibility criteria and were randomized to CCBT alone (n = 301), CCBT+ISG (n = 302), or usual care (n = 101). Intent-to-treat analyses were conducted November 2015 to January 2017.InterventionsSix months of guided access to an 8-session CCBT program provided by care managers who informed primary care physicians of their patients' progress and promoted patient engagement with our online programs.Main outcomes and measuresMental health-related quality of life (12-Item Short-Form Health Survey Mental Health Composite Scale) and depression and anxiety symptoms (Patient-Reported Outcomes Measurement Information System) at 6-month follow-up, with treatment durability assessed 6 months later.ResultsOf the 704 randomized patients, 562 patients (79.8%) were female, and the mean (SD) age was 42.7 (14.3) years. A total of 604 patients (85.8%) completed our primary 6-month outcome assessment. At 6-month assessment, 254 of 301 patients (84.4%) receiving CCBT alone started the program (mean [SD] sessions completed, 5.4 [2.8]), and 228 of 302 patients (75.5%) in the CCBT+ISG cohort logged into the ISG at least once, of whom 141 (61.8%) provided 1 or more comments or posts (mean, 10.5; median [range], 3 [1-306]). Patients receiving CCBT+ISG reported similar 6-month improvements in mental health-related quality of life, mood, and anxiety symptoms compared with patients receiving CCBT alone. However, compared with patients receiving usual care, patients in the CCBT alone cohort reported significant 6-month effect size improvements in mood (effect size, 0.31; 95% CI, 0.09-0.53) and anxiety (effect size, 0.26; 95% CI, 0.05-0.48) that persisted 6 months later, and completing more CCBT sessions produced greater effect size improvements in mental health-related quality of life and symptoms.Conclusions and relevanceWhile providing moderated access to an ISG provided no additional benefit over guided CCBT at improving mental health-related quality of life, mood, and anxiety symptoms, guided CCBT alone is more effective than usual care for these conditions.Trial registrationclinicaltrials.gov Identifier: NCT01482806.
| S-EPMC5833533 | biostudies-literature
Project description:BackgroundResearch increasingly supports a transdiagnostic conceptualization of emotional disorders (ie applying the same underlying treatment principles across mental disorders, without tailoring the protocol to specific diagnoses), and many international researchers are currently investigating this issue.ObjectiveThe aim of this study was to evaluate the efficacy and acceptability of a Web-based transdiagnostic program using a sample of Romanian adults diagnosed with anxiety and/or depression.MethodsVolunteer participants registered for the study and completed a series of online self-report measures. Participants who fulfilled basic inclusion criteria on these measures were contacted for a telephone diagnostic interview using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Axis I Disorders (SCID-I). Enrolled participants were randomized to either the active treatment group (N=69) or the wait-list control group (N=36) using a 2:1 ratio. The transdiagnostic treatment was based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al, 2011) that addresses common underlying mechanisms of anxiety and depression. Participants randomized to the active treatment condition received 10 weeks of Web-based treatment based on the UP. Throughout treatment, graduate students in clinical psychology provided guidance that consisted of asynchronous written communication on a secure Web platform. After the intervention, participants in both study conditions were invited to complete a set of self-report measures and a postintervention SCID-I interview conducted by a different team of graduate students blinded to participants' group and diagnostic status. Six months later, participants in the active treatment group were invited to complete an online follow-up assessment.ResultsDuring the intervention, active treatment participants completed on average 19 homework assignments (SD 12.10), and we collected data from 79.0% (83/105) at postintervention and 51% (35/69) at follow-up for self-report measures. Postintervention SCID-I interviews were collected from 77.1% (81/105) participants. Relative to the wait-list control group, the transdiagnostic intervention yielded overall medium to large effect sizes for the primary outcome measures (within-group Hedges g=0.52-1.34 and between-group g=0.39-0.86), and also for anxiety sensitivity (g=0.80), symptom interference (g=0.48), and quality of life (g=0.38). Significant within-groups effects only were reported for the active treatment group on Panic Disorder Severity Scale-Self Report (PDSS-SR, g=0.58-0.65) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS, g=0.52-0.58).ConclusionsInsignificant between-group differences for the Y-BOCS and PDSS-SR could be explained by the small number of participants with the associated primary diagnostic (eg, only 3 participants with obsessive compulsive disorder) by the choice of outcome measure (PDSS-SR was not rated among the evidence-based measures) and by the fact that these disorders may be more difficult to treat. However, the overall results suggest that the transdiagnostic intervention tested in this study represents an effective treatment option that may prove easier to disseminate through the use of Web-based delivery systems.Trial registrationClinicalTrials.gov CT02739607; https://clinicaltrials.gov/ct2/show/study/NCT02739607 (Archived by WebCite at http://www.webcitation.org/6yY1VeYIZ).
| S-EPMC5992454 | biostudies-literature
Project description:BackgroundLittle is known about effective strategies for disseminating and implementing complex clinical innovations across large healthcare systems. This paper describes processes undertaken and tools developed by the U.S. Department of Veterans Affairs (VA) Mental Health Quality Enhancement Research Initiative (MH-QUERI) to guide its efforts to partner with clinical leaders to prepare for national dissemination and implementation of collaborative care for depression.MethodsAn evidence-based quality improvement (EBQI) process was used to develop an initial set of goals to prepare the VA for national dissemination and implementation of collaborative care. The resulting product of the EBQI process is referred to herein as a "National Dissemination Plan" (NDP). EBQI participants included: a) researchers with expertise on the collaborative care model for depression, clinical quality improvement, and implementation science, and b) VA clinical and administrative leaders with experience and expertise on how to adapt research evidence to organizational needs, resources and capacity. Based on EBQI participant feedback, drafts of the NDP were revised and refined over multiple iterations before a final version was approved by MH-QUERI leadership. 'Action Teams' were created to address each goal. A formative evaluation framework and related tools were developed to document processes, monitor progress, and identify and act upon barriers and facilitators in addressing NDP goals.ResultsThe National Dissemination Plan suggests that effectively disseminating collaborative care for depression in the VA will likely require attention to: Guidelines and Quality Indicators (4 goals), Training in Clinical Processes and Evidence-based Quality Improvement (6 goals), Marketing (7 goals), and Informatics Support (1 goal). Action Teams are using the NDP as a blueprint for developing infrastructure to support system-wide adoption and sustained implementation of collaborative care for depression. To date, accomplishments include but are not limited to: conduct of a systematic review of the literature to update VA depression treatment guidelines to include the latest evidence on collaborative care for depression; training for clinical staff on TIDES (Translating Initiatives for Depression into Effective Solutions project) care; spread of TIDES care to new VA facilities; and integration of TIDES depression assessment tools into a planned update of software used in delivery of VA mental health services. Thus far, common barriers encountered by Action Teams in addressing NDP goals include: a) limited time to address goals due to competing tasks/priorities, b) frequent turnover of key organizational leaders/stakeholders, c) limited skills and training among team members for addressing NDP goals, and d) difficulty coordinating activities across Action Teams on related goals.ConclusionMH-QUERI has partnered with VA organizational leaders to develop a focused yet flexible plan to address key factors to prepare for national dissemination and implementation of collaborative care for depression. Early indications suggest that the plan is laying an important foundation that will enhance the likelihood of successful implementation and spread across the VA healthcare system.
| S-EPMC2631596 | biostudies-literature
Project description:ContextPatients with depression and poorly controlled diabetes mellitus, coronary heart disease (CHD), or both have higher medical complication rates and higher health care costs, suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life.ObjectiveTo evaluate the cost-effectiveness of a multicondition collaborative treatment program (TEAMcare) compared with usual primary care (UC) in outpatients with depression and poorly controlled diabetes or CHD.DesignRandomized controlled trial of a systematic care management program aimed at improving depression scores and hemoglobin A(1c) (HbA(1c)), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) levels.SettingFourteen primary care clinics of an integrated health care system.PatientsPopulation-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD.InterventionPhysician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors.Main outcome measuresBlinded assessments evaluated depressive symptoms, SBP, and HbA(1c) at baseline and at 6, 12, 18, and 24 months. Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months. Health plan accounting records were used to assess medical service costs. Quality-adjusted life-years (QALYs) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c), LDL-C, and SBP levels over 24 months.ResultsOver 24 months, compared with UC controls, intervention patients had a mean of 114 (95% CI, 79 to 149) additional depression-free days and an estimated 0.335 (95% CI, -0.18 to 0.85) additional QALYs. Intervention patients also had lower mean outpatient health costs of $594 per patient (95% CI, -$3241 to $2053) relative to UC patients.ConclusionsFor adults with depression and poorly controlled diabetes, CHD, or both, a systematic intervention program aimed at improving depression scores and HbA(1c), SBP, and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs.Trial registrationclinicaltrials.gov Identifier: NCT00468676
| S-EPMC3840955 | biostudies-literature
Project description:Background and objectiveCommon mental disorders (CMD) are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India.Study designA cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios.ImplicationsThis will be the first trial of the effectiveness of a complex intervention aiming to integrate efficacious treatments for CMD into routine primary care in a developing country. If effective, its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world, but mostly in those countries where specialist mental health services are few.Study registrationThe MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407.
| S-EPMC2265673 | biostudies-literature
Project description:BackgroundSome data suggest that older adults with anxiety disorders do not respond as well to treatment as do younger adults.AimsWe examined age differences in outcomes from the Coordinated Anxiety Learning and Management (CALM) study, an effectiveness trial comparing usual care to a computer-assisted collaborative care intervention for primary care patients with panic disorder, generalised anxiety disorder, post-traumatic stress disorder (PTSD), and/or social anxiety disorder. This is the first study to examine the efficacy of a collaborative care intervention in a sample that included both younger and older adults with anxiety disorders. We hypothesised that older adults would show a poorer response to the intervention than younger adults.MethodWe examined findings for the overall sample, as well as within each diagnostic category (clinicaltrials.gov identifier: NCT00347269).ResultsThe CALM intervention was more effective than usual care among younger adults overall and for those with generalised anxiety disorder, panic disorder and social anxiety disorder. Among older adults, the intervention was effective overall and for those with social anxiety disorder and PTSD but not for those with panic disorder or generalised anxiety disorder. The effects of the intervention also appeared to erode by the 18-month follow-up, and there were no significant effects on remission among the older adults.ConclusionsThese results are consistent with the findings of other investigators suggesting that medications and psychotherapy for anxiety disorders may not be as effective for older individuals as they are for younger people.
| S-EPMC3696879 | biostudies-literature
Project description:To determine if laypersons' knowledge about palliative care can improve with a brief education intervention.152 adults were recruited to participate in a web-based randomized intervention trial that followed a 2 (content)×2 (format) between-subjects design. Groups received either a video intervention, an information page intervention, a video control, or an information page control. An ANCOVA with contrast coding of two factors was utilized to assess if knowledge, as measured by the Palliative Care Knowledge Scale (PaCKS), increased post intervention.There was a significant difference between intervention group means and control group means on PaCKS scores from T1 to T2 F(1, 139)=11.10, p=0.00, ηp2=0.074. There was no significant difference in PaCKS change scores between the video intervention and information page intervention.This study demonstrates that an information page and a brief video can improve knowledge of palliative care in laypersons.Self-administered educational interventions could be made available in diverse settings in order to reach patients and their families who may benefit from but are unaware of palliative care. Interventions more intensive than the one tested in this study might result in even more significant improvements in knowledge.
| S-EPMC5879772 | biostudies-other
Project description:ObjectivePersons with chronic mental disorders are disproportionately burdened with physical health conditions. We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months.MethodsThis single-blind randomized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic. Patients (N = 293 out of 474 eligible approached) with an ICD-9-CM diagnosis of schizophrenia, bipolar disorder, or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were randomized (February 24, 2010, to April 29, 2015) to Life Goals (n = 146) or usual care (n = 147). A total of 287 completed baseline assessments, and 245 completed 12-month follow-up assessments. Life Goals included 5 weekly sessions that provided semistructured guidance on managing physical and mental health symptoms through healthy behavior changes, augmented by ongoing care coordination. The primary outcome was change in physical health-related quality of life score (Veterans RAND 12-item Short Form Health Survey [VR-12] physical health component score). Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months (blood pressure, lipids, weight), mental health-related quality of life, and mental health symptoms.ResultsAmong patients completing baseline and 12-month outcomes assessments (N = 245), the mean age was 55.3 years (SD = 10.8; range, 25-78 years), and 15.4% were female. Intent-to-treat analysis revealed that compared to those in usual care, patients randomized to Life Goals had slightly increased VR-12 physical health scores (coefficient = 3.21; P = .01).ConclusionsPatients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life.Trial registrationClinicalTrials.gov identifiers: NCT01487668 and NCT01244854.
| S-EPMC5272777 | biostudies-literature
Project description:BackgroundSurvivorship care plans seek to improve the transition to survivorship, but the required resources present implementation barriers. This randomized controlled trial aimed to identify the simplest, most effective approach for survivorship care planning.MethodsStage 1-3 breast, colorectal, and prostate cancer patients aged 21 years or older completing treatment were recruited from an urban-academic and rural-community cancer center. Participants were randomly assigned, stratified by recruitment site and cancer type 1:1:1 to a mailed plan, plan delivered during a 1-time transition visit, or plan delivered during a transition visit plus 6-month follow-up visit. Health service use data were collected from participants and medical records for 18 months. The primary outcome, receipt of all plan-recommended care, was compared across intervention arms using logistic regression adjusting for cancer type and recruitment site, with P less than .05 considered statistically significant.ResultsOf 378 participants randomly assigned, 159 (42.1%) were breast, 142 (37.6%) prostate, and 77 (20.4%) colorectal cancer survivors; 207 (54.8%) from the academic site and 171 (45.2%) from the community site; 316 were analyzable for the primary outcome. There was no difference across arms in the proportion of participants receiving all plan-recommended care: 45.2% mail, 50.5% 1-visit, 42.7% 2-visit (2-sided P = .60). Adherence by cancer type for mail, 1-visit, and 2-visit, respectively, was 52.2%, 53.3%, and 40.0% for breast cancer; 48.6%, 64.1%, and 57.1% for prostate cancer; and 23.8%, 19.0%, and 26.1% for colorectal cancer. There were no statistically significant interactions by recruitment site or cancer type.ConclusionsThis study did not find differences in receipt of recommended follow-up care by plan delivery approach. Feasibility and other factors may determine the best approach for survivorship care planning.
| S-EPMC8755486 | biostudies-literature