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Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation.

ABSTRACT: When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting.We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1) improving depressive symptoms, 2) improving blood glucose, blood pressure and cholesterol, and 3) improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled "on-off" trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol). Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all measured outcomes. Direct costing of all intervention components and measurement of all health care utilization using linked administrative databases will be used to determine the cost-effectiveness of the intervention relative to usual care.Our comprehensive evaluation will generate evidence to reliability, effectiveness and sustainability of this collaborative care model for patients with chronic diseases and depression.Clinicaltrials.gov Identifier: NCT01328639.

SUBMITTER: Johnson JA

PROVIDER: S-EPMC3445824 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation.

Johnson Jeffrey A JA Al Sayah Fatima F Wozniak Lisa L Rees Sandra S Soprovich Allison A Chik Constance L CL Chue Pierre P Florence Peter P Jacquier Jennifer J Lysak Pauline P Opgenorth Andrea A Katon Wayne J WJ Majumdar Sumit R SR

BMC health services research 20120816

<h4>Background</h4>When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective ...[more]

PMID: 22897901

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Project description:Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness.The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM.For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months.Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003).Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed.ClinicalTrials.gov: NCT00105820.

Project description:ImportanceUp to 20% of adolescents experience an episode of major depression by age 18 years yet few receive evidence-based treatments for their depression.ObjectiveTo determine whether a collaborative care intervention for adolescents with depression improves depressive outcomes compared with usual care.DesignRandomized trial with blinded outcome assessment conducted between April 2010 and April 2013.SettingNine primary care clinics in the Group Health system in Washington State.ParticipantsAdolescents (aged 13-17 years) who screened positive for depression (Patient Health Questionnaire 9-item [PHQ-9] score ≥10) on 2 occasions or who screened positive and met criteria for major depression, spoke English, and had telephone access were recruited. Exclusions included alcohol/drug misuse, suicidal plan or recent attempt, bipolar disorder, developmental delay, and seeing a psychiatrist.InterventionsTwelve-month collaborative care intervention including an initial in-person engagement session and regular follow-up by master's-level clinicians. Usual care control youth received depression screening results and could access mental health services through Group Health.Main outcomes and measuresThe primary outcome was change in depressive symptoms on a modified version of the Child Depression Rating Scale-Revised (CDRS-R; score range, 14-94) from baseline to 12 months. Secondary outcomes included change in Columbia Impairment Scale score (CIS), depression response (≥50% decrease on the CDRS-R), and remission (PHQ-9 score <5).ResultsIntervention youth (n = 50), compared with those randomized to receive usual care (n = 51), had greater decreases in CDRS-R scores such that by 12 months intervention youth had a mean score of 27.5 (95% CI, 23.8-31.1) compared with 34.6 (95% CI, 30.6-38.6) in control youth (overall intervention effect: F2,747.3 = 7.24, P < .001). Both intervention and control youth experienced improvement on the CIS with no significant differences between groups. At 12 months, intervention youth were more likely than control youth to achieve depression response (67.6% vs 38.6%, OR = 3.3, 95% CI, 1.4-8.2; P = .009) and remission (50.4% vs 20.7%, OR = 3.9, 95% CI, 1.5-10.6; P = .007).Conclusions and relevanceAmong adolescents with depression seen in primary care, a collaborative care intervention resulted in greater improvement in depressive symptoms at 12 months than usual care. These findings suggest that mental health services for adolescents with depression can be integrated into primary care.Trial registrationclinicaltrials.gov Identifier: NCT01140464.

Project description:BACKGROUND:Despite the growing consensus that collaborative care is effective, limited research has focused on the importance of collaborative care fidelity as it relates to mental health clinical outcomes. OBJECTIVE:To assess the relationship of collaborative care fidelity on symptom trajectories and clinical outcomes among military service members enrolled in a multi-site randomized controlled trial for the treatment of depression and posttraumatic stress disorder (PTSD). DESIGN:Study data for our analyses came from a two-parallel arm randomized trial that evaluated the effectiveness of a centralized collaborative care model compared to the existing collaborative care model for the treatment of PTSD and depression. All patients were included in the analyses to evaluate how longitudinal trajectories of PTSD and depression scores differed across various collaborative care fidelity groupings. PARTICIPANTS:A total of 666 US Military Service members screening positive for probable PTSD or depression through primary care. MAIN MEASURES:Disease registry data from a web-based clinical management support tool was used to measure collaborative care fidelity for patients enrolled in the trial. Participant depression and PTSD symptoms were collected independently from research survey assessments at four time points across the 1-year trial period. Treatment utilization records were acquired from the Military Health System administrative records to determine mental health service use. KEY RESULTS:Consistent and late fidelity to the collaborative care model predicted an improving symptom trajectory over the course of treatment. This effect was more pronounced for patients with depression than for patients with PTSD. CONCLUSIONS:Long-term fidelity to key collaborative care elements throughout care episodes may improve depression outcomes, particularly for patients with elevated symptoms. More controlled research is needed to further understand the influence of collaborative care fidelity on clinical outcomes. TRIAL REGISTRATION:Clinicaltrials.gov Identifier NCT01492348.

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Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation.

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Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation.

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