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Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

ABSTRACT: Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment.To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing.Randomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California.DEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control).Among depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted.Of the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control,?-0.2 (95% CI, -1.2 to 0.8); IMCP vs control,? 0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point difference [PPD]: DEV vs control,?-2.2 [90% CI, -8.0 to 3.49], P?=?.0499 for noninferiority; IMCP vs control,?-3.3 [90% CI, -9.1 to 2.4], P?=?.02 for noninferiority); patient-reported antidepressant recommendation did not achieve noninferiority (mean PPD: DEV vs control, ?0.9 [90% CI, -4.9 to 6.7], P?=?.23 for noninferiority; IMCP vs control,? 0.3 [90% CI, -5.1 to 5.7], P?=?.16 for noninferiority).A tailored IMCP increased clinician recommendations for antidepressant drugs, a mental health referral, or both among depressed patients but had no effect on mental health at the 12-week follow-up. The possibility that the IMCP and DEV increased patient-reported clinician recommendations for an antidepressant drug among nondepressed patients could not be excluded.clinicaltrials.gov Identifier: NCT01144104.

SUBMITTER: Kravitz RL

PROVIDER: S-EPMC4493759 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

Kravitz Richard L RL Franks Peter P Feldman Mitchell D MD Tancredi Daniel J DJ Slee Christina A CA Epstein Ronald M RM Duberstein Paul R PR Bell Robert A RA Jackson-Triche Maga M Paterniti Debora A DA Cipri Camille C Iosif Ana-Maria AM Olson Sarah S Kelly-Reif Steven S Hudnut Andrew A Dvorak Simon S Turner Charles C Jerant Anthony A

JAMA 20131101 17

<h4>Importance</h4>Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment.<h4>Objective</h4>To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing.<h4>Design, setting, and participants</h4>Randomized clinical trial comp ...[more]

PMID: 24193079

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Project description:BackgroundDepression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients' reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression.Methods/designThe Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions -- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)-- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient's index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second.DiscussionBased on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions' potential benefits among depressed persons, and the potential hazards among the non-depressed.Trial registrationClinicialTrials.gov Identifier: NCT01144104.

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:Importance:Nonadherence to antidepressant medication is common and leads to poor outcomes. Early nonadherence is especially problematic. Objective:To test the effectiveness of a psychosocial intervention to improve early adherence among older patients whose primary care physician newly initiated an antidepressant for depression. Design, Setting, and Participants:The Treatment Initiation and Participation Program (TIP) was offered in a 2-site randomized clinical effectiveness study between January 2011 and December 2014 at primary care practices in New York, New York, and Ann Arbor, Michigan. Analyses began in February 2016. All participants were middle-aged and older adults (aged ?55 years) who received newly initiated depression treatment by their primary care physician and recruited within 10 days of their prescription. Analyses were intention-to-treat. Interventions:Participants were randomly assigned to the intervention (TIP) or treatment as usual. Participants in the TIP group identified and addressed barriers to adherence, including stigma, misconceptions, and fears about treatment, before developing a personalized adherence strategy. The Treatment Initiation and Participation Program was delivered in three 30-minute contacts scheduled during a 6-week period just after the antidepressant was prescribed. Main Outcomes and Measures:The primary outcome was self-reported adherence on the Brief Medication Questionnaire, with adequate early adherence defined as taking 80% or more of the prescribed doses at 6 and 12 weeks. The secondary outcome was depression severity. Results:In total, 231 middle-aged and older adults (167 women [72.3%] and 64 men [27.7%]) without significant cognitive impairment were randomly assigned to the TIP intervention (n?=?115) or treatment as usual (n?=?116). Participants had a mean (SD) age of 67.3 (8.4) years. Participants in the TIP group were 5 times more likely to be adherent at 6 weeks (odds ratio,?5.54; 95% CI, 2.57 to 11.96; ?21?=?19.05; P?<?.001) and 3 times more likely to be adherent at both 6 and 12 weeks (odds ratio,?3.27; 95% CI, 1.73 to 6.17; ?21?=?13.34; P?<?.001). Participants in the TIP group showed a significant earlier reduction (24.9%) in depressive symptoms (95% CI, 13.9 to 35.9; t337?=?4.46; adjusted P?<?.001). In both groups, participants who were 80% adherent at weeks 6 and 12 had a 15% greater improvement in depressive symptoms from baseline over the course of treatment (95% CI, -0.2 to -30; t369?=?1.93; P?=?.051). Conclusions and Relevance:The Treatment Initiation and Participation Program is an effective intervention to improve early adherence to pharmacotherapy. Improved adherence can promote improvement in depression. Trial Registration:clinicaltrials.gov Identifier: NCT01301859.

Project description:BackgroundAs a major public health issue in China and worldwide, late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Like other chronic diseases in elders such as hypertension and diabetes, depression is a chronic disease that the new National Health Policy of China indicates should be managed in primary care settings. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management (DCM) intervention, and examine its effectiveness on the depressive symptoms of older patients in Chinese primary care settings.Methods/designThe trial is a multi-site, primary clinic based randomized controlled trial design in Hangzhou, China. Sixteen primary care clinics will be enrolled in and randomly assigned to deliver either DCM or care as usual (CAU) (8 clinics each) to 320 patients (aged ≥ 60 years) with major depression (20/clinic; n = 160 in each treatment condition). In the DCM arm, primary care physicians (PCPs) will prescribe 16 weeks of antidepressant medication according to the treatment guideline protocol. Care managers monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. Depressive symptoms, functional status, treatment stigma and clients' satisfaction will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.DiscussionThis will be the first trial of the effectiveness of a collaborative care intervention aiming to the management of late-life depression in China primary care. If effective, its finding will have relevance to policy makers who wish to scale up DCM treatments for late-life depression in national wide primary care across China.Study registrationThe DCM project is registered through the National Institutes of Health sponsored by clinical trials registry and has been assigned the identifier: NCT01287494.

Project description:BackgroundDepression is prevalent in primary care (PC) practices and poses a considerable public health burden in the United States. Despite nearly four decades of efforts to improve depression care quality in PC practices, a gap remains between desired treatment outcomes and the reality of how depression care is delivered.ObjectiveThis article presents a real-world PC practice model of depression care, elucidating the processes and their influencing conditions.DesignGrounded theory methodology was used for the data collection and analysis to develop a depression care model. Data were collected from 70 individual interviews (60 to 70 min each), three focus group interviews (n = 24, 2 h each), two surveys per clinician, and investigators' field notes on practice environments. Interviews were audiotaped and transcribed for analysis. Surveys and field notes complemented interview data.ParticipantsSeventy primary care clinicians from 52 PC offices in the Midwest: 28 general internists, 28 family physicians, and 14 nurse practitioners.Key resultsA depression care model was developed that illustrates how real-world conditions infuse complexity into each step of the depression care process. Depression care in PC settings is mediated through clinicians' interactions with patients, practice, and the local community. A clinician's interactional familiarity ("familiarity capital") was a powerful facilitator for depression care. For the recognition of depression, three previously reported processes and three conditions were confirmed. For the management of depression, 13 processes and 11 conditions were identified. Empowering the patient was a parallel process to the management of depression.ConclusionsThe clinician's ability to develop and utilize interactional relationships and resources needed to recognize and treat a person with depression is key to depression care in primary care settings. The interactional context of depression care makes empowering the patient central to depression care delivery.

Project description:ImportanceMore than 30% of pregnant people have at least 1 chronic medical condition, and nearly 20% develop gestational diabetes or pregnancy-related hypertension, increasing the risk of future chronic disease. While these individuals are often monitored closely during pregnancy, they face major barriers when transitioning to primary care following delivery, due in part to a lack of health care support for this transition.ObjectiveTo evaluate the impact of an intervention designed to improve postpartum primary care engagement by reducing patient administrative burden and information gaps.Design, setting, and participantsAn individual-level randomized clinical trial was conducted from November 3, 2022, to October 11, 2023, at 1 hospital-based and 5 community-based outpatient obstetric clinics affiliated with a large academic medical center. Participants included English- and Spanish-speaking pregnant or recently postpartum adults with obesity, anxiety, depression, diabetes, chronic hypertension, gestational diabetes, or pregnancy-related hypertension and a primary care practitioner (PCP) listed in their electronic health record.InterventionA behavioral economics-informed intervention bundle, including default scheduling of postpartum PCP appointments and tailored messages.Main outcome and measuresCompletion of a PCP visit for routine or chronic condition care within 4 months of delivery was the primary outcome, ascertained directly by reviewing the patient's electronic health record approximately 5 months after their estimated due date. Intention-to-treat analysis was conducted.ResultsA total of 360 patients were randomized (control, 176; intervention, 184). Individuals had a mean (SD) age of 34.1 (4.9) years and median gestational age of 36.3 (IQR, 34.0-38.6) weeks at enrollment. The distribution of self-reported race and ethnicity was 6.8% Asian, 7.4% Black, 68.6% White, and 15.0% multiple races or other. Most participants (75.4%) had anxiety or depression, 16.1% had a chronic or pregnancy-related hypertensive disorder, 19.5% had preexisting or gestational diabetes, and 40.8% had a prepregnancy body mass index of 30 or greater. Medicaid was the primary payer for 21.2% of patients. Primary care practitioner visit completion within 4 months occurred in 22.0% (95% CI, 6.4%-28.8%) of individuals in the control group and 40.0% (95% CI, 33.1%-47.4%) in the intervention group. In regression models accounting for randomization strata, the intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points). Intervention participants also had fewer postpartum readmissions (1.7% vs 5.8%) and increased receipt of the following services by a PCP: blood pressure screening (42.8% vs 28.3%), weight assessment (42.8% vs 27.7%), and depression screening (32.8% vs 16.8%).Conclusions and relevanceThe findings of this randomized clinical trial suggest that the current lack of support for postpartum transitions to primary care is a missed opportunity to improve recently pregnant individual's short- and long-term health. Reducing patient administrative burdens may represent relatively low-resource, high-impact approaches to improving postpartum health and well-being.Trial registrationClinicalTrials.gov Identifier: NCT05543265.

Project description:Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife).CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients.Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations.Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.

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Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

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Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

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