BMJ  2004;329:602 (11 September), doi:10.1136/bmj.38219.481250.55 (published 2 September 2004)

Primary care

Re-engineering systems for the treatment of depression in primary care: cluster randomised controlled trial

¹ Dartmouth Medical School, HB 7250, Hanover, NH 03755, USA, ² Center for Health Services Research. Durham Veterans Affairs Medical Center, Durham, NC 27705, USA, ³ Weill Medical College of Cornell University, White Plains, NY 10605, USA, ⁴ University of Colorado Health Sciences Center, UCHSC at Fitzsimmons, Aurora, CO 80010, USA, ⁵ Regenstrief Institute, Indianapolis, IN 46202-2859, USA, ⁶ Portland Veterans Administration Medical Center, Portland, OR 97207-1034, USA, ⁷ Center for Research Strategies, Denver, CO 80203-1694, USA

Abstract

Objective To test the effectiveness of an evidence based model for management of depression in primary care with support from quality improvement resources.

Design Cluster randomised controlled trial.

Setting Five healthcare organisations in the United States and 60 affiliated practices.

Patients 405 patients, aged 18 years, starting or changing treatment for depression.

Intervention Care provided by clinicians, with staff providing telephone support under supervision from a psychiatrist.

Main outcome measures Severity of depression at three and six months (Hopkins symptom checklist-20): response to treatment ( 50% decrease in scores) and remission (score of < 0.5).

Results At six months, 60% (106 of 177) of patients in intervention practices had responded to treatment compared with 47% (68 of 146) of patients in usual care practices (P = 0.02). At six months, 37% of intervention patients showed remission compared with 27% for usual care patients (P = 0.014). 90% of intervention patients rated their depression care as good or excellent at six months compared with 75% of usual care patients (P = 0.0003).

Conclusion Resources such as quality improvement programmes can be used effectively in primary care to implement evidence based management of depression and improve outcomes for patients with depression.

Introduction

Depression is frequently treated in primary care,¹ yet there are barriers to its effective management.^{2 3} Recent randomised controlled trials have shown benefits for patients with depression from increased telephone support, better cooperation between primary care and mental health professionals, and more systematic follow up.^4-6 Some of these changes are costly, however, and their implementation has required intensive support from research teams. Changes have also proved difficult to sustain outside externally funded research.⁷

We developed and tested a model of evidence based management of depression that could be widely disseminated. We hypothesised that implementation would improve targeted processes for management of depression and improve outcomes at six months.

Methods

We recruited five healthcare organisations (three medical groups and two health plans) across the United States. To be eligible, each needed to be affiliated with at least 10 primary care practices, have an established quality improvement programme, and be willing to sustain and disseminate our model if it added value at reasonable cost. Methods are described in detail elsewhere.⁸

Leaders of the five organisations invited the affiliated practices to participate. Sixty practices were identified. An evaluation centre randomised these practices after stratification by healthcare organisation. The practices were paired on the basis of clinicians' specialty (internal medicine or family practice), number of clinicians, onsite mental health care, and distance from the organisation's central office. Within pairs, practices were randomly assigned to treatment by flip of a coin.

Participant flow and follow up
Between February 2002 and February 2003 the clinicians identified patients aged 18 years or older who were starting or changing treatment for depression. The evaluation centre determined diagnoses using a structured interview.⁹ The severity of depression was assessed with the Hopkins symptom checklist-20, with a score of 0.5 or more required for enrolment.¹⁰

Patients were excluded if they were unobtainable for an evaluation interview within 14 days of their index visit, were pregnant, or had suicidal thoughts, schizophrenia, bipolar disorder, post-traumatic stress disorder, or a substance misuse disorder (see bmj.com for flow of patients through the trial).

Treatment groups
The intervention concerned a systematic approach to the assessment and management of depression by the clinician, with a centrally based care manager providing telephone support for patients.¹¹ The patient health questionnaire-9 was used to aid in diagnosis, to monitor treatment response, and to guide changes in treatment.^{9 12 13}

Patients received a follow up telephone call from the care manager one week after their initial visit. Thereafter they were telephoned monthly and as needed until remission. At the monthly calls the questionnaire was re-administered. The clinician was provided with the reports.

Psychiatrists employed by the organisations supervised the care managers through weekly telephone contact. During these contacts, the care managers presented both new patients and follow up contacts. Based on responses to the questionnaire, the psychiatrist could suggest changes either through the care manager or by contacting the clinician. The clinicians were able to contact the psychiatrists for informal telephone advice. (See bmj.com for details on training.)

Clinicians in the practices allocated to usual care took part in a 45-60 minute programme on diagnosis of depression and assessment of suicidal thoughts.

Blinding, data collection, and statistical analysis
Interviewers were blind to study group assignment, followed computer aided scripts, and had no knowledge of the purpose of the study or of the intervention. The Hopkins symptom checklist-20 was used to assess the severity of depression. The interviewers also asked about current drugs, recent care, and satisfaction with care.

We used means (standard deviations) for continuous variables and percentages for categorical variables. Our primary outcomes included depressive symptoms (scores on the Hopkins symptom checklist-20), response to treatment (50% or more reduction in depression score from baseline), and remission (< 0.5 depression score). The process of treatment was analysed for several variables (see bmj.com).

We used linear mixed effects regression models, including both fixed and random effects, to analyse the effect of the intervention on continuous outcomes. We analysed the effect of the intervention on binary outcomes with generalised linear mixed effect models with a logit link. We fitted the mixed effects using SAS Proc mixed and Proc nlmixed.

We fitted a random intercept model that included the fixed effects of depression severity at baseline, intervention, and time. We also fit models of a two way interaction (intervention by time) for both the continuous and binary outcomes. Further, we tested a three way interaction among intervention, time, and baseline depression scores by testing intervention by time interaction effect within each stratum defined by baseline scores of more than two.

Results

The characteristics of the practices and patients were well balanced (see bmj.com). The mean depression score on the Hopkins symptom checklist-20 for the total sample was 2.01, which is consistent with moderate to severe symptoms. According to the mental disorders patient health questionnaire¹⁴, 47% of usual care patients and 51% of intervention patients (P = 0.42) had generalised anxiety, panic disorder, or both.

Compared with the usual care clinicians the intervention clinicians more often asked patients about suicidal thoughts, offered educational materials, and assisted in setting self management goals. Intervention patients also received more follow up by visits or telephone and were significantly more likely at both three and six months to report receiving good or excellent care. The patterns of management did not differ significantly. No adverse events were reported.

The table presents depression scores, response, and remission based on intention to treat. Intervention patients had better outcomes on all measures at both follow up intervals. Although mean depression scores declined among patients in both groups, the decline was significantly greater in intervention patients: the intervention sizes on the Hopkins symptom checklist were 0.23 at three months and 0.29 at six months.

View this table: [in this window] [in a new window]   Clinical outcomes for patients being managed for depression with evidence based model or usual care. Values are percentages (number of patients/total number) unless stated otherwise

 

A mean of 20 minutes was expended for each telephone call, including record keeping. The clinicians reported negligible time demands from the model aside from administrative duties such as obtaining consent.

Discussion

Enhanced management of depression can improve outcomes for patients when implemented through quality improvement resources increasingly available to community practices. Depressed patients in our intervention practices reported significantly milder symptoms of depression and had higher response and remission rates at follow up than patients in the usual care practices.

We identified elements that possibly influence clinical outcomes. The intervention patients had more telephone contacts and more visits. Intervention patients reported that the clinicians were more likely to assess suicide risk, offer educational materials, and assist with self management goals. Counselling and adherence to antidepressants were similar between the groups, suggesting that specific but modest support for patients results in better outcomes for depression and higher patient ratings for quality of care.

Although clinical outcomes were enhanced, these effects were modest. At least four features of our study may help to explain this. Firstly, rather than identifying potentially ambivalent patients through screening, all patients were identified during routine care by the clinicians, had accepted the diagnosis of depression, and had agreed to be managed with drugs or by counselling. Secondly, the usual care clinicians performed well on process and outcome measures compared with those in other trials,^{15 16} creating a high standard of comparison. Thirdly, there was potential for attenuation of the intervention tasks compared with their direct implementation by researchers using a strict protocol.¹⁷ Finally, our intervention was modest compared with other recent large trials.^{16 18 19}

Although remission rates at six months indicate that most patients had at least partial symptoms, these patients continued to receive support and may have improved further.

We suggest that by recruiting 60 practices in diverse locations, our trial extends the generalisability of earlier findings on efficacy of telephone support and primary care specialty cooperation beyond special settings. Many of these earlier studies took place in health maintenance organisations, academic sites, or veterans administration practices.^20-24 Our trial adds to this knowledge by showing that modest resources delivered through established programmes can approach outcomes achieved by more research intense, resource rich interventions.

The generalisability of our findings to primary care is constrained because the practices had access to established quality improvement programmes and care management staff, resources which are becoming more widely, but not yet universally, available. Primary care trusts in the United Kingdom may be able to assume this function, and in some countries professional societies and regional health authorities could play a part.

Our model for depression produced significantly better outcomes and more favourable patient responses on quality of care than usual care. The model requires only modest changes from practices and creates a framework to study long term sustainability and dissemination of evidence based care.

What is already known on this topic Trials have shown improved outcomes for depression in primary care patients using models for the management of chronic illness These models involve more systematic follow up and monitoring, patient telephone support, and cooperation between primary care and psychiatry Implementation of these models has usually depended on research teams and has not been sustainable when research support ends What this study adds Evidence based models of depression management can be implemented in primary care with support from existing quality improvement resources These models can improve outcomes for depression

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This is the abridged version of an article that was posted on bmj.com on 2 September 2004: http://bmj.com/cgi/doi/10.1136/bmj.38219.481250.55

We thank James E Barrett, Leon Eisenberg (initiative steering committee), Laurie Garduque, Robert Rose (John D and Catherine T MacArthur Foundation) for their contributions to this work. For their leadership: Wayne Cannon, Brenda Reiss-Brennan, and Debby Giordano (Intermountain Health Care); Neil Korsen, Lisa M Letourneau, and Robert McArtor, (MaineHealth); James Cox-Chapman, Jonathan Rosen, and Steven Cole MD of ProHealth; Marshall Thomas MD and Jeannette Waxmonsky PhD of Colorado Access; and Alan Axelson, Carol Chase, and Scott Leatherbery (Highmark, an independent licensee of the Blue Cross Blue Shield Association). Training manuals and other resources are available at www.depressionprimarycare.org/clinicians/re_engineering/

Contributors: See bmj.com

Funding: John D and Catherine T MacArthur Foundation through its initiative on depression and primary care. The staff participated in discussions about the conceptualisation of the study, but were not otherwise involved. The views expressed in this article are those of the authors and do not necessarily represent the views of the foundation or of the US Department of Veterans Affairs.

Competing interests: AJD has received honorariums from Forest Laboratories and Pfizer and has consulted for Wyeth Pharmaceuticals. TEO has received honorariums from Pfizer for presenting at two conferences on primary care education. JWWJr has received honorariums from GlaxoSmithKline, Pfizer, and Wyeth-Ayerst and has received funding from Eli Lilly and Pfizer. MLB has received an unrestricted education grant from Janssen Pharmaceuticals. KR has been reimbursed by Forest Pharmaceuticals for attending a symposium. KK has received research support and honorariums from Eli Lilly and Wyeth and honorariums from Pfizer. PAN has been funded by Eli Lilly to study patient perceptions of the options for hormone replacement therapy as presented by primary care clinicians. Ethical approval: Our study was approved by the committees for the protection of human participants at Dartmouth Medical School, Weill Medical College of Cornell University, and participating organisations.

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(Accepted 19 July 2004)

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