Juliana J. Petersen

Case Management for Depression by Health Care Assistants in Small Primary Care Practices: A Cluster Randomized Trial

Context Few studies have evaluated whether health care assistants can improve care for depressed patients. Contribution Patients who were randomly assigned to receive telephone case management by health care assistants reported slightly greater improvements in depression symptoms, better adherence to antidepressant therapies, and more favorable assessments of the quality of their care than did patients randomly assigned to receive usual care. Implication Telephone case management facilitated by health care assistants may be a feasible mechanism for small primary care practices to improve care of their patients with depression. The Editors Depression causes a substantial disease burden (1) and is responsible for annual health care costs of about

Relative Impact of Multimorbid Chronic Conditions on Health-Related Quality of Life – Results from the MultiCare Cohort Study

83.1 billion in the United States (2, 3). Most patients with depression are treated in primary care (46). Collaborative care can improve depression outcomes by providing decision support and clinical information for family physicians, as well as self-management support and follow-up for patients. However, evidence regarding collaborative depression care stems mostly from academic or managed care settings in the United States (711). In these trials, family physicians generally relied on mental health case managers and decision support from mental health specialists (12). Case management is a patient-centered element of collaborative care that may be effective in primary care (13). It comprises systematic tracking of patients, support for continuing the treatment, and taking action in the case of nonadherence or lack of improvement (14). Collaborative depression care has generally yielded positive results in diverse primary care settings (7). The IMPACT (Improving MoodPromoting Access to Collaborative Treatment) trial found that care managers who were supervised by psychiatrists and who provided education and support for medication adherence reduced depression symptoms in older patients (15). Dietrich and colleagues (16) found that telephone support, provided by a trained, centrally based mental health care manager who was supervised by a psychiatrist, improved depression symptoms. Dobscha and colleagues (17) evaluated a primary care decision-support team for depression (comprising a psychiatrist and a mental health nurse) and found improved care processes but no differences in depression symptoms (17), possibly because of less intensive follow-up of patients. Small, isolated primary care settings often have limited resources (18). In the United States, 26% of primary care practices are solo practices or 2-person partnerships, in which extensive collaborative models would be difficult to implement, and 22% are located in rural areas with limited access to mental health specialists (19). Health care assistants are established professionals in primary care settings. They have less training than U.S. physician assistants or nurse practitioners, who provide first-contact care, and need not be college graduates (20). In Germany, health care assistants have 3 years of on-the-job training. They are mainly responsible for administrative tasks in general practice but provide basic clinical procedures (21). Health care assistants are a potentially important resource for enhancing patient care in primary care settings (20). Our aim was to evaluate whether case management by a practice-based health care assistant can reduce depression symptoms and improve the process of care for patients with major depression in small primary care practices. Methods We designed a pragmatic, cluster randomized, controlled trial that used practice as the unit of randomization to avoid contamination (22). The institutional review board of Goethe University Frankfurt am Main, Frankfurt am Main, Germany, approved the study protocol on 25 April 2005 (23). We used written consent procedures for family physicians and patients. We recruited practices between February 2005 and May 2005 and patients between May 2005 and July 2006. We carried out the intervention between June 2005 and August 2007. We completed the last follow-up for study patients in September 2007. Setting and Participants After calculating the sample size (24), we informed all 1600 family physicians registered with the medical association of the state of Hesse, Germany (mandatory registration), about the trial and invited them by mail to participate in information meetings. As the registration list presents only names and addresses, we checked inclusion criteria only for those who participated in the meetings. We stopped recruiting when 74 practices had enrolled, even though more practices were interested in participating. Inclusion criteria for the practices were acceptance of all major health plans (90% of patients are covered by this type of insurance) (25); provision of a primary care service, according to the definition of Starfield and colleagues (26); and management by a family physician. Patients were screened on special dates and referred to the trial by the family physician in the primary care practice. Inclusion criteria for patients were diagnosis of major depression with indication for any antidepressive treatment, age 18 to 80 years, access to a private telephone, ability to give informed consent, and ability to communicate in German. The diagnosis of major depression was based on a score of more than 9 points and a categorical diagnosis in the Patient Health Questionnaire-9 (PHQ-9) (27), and was confirmed by the family physician by using the checklists in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and International Classification of Diseases, Tenth Edition. New patients were double-screened with the same procedure within 2 weeks. Exclusion criteria were confirmed pregnancy, severe alcohol or illicit drug consumption, or acute suicidal ideation assessed by the family physician. Randomization and Interventions The data safety and monitoring board stratified the practices according to the size of the city and performed computer-based randomization. Patient random assignment status was nested within the practice status. The data safety and monitoring board was responsible for allocation concealment by keeping the randomization results in a secure database. Because of the practice staff training required for the behavioral intervention, patients, health care assistants, family physicians, and researchers were not blinded to assignment once the trial was started. We designed our case management intervention in accordance with the Chronic Care Model (28, 29), which emphasizes proactive support for the patient by the entire practice team. We trained 1 health care assistant from each practice assigned to the intervention group in 2 workshops (an 11-hour and a 6-hour workshop). This interactive training included information on depression, communication skills, telephone monitoring, and behavioral activation for the patient (3032). The health care assistants contacted their patients by telephone twice a week in the first month and than once a month for the following 11 months. They monitored depression symptoms and adherence to medication by using the Depression Monitoring List (33). Health care assistants also encouraged patients to follow self-management activities, such as medication adherence and activation for pleasant or social activities. The assistants provided this information to the family physician in a structured report that stratified the urgency of the contact by a robot scheme. Family physicians in both the intervention and control groups received training on evidence-based depression treatment guidelines (34). During the trial, other forms of disease or case management programs were uncommon in Germany (35). No study practice carried out case management for any other diseases. Outcomes and Follow-up Self-rating questionnaires were handed out to the patients at baseline and at 6 and 12 months after baseline. Patients filled in the questionnaires at home and sent them back to the practice. We collected the questionnaires in the practices and collected data from patient records (number of family physician and specialist contacts, hospitalization, and prescribed medication). Research staff carried out data input and management (36). Serious adverse events were reported to the data safety and monitoring board. Clinical Outcomes The primary outcome was depression symptoms, which we assessed by using the primary carevalidated PHQ-9 (37). Each item is scored from 0 (not at all) to 3 (nearly every day), for a total score that ranges from 0 to 27 (high scores indicate more severe depression). We assessed response (50% improvement in PHQ-9 score) and remission status (PHQ-9 score<5) as secondary outcomes. We also report data for the following secondary outcomes: quality of life, patient assessment of chronic illness care, and medication adherence. We measured health-related quality of life by using the Medical Outcomes Study Short Form 36 (SF-36) (38, 39) and the EuroQol-5D (40). The SF-36 allows the calculation of scores for physical health and mental health (range, 0 to 100; higher scores indicate better status). The EuroQol-5D is a generic instrument that measures health-related quality of life with a visual analogue scale (range, 0 to 100; higher ratings indicate higher quality of life). We determined the number of physical comorbid conditions by counting the documented diagnoses from different diagnostic groups listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and International Classification of Diseases, Tenth Edition, excluding all psychiatric diagnoses in the patient record. We assessed severity of chronic physical diseases by using the Chronic Disease Score, on the basis of prescription data from the patient record (41). Process-of-Care Outcomes We assessed the number of family physician and mental health specialist contacts, as well as prescriptions for ant

Predictors of suicidal ideation in depressive primary care patients

Background Multimorbidity has a negative impact on health-related quality of life (HRQL). Previous studies included only a limited number of conditions. In this study, we analyse the impact of a large number of conditions on HRQL in multimorbid patients without preselecting particular diseases. We also explore the effects of these conditions on the specific dimensions of HRQL. Materials and Methods This analysis is based on a multicenter, prospective cohort study of 3189 multimorbid primary care patients aged 65 to 85. The impact of 45 conditions on HRQL was analysed. The severity of the conditions was rated. The EQ-5D, consisting of 5 dimensions and a visual-analogue-scale (EQ VAS), was employed. Data were analysed using multiple ordinary least squares and multiple logistic regressions. Multimorbidity measured by a weighted count score was significantly associated with lower overall HRQL (EQ VAS), b = −1.02 (SE: 0.06). Parkinson’s disease had the most pronounced negative effect on overall HRQL (EQ VAS), b = −12.29 (SE: 2.18), followed by rheumatism, depression, and obesity. With regard to the individual EQ-5D dimensions, depression (OR = 1.39 to 3.3) and obesity (OR = 1.44 to 1.95) affected all five dimensions of the EQ-5D negatively except for the dimension anxiety/depression. Obesity had a positive effect on this dimension, OR = 0.78 (SE: 0.07). The dimensions “self-care”, OR = 4.52 (SE: 1.37) and “usual activities”, OR = 3.59 (SE: 1.0), were most strongly affected by Parkinson’s disease. As a limitation our sample may only represent patients with at most moderate disease severity. Conclusions The overall HRQL of multimorbid patients decreases with an increasing count and severity of conditions. Parkinson’s disease, depression and obesity have the strongest impact on HRQL. Further studies should address the impact of disease combinations which require very large sample sizes as well as advanced statistical methods.

Agreement between self-reported and general practitioner-reported chronic conditions among multimorbid patients in primary care - results of the MultiCare Cohort Study

BACKGROUND Suicidal ideation is common in patients suffering from depression, but it often remains undetected. General practitioners play an important role in the management of depression and suicidality. The aim of this study was to identify predictors for suicidal ideation in patients with major depression in primary health care. METHOD We conducted a cross-sectional study. Patients were recruited from 74 primary care practices in Germany. Data was collected between April 2005 and July 2006. We calculated a binary logistic regression model to evaluate whether depression severity (Patient Health Questionnaire, PHQ-9), physical pain (SF-36 Physical Pain Scale), physical comorbidity, intake of antidepressant medication, sex and age were predictors of suicidal ideation. RESULTS We enrolled 626 patients, aged 18 to 80 with major depression. Depression severity (OR 1.16 per unit PHQ-9 score, 95% CI 1.09-1.22, p<0.001) and male sex (OR 1.71, 95% CI 1.13-2.58, p=0.012) were associated with suicidal ideation, while absence of pain (OR 0.99 per unit SF-36 Physical Pain Scale, 95% CI 0.98-1.00, p=0.004) and older age (>60) compared to the reference group aged 40 to 60 (OR 0.55, 95% CI 0.35-0.86, p=0.009) were protective factors. LIMITATIONS This cross-sectional study allows the generation of hypotheses. CONCLUSIONS Depression severity is a predictor for suicidal ideation in primary care patients with major depression. In addition, physical pain appears to be a predictor. Results should be confirmed using a prospective study design.

The Patient Assessment of Chronic Illness Care Questionnaire: Evaluation in Patients with Mental Disorders in Primary Care

BackgroundMultimorbidity is a common phenomenon in primary care. Until now, no clinical guidelines for multimorbidity exist. For the development of these guidelines, it is necessary to know whether or not patients are aware of their diseases and to what extent they agree with their doctor. The objectives of this paper are to analyze the agreement of self-reported and general practitioner-reported chronic conditions among multimorbid patients in primary care, and to discover which patient characteristics are associated with positive agreement.MethodsThe MultiCare Cohort Study is a multicenter, prospective, observational cohort study of 3,189 multimorbid patients, ages 65 to 85. Data was collected in personal interviews with patients and GPs. The prevalence proportions for 32 diagnosis groups, kappa coefficients and proportions of specific agreement were calculated in order to examine the agreement of patient self-reported and general practitioner-reported chronic conditions. Logistic regression models were calculated to analyze which patient characteristics can be associated with positive agreement.ResultsWe identified four chronic conditions with good agreement (e.g. diabetes mellitus κ = 0.80;PA = 0,87), seven with moderate agreement (e.g. cerebral ischemia/chronic stroke κ = 0.55;PA = 0.60), seventeen with fair agreement (e.g. cardiac insufficiency κ = 0.24;PA = 0.36) and four with poor agreement (e.g. gynecological problems κ = 0.05;PA = 0.10).Factors associated with positive agreement concerning different chronic diseases were sex, age, education, income, disease count, depression, EQ VAS score and nursing care dependency. For example: Women had higher odds ratios for positive agreement with their GP regarding osteoporosis (OR = 7.16). The odds ratios for positive agreement increase with increasing multimorbidity in almost all of the observed chronic conditions (OR = 1.22-2.41).ConclusionsFor multimorbidity research, the knowledge of diseases with high disagreement levels between the patients’ perceived illnesses and their physicians’ reports is important. The analysis shows that different patient characteristics have an impact on the agreement. Findings from this study should be included in the development of clinical guidelines for multimorbidity aiming to optimize health care. Further research is needed to identify more reasons for disagreement and their consequences in health care.Trial registrationISRCTN89818205

Health Care Assistants in Primary Care Depression Management: Role Perception, Burdening Factors, and Disease Conception

The Chronic Care Model provides evidence-based recommendations to improve the care for patients with chronic conditions. The Patient Assessment of Chronic Illness Care questionnaire (PACIC) is an instrument to evaluate the patient’s perspective on receipt of care delivered in the five domains patient activation, delivery system, goal setting, problem solving, and follow-up. The aim of this study was to assess the psychometric characteristics of the PACIC in 442 primary care patients with major depression. The psychometric properties were good. We found possible ceiling effects in the two subscales ‘patient activation’ (12.9%) and ‘problem solving/contextual’ (8.9%), as well as floor effects in ‘goal setting/tailoring’ (4.6%). The Cronbach’s α coefficient for the total scale was excellent (0.91). We found two major factors, which we labeled according to the PACIC domains as composite factors ‘patient activation and problem solving’ as well as ‘goal setting and coordination’. The perspective of patients with mental disorders, such as depression, on primary chronic illness care can be assessed adequately by the PACIC.

A survey on worries of pregnant women - testing the German version of the Cambridge Worry Scale

PURPOSE In primary care, the involvement of health care assistants (HCAs) in clinical depression management is an innovative approach. Little is known, however, about how HCAs experience their new tasks. We wanted to describe the perceptions and experiences of HCAs who provided case management to patients with depression in small primary care practices. METHODS This qualitative study was nested in the Primary Care Monitoring for Depressive Patients Trial on case management in Germany. We used a semi-structured instrument to interview 26 HCAs and undertook content analysis. We focussed on 3 key aspects: role perception, burdening factors, and disease conception. RESULTS Most HCAs said their new role provided them with personal and professional enrichment, and they were interested in improving patient-communication skills. They saw their major function as interacting with the patient and considered support for the family physician to be of less importance. Even so, some saw their role as a communication facilitator between family physician and patient. Burdening factors implementing the new tasks were the increased workload, the work environment, and difficulties interacting with depressed patients. HCAs’ disease conception of depression was heterogeneous. After 1 year HCAs believed they were sufficiently familiar with their duties as case managers in depression management. CONCLUSION HCAs were willing to extend their professional responsibilities from administrative work to more patient-centred work. Even if HCAs perform only monitoring tasks within the case management concept, the resulting workload is a limiting factor.

How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial

BackgroundPregnancy is a transition period in a womans life characterized by increased worries and anxiety. The Cambridge Worry Scale (CWS) was developed to assess the content and extent of maternal worries in pregnancy. It has been increasingly used in studies over recent years. However, a German version has not yet been developed and validated.The aim of this study was (1) to assess the extent and content of worries in pregnancy on a sample of women in Germany using a translated and adapted version of the Cambridge Worry Scale, and (2) to evaluate the psychometric properties of the German version.MethodsWe conducted a cross-sectional study and enrolled 344 pregnant women in the federal state of Baden-Württemberg, Germany. Women filled out structured questionnaires that contained the CWS, the Spielberger-State-Trait-Anxiety Inventory (STAI), as well as questions on their obstetric history. Antenatal records were also analyzed.ResultsThe CWS was well understood and easy to fill in. The major worries referred to the process of giving birth (CWS mean value 2.26) and the possibility that something might be wrong with the baby (1.99), followed by coping with the new baby (1.57), going to hospital (1.29) and the possibility of going into labour too early (1.28). The internal consistency of the scale (0.80) was satisfactory, and we found a four-factor structure, similar to previous studies. Tests of convergent validity showed that the German CWS represents a different construct compared with state and trait anxiety but has the desired overlap.ConclusionsThe German CWS has satisfactory psychometric properties. It represents a valuable tool for use in scientific studies and is likely to be useful also to clinicians.

Implementation of chronic illness care in German primary care practices – how do multimorbid older patients view routine care? A cross-sectional study using multilevel hierarchical modeling

BackgroundPatients with chronic kidney disease (CKD) are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care.MethodsA cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (≥70 years) suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by more than 30%.ResultsData from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%.ConclusionsA multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices.Trial registrationCurrent Controlled Trials ISRCTN02900734

Obesity and associated lifestyle in a large sample of multi-morbid German primary care attendees.

BackgroundIn primary care, patients with multiple chronic conditions are the rule rather than the exception. The Chronic Care Model (CCM) is an evidence-based framework for improving chronic illness care, but little is known about the extent to which it has been implemented in routine primary care. The aim of this study was to describe how multimorbid older patients assess the routine chronic care they receive in primary care practices in Germany, and to explore the extent to which factors at both the practice and patient level determine their views.MethodsThis cross-sectional study used baseline data from an observational cohort study involving 158 general practitioners (GP) and 3189 multimorbid patients. Standardized questionnaires were employed to collect data, and the Patient Assessment of Chronic Illness Care (PACIC) questionnaire used to assess the quality of care received. Multilevel hierarchical modeling was used to identify any existing association between the dependent variable, PACIC, and independent variables at the patient level (socio-economic factors, weighted count of chronic conditions, instrumental activities of daily living, health-related quality of life, graded chronic pain, no. of contacts with GP, existence of a disease management program (DMP) disease, self-efficacy, and social support) and the practice level (age and sex of GP, years in current practice, size and type of practice).ResultsThe overall mean PACIC score was 2.4 (SD 0.8), with the mean subscale scores ranging from 2.0 (SD 1.0, subscale goal setting/tailoring) to 3.5 (SD 0.7, delivery system design). At the patient level, higher PACIC scores were associated with a DMP disease, more frequent GP contacts, higher social support, and higher autonomy of past occupation. At the practice level, solo practices were associated with higher PACIC values than other types of practice.ConclusionsThis study shows that from the perspective of multimorbid patients receiving care in German primary care practices, the implementation of structured care and counseling could be improved, particularly by helping patients set specific goals, coordinating care, and arranging follow-up contacts. Studies evaluating chronic care should take into consideration that a patient’s assessment is associated not only with practice-level factors, but also with individual, patient-level factors.Trial registrationCurrent Controlled Trials ISRCTN89818205.