Ferdinand M. Gerlach

Health-related quality of life among general practice patients with differing chronic diseases in Germany: Cross sectional survey

BackgroundThis study was carried out to compare the HRQoL of patients in general practice with differing chronic diseases with the HRQoL of patients without chronic conditions, to evaluate the HRQoL of general practice patients in Germany compared with the HRQoL of the general population, and to explore the influence of different chronic diseases on patients HRQoL, independently of the effects of multiple confounding variables.MethodsA cross-sectional questionnaire survey including the SF-36, the EQ-5D and demographic questions was conducted in 20 general practices in Germany. 1009 consecutive patients aged 15–89 participated. The SF-36 scale scores of general practice patients with differing chronic diseases were compared with those of patients without chronic conditions. Differences in the SF-36 scale/summary scores and proportions in the EQ-5D dimensions between patients and the general population were analyzed. Independent effects of chronic conditions and demographic variables on the HRQoL were analyzed using multivariable linear regression and polynomial regression models.ResultsThe HRQoL for general practice patients with differing chronic diseases tended to show more physical than mental health impairments compared with the reference group of patients without. Patients in general practice in Germany had considerably lower SF-36 scores than the general population (P < 0.001 for all) and showed significantly higher proportions of problems in all EQ-5D dimensions except for the self-care dimension (P < 0.001 for all). The mean EQ VAS for general practice patients was lower than that for the general population (69.2 versus 77.4, P < 0.001). The HRQoL for general practice patients in Germany seemed to be more strongly affected by diseases like depression, back pain, OA of the knee, and cancer than by hypertension and diabetes.ConclusionGeneral practice patients with differing chronic diseases in Germany had impaired quality of life, especially in terms of physical health. The independent impacts on the HRQoL were different depending on the type of chronic disease. Findings from this study might help health professionals to concern more influential diseases in primary care from the patients perspective.

The German MultiCare-study: Patterns of multimorbidity in primary health care – protocol of a prospective cohort study

BackgroundMultimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects.Methods/DesignThe study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed.DiscussionThe main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns) with a comparable impact (e.g. on quality of life and/or functional status) will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an instrument for prediction of the deterioration of the illness process and point at possibilities of prevention. The practical consequences of the study results for primary care will be analysed in expert focus groups in order to develop strategies for the inclusion of the aspects of multimorbidity in primary care guidelines.

Case management for the treatment of patients with major depression in general practices - rationale, design and conduct of a cluster randomized controlled trial - PRoMPT (Primary care Monitoring for depressive Patient's Trial) (ISRCTN66386086) - Study protocol

BackgroundDepression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO) settings and which might also be effective in other, less structured settings.Methods/DesignPRoMPT (PRimary care Monitoring for depressive Patients Trial) is a cluster randomised controlled trial with General Practice (GP) as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patients status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9) from the German version of the Prime MD Patient Health Questionnaire (PHQ-D). Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey) and the SF-36. In addition, data are collected about patients satisfaction (EUROPEP-tool), medication, health care utilization, comorbidity, suicide attempts and days out of work.The study comprises three assessment times: baseline (T0) , follow-up after 6 months (T1) and follow-up after 12 months (T2).DiscussionDepression is now recognized as a disorder with a high prevalence in primary care but with insufficient treatment response. Case management seems to be a promising intervention which has the potential to bridge the gap of the usually time-limited and fragmented provision of care. Case management has been proven to be effective in several studies but its application in the private general medical practice setting remains unclear.

Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]

BackgroundCare management programmes are an effective approach to care for high risk patients with complex care needs resulting from multiple co-occurring medical and non-medical conditions. These patients are likely to be hospitalized for a potentially avoidable cause. Nurse-led care management programmes for high risk elderly patients showed promising results. Care management programmes based on health care assistants (HCAs) targeting adult patients with a high risk of hospitalisation may be an innovative approach to deliver cost-efficient intensified care to patients most in need.Methods/DesignPraCMan is a cluster randomized controlled trial with primary care practices as unit of randomisation. The study evaluates a complex primary care practice-based care management of patients at high risk for future hospitalizations. Eligible patients either suffer from type 2 diabetes mellitus, chronic obstructive pulmonary disease, chronic heart failure or any combination. Patients with a high likelihood of hospitalization within the following 12 months (based on insurance data) will be included in the trial.During 12 months of intervention patients of the care management group receive comprehensive assessment of medical and non-medical needs and resources as well as regular structured monitoring of symptoms. Assessment and monitoring will be performed by trained HCAs from the participating practices. Additionally, patients will receive written information, symptom diaries, action plans and a medication plan to improve self-management capabilities. This intervention is addition to usual care.Patients from the control group receive usual care.Primary outcome is the number of all-cause hospitalizations at 12 months follow-up, assessed by insurance claims data. Secondary outcomes are health-related quality of life (SF12, EQ5D), quality of chronic illness care (PACIC), health care utilisation and costs, medication adherence (MARS), depression status and severity (PHQ-9), self-management capabilities and clinical parameters. Data collection will be performed at baseline, 12 and 24 months (12 months post-intervention).DiscussionPractice-based care management for high risk individuals involving trained HCAs appears to be a promising approach to face the needs of an aging population with increasing care demands.Trial registrationCurrent Controlled Trials ISRCTN56104508

Predictors of suicidal ideation in depressive primary care patients

BACKGROUNDnSuicidal 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.nnnMETHODnWe 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.nnnRESULTSnWe 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.nnnLIMITATIONSnThis cross-sectional study allows the generation of hypotheses.nnnCONCLUSIONSnDepression 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

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.

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

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

Patients' perspectives on depression case management in general practice - a qualitative study.

OBJECTIVEnGeneral practice-based case management is effective in improving symptoms, adherence, and the perceived process of care of patients living with major depression. The aim was to explore the patients perceptions of practice-based depression case management, their satisfaction with it and how living with depression contextualizes case management.nnnMETHODSnThis qualitative study was nested in a large cluster-randomized controlled trial on the effectiveness of case management for patients living with major depression. Case management was provided over 12 months by practice-based health care assistants, who monitored symptoms. We undertook semi-structured interviews with 41 patients, then transcribed and analysed them using qualitative content analysis.nnnRESULTSnPatients described depression as the unfortunate situation, where loneliness and lack of energy lead to being unable to actively seek help. Case management was appreciated because of regular, proactive contact and support by health care assistants. It was crucial to patients that they could trust the health care assistant. Some patients complained that case management was undertaken too mechanically and lacked empathy.nnnCONCLUSIONnPatients living with depression may perceive practice-based case management as beneficial if carried out in a trustworthy and empathetic manner.nnnPRACTICE IMPLICATIONSnGeneral practices should ensure that depression case management is patient-centered and non-mechanical.

The Systematic Guideline Review: Method, rationale, and test on chronic heart failure

BackgroundEvidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources – especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development – the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF).MethodsA systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline.ResultsOf 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) – the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer.ConclusionThe systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines.

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial

Background The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. Methods We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9u2005months during three facilitated team sessions in intervention practices. At baseline and after 12u2005months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. Results During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12u2005months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Conclusions Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. Trial registration German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145