German Ministry of Education and Research.
PURPOSEIn 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. METHODSThis qualitative study was nested in the Primary Care Monitoring for Depressive Patients Trial on case management in Germany. We used a semistructured 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 diffi culties interacting with depressed patients. HCAs' disease conception of depression was heterogeneous. After 1 year HCAs believed they were suffi ciently 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.
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 patient's 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.
Alle an Menschen durchgeführten Studien unterliegen nationalen und internationalen Gesetzen, Standards und ethischen Prinzipien, die dazu dienen sollen, den Schutz der Studienteilnehmer und die Validität der Studiendaten sicher zustellen. Wesentlich ist dabei die Erwartung, dass der durch persönlichen Einsatz von Patienten ermöglichte Erkenntnisgewinn uneingeschränkt für die Gesundheitsversorgung sowie für die Planung und Durchführung nachfolgender Studien zur Verfügung steht" [1].An die Qualität von Studien in der Allgemeinmedizin werden steigende Anforderungen gestellt. Im folgenden Artikel wird die praktische Durchführung einer klinischen Studie am Beispiel der Studie "Hausarztpraxisbasiertes Case Management zur Behandlung von Patienten mit Major Depression" beschrieben. Es wird ein Datenmanagement-Konzept vorgestellt, das alle Prozesse von der Datenerhebung, der Datenhaltung und der Daten-und Projektdokumentation beschreibt. Weiterhin werden anhand der Studie einige Prinzipien der guten klinischen Praxis, sowie ethische und aus dem Datenschutz resultierende Grundanforderungen näher erläutert. Der Aufsatz richtet sich vor allem an erstmals in der Forschung tätige Allgemeinärzte und will zusammenhängend einen Überblick über die wichtigsten Anforderungen an methodisch hochwertige Studien in der Allgemeinmedizin geben. Die in diesem Artikel erläuterten Grundsätze können exemplarisch auch auf andere Forschungsvorhaben übertragen werden. SchlüsselwörterDatenmanagement · gute klinische Praxis · randomisierte klinische Studie · Datensicherheit · Allgemeinmedizin Abstract There are increasing requirements for high-quality clinical trials in general practice. The article describes the practical problems and solutions of such a clinical trial, with the example of the study "primary care monitoring for depressive patients trial" (PRoMPT). We present the principles of ensuring good clinical practice (GCP), the concept of data management, and describe the processes of data collection, data storage and verification, and project documentation. Problems of GCP are closely linked to ethical and privacy requirements. The article is primarily directed to GPs with research interests, who are only starting their scientific experience and want to get an overview about requirements of high-quality trials and the GCP respecting ethical and privacy concerns. Readers should be capable to transfer the principles and some of the solutions to their own project.
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