title: Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508].
abstract: BACKGROUND
  Care 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
  PraCMan 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).
  
  
  CONCLUSIONS
  Practice-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.
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstrasse 2, 69115 Heidelberg, Germany. tobias.freund@med.uni-heidelberg.de
authors.forename: Tobias
authors.initials: T
authors.lastname: Freund
authors.forename: Frank
authors.initials: F
authors.lastname: Peters-Klimm
authors.forename: Justine
authors.initials: J
authors.lastname: Rochon
authors.forename: Cornelia
authors.initials: C
authors.lastname: Mahler
authors.forename: Jochen
authors.initials: J
authors.lastname: Gensichen
authors.forename: Antje
authors.initials: A
authors.lastname: Erler
authors.forename: Martin
authors.initials: M
authors.lastname: Beyer
authors.forename: Annika
authors.initials: A
authors.lastname: Baldauf
authors.forename: Ferdinand M
authors.initials: FM
authors.lastname: Gerlach
authors.forename: Joachim
authors.initials: J
authors.lastname: Szecsenyi
mesh_terms: D019090:Case Management / Q000191:economics / Q000458:organization & administration; D002908:Chronic Disease; D016000:Cluster Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000706:statistics & numerical data; D003863:Depression / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D005858:Germany; D017048:Health Care Costs; D006301:Health Services Needs and Demand; D006302:Health Services Research; D006333:Heart Failure / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D006760:Hospitalization; D006801:Humans; D055118:Medication Adherence; D009937:Organizational Objectives; D010348:Patient Care Team / Q000191:economics / Q000458:organization & administration; D011320:Primary Health Care / Q000191:economics / Q000458:organization & administration; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D011787:Quality of Health Care; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome