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

<p>Abstract</p> <p>Background</p> <p>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 p...

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Main Authors: Baldauf Annika, Beyer Martin, Erler Antje, Gensichen Jochen, Mahler Cornelia, Rochon Justine, Peters-Klimm Frank, Freund Tobias, Gerlach Ferdinand M, Szecsenyi Joachim
Format: Article
Language:English
Published: BMC 2011-06-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/12/1/163
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author Baldauf Annika
Beyer Martin
Erler Antje
Gensichen Jochen
Mahler Cornelia
Rochon Justine
Peters-Klimm Frank
Freund Tobias
Gerlach Ferdinand M
Szecsenyi Joachim
author_facet Baldauf Annika
Beyer Martin
Erler Antje
Gensichen Jochen
Mahler Cornelia
Rochon Justine
Peters-Klimm Frank
Freund Tobias
Gerlach Ferdinand M
Szecsenyi Joachim
author_sort Baldauf Annika
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>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.</p> <p>Patients from the control group receive usual care.</p> <p>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).</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN56104508">ISRCTN56104508</a></p>
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spelling doaj.art-51687ba97e0f41c295694c198ff435882022-12-22T01:44:10ZengBMCTrials1745-62152011-06-0112116310.1186/1745-6215-12-163Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]Baldauf AnnikaBeyer MartinErler AntjeGensichen JochenMahler CorneliaRochon JustinePeters-Klimm FrankFreund TobiasGerlach Ferdinand MSzecsenyi Joachim<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>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.</p> <p>Patients from the control group receive usual care.</p> <p>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).</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN56104508">ISRCTN56104508</a></p>http://www.trialsjournal.com/content/12/1/163
spellingShingle Baldauf Annika
Beyer Martin
Erler Antje
Gensichen Jochen
Mahler Cornelia
Rochon Justine
Peters-Klimm Frank
Freund Tobias
Gerlach Ferdinand M
Szecsenyi Joachim
Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
Trials
title Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
title_full Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
title_fullStr Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
title_full_unstemmed Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
title_short Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
title_sort primary care practice based care management for chronically ill patients pracman study protocol for a cluster randomized controlled trial isrctn56104508
url http://www.trialsjournal.com/content/12/1/163
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