Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
190/09
Study information
Scientific title
Primary care practice based care management for chronically ill patients: An open multicentre cluster randomised controlled trial
Acronym
PraCMan
Study hypothesis
Primary care practice based care management reduces the number of all-cause hospitalisations in a population of chronically ill patients at high risk for future hospitalisation. The intervention will improve patients' quality of life, self-management and clinical status.
Ethics approval
1. The Ethical Commitee of the University Hospital Heidelberg, 30/07/2010, ref: S-232/2010
2. The Ethical Committee of the Federal Medical Association Baden-Wuerttemberg, 31/08/2010, ref: B-F-2010-043
Study design
Open multicentre cluster randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Chronic disease management; Type 2 diabetes mellitus; Chronic obstructive pulmonary disease; Chronic heart failure and comorbid conditions
Intervention
Care management delivered by teams of primary care physicians and trained health care assistants compared to usual care. Care management consists of comprehensive assessment of medical and non-medical needs, individualised care planning and goal setting, self-management support and care coordination and regular telephone monitoring of symptoms and self-management. The intervention period is 12 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of all-cause hospitalisations within 12 months of intervention/control
Secondary outcome measures
1. Health related quality of life (SF-12, EQ5D)
2. Medication adherence
3. Self-management
4. Patient reported delivery of chronic care elements (PACIC)
5. Health care costs
6. Contacts with specialists/generalists and supportive services
7. Mortality
8. Clinical status
9. Depression
All outcomes will be assessed at 12 and 24 months.
Overall trial start date
01/10/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (18 years+) with any of the following index conditions and a high predicted likelihood of hospitalisation based on insurance claims data analysis:
1.1. Type 2 diabetes
1.2. Chronic obstructive pulmonary disease
1.3. Chronic heart failure
2. Beneficiaries of a GP-centred care contract of the General Regional Health Fund (AOK)
3. Listed in one of the participating practices
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2700
Participant exclusion criteria
1. Active cancer disease (under ongoing radio- or chemotherapy)
2. Undergoing dialysis
3. Moderate to severe dementia
4. Concurrent participation in other clinical trials
5. Living in nursing homes
6. Physical, mental or other conditions that hinder active participaton in the trial
Recruitment start date
01/10/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Heidelberg
Heidelberg
69115
Germany
Sponsor information
Organisation
University Hospital Heidelberg (Germany)
Sponsor details
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Baden-Wuerttemberg (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
General Local Health Insurance (Allgemeine Ortskrankenkasse [AOK]) Bundesverband (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21714883
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26833209
Publication citations
-
Protocol
Freund T, Peters-Klimm F, Rochon J, Mahler C, Gensichen J, Erler A, Beyer M, Baldauf A, Gerlach FM, Szecsenyi J, Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]., Trials, 2011, 12, 163, doi: 10.1186/1745-6215-12-163.
-
Results
Freund T, Peters-Klimm F, Boyd CM, Mahler C, Gensichen J, Erler A, Beyer M, Gondan M, Rochon J, Gerlach FM, Szecsenyi J, Medical Assistant-Based Care Management for High-Risk Patients in Small Primary Care Practices: A Cluster Randomized Clinical Trial, Ann Intern Med, 2016 , doi: 10.7326/M14-2403.