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A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sabrina Storgaard Soerensen, Kronikerenheden Nordjylland
ClinicalTrials.gov Identifier:
NCT01512836
First received: January 15, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients.

The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
 Behavioral: Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease (COPD) in a Danish Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kronikerenheden Nordjylland:

Primary Outcome Measures:
  • COPD hospitalization rates [ Time Frame: 1 year (study inclusion - 12 months of follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 1 year (study inclusion - 12 months of follow-up) ] [ Designated as safety issue: No ]
  • Self Care [ Time Frame: A baseline measure at study inclusion and after 12 months of follow-up ] [ Designated as safety issue: No ]
    The Patient-Activation Measure short form (PAM-13) will be used to evaluate change in self care. The investigators will obtain 2 measurements from each patient during the study period.

  • Quality of Life (QoL) [ Time Frame: A baseline measure at study inclusion and after 12 months of follow-up ] [ Designated as safety issue: No ]
    The investigators will obtain 2 measurements from each patient and are therefore able to evaluate the change in Qol from baseline to end of study (1 year in total). Both generic (EQ-5D, SF-12) and disease-specific questionnaires (Sct. George Respiratory questionnaire, SG-RQ) will be used.

  • Cost-effectiveness of case management [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    The cost-effectiveness analysis will examine and compare the cost of health care resources and health outcomes between the two groups. The costs will include all health care utilization during the 1 year of follow-up.

    Quality adjusted life years (QALYs) is the preferred measure for cost-effectivenes analysis. QALYs will be calculated based on the EuroQol (EQ-5D).



Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case Management
The patients who are randomized to the intervention group will be assigned to case management. The case manager is expected to integrate care from a health maintenance and promotion perspective, where the overall goal is the promote and support the patients self care (see intervention description).
 Behavioral: Case Management

Patients, who are randomized to the intervention group, will receive case management from a trained and experienced nurse. The case manager will carry out following tasks:

  • Formulation and implementation of care plans together with the patient
  • Monitoring of individual status and care plan effectuation
  • Overall coordination between health care providers
  • Support to the patient and their caregivers during times of transition related to health status and environmental changes (e.g. hospital to home)
  • Regular telephone consultations and home visits
  • Promote disease-self management through coaching
Other Name: Care management, integrated care, shared care
No Intervention: Usual Care
Patients randomized to the usual care group will receive conventional health and social services. Patients in this group will not receive support from a case manager.

Detailed Description:

Case management is being implemented as a health service strategy that should contribute to maximize health outcomes within a cost-constrained environment. Evaluations of case management in Danish settings are sparse, and so far no Danish studies have evaluated the cost-effectiveness of case management.

This study is performed as a RCT, and the study focuses exclusively on patients with COPD. The patients will be enrolled and randomized after being referred to rehabilitation at the local rehabilitation center in Aalborg municipality, Denmark. 150 patients will be randomly assigned to two groups of 75 patients each. Participants in the control group will receive usual care, whereas patients assigned to the interventional group will receive case management besides their usual care. Each patient will be followed for 12 months. Patients in both groups will fill out questionnaires at baseline and 12 months. The data register system "Health - Planning and Quality" in the Northern Region of Jutland will be used to determine health care services and costs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are clinically referred to rehabilitation at Aalborg Rehabilitation Center for their diagnosed COPD

Exclusion Criteria:

  • Patients living outside Aalborg municipality, or who is considering to move to another municipality or country in near future.
  • Patients without a telephone
  • Patients with dementia
  • Patients participating in other research studies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512836

Locations
Denmark
Kronikerenheden, Nordjylland
Aalborg, Denmark, 9000
Sponsors and Collaborators
Kronikerenheden Nordjylland
Investigators
Principal Investigator: Sabrina S Sørensen, Ph.d. Kronikerenheden Nordjylland
  More Information

No publications provided

Responsible Party: Sabrina Storgaard Soerensen, Ph.d. student, Kronikerenheden Nordjylland
ClinicalTrials.gov Identifier: NCT01512836     History of Changes
Other Study ID Numbers: RN-1
Study First Received: January 15, 2012
Last Updated: October 29, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Kronikerenheden Nordjylland:
COPD
Case management
CEA
Health economy
Quality of Life

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013