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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01512836
• Lead Sponsor: Kronikerenheden Nordjylland

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2012-01-15
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Study Start: 2012-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COPD hospitalization rates	1 year (study inclusion - 12 months of follow-up)

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year (study inclusion - 12 months of follow-up)
Self Care	A baseline measure at study inclusion and after 12 months of follow-up	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)	A baseline measure at study inclusion and after 12 months of follow-up	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	1 year	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).

Trial Locations

Locations (1)

Kronikerenheden, Nordjylland; 🇩🇰 Aalborg, Denmark