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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512836
• Other study ID #: RN-1
• Status: Completed
• Phase: N/A
• First received: January 15, 2012
• Last updated: March 31, 2015
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Kronikerenheden Nordjylland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Denmark	Kronikerenheden, Nordjylland	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Kronikerenheden Nordjylland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD hospitalization rates		1 year (study inclusion - 12 months of follow-up)	No
Secondary	Mortality		1 year (study inclusion - 12 months of follow-up)	No
Secondary	Self Care	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.	A baseline measure at study inclusion and after 12 months of follow-up	No
Secondary	Quality of Life (QoL)	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.	A baseline measure at study inclusion and after 12 months of follow-up	No
Secondary	Cost-effectiveness of case management	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).	1 year	No