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

Sponsor

Kronikerenheden Nordjylland (Other)

Overall Status

Completed

CT.gov ID

NCT01512836

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Behavioral: Case Management	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

COPD hospitalization rates [1 year (study inclusion - 12 months of follow-up)]

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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