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

Kronikerenheden Nordjylland

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Behavioral: Case Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01512836

RN-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Case Management

Experimental group

Description:

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).

Treatment:

Behavioral: Case Management

Usual Care

No Intervention group

Description:

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.