Clinical trial NCT01512836: A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Chronic Obstructive Pulmonary Disease (COPD) Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Case management
CEA
Health economy
Quality of Life
Lead sponsor: Kronikerenheden Nordjylland
Sponsor class: OTHER_GOV
First posted: 2012-01-19
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: COPD hospitalization rates
timeFrame: 1 year (study inclusion - 12 months of follow-up)
Secondary outcomes:
measure: Mortality
timeFrame: 1 year (study inclusion - 12 months of follow-up)
measure: Self Care
timeFrame: A baseline measure at study inclusion and after 12 months of follow-up
measure: Quality of Life (QoL)
timeFrame: A baseline measure at study inclusion and after 12 months of follow-up
measure: Cost-effectiveness of case management
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Kronikerenheden, Nordjylland
Study officials:
affiliation: Kronikerenheden Nordjylland
name: Sabrina S Sørensen, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen SS, Pedersen KM, Weinreich UM, Ehlers L. Economic Evaluation of Community-Based Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease. Appl Health Econ Health Policy. 2017 Jun;15(3):413-424. doi: 10.1007/s40258-016-0298-2.