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

NCT ID: NCT01512836

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-01-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Case Management

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Care management, integrated care, shared care

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kronikerenheden Nordjylland

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sabrina Storgaard Soerensen

Ph.d. student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabrina S Sørensen, Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Kronikerenheden Nordjylland

Locations

Kronikerenheden, Nordjylland

Aalborg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27928660 (View on PubMed)

Other Identifiers

RN-1

Identifier Type: -

Identifier Source: org_study_id