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NCT Number: NCT01512836

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kronikerenheden, Nordjylland

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case Management

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

Other names: Care management, integrated care, shared care

Primary outcomes

  1. COPD hospitalization rates

    Time frame: 1 year (study inclusion - 12 months of follow-up)

Secondary outcomes

  1. Mortality

    Time frame: 1 year (study inclusion - 12 months of follow-up)

  2. Self Care

    Time frame: 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.

  3. Quality of Life (QoL)

    Time frame: 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.

  4. Cost-effectiveness of case management

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kronikerenheden Nordjylland

Other Gov

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2012
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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