Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users

October 21, 2015 updated by: Knud Rasmussen, MD, DMSci, Region Sjælland

Randomised Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users

The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.

Study Overview

Status

Unknown

Conditions

Detailed Description

Participants are identified by administrative data and a model predicting high risk of future healthcare utilization. Participants are invited to the study by mail. After informed consent participants are randomized to either active treatment or control 3:1. Active patients have an in depth interview with a specially trained nurse. Further counselling by telephone weekly for 6-9 months.

Quality of Life is measured by SF-36 every 3 months for one year both in active participants and in controls.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Roskilde, Denmark, 4000
        • Regional Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient > 18 years
  • Recent history of contact with hospital
  • Anticipated sustained high visit frequency

Exclusion Criteria:

  • Dementia (ICD10: F00-F03 or F051)
  • Psychoses (ICD10: F20-F29)
  • Drug abuse (ICD10: F10-F19)
  • Metastases (ICD10: C77-C80)
  • Hearing impairment or language difficulties
  • Life expectancy < 1 year No telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active patient support
Interview followed by frequent telephone support Questionnaire every 3 months
Interview followed by telephone support
No Intervention: Controls
Questionnaire every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life reported by the participants with use of Short Form 36
Time Frame: Questionaire Short Form-36 Every 3 months for one year
Questionaire Short Form-36 Every 3 months for one year
Health Care Utilization - Admissions to and days in hospital
Time Frame: One year
The use of different health care systems will be recorded
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Knud Rasmussen, MD DMSci, Research Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SJ-499

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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