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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02583555
• Other study ID #: SJ-499
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2015
• Last updated: October 21, 2015
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: October 2015
• Source: Region Sjælland
• Contact: Knud Rasmussen, MD DMSci
• Phone: +45 60168891
• Email: kra[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Interview followed by frequent telephone support
Interview followed by telephone support

Locations

Country	Name	City	State
Denmark	Regional Research	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Region Sjælland	Health Navigator

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life reported by the participants with use of Short Form 36		Questionaire Short Form-36 Every 3 months for one year	No
Primary	Health Care Utilization - Admissions to and days in hospital	The use of different health care systems will be recorded	One year	No