Case Management Study to Reduce Health Care Utilization f... | NCT02583555

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

NCT02583555

Sponsor

Region Sjælland

Status

Unknown status

Last Update Posted

Oct 22, 2015Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Quality of Life

Interventions

Interview followed by frequent telephone support

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

May 2017Estimated

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Oct 21, 2015

First Posted Date

Oct 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2015

Last Update Posted Date

Oct 22, 2015Estimated

Name	Class
Health Navigator	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active patient support	Active Comparator	Interview followed by frequent telephone support Questionnaire every 3 months	Behavioral: Interview followed by frequent telephone support
Controls	No Intervention	Questionnaire every 3 months

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview followed by frequent telephone support	Behavioral	Interview followed by telephone support	Active patient support

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Knud Rasmussen, MD DMSci	Contact	+45 60168891		kra@regionsjaelland.dk
Ellen B Zacho, Chief Consul	Contact	+ 45 24835717		ellenz@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Knud Rasmussen, MD DMSci	Research Consultant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional Research		Roskilde		4000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010342	Patient Acceptance of Health Care

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided