Acute Admission to Hallingdal Sjukestugu | NCT01069107

Studies
Acute Admission to Hallingdal Sjukestugu

NCT01069107

Sponsor

Helse Sor-Ost

Status

Completed

Last Update Posted

Feb 19, 2016Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Morbidity
Health Economy
Quality

Interventions

Cottage Hospital Care

Countries

Norway

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

ID	Type	Description	Link
20100101	Other Identifier	Helse Sorost

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Sep 2015Actual

First Submitted Date

Feb 4, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

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

Feb 17, 2016

Last Update Posted Date

Feb 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oystein Lappegard, Forsker, Helse Sor-OstPrincipal Investigator

Lead Sponsor

Helse Sor-OstOTHER_GOV

Collaborators

Name	Class
Ringerike sykehus, Vestre Viken HF	UNKNOWN
University of Oslo	OTHER
Norwegian University of Science and Technology	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 main objective of the project is to assess whether a community hospital may have or should have a role in the Norwegian health care system in the acute treatment of a defined group of patients.

Detailed Description

The research project's objective is to analyze whether acute admissions to Hallingdal sjukestugu (HSS) is a real alternative to hospitalization in a general hospital.

HSS is a community hospital and a department under Ringerike General Hospital (RS) and is located in Hallingdal 170 km from the RS. It is an established practice that the general practitioners in Hallingdal send selected patients in need for acute treatment to HSS in place of RS. In 2008 this accounted for 10.1% of the total number of acute inpatients from the six municipalities of Hallingdal.

The research program includes a prospective, randomized study in which all patients intended for acute inpatient at HSS are distributed randomly into two groups, an intervention group who is admitted to HSS, and a control group who is sent to RS. A minimum of 70 patients are included in each group.

The patients are going to be followed through one year after the hospital stay and all contacts with the specialist health services and the municipal health care services will be registered. There will also be collected data on the patients' functioning level and the patients' opinion about quality of the hospital stay. Through standardized questionnaire the involved health professional will be asked about their reviews.

Three studies will analyze the patients' progress, economics and quality in the two groups. The three studies will together constitute a doctoral thesis.

The research project will provide a better basis for assessing the role of local medical centers in the Norwegian health care in the acute treatment of a defined group of patients.

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

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Consume of health services	Active Comparator	One year follow-up of patients randomized to two different levels of health care	Other: Cottage Hospital Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cottage Hospital Care	Other	Care at a cottage hospital compared with care at a general hospital	Consume of health services

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A triangulation of patient health consequences, patients' perceived quality and a health economy analyses.		One year

Secondary Outcomes

Measure	Description	Time Frame
All contacts with the specialist health services and the municipal health care services will be registered.		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who by the general practitioner are intended for acute admission to HSS and where the specialist on call at RS approves such admissions.
Patients residing in Hallingdal municipalities.

Exclusion Criteria:

Patients with injuries and acute and/or unclear illnesses in need of diagnosis, treatment or monitoring in an acute hospital.
Urgent births at HSS.
Acute psychiatric admissions to hospital.
Patients with serious mental disorders.
Patients who during the follow-up year move to a municipality outside of Hallingdal.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Hjortdahl, Prof.	Institute of General Practice and Community Medicine , University of Oslo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallingdal sjukestugu		Ål	Buskerud	3570	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25491726	Derived	Lappegard O, Hjortdahl P. Acute admissions to a community hospital - health consequences: a randomized controlled trial in Hallingdal, Norway. BMC Fam Pract. 2014 Dec 10;15:198. doi: 10.1186/s12875-014-0198-1.