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Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI) (INUT)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
fast post MI care
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring ST elevation acute myocardial infarction, Primary percutaneous coronary intervention, Discharge, Health status, Quality of care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ST elevation acute myocardial infarction
  • Undergoing primary PCI

Exclusion Criteria:

  • Zwolle low risk criteria score >4
  • Re-infarction, post AMI ischemia.
  • Need for urgent repeat invasive procedures.
  • Non-cardiac complication (bleeding, stroke oa.) or concomitant diseases likely to increase length of hospital stay.
  • Patient or caring physician refuse to early discharge or study inclusion.
  • Early discharge impossible due to social, nursing or family reasons.

Sites / Locations

  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard care

Early discharge

Arm Description

Randomised to standard post MI care and length of hospital stay decided by treating physician.

Randomised patient where all post MI investigations, treatment, follow-up plans and information will be performed within 3 days, and the patients are thereafter discharged.

Outcomes

Primary Outcome Measures

Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients.
This is an equivalence study comparing health related quality of life(HRQOL) and quality-of-care satisfaction between the 3 days stay and standard regimen groups at 30 days after AMI. The scores of the SF-36, Seattle Angina Questionaire and Hospital Anxiety & Depression Scale for patients in both study groups will be compared. The forms will be filled out by the patients at baseline and at 30 days follow-up.

Secondary Outcome Measures

Comparison between the study groups of readmission rates within 1 month.
Comparison between the study groups of compliance with, and target dosing of medical therapy.

Full Information

First Posted
October 12, 2010
Last Updated
May 7, 2013
Sponsor
Helse Stavanger HF
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1. Study Identification

Unique Protocol Identification Number
NCT01244841
Brief Title
Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI)
Acronym
INUT
Official Title
The Effect on 30 Day Health Status After Early Discharge in Patient With ST Elevation Myocardial Infarction Treated With Primary PCI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients with ST elevation myocardial infarction (STEMI)treated with primary percutaneous coronary intervention (PPCI) a subset with low risk for late complications can be identified. Early discharge (<72h) of these patients can compromise initiation of prophylaxis, information and other investigations. The researchers want to investigate prospectively whether early discharge compared to regular care have comparable patient centered outcomes at 30 days follow-up.
Detailed Description
The safety and feasibility of early discharge of low-risk STEMI treated with thrombolysis or PPCI patients have previously been investigated. It is possible to identify a subset of patients with very low risk for subsequent cardiac events in the short-term, where prolonged hospital stay beyond three days does not alter the outcome. Early discharge have however, not been included in STEMI management guidelines formally. The effects of this discharge regimen on STEMI patients' health status (symptoms, functional capacity and quality of life) is not previously investigated. Shorter hospital stays saves health care resources. On the other hand, short in-hospital stay can affect the perceived satisfaction of care. Initiation of medical treatment, patient education, life style counselling and follow-up routines may suffer. Additionally, early discharge can increase anxiety and symptom level reducing the health related quality of life (HRQOL) and also lead to readmission. Patient satisfaction has become a recognised measure of the quality of health care.Currently there is little information on how early discharge influence the patients' satisfaction with the health care or the subjective perceived of HRQOL after discharge. We therefore wish to perform a prospective trial comparing outcomes with regard to satisfaction of care and HRQOL in patients admitted for STEMI randomised to either early discharge or standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
ST elevation acute myocardial infarction, Primary percutaneous coronary intervention, Discharge, Health status, Quality of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Randomised to standard post MI care and length of hospital stay decided by treating physician.
Arm Title
Early discharge
Arm Type
Active Comparator
Arm Description
Randomised patient where all post MI investigations, treatment, follow-up plans and information will be performed within 3 days, and the patients are thereafter discharged.
Intervention Type
Procedure
Intervention Name(s)
fast post MI care
Intervention Description
All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.
Primary Outcome Measure Information:
Title
Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients.
Description
This is an equivalence study comparing health related quality of life(HRQOL) and quality-of-care satisfaction between the 3 days stay and standard regimen groups at 30 days after AMI. The scores of the SF-36, Seattle Angina Questionaire and Hospital Anxiety & Depression Scale for patients in both study groups will be compared. The forms will be filled out by the patients at baseline and at 30 days follow-up.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Comparison between the study groups of readmission rates within 1 month.
Time Frame
30 days
Title
Comparison between the study groups of compliance with, and target dosing of medical therapy.
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ST elevation acute myocardial infarction Undergoing primary PCI Exclusion Criteria: Zwolle low risk criteria score >4 Re-infarction, post AMI ischemia. Need for urgent repeat invasive procedures. Non-cardiac complication (bleeding, stroke oa.) or concomitant diseases likely to increase length of hospital stay. Patient or caring physician refuse to early discharge or study inclusion. Early discharge impossible due to social, nursing or family reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Melberg, MD PhD
Organizational Affiliation
Stavanger University Hospital, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4068
Country
Norway

12. IPD Sharing Statement

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Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI)

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