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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01244841
First received: October 12, 2010
Last updated: May 7, 2013
Last verified: May 2013

October 12, 2010
May 7, 2013
September 2010
November 2012   (final data collection date for primary outcome measure)
Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01244841 on ClinicalTrials.gov Archive Site
  • Comparison between the study groups of readmission rates within 1 month. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Comparison between the study groups of compliance with, and target dosing of medical therapy. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI)
The Effect on 30 Day Health Status After Early Discharge in Patient With ST Elevation Myocardial Infarction Treated With Primary PCI

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
Procedure: fast post MI care
All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.
  • No Intervention: Standard care
    Randomised to standard post MI care and length of hospital stay decided by treating physician.
  • Active Comparator: Early discharge
    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: Procedure: fast post MI care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01244841
2009/807-4
No
Helse Stavanger HF
Helse Stavanger HF
Not Provided
Principal Investigator: Tor Melberg, MD PhD Stavanger University Hospital, Norway
Helse Stavanger HF
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP