Clinical trial NCT01244841: Effects on Health Status in Patients Early Discharged After Primary Percutaneous Coronary Intervention (PCI)
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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: ST elevation acute myocardial infarction
Primary percutaneous coronary intervention
Discharge
Health status
Quality of care
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2010-11-19
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate whether the health status after early discharge compared to standard care is comparable in low-risk primary PCI patients.
timeFrame: 1 month
Secondary outcomes:
measure: Comparison between the study groups of readmission rates within 1 month.
timeFrame: 30 days
measure: Comparison between the study groups of compliance with, and target dosing of medical therapy.
timeFrame: 1 month
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Tor Melberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: