Personal Satisfaction Clinical Trial
Official title:
Impact of a Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department, Randomized Clinical Study
Verified date | April 2017 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized clinical trial with two parallel groups (control and intervened) in the
Emergency Department (ED) at the Clinical Hospital of the University of Chile will take
place. The sample will be of 996 patients (498 per group).
The control group will receive hospital care and discharge plan usual, while the
intervention group also receive a Program of Pharmaceutical Interventions while in the
service and at discharge, which includes an analysis of the therapy recommended by the
physician, assessing the safer alternatives for the patient population and the special
conditions of their pathology, emphasizing evaluations of effectiveness, safety and
tolerability of medication, drug interactions, potential adverse events, dose adjustments as
needed according to the patient's condition ; verification that the administration is
optimal, including choosing the best route to this and the time when the drugs are infused
into the patient.Interventions aimed at patient occur during the stay and at discharge,
focusing on clarifying administration regimens, reasons for using drugs, prevent
drug-related problems, clarify doubts and educate about pharmacotherapy and make a
reinforcement of adherence.
The selection and patient recruitment will take place during the first hour of admission to
care box, where they were invited to participate and signed informed consent.
In both groups, a doctor and a pharmacist, blind to treatment assignment, will gather
information during the stay, discharge and post-discharge, the latter by telephone 30 days
after discharge from the ED, in this second interview also verify the existence of a
readmission and / or unscheduled medical consultation. In addition, discharge of each
patient satisfaction was measured with respect to the service received by a user
satisfaction survey applied by external and impartial staff. In addition, two independent
trained evaluators (Emergency Medical and Pharmaceutical Chemistry), blinded to treatment
assignment, evaluate the background of each case and by consensus allocated the presence of
problems related to drugs, and classified as preventable or not preventable, according
severity.
X2 test or Fisher exact test was used to test the hypothesis that the Programme of
Pharmaceutical Interventions decreases at least 30% the user dissatisfaction compared with
usual care in the ED.
Status | Completed |
Enrollment | 1001 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients admitted to the emergency department of clinical hospital of the University of Chile - Patients who sign the informed consent form - Patients in triage categories C2, C3, C4 and C5 Exclusion Criteria: - Patients with inability to communicate and don't have a responsible caregiver to provide reliable information about the patient's therapy - Patients who are participating in another study - Patients not taking drugs regularly and who don't receive them during care in the ED |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | User satisfaction | 4 months | ||
Secondary | Readmission | 4 months | ||
Secondary | Drug Related Problem | 4 months | ||
Secondary | Adherence measured by four question Morisky-Green test | If the patient answers all question "NO", the patient is adherent. Measured in two times in the study. The proportion of adherent patients will be measured with respect to the total of them. | 5 months | |
Secondary | Proportion of recommendations to the health team accepted | Recommendations made by a clinical pharmacist can be accepted or rejected. The measurement will be (accepted recommendations/total of recommendations) x100 | 4 months |
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