Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department

NCT03116607 | Completed DMC

• 1 other identifier: UCh2015
• Study Type: interventional
• Target: 1,001
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Personal Satisfaction

Keywords

User satisfaction; Readmission; Emergency department; Pharmaceutical intervention

Outcome Measures

Primary Outcomes (1)

• User satisfaction

  4 months

Secondary Outcomes (4)

• Readmission

  4 months

• Drug Related Problem

  4 months

• Adherence measured by four question Morisky-Green test

  5 months

• Proportion of recommendations to the health team accepted

  4 months

Study Arms (2)

Control

NO INTERVENTION

The control group will receive the usual hospital care. In addition, an interview that allows the characterization of the sample and the measurement of variables such as adherence, problems related to medication and user satisfaction.

Intervened

EXPERIMENTAL

The intervention group will receive a Pharmaceutical Intervention Program during their stay in the Service and discharge. In addition, an interview that allows the characterization of the sample and the measurement of variables such as adherence, problems related to medication and user satisfaction. patient education/ recommendations to the health team

Other: patient education/ recommendations to the health team

Interventions

patient education/ recommendations to the health team OTHER

The intervention group will receive a Pharmaceutical Intervention Program during their stay in the Service and discharge that includes an analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of their pathology, with emphasis on Assessments of effectiveness, safety and tolerability of medication, drug interactions, possible adverse events, dose adjustments as necessary according to patient conditions; Verification that the administration is optimal, including the choice of the best route for this and the time in which the drugs are infused to the patient.

Intervened

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

MeSH Terms

Conditions

Personal Satisfaction; Emergencies

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matías Martínez, Msc

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Model Details: parallels groups: control arm will recieve normal healthcare, intervention arm will recieve a pharmaceutilcal intervention program.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 17, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share