Personal SatisfactionNCT03116607
Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department
A study testing patient education/ recommendations to the health team in people with Personal Satisfaction, run by University of Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- What is being tested?
- patient education/ recommendations to the health team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Impact of a Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department, Randomized Clinical Study
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.
Read more
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.
Read the detailed description
Process:
For the selection of patients, a research team consisting of a Physician and a Pharmaceutical Chemist review the inclusion and exclusion criteria within the first hour after the patient enters the care box. Patients who meet the selection criteria are invited to participate in the study and sign the informed consent form. To standardize the sampling and avoid differences by daily or seasonal variation are included in the study of 6 patients per day.
For each of the included patients, information will be collected that allows the characterization: sociodemographic, which includes: sex, age, foresight, schooling, marital status; Morbid antecedents before, during the care and after the high diagnostic illness, reason of admission and previous hospitalizations; Pharmacotherapeutic which includes medicines used, dosage, self-medication, adherence (Morisky \& Green Scale), performed before, during the stay in the emergency department and high and post discharge. In addition, the Triage category and the duration of the stay are recorded.
In both groups, a physician and a pharmacist, blind to the allocation of treatment, collect the demographic, morbid and pharmacotherapeutic antecedents, by means of a file specially designed for the study. The post-discharge evaluation is done through the telephone interview 30 days after the discharge from the US.
All information collected on the follow-up sheets of each study patient will be added to an Excel® database. A project investigator will be responsible for ensuring the monitoring of the study, ensuring that Good Clinical Practices are complied with, as well as the quality and reliability of the information recorded on both the records and the database. Both the database and each of the study collection records will include only a patient identification code, in order to maintain their confidentiality. The list that relates the code to the patient's name will be kept protected with access only to the principal investigator.
In the case of the patients who are part of the intervention group, in addition to the care received by the control group, I received a pharmaceutical care program aimed at improving drug use and patient safety. It includes a finished analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of his pathology, emphasizing evaluations of the effectiveness, safety and tolerability of the medication, drug interactions, possible events Adverse effects, dose adjustments by sea, patient conditions; Verification of what the sea of optimal management, including the choice of the best route for the shelf and the time in which the medicines are infused to the patient.
The intervention is performed at moments one during the stay in the service where they communicate and educate the patient about all the medications indicated and the relationship, which have their health status, as well as the benefits and expected results with their administration. A second moment just after high medicine, where the same review of medications is done and recommendations are given to the patient on how to administer them, promoting adherence to treatment. In addition to all the knowledge he has about his pathology and treatment.
To see that the patient started therapy, the last 7 days after discharge / transfer of the Emergency Service, a member of the team communicated by telephone with the patient. In case you have not started looking for the factors that affected your behavior.
At 30 days after discharge / transfer, an independent external evaluator, blinded to pharmaceutical care, who will not know the group to which the patient belongs, will be contacted by telephone and evaluated again, in addition to consulting medical prescriptions Received and medications purchased to evaluate hospital readmissions or unscheduled medical consultations.
If an error is detected in the control group, it will be communicated to the health team
- Conditions
- Personal Satisfaction
- Being tested
- patient education/ recommendations to the health team
- Keywords
- User satisfaction, Readmission, Emergency department, Pharmaceutical intervention
- Medical subject headings
- Personal Satisfaction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient education/ recommendations to the health teamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: patient education/ recommendations to the health team |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction
Measured: 4 months
Secondary outcomes (4)
Readmission
Measured: 4 months
Drug Related Problem
Measured: 4 months
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.
Measured: 5 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallels groups: control arm will recieve normal healthcare, intervention arm will recieve a pharmaceutilcal intervention program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matías Fernando Martínez Olguín, University of Chile
- Investigators
- Matías Martínez, Msc, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116607
- Sponsor's protocol ID
- UCh2015
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmaceutical Intervention Program at Readmission and User Satisfaction in a Emergency Department, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03116607
- Acronym / sponsor ID
- UCh2015
- Conditions
- Personal Satisfaction
- Keywords
- User satisfaction, Readmission, Emergency department, Pharmaceutical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Process:
For the selection of patients, a research team consisting of a Physician and a Pharmaceutical Chemist review the inclusion and exclusion criteria within the first hour after the patient enters the care box. Patients who meet the selection criteria are invited to participate in the study and sign the informed consent form. To standardize the sampling and avoid differences by daily or seasonal variation are included in the study of 6 patients per day.
For each of the included patients, information will be collected that allows the characterization: sociodemographic, which includes: sex, age, foresight, schooling, marital status; Morbid antecedents before, during the care and after the high diagnostic illness, reason of admission and previous hospitalizations; Pharmacotherapeutic which includes medicines used, dosage, self-medication, adherence (Morisky \& Green Scale), performed before, during the stay in the emergency department and high and post discharge. In addition, the Triage category and the duration of the stay are recorded.
In both groups, a physician and a pharmacist, blind to the allocation of treatment, collect the demographic, morbid and pharmacotherapeutic antecedents, by means of a file specially designed for the study. The post-discharge evaluation is done through the telephone interview 30 days after the discharge from the US.
All information collected on the follow-up sheets of each study patient will be added to an Excel® database. A project investigator will be responsible for ensuring the monitoring of the study, ensuring that Good Clinical Practices are complied with, as well as the quality and reliability of the information recorded on both the records and the database. Both the database and each of the study collection records will include only a patient identification code, in order to maintain their confidentiality. The list that relates the code to the patient's name will be kept protected with access only to the principal investigator.
In the case of the patients who are part of the intervention group, in addition to the care received by the control group, I received a pharmaceutical care program aimed at improving drug use and patient safety. It includes a finished analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of his pathology, emphasizing evaluations of the effectiveness, safety and tolerability of the medication, drug interactions, possible events Adverse effects, dose adjustments by sea, patient conditions; Verification of what the sea of optimal management, including the choice of the best route for the shelf and the time in which the medicines are infused to the patient.
The intervention is performed at moments one during the stay in the service where they communicate and educate the patient about all the medications indicated and the relationship, which have their health status, as well as the benefits and expected results with their administration. A second moment just after high medicine, where the same review of medications is done and recommendations are given to the patient on how to administer them, promoting adherence to treatment. In addition to all the knowledge he has about his pathology and treatment.
To see that the patient started therapy, the last 7 days after discharge / transfer of the Emergency Service, a member of the team communicated by telephone with the patient. In case you have not started looking for the factors that affected your behavior.
At 30 days after discharge / transfer, an independent external evaluator, blinded to pharmaceutical care, who will not know the group to which the patient belongs, will be contacted by telephone and evaluated again, in addition to consulting medical prescriptions Received and medications purchased to evaluate hospital readmissions or unscheduled medical consultations.
If an error is detected in the control group, it will be communicated to the health team
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallels groups: control arm will recieve normal healthcare, intervention arm will recieve a pharmaceutilcal intervention program.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: patient education/ recommendations to the health teamThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient education/ recommendations to the health teamThe 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. | Other | Intervened |
Primary outcome
User satisfaction
Time frame: 4 months
4 secondary outcomes
Readmission
Time frame: 4 months
Drug Related Problem
Time frame: 4 months
Adherence measured by four question Morisky-Green test
Time frame: 5 months
Proportion of recommendations to the health team accepted
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matías Martínez, Msc principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
A study testing patient education/ recommendations to the health team in people with Personal Satisfaction, run by University of Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.