Drug-Related Side Effects and Adverse ReactionsNCT03156348
Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults
A study testing Clinical Pharmacist Care in people with Drug-Related Side Effects and Adverse Reactions, run by University of Chile at 1 site in Chile.
Trial summary
Adverse drug events (ADE) are one of the major problems affecting quality of care and achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital stays, resource use, and problems on patient safety. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- Clinical Pharmacist Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2015to 22 Dec 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attended by the staff of internists of the internal medicine service of the Clinical Hospital of the University of Chile for acute condition or decompensation of chronic pathology.
- Patients with an estimated survival of more than 6 months.
- Patients who are on pharmacological therapy.
- Patients who have a contact person or responsible caregiver, willing to comply with the scheduled care plan.
- Patients who have a contact telephone number
Who cannot join
- Patients without cognitive autonomy in which it is not possible to establish contact with the caregiver.
- Any other condition that in the judgment of the research team affects the quality of the collection of the information.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan
Jorge Hasbun, Dr, (56-2) 2978 80 00, comiteetica@hcuch.cl
About this study
Official title: Impact of Clinical Pharmacist on Post-discharge Prevention of Adverse Drug Events in Older Adults: Randomized Clinical Trial.
Adverse drug events (ADE) are one of the major problems affecting quality of care and achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital stays, resource use, and problems on patient safety. The present study aim is to determine the impact of the clinical pharmacist interventions on the prevention of ADE in OA at 3 months post-discharge compared to usual care.
A randomized clinical trial of two parallel groups 1: 1 (control and intervention) plus a historical control group will be carried out at the Internal Medicine Service (IMS) of the teaching Hospital at the University of Chile. The sample will be of 611 patients (242 per each parallel group and 127 of the historical control group) of 60 years or older, admitted to the IMS for acute pathology or decompensation of chronic pathology, with survival over 6 months, who is under pharmacological therapy and have a caretaker or responsible contact person at discharge.
The historical control group will receive usual care and the parallel control group will also receive training on pharmacogeriatrics. The intervention group will receive the care of a clinical pharmacist during hospitalization, at discharge and post-discharge, through a home visit at 30 days post-discharge and a telephone call at 60 days post discharge.
Read the detailed description
The intervention plan during hospitalization will consist of daily monitoring of pharmacological efficacy and safety, participating in clinical rounds and patient interviews. To review, assess the indications according to the conditions of each patient and evaluating possible interactions of clinical importance, dose adjustments, potentially inappropriate medication for older adult (OA), adverse effects and omissions of therapy. To make recommendations to the healthcare team regarding pharmacological therapy received during hospitalization and at discharge.
Patient-directed interventions will occur at discharge and post-discharge, focusing on clarifying management regimens, drug use motives, preventing drug-related problems, clarifying doubts and educating on pharmacotherapy, and enhancing adherence to treatment. The selection and recruitment of the patients will be made during the first 48 hours of their admission to the Internal Medicine Service (IMS), where they will be invited to participate and sign the informed consent.
In all groups, a physician, pharmacist, and occupational therapist, blind to treatment assignment, will collect sociodemographic, morbid, pharmacotherapeutic, and functional (Barthel Index and Lawton \& Brody Scale), adherence (Morisky \& Green Scale), delirium (Confusion Assessment Method, CAM), comorbidity (cumulative illness rating scale in Geriatrics (CIRS-G)), anticholinergic burden (Anticholinergic Burden Scale and Ars Risk Scale), potentially inappropriate medications (Beers Criteria and screening tool of older people's prescriptions \& screening tool to alert to right treatment criteria (STOPP \& START)) before, during hospitalization, at discharge and post-discharge. Also a follow up by telephone interviews at 30, 60 and 90 days after hospital discharge from the IMS.
Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment assignment, will evaluate the history of each case and by consensus will assign the presence of Adverse Drug Events (ADE), and classify them as preventable or not and according to severity. The Chi-squared or Fisher exact test will be used to test the hypothesis that clinical pharmacist intervention prevents at least 50% of ADE at 3 months post-discharge in OA compared to usual care in the IMS.
- Being tested
- Clinical Pharmacist Care
- Keywords
- Pharmaceutical intervention, Older adult, Internal medicine, Adverse drug event
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist CareOther
During hospitalization and at discharge a clinical pharmacist (CP) will monitor daily pharmacological safety and efficacy of the medication to asses and make appropriate recommendations. CP will explain the use reasons of each of the drugs.
At 30 days post-discharge, the CP will review the updated clinical record of patient and conduct a home visit to enhance and ask about adherence, self-medication, medication use at that time and possible results of laboratory tests performed and clarify doubts regarding the use of current medications. The same activities will be made at 60 days by telephonic way, to reinforce the recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Intervented | Experimental | The intervention group will receive in addition to the usual care, it will receive the Clinical Pharmacist Care during hospitalization, discharge and during 2 months post-discharge, through a home visit at 30 ± 5 days post-discharge and a telephone call at 60 ± 5 days. Receives: Other: Clinical Pharmacist Care |
| Control | No intervention | The control group will receive hospital care and discharge from a clinical team previously trained in geriatric clinical pharmacology, which includes epicrisis, indications that the physician deems pertinent to the discharge and prescriptions if necessary and a medical control at 15 days post-discharge. Information will be collected that allows the characterization: * Sociodemographic * Morbid * Pharmaco-therapeutic * Functionality before (baseline), during and after hospitalization A physician, a pharmacist and an occupational therapist, blind to the treatment assignment, will collect the records using a specially designed record. Post-discharge evaluations will be conducted through telephone interviews at 30, 60 and 90 days after hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Drug Events at 90 days post discharge
Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment allocation, will evaluate the history of each case and by consensus will assign the presence of ADE, and classify them as preventable or not preventable and according to severity.
Measured: 90 days post discharge
Secondary outcomes (8)
Adherence measured with Morisky & Green Scale
test with 4 question to know adherence to treatment of the patient
Measured: 90 days post discharge
Incidence of potentially inappropriate medication
The evaluation of which drugs will be considered inappropriate will be performed according to the Beers criteria and STOPP \& START criteria, both allow to evaluate if the indicated medicines are appropriate for the older adults.
Measured: 90 days post discharge
Incidence of adverse drug reactions
The analysis of the direct relationship between adverse reaction and drug use, will be determined by a multidisciplinary team following validated instruments.
Measured: 90 days post discharge
Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital
Measured: 90 days post discharge
Prevalence of Polypharmacy (5 or more drugs)
polypharmacy is a risk factor for many clinical outcomes related with treatment failure or drug related problems
Measured: 90 days post discharge
Prevalence of self medication in each group
when patient take a drug without medical indications, it is considerate self medication.
Measured: 90 days post discharge
Presence of clinically relevant drug interactions
Clinical relevance will be discussed with a multidisciplinary group
Measured: 90 days post discharge
Characterization of the interventions made by the clinical pharmacist to the health team
Cinical phasrmacist interventions may be:
- Dose adjustments
- Change, addition or withdrawal of a drug
- change in treatment regimen or schedule
- Medication errors prevention
- Drug-drug Interactions prevention
- Patient or health team education.
- Actions to improve the clinical outcome of the patients.
Interventions relevance will be discussed with a multidisciplinary group
Measured: 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start2 May 2015
- Primary completion22 Sep 2017 (estimated)
- Study completion22 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Related Side Effects and Adverse ReactionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallels groups: control arm will receive usual care, intervention arm will receive a Clinical Pharmacist Care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 611 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Jirón Aliste, University of Chile
- Investigators
- Marcela Jirón, PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156348
- Sponsor's protocol ID
- SA14ID0141
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 17 May 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacist on Post-discharge Prevention of Adverse Drug Events in Older Adults: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03156348
- Acronym / sponsor ID
- SA14ID0141
- Keywords
- Pharmaceutical intervention, Older adult, Internal medicine, Adverse drug event
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 611 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 2 May 2015 (actual)
- Primary completion
- 22 Sep 2017 (estimated)
- Study completion
- 22 Dec 2017 (estimated)
- First posted
- 17 May 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.
Adverse drug events (ADE) are one of the major problems affecting quality of care and achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital stays, resource use, and problems on patient safety. The present study aim is to determine the impact of the clinical pharmacist interventions on the prevention of ADE in OA at 3 months post-discharge compared to usual care.
A randomized clinical trial of two parallel groups 1: 1 (control and intervention) plus a historical control group will be carried out at the Internal Medicine Service (IMS) of the teaching Hospital at the University of Chile. The sample will be of 611 patients (242 per each parallel group and 127 of the historical control group) of 60 years or older, admitted to the IMS for acute pathology or decompensation of chronic pathology, with survival over 6 months, who is under pharmacological therapy and have a caretaker or responsible contact person at discharge.
The historical control group will receive usual care and the parallel control group will also receive training on pharmacogeriatrics. The intervention group will receive the care of a clinical pharmacist during hospitalization, at discharge and post-discharge, through a home visit at 30 days post-discharge and a telephone call at 60 days post discharge.
Detailed description
The intervention plan during hospitalization will consist of daily monitoring of pharmacological efficacy and safety, participating in clinical rounds and patient interviews. To review, assess the indications according to the conditions of each patient and evaluating possible interactions of clinical importance, dose adjustments, potentially inappropriate medication for older adult (OA), adverse effects and omissions of therapy. To make recommendations to the healthcare team regarding pharmacological therapy received during hospitalization and at discharge.
Patient-directed interventions will occur at discharge and post-discharge, focusing on clarifying management regimens, drug use motives, preventing drug-related problems, clarifying doubts and educating on pharmacotherapy, and enhancing adherence to treatment. The selection and recruitment of the patients will be made during the first 48 hours of their admission to the Internal Medicine Service (IMS), where they will be invited to participate and sign the informed consent.
In all groups, a physician, pharmacist, and occupational therapist, blind to treatment assignment, will collect sociodemographic, morbid, pharmacotherapeutic, and functional (Barthel Index and Lawton \& Brody Scale), adherence (Morisky \& Green Scale), delirium (Confusion Assessment Method, CAM), comorbidity (cumulative illness rating scale in Geriatrics (CIRS-G)), anticholinergic burden (Anticholinergic Burden Scale and Ars Risk Scale), potentially inappropriate medications (Beers Criteria and screening tool of older people's prescriptions \& screening tool to alert to right treatment criteria (STOPP \& START)) before, during hospitalization, at discharge and post-discharge. Also a follow up by telephone interviews at 30, 60 and 90 days after hospital discharge from the IMS.
Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment assignment, will evaluate the history of each case and by consensus will assign the presence of Adverse Drug Events (ADE), and classify them as preventable or not and according to severity. The Chi-squared or Fisher exact test will be used to test the hypothesis that clinical pharmacist intervention prevents at least 50% of ADE at 3 months post-discharge in OA compared to usual care in the IMS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallels groups: control arm will receive usual care, intervention arm will receive a Clinical Pharmacist Care
| Arm | Type | Receives |
|---|---|---|
| Intervented | Experimental | Other: Clinical Pharmacist CareThe intervention group will receive in addition to the usual care, it will receive the Clinical Pharmacist Care during hospitalization, discharge and during 2 months post-discharge, through a home visit at 30 ± 5 days post-discharge and a telephone call at 60 ± 5 days. |
| Control | No intervention | –The control group will receive hospital care and discharge from a clinical team previously trained in geriatric clinical pharmacology, which includes epicrisis, indications that the physician deems pertinent to the discharge and prescriptions if necessary and a medical control at 15 days post-discharge. Information will be collected that allows the characterization: * Sociodemographic * Morbid * Pharmaco-therapeutic * Functionality before (baseline), during and after hospitalization A physician, a pharmacist and an occupational therapist, blind to the treatment assignment, will collect the records using a specially designed record. Post-discharge evaluations will be conducted through telephone interviews at 30, 60 and 90 days after hospital discharge. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients attended by the staff of internists of the internal medicine service of the Clinical Hospital of the University of Chile for acute condition or decompensation of chronic pathology.
- Patients with an estimated survival of more than 6 months.
- Patients who are on pharmacological therapy.
- Patients who have a contact person or responsible caregiver, willing to comply with the scheduled care plan.
- Patients who have a contact telephone number
Key exclusion criteria (2 listed)
- Patients without cognitive autonomy in which it is not possible to establish contact with the caregiver.
- Any other condition that in the judgment of the research team affects the quality of the collection of the information.
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 |
|---|---|---|
| Clinical Pharmacist CareDuring hospitalization and at discharge a clinical pharmacist (CP) will monitor daily pharmacological safety and efficacy of the medication to asses and make appropriate recommendations. CP will explain the use reasons of each of the drugs. At 30 days post-discharge, the CP will review the updated clinical record of patient and conduct a home visit to enhance and ask about adherence, self-medication, medication use at that time and possible results of laboratory tests performed and clarify doubts regarding the use of current medications. The same activities will be made at 60 days by telephonic way, to reinforce the recommendations. | Other | Intervented |
Primary outcome
Incidence of Adverse Drug Events at 90 days post discharge
Time frame: 90 days post discharge
Two trained and independent evaluators (geriatrician and clinical pharmacist), blind to treatment allocation, will evaluate the history of each case and by consensus will assign the presence of ADE, and classify them as preventable or not preventable and according to severity.
8 secondary outcomes
Adherence measured with Morisky & Green Scale
Time frame: 90 days post discharge
Incidence of potentially inappropriate medication
Time frame: 90 days post discharge
Incidence of adverse drug reactions
Time frame: 90 days post discharge
Incidence of non-programmed/programmed consultations or hospitalizations after discharge from the hospital
Time frame: 90 days post discharge
Prevalence of Polypharmacy (5 or more drugs)
Time frame: 90 days post discharge
Prevalence of self medication in each group
Time frame: 90 days post discharge
Presence of clinically relevant drug interactions
Time frame: 90 days post discharge
Characterization of the interventions made by the clinical pharmacist to the health team
Time frame: 90 days post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Hospital Clínico de la Universidad de Chile
Independencia, Chile
Marcela Jirón, PhD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist Care in people with Drug-Related Side Effects and Adverse Reactions, run by University of Chile at 1 site in 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Drug Events at 90 days post discharge (time frame: 90 days post discharge). 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 17 May 2017.