Heart FailureNCT02368548
Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency Department
A study testing Pharmaceutical Care Program in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pharmaceutical Care Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: 65 years and over
- Admission in the Emergency Department for a period equal to or higher than 12 hours;
- Number of home medication equal to or higher than four;
- Diagnose in the Emergency Department episode: decompensated heart failure and/or decompensated COPD.
Who cannot join
- Suffering from dementia, severe mental disorders and living in nursing homes.
About this study
The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.
Read the detailed description
Clinical trial aimed to assess the impact of a pharmaceutical care program initiated in the Emergency Department vs standard care in patients with heart failure and/or COPD, conducted at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) between Jan12-Feb13.
The researchers hypothesize that a systematic, standardized pharmaceutical care program may be related to a lower frequency of drug related problems (DRP). Moreover, the investigators also hypothesize that 6-month mortality, the average length of the hospital stay, and its related cost may also be decreased.
This study was approved by the Hospital de la Santa Creu i Sant Pau Ethics Committee. Written informed consent will be obtained from the participants .
The study will include 100 patients who fulfill all the inclusion criteria, described in the Eligibility Section.
- Being tested
- Pharmaceutical Care Program, Standard Care
- Keywords
- Pharmaceutical care, Emergency Service
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical Care ProgramOther
Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
Standard CareOther
Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical care program | Experimental | 1. Initiated in the Emergency Department (ED):
1. Review of home medication and medication reconciliation based on Primary Care data
2. Patient interview. Assessment of the patient's knowledge on the pharmacological treatment
3. Development of the pharmacological history and registration in the medical record
4. Adequacy of drug therapy. Identification of Drug Related Problems including reconciliation errors (DRP) and communication to medical team
5. Pharmacotherapy monitoring
6. Treatment validation and medication reconciliation at discharge
2. During the hospitalization (if admission from the ED):
1. Treatment review and medication reconciliation
2. Pharmacokinetics monitoring
3. Retrospective validation of prescriptions and assessment of drugs appropriateness. DRP identification and communication to medical team
4. Pharmacotherapy monitoring
5. Validation and medication reconciliation at discharge
6. Patient education at discharge Receives: Other: Pharmaceutical Care Program |
| Standard Care | Other | Stages:
1. Pharmaceutical care program in the episode at the Emergency Department:
a. There was no monitoring of the patient by the pharmacist. Retrospective validation of the prescriptions was not performed.
2. During the hospitalization (if admission from the ED):
1. Pharmacokinetics monitoring
2. Retrospective validation of prescriptions and assessment of drugs appropriateness. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Related Problems (DRP)
Patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use or errors in the use of medicines
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Mortality
Patients who died during the following 6 months after inclusion
Measured: 6-month after inclusion
Average length of the hospital stay
Duration of the stay (in hours) from the emergency episode until discharge from the hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Readmissions
Number of visits (emergency department/hospitalization) due to HF and/or COPD decompensation after the first episode (inclusion in the study), in the next 1180 days.
Measured: 6-month after inclusion
Average cost of hospital stay
Average money spent per patient in Euros.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368548
- Sponsor's protocol ID
- IIBSP-PAF-2011-81
- Other IDs
- IIBSP-PAF-2011-81
- Status last verified
- Feb 2015
- First submitted
- 20 Jan 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.
PubMed 24091839Gorgas Torner MQ, Paez Vives F, Camos Ramio J, de Puig Cabrera E, Jolonch Santasusagna P, Homs Peipoch E, Schoenenberger Arnaiz JA, Codina Jane C, Gomez-Arbones J. [Integrated pharmaceutical care programme in patients with chronic diseases]. Farm Hosp. 2012 Jul-Aug;36(4):229-39. doi: 10.1016/j.farma.2011.06.015. Epub 2011 Dec 3. Spanish.
PubMed 22137609Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
PubMed 19433702Koehler BE, Richter KM, Youngblood L, Cohen BA, Prengler ID, Cheng D, Masica AL. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009 Apr;4(4):211-8. doi: 10.1002/jhm.427.
PubMed 19388074Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22.
PubMed 23695594Juanes A, Garin N, Mangues MA, Herrera S, Puig M, Faus MJ, Baena MI. Impact of a pharmaceutical care programme for patients with chronic disease initiated at the emergency department on drug-related negative outcomes: a randomised controlled trial. Eur J Hosp Pharm. 2018 Sep;25(5):274-280. doi: 10.1136/ejhpharm-2016-001055. Epub 2017 Feb 23.
PubMed 31157039
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency Department
- ClinicalTrials.gov ID
- NCT02368548
- Acronym / sponsor ID
- IIBSP-PAF-2011-81
- Keywords
- Pharmaceutical care, Emergency Service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Feb 2015 (estimated)
- 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.
The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.
Detailed description
Clinical trial aimed to assess the impact of a pharmaceutical care program initiated in the Emergency Department vs standard care in patients with heart failure and/or COPD, conducted at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) between Jan12-Feb13.
The researchers hypothesize that a systematic, standardized pharmaceutical care program may be related to a lower frequency of drug related problems (DRP). Moreover, the investigators also hypothesize that 6-month mortality, the average length of the hospital stay, and its related cost may also be decreased.
This study was approved by the Hospital de la Santa Creu i Sant Pau Ethics Committee. Written informed consent will be obtained from the participants .
The study will include 100 patients who fulfill all the inclusion criteria, described in the Eligibility Section.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical care program | Experimental | Other: Pharmaceutical Care Program1. Initiated in the Emergency Department (ED): 1. Review of home medication and medication reconciliation based on Primary Care data 2. Patient interview. Assessment of the patient's knowledge on the pharmacological treatment 3. Development of the pharmacological history and registration in the medical record 4. Adequacy of drug therapy. Identification of Drug Related Problems including reconciliation errors (DRP) and communication to medical team 5. Pharmacotherapy monitoring 6. Treatment validation and medication reconciliation at discharge 2. During the hospitalization (if admission from the ED): 1. Treatment review and medication reconciliation 2. Pharmacokinetics monitoring 3. Retrospective validation of prescriptions and assessment of drugs appropriateness. DRP identification and communication to medical team 4. Pharmacotherapy monitoring 5. Validation and medication reconciliation at discharge 6. Patient education at discharge |
| Standard Care | Other | Other: Standard CareStages: 1. Pharmaceutical care program in the episode at the Emergency Department: a. There was no monitoring of the patient by the pharmacist. Retrospective validation of the prescriptions was not performed. 2. During the hospitalization (if admission from the ED): 1. Pharmacokinetics monitoring 2. Retrospective validation of prescriptions and assessment of drugs appropriateness. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age: 65 years and over
- Admission in the Emergency Department for a period equal to or higher than 12 hours;
- Number of home medication equal to or higher than four;
- Diagnose in the Emergency Department episode: decompensated heart failure and/or decompensated COPD.
Key exclusion criteria (1 listed)
- Suffering from dementia, severe mental disorders and living in nursing homes.
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 |
|---|---|---|
| Pharmaceutical Care ProgramIntensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description. | Other | Pharmaceutical care program |
| Standard CareStandard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description. | Other | Standard Care |
Primary outcome
Drug Related Problems (DRP)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use or errors in the use of medicines
Mortality
Time frame: 6-month after inclusion
Patients who died during the following 6 months after inclusion
Average length of the hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Duration of the stay (in hours) from the emergency episode until discharge from the hospital
Readmissions
Time frame: 6-month after inclusion
Number of visits (emergency department/hospitalization) due to HF and/or COPD decompensation after the first episode (inclusion in the study), in the next 1180 days.
Average cost of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Average money spent per patient in Euros.
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 23 Feb 2015.
- Background: PubMed 24091839Baena MI, Fajardo PC, Pintor-Marmol A, Faus MJ, Marin R, Zarzuelo A, Martinez-Olmos J, Martinez-Martinez F. Negative clinical outcomes of medication resulting in emergency department visits. Eur J Clin Pharmacol. 2014 Jan;70(1):79-87. doi: 10.1007/s00228-013-1562-0. Epub 2013 Oct 3.
- Background: PubMed 22137609Gorgas Torner MQ, Paez Vives F, Camos Ramio J, de Puig Cabrera E, Jolonch Santasusagna P, Homs Peipoch E, Schoenenberger Arnaiz JA, Codina Jane C, Gomez-Arbones J. [Integrated pharmaceutical care programme in patients with chronic diseases]. Farm Hosp. 2012 Jul-Aug;36(4):229-39. doi: 10.1016/j.farma.2011.06.015. Epub 2011 Dec 3. Spanish.
- Background: PubMed 19433702Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
- Background: PubMed 19388074Koehler BE, Richter KM, Youngblood L, Cohen BA, Prengler ID, Cheng D, Masica AL. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009 Apr;4(4):211-8. doi: 10.1002/jhm.427.
- Background: PubMed 23695594Castro I, Guardiola JM, Tuneu L, Sala ML, Faus MJ, Mangues MA. Drug-related visits to the emergency department in a Spanish university hospital. Int J Clin Pharm. 2013 Oct;35(5):727-35. doi: 10.1007/s11096-013-9795-7. Epub 2013 May 22.
- Derived from this study: PubMed 31157039Juanes A, Garin N, Mangues MA, Herrera S, Puig M, Faus MJ, Baena MI. Impact of a pharmaceutical care programme for patients with chronic disease initiated at the emergency department on drug-related negative outcomes: a randomised controlled trial. Eur J Hosp Pharm. 2018 Sep;25(5):274-280. doi: 10.1136/ejhpharm-2016-001055. Epub 2017 Feb 23.
- Third Consensus of Granada on Drug Related Problems (DRP) and NegativeLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical Care Program in people with Heart Failure and Pulmonary Disease, Chronic Obstructive, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 4 inclusion and 1 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 23 Feb 2015. 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?
Drug Related Problems (DRP) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368548, which also lists 6 linked publications.
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 23 Feb 2015.