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Drug Related ProblemsNCT03607097

Integral Management of Healthcare Problems Related With Drugs in Polimedicated Patients: Medication Code

A study testing Secondary prevention program for drug related problems in people with Drug Related Problems and Pharmaceutical Care, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Although Drug- related Problems (DRPs) in polimedicated patients are a major public health problem in western countries and many of them have been considered avoidable, secondary and primary prevention policies have not been systematized, beyond pharmaceutical care programs in certain settings and on… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug Related Problems, Pharmaceutical Care
What is being tested?
Secondary prevention program for drug related problems
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
808 participants
Where
1 siteSpain
Study dates
28 Aug 2018to 31 Dec 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years
  • Drug Related Problems (DRP) related to drugs from Anatomical Therapeutic Chemical (ATC) groups A, B and C

Who cannot join

  • DRP due to autolytic attempt or final phase of life.
  • Denied informed consent

Trial locations and contacts

1 site in 1 country.

Ana M Juanes, PhD contact

+34932919000 ext. 1887

ajuanes@santpau.cat

Jesus Ruiz, PhD contact

+34932919000 ext. 1887

jrzrms@gmail.com

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Ana Juanes

    Recruiting

Other trials in Spain

About this study

Official title: Integral Management of Healthcare Problems Related With Drugs in Polimedicated Patients: Drug Code

Background:

Although Drug- related Problems (DRPs) in polimedicated patients are a major public health problem in western countries and many of them have been considered avoidable, secondary and primary prevention policies have not been systematized, beyond pharmaceutical care programs in certain settings and on specific patients.

Read more

Objectives:

The main objective of this study is to evaluate the impact of implementing the Medication Code (CM) on patients who consult the emergency department for a DRP (secondary prevention of DRP). It is also intended to draw conclusions, based on the knowledge obtained in terms of DRP that will allow the establishment of future actions to reduce its prevalence (primary prevention actions).

Method:

A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

Read the detailed description

A single-centre clinical trial is proposed in which adult patients will be selected to consult the Hospital Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCSP) for a primary or secondary diagnosis of DRP and will be randomised with a 1:1 distribution to be included in the medication code (intervention group) or to receive usual care (control group). The intervention will be evaluated in terms of health outcomes (ED consultations and hospital readmission).

Being tested
Secondary prevention program for drug related problems
Keywords
secondary prevention, pharmaceutical care, drug related problems, emergency department
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secondary prevention program for drug related problemsProcedure or surgery

    Also called Medication Code

    The interventions consists of three stages: 1) actions aimed at improving the chronic prescription of the patient, 2) actions aimed at improving the therapeutic adherence and 3) actions aimed at improving the assistance healthcare levels coordination

Study groups in NCT03607097
Study groupRoleWhat they receive
Secondary prevention of DRPs (medication code) (intervention)ExperimentalThe intervention consists of :1)Patient-centred prescription Espaulella-Panicot J model (review model that includes different strategies in a single intervention. It is performed by a multidisciplinary team, and allows them to adapt the pharmacological plan of patients with clinical complexity). 2)strategies to improve medication adherence
Receives: Procedure: Secondary prevention program for drug related problems
Usual care (control group)No interventionThe patient is reviewed according to the standard procedure, consisting only on the review of the medical prescription in the emergency department by the pharmacist assisting the unit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 day readmission

    Readmissions during the 30 days after the intervention in any hospital centre from the "Àrea Integral de Salut Barcelona Dreta" after consulting the Hospital de la Santa Creu i Sant Pau (HSCSP) emergency department.

    Measured: 30 days

Secondary outcomes (3)

  1. 30 day consultation

    Consultation 30 days after the intervention for any cause to the HSCSP

    Measured: 30 days

  2. 30 day mortality

    Any cause mortality 30 days after the intervention

    Measured: 30 days

  3. Time on Emergency Department

    Time from patient admission to discharge from the emergency department

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start28 Aug 2018
  3. Primary completion30 Oct 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
808 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607097
Sponsor's protocol ID
IIBSP-COD-2018-25
Status last verified
Feb 2020
First submitted
20 Jul 2018
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nivya K, Sri Sai Kiran V, Ragoo N, Jayaprakash B, Sonal Sekhar M. Systemic review on drug related hospital admissions - A pubmed based search. Saudi Pharm J. 2015 Jan;23(1):1-8. doi: 10.1016/j.jsps.2013.05.006. Epub 2013 May 30.

    PubMed 25685036

  • 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 24091839

  • Castro 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 23695594

  • Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy. 2002 Jul;22(7):915-23. doi: 10.1592/phco.22.11.915.33630.

    PubMed 12126224

  • Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, Leverve X, Lapostolle F, Borron SW, Adnet F; Association Pedagogique Nationale pour l'Enseignement de la Therapeutique (APNET). Emergency department visits caused by adverse drug events: results of a French survey. Drug Saf. 2007;30(1):81-8. doi: 10.2165/00002018-200730010-00008.

    PubMed 17194173

  • Wei L, Yang X, Li J, Liu L, Luo H, Zheng Z, Wei Y. Effect of pharmaceutical care on medication adherence and hospital admission in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled study. J Thorac Dis. 2014 Jun;6(6):656-62. doi: 10.3978/j.issn.2072-1439.2014.06.20.

    PubMed 24976987

  • Obreli-Neto PR, Marusic S, Guidoni CM, Baldoni Ade O, Renovato RD, Pilger D, Cuman RK, Pereira LR. Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial. J Manag Care Spec Pharm. 2015 Jan;21(1):66-75. doi: 10.18553/jmcp.2015.21.1.66.

    PubMed 25562774

  • Koshman SL, Charrois TL, Simpson SH, McAlister FA, Tsuyuki RT. Pharmacist care of patients with heart failure: a systematic review of randomized trials. Arch Intern Med. 2008 Apr 14;168(7):687-94. doi: 10.1001/archinte.168.7.687.

    PubMed 18413550

  • Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, Nielsen ML, Eriksen CS, Buck TC, Pottegard A, Hansen MR, Hallas J. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial. JAMA Intern Med. 2018 Mar 1;178(3):375-382. doi: 10.1001/jamainternmed.2017.8274.

    PubMed 29379953

  • Juanes A, Ruiz J, Puig M, Blazquez M, Gilabert A, Lopez L, Baena MI, Guiu JM, Antonia Mangues M. The Effect of the Drug-Related Problems Prevention Bundle on Early Readmissions in Patients From the Emergency Department: A Randomized Clinical Trial. Ann Pharmacother. 2023 Sep;57(9):1025-1035. doi: 10.1177/10600280221143237. Epub 2022 Dec 20.

    PubMed 36539949

Questions about this trial

What is this clinical trial studying?

A study testing Secondary prevention program for drug related problems in people with Drug Related Problems and Pharmaceutical Care, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 2 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 13 Feb 2020. 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 Spain. 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?

Contact Ana M Juanes, PhD (+34932919000 ext. 1887, ajuanes@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 day readmission (time frame: 30 days). 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 NCT03607097, which also lists 10 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 13 Feb 2020.

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