Secondary Prevention of Dug-related Problems Through Digital Health
8 aprile 2021 aggiornato da: Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized.
The project is structured in two consecutive phases.
- st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study.
- nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
200
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ana Juanes Borrego, Doctor
- Numero di telefono: 7459 932 91 90 00
- Email: ajuanes@santpau.cat
Backup dei contatti dello studio
- Nome: Jesús Ruiz Ramos, Doctor
- Numero di telefono: 7459 932 91 90 00
- Email: jruiz@santpau.cat
Luoghi di studio
-
-
-
Barcelona, Spagna
- Hospital de la Santa Creu i Sant Pau
-
Contatto:
- Ana Juanes, Doctor
- Email: ajuanes@santpau.cat
-
Contatto:
- Jesús Ruiz, Doctor
- Email: jruiz@santpau.cat
-
Investigatore principale:
- Laia López
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N.
- Be independent for activities of daily living (equivalent to Barthel 100).
- Have a Chalson Comorbidity Index 2 <= 3.
- Not present cognitive impairment.
- Be directly responsible for pharmacotherapy.
- Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.
Exclusion Criteria:
- Important language barrier.
- Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study.
- Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria.
- Patients not residing in the territory who cannot be followed-up later.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Drug Code Active Patient o DCAP
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
|
|
Comparatore placebo: Standard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge. |
Inclusion in the control group do not involves the use of MyPlan digital health tool.
Patients will receive the standard of care.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Lasso di tempo: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
|
Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Lasso di tempo: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
|
Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Lasso di tempo: Baseline
|
Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
|
Baseline
|
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Identify risk factors for ED visits related to DRP
Lasso di tempo: Baseline
|
Age, sex, social and familiar environment, blood presure (mmHg), heart frequency (bpm), Hb1Ac (%), pain (visual analog scale), weight (kg) and height (cm), chronic kidney disease, number of drugs at admission and at discharge, number of chronic health problems.
|
Baseline
|
|
Identify which groups of drugs are more frequently associated to DRP
Lasso di tempo: Baseline
|
Using ATC group classification
|
Baseline
|
|
Change in the patient therapeutic adherence
Lasso di tempo: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
|
Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
|
Change in the patient therapeutic adherence
Lasso di tempo: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
|
Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
|
Mesure therapeutic complexity
Lasso di tempo: Baseline
|
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
|
Baseline
|
|
Identify predictive factors of a greater capacity for digital empowerment.
Lasso di tempo: Baseline
|
Using the CAMBADOS questionnaire
|
Baseline
|
|
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Lasso di tempo: 90-day after discharge (in phase I, Pilot Trial)
|
Using the TrilemaSalud questionnaire
|
90-day after discharge (in phase I, Pilot Trial)
|
|
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Lasso di tempo: 12-month after discharge (in phase II, Clinical Trial)
|
Using the TrilemaSalud questionnaire
|
12-month after discharge (in phase II, Clinical Trial)
|
|
Change in the quality of life of patients in the active group
Lasso di tempo: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Using the EQ-5D-3L51 questionnaire
|
Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
|
Change in the quality of life of patients in the active group
Lasso di tempo: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Using the EQ-5D-3L51 questionnaire
|
Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr. 2009 Jan 28;9:5. doi: 10.1186/1471-2318-9-5.
- de la Torre-Diez I, Lopez-Coronado M, Vaca C, Aguado JS, de Castro C. Cost-utility and cost-effectiveness studies of telemedicine, electronic, and mobile health systems in the literature: a systematic review. Telemed J E Health. 2015 Feb;21(2):81-5. doi: 10.1089/tmj.2014.0053. Epub 2014 Dec 4.
- Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014 Sep;70(9):1932-1953. doi: 10.1111/jan.12400. Epub 2014 Apr 1.
- 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.
- 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.
- 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.
- Banerjee J, Conroy S, Cooke MW. Quality care for older people with urgent and emergency care needs in UK emergency departments. Emerg Med J. 2013 Sep;30(9):699-700. doi: 10.1136/emermed-2012-202080. Epub 2012 Dec 18. No abstract available.
- Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
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- Campins L, Serra-Prat M, Palomera E, Bolibar I, Martinez MA, Gallo P. Reduction of pharmaceutical expenditure by a drug appropriateness intervention in polymedicated elderly subjects in Catalonia (Spain). Gac Sanit. 2019 Mar-Apr;33(2):106-111. doi: 10.1016/j.gaceta.2017.09.002. Epub 2017 Nov 20.
- Perez Menendez-Conde C, Bermejo Vicedo T, Delgado Silveira E, Carretero Accame E. Adverse drug reactions which provoke hospital admission. Farm Hosp. 2011 Sep-Oct;35(5):236-43. doi: 10.1016/j.farma.2010.08.003. Epub 2011 May 12. English, Spanish.
- Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny MP, Sheikh A. Medication Without Harm: WHO's Third Global Patient Safety Challenge. Lancet. 2017 Apr 29;389(10080):1680-1681. doi: 10.1016/S0140-6736(17)31047-4. No abstract available.
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- Ritterband LM, Andersson G, Christensen HM, Carlbring P, Cuijpers P. Directions for the International Society for Research on Internet Interventions (ISRII). J Med Internet Res. 2006 Sep 29;8(3):e23. doi: 10.2196/jmir.8.3.e23.
- Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial. J Med Internet Res. 2015 Jun 10;17(6):e142. doi: 10.2196/jmir.4550.
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- Comin-Colet J, Enjuanes C, Verdu-Rotellar JM, Linas A, Ruiz-Rodriguez P, Gonzalez-Robledo G, Farre N, Moliner-Borja P, Ruiz-Bustillo S, Bruguera J. Impact on clinical events and healthcare costs of adding telemedicine to multidisciplinary disease management programmes for heart failure: Results of a randomized controlled trial. J Telemed Telecare. 2016 Jul;22(5):282-95. doi: 10.1177/1357633X15600583. Epub 2015 Sep 7.
- 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.
- 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.
- 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.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 aprile 2021
Completamento primario (Anticipato)
1 ottobre 2021
Completamento dello studio (Anticipato)
1 aprile 2023
Date di iscrizione allo studio
Primo inviato
18 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
8 aprile 2021
Primo Inserito (Effettivo)
12 aprile 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 aprile 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IIBSP-COD-2019-46
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano IPD
Monitor clinical trial will have access to all study data
Periodo di condivisione IPD
Data will be avaliable for monitor during the whole study period
Criteri di accesso alla condivisione IPD
All data may be analysed and revised during the whole study period by the monitor and investigators
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
- Modulo di consenso informato (ICF)
- Relazione sullo studio clinico (CSR)
- Codice analitico
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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