Secondary Prevention of Dug-related Problems Through Digital Health
8 de abril de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Anticipado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ana Juanes Borrego, Doctor
- Número de teléfono: 7459 932 91 90 00
- Correo electrónico: ajuanes@santpau.cat
Copia de seguridad de contactos de estudio
- Nombre: Jesús Ruiz Ramos, Doctor
- Número de teléfono: 7459 932 91 90 00
- Correo electrónico: jruiz@santpau.cat
Ubicaciones de estudio
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-
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Barcelona, España
- Hospital De La Santa Creu I Sant Pau
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Contacto:
- Ana Juanes, Doctor
- Correo electrónico: ajuanes@santpau.cat
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Contacto:
- Jesús Ruiz, Doctor
- Correo electrónico: jruiz@santpau.cat
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Investigador principal:
- Laia López
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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Comparador de placebos: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Periodo de tiempo: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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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)
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Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Periodo de tiempo: Baseline
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Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
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Baseline
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Identify risk factors for ED visits related to DRP
Periodo de tiempo: Baseline
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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.
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Baseline
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Identify which groups of drugs are more frequently associated to DRP
Periodo de tiempo: Baseline
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Using ATC group classification
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Baseline
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Change in the patient therapeutic adherence
Periodo de tiempo: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
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Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
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Change in the patient therapeutic adherence
Periodo de tiempo: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
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Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
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Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
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Mesure therapeutic complexity
Periodo de tiempo: Baseline
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Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
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Baseline
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Identify predictive factors of a greater capacity for digital empowerment.
Periodo de tiempo: Baseline
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Using the CAMBADOS questionnaire
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Baseline
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Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Periodo de tiempo: 90-day after discharge (in phase I, Pilot Trial)
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Using the TrilemaSalud questionnaire
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90-day after discharge (in phase I, Pilot Trial)
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Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Periodo de tiempo: 12-month after discharge (in phase II, Clinical Trial)
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Using the TrilemaSalud questionnaire
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12-month after discharge (in phase II, Clinical Trial)
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Change in the quality of life of patients in the active group
Periodo de tiempo: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
|
Using the EQ-5D-3L51 questionnaire
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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
Periodo de tiempo: 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)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
- Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. Am J Occup Ther. 2013 Mar-Apr;67(2):171-6. doi: 10.5014/ajot.2013.006270.
- Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum In: J Clin Oncol. 2016 Jun 20;34(18):2198. J Clin Oncol. 2019 Feb 20;37(6):528.
- Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
- 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.
- Gheewala PA, Peterson GM, Curtain CM, Nishtala PS, Hannan PJ, Castelino RL. Impact of the pharmacist medication review services on drug-related problems and potentially inappropriate prescribing of renally cleared medications in residents of aged care facilities. Drugs Aging. 2014 Nov;31(11):825-35. doi: 10.1007/s40266-014-0208-y.
- Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014 Oct 7;(10):CD008165. doi: 10.1002/14651858.CD008165.pub3. Review. Update in: Cochrane Database Syst Rev. 2018 Sep 03;9:CD008165.
- 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.
- Lancaster K, Abuzour A, Khaira M, Mathers A, Chan A, Bui V, Lok A, Thabane L, Dolovich L. The Use and Effects of Electronic Health Tools for Patient Self-Monitoring and Reporting of Outcomes Following Medication Use: Systematic Review. J Med Internet Res. 2018 Dec 18;20(12):e294. doi: 10.2196/jmir.9284.
- Martinez-Pillado M, Said-Criado I, Regueiro-Martinez A, Rodriguez IC. E-young chronics y e-senior chronics como nuevos modelos para la atencion a la cronicidad. J Healthc Qual Res. 2018 May-Jun;33(3):119-120. doi: 10.1016/j.jhqr.2018.07.001. No abstract available. Spanish.
- 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.
- Piette JD, List J, Rana GK, Townsend W, Striplin D, Heisler M. Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management. Circulation. 2015 Nov 24;132(21):2012-27. doi: 10.1161/CIRCULATIONAHA.114.008723.
- 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.
- Gomis-Pastor M, Roig Mingell E, Mirabet Perez S, Brossa Loidi V, Lopez Lopez L, Diaz Bassons A, Aretio Pousa A, Feliu Ribera A, Ferrero-Gregori A, Guirado Perich L, Mangues Bafalluy MA. Multimorbidity and medication complexity: New challenges in heart transplantation. Clin Transplant. 2019 Oct;33(10):e13682. doi: 10.1111/ctr.13682. Epub 2019 Aug 28.
- Anglada-Martinez H, Martin-Conde M, Rovira-Illamola M, Sotoca-Momblona JM, Sequeira E, Aragunde V, Moreno MA, Catalan M, Codina-Jane C. Feasibility and Preliminary Outcomes of a Web and Smartphone-Based Medication Self-Management Platform for Chronically Ill Patients. J Med Syst. 2016 Apr;40(4):99. doi: 10.1007/s10916-016-0456-y. Epub 2016 Feb 12.
- Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.
- Chen CE, Harrington RA, Desai SA, Mahaffey KW, Turakhia MP. Characteristics of Digital Health Studies Registered in ClinicalTrials.gov. JAMA Intern Med. 2019 Jun 1;179(6):838-840. doi: 10.1001/jamainternmed.2018.7235.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de abril de 2021
Finalización primaria (Anticipado)
1 de octubre de 2021
Finalización del estudio (Anticipado)
1 de abril de 2023
Fechas de registro del estudio
Enviado por primera vez
18 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2021
Publicado por primera vez (Actual)
12 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IIBSP-COD-2019-46
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
Monitor clinical trial will have access to all study data
Marco de tiempo para compartir IPD
Data will be avaliable for monitor during the whole study period
Criterios de acceso compartido de IPD
All data may be analysed and revised during the whole study period by the monitor and investigators
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
- Código analítico
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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