Secondary Prevention of Dug-related Problems Through Digital Health
8. april 2021 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ana Juanes Borrego, Doctor
- Telefonnummer: 7459 932 91 90 00
- E-post: ajuanes@santpau.cat
Studer Kontakt Backup
- Navn: Jesús Ruiz Ramos, Doctor
- Telefonnummer: 7459 932 91 90 00
- E-post: jruiz@santpau.cat
Studiesteder
-
-
-
Barcelona, Spania
- Hospital de la Santa Creu i Sant Pau
-
Ta kontakt med:
- Ana Juanes, Doctor
- E-post: ajuanes@santpau.cat
-
Ta kontakt med:
- Jesús Ruiz, Doctor
- E-post: jruiz@santpau.cat
-
Hovedetterforsker:
- Laia López
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Placebo komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Tidsramme: 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.
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Using ATC group classification
|
Baseline
|
|
Change in the patient therapeutic adherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
|
Baseline
|
|
Identify predictive factors of a greater capacity for digital empowerment.
Tidsramme: Baseline
|
Using the CAMBADOS questionnaire
|
Baseline
|
|
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
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- 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.
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- 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.
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- 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.
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- 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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- 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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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. april 2021
Primær fullføring (Forventet)
1. oktober 2021
Studiet fullført (Forventet)
1. april 2023
Datoer for studieregistrering
Først innsendt
18. mars 2021
Først innsendt som oppfylte QC-kriteriene
8. april 2021
Først lagt ut (Faktiske)
12. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IIBSP-COD-2019-46
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
Monitor clinical trial will have access to all study data
IPD-delingstidsramme
Data will be avaliable for monitor during the whole study period
Tilgangskriterier for IPD-deling
All data may be analysed and revised during the whole study period by the monitor and investigators
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
- Informert samtykkeskjema (ICF)
- Klinisk studierapport (CSR)
- Analytisk kode
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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