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Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions

27. august 2026 oppdatert av: Hospital de Clinicas de Porto Alegre

Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions After Discharge: a Randomized Clinical Trial.

Hospitalizations for Primary Care-Sensitive Conditions (PCSCs) are potentially avoidable hospital admissions that may be prevented when Primary Health Care provides effective and timely care through prevention, early diagnosis, appropriate management of chronic conditions, and control of acute episodes.

This study proposes an open-label, pragmatic, cluster-randomized clinical trial to evaluate the effectiveness of continuous telecare, supported by digital health tools, in the post-discharge follow-up of patients hospitalized for PCSCs.

The main outcome will be the occurrence of non-elective hospital readmissions and urgent or emergency care visits within 180 days after discharge, compared with usual care.

The intervention will include pharmacist-led teleconsultations, a communication channel through a messaging app, and the development of an individualized care plan. Participants in the control group will receive the usual care provided by the healthcare network.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

3220

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: Bianca V Bianchini, PhD
  • Telefonnummer: +55 51 31914125
  • E-post: bianca@noharm.ai

Studiesteder

  • Brasil
      • Porto Alegre, Brasil
        • Hospital de Clinicas de Porto Alegre

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Individuals aged 18 years or older;
  • Residing in the municipality of Porto Alegre;
  • Hospitalized at Hospital de Clínicas de Porto Alegre for selected Primary Care-Sensitive Conditions (PCSCs): respiratory diseases (such as asthma, chronic obstructive pulmonary disease, and tuberculosis), cardiovascular diseases (such as arterial hypertension, angina, and heart failure), cerebrovascular diseases (such as stroke), and metabolic diseases (such as diabetes mellitus).

Exclusion Criteria:

  • Individuals who are unable to be contacted by telephone;
  • Individuals with language or cognitive barriers that cannot be overcome with the assistance of a caregiver or legal representative;
  • Individuals participating in another clinical trial that conflicts with the present study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Pharmacist-led teleconsultations
Continuous pharmacist-led care program supported by digital health tools, which will include: three pharmacist teleconsultations, with the first consultation within 15 days after hospital discharge, the second within 30 days, and the third within 90 days; an open communication channel through a messaging app; an individualized care plan; and referrals to Primary Health Care professionals, when necessary.
Atferdsmessig: Pharmacist-led teleconsultations
Continuous pharmacist-led care program supported by digital health tools, which will include: three pharmacist teleconsultations, with the first consultation within 15 days after hospital discharge, the second within 30 days, and the third within 90 days; an open communication channel through a messaging app; an individualized care plan; and referrals to other Primary Health Care professionals, when necessary.
Andre navn:
  • Farmasøytiske tjenester
  • Behandling av medisiner
  • Remote Consultation
  • Remote Patient Monitoring
  • Community Pharmacy Services
  • Pharmaceutical Services, Online
Ingen inngripen: Usual care
Usual care provided by the hospital and Primary Health Care services, without implementation of the structured pharmacist-led care program supported by digital health tools.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge
Tidsramme: From enrollment until 180 days after hospital discharge
Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge, assessed through patient/caregiver reports during follow-up visits and electronic medical records.
From enrollment until 180 days after hospital discharge

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants who died within 180 days after hospital discharge
Tidsramme: From enrollment until 180 days after hospital discharge
Proportion of participants who died within 180 days after hospital discharge, assessed through caregiver reports and medical records.
From enrollment until 180 days after hospital discharge
Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan
Tidsramme: From enrollment until 180 days after hospital discharge
Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan, as documented in pharmacist teleconsultations and medical records. An individualized care plan will be developed for each participant based on the Clinical Protocols and Therapeutic Guidelines of the Brazilian Ministry of Health and will include agreed-upon actions. Throughout the follow-up period, completion of the planned actions will be documented. Participants will be considered adherent to the care plan if there is documentation that they completed all planned actions or at least 75% of them within the defined period.
From enrollment until 180 days after hospital discharge
Satisfaction with continuous pharmacist-led care
Tidsramme: From enrollment until 180 days after hospital discharge
Satisfaction with continuous pharmacist-led care will be assessed using the Net Promoter Score (NPS), based on the standard question: "On a scale from 0 to 10, how likely are you to recommend pharmacist-led telecare to a friend or family member?". Respondents will be classified as promoters (score 9-10), passives (score 7-8), or detractors (score 0-6). The NPS will be calculated as the difference between the percentage of promoters and the percentage of detractors, resulting in a score ranging from -100 to +100 (NPS = % Promoters - % Detractors).
From enrollment until 180 days after hospital discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital de Clinicas de Porto Alegre

Samarbeidspartnere

Institute of Artificial Intelligence in Health

Etterforskere

  • Studiestol: Diego Gnatta, PhD, Federal University of Rio Grande do Sul

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 (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0354
  • 99456126.3.0000.5327 (Annen identifikator: Certificate of Presentation for Ethical Assessment)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is no plan to make individual participant data available to external researchers. The study protocol approved by the institutional Research Ethics Committee does not include the sharing of individual participant data with researchers outside the primary research team. Individual participant data collected in this study include sensitive personal health information and will be used exclusively for the purposes specified in the approved study protocol. Study findings will be disseminated through scientific publications and other scientific communications using aggregate data.

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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