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

27. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

  • Brasilien
      • Porto Alegre, Brasilien
        • Hospital de Clinicas de Porto Alegre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Adfærdsmæssigt: 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 navne:
  • Farmaceutiske tjenester
  • Håndtering af medicinterapi
  • Remote Consultation
  • Remote Patient Monitoring
  • Community Pharmacy Services
  • Pharmaceutical Services, Online
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clinicas de Porto Alegre

Samarbejdspartnere

Institute of Artificial Intelligence in Health

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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