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

27 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

3220

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

  • Brazilië
      • Porto Alegre, Brazilië
        • Hospital de Clinicas de Porto Alegre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.
Andere namen:
  • Farmaceutische diensten
  • Beheer van medicatietherapie
  • Remote Consultation
  • Remote Patient Monitoring
  • Community Pharmacy Services
  • Pharmaceutical Services, Online
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants who died within 180 days after hospital discharge
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital de Clinicas de Porto Alegre

Medewerkers

Institute of Artificial Intelligence in Health

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 januari 2029

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0354
  • 99456126.3.0000.5327 (Andere identificatie: Certificate of Presentation for Ethical Assessment)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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