NCT07789353

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,220

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Jan 2029

Study Start

First participant enrolled

August 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

Transitional CareAmbulatory Care Sensitive ConditionsRemote Patient MonitoringPatient ReadmissionPatient Discharge

Outcome Measures

Primary Outcomes (1)

  • Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 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

Secondary Outcomes (3)

  • Proportion of participants who died within 180 days after hospital discharge

    From enrollment until 180 days after hospital discharge

  • Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan

    From enrollment until 180 days after hospital discharge

  • Satisfaction with continuous pharmacist-led care

    From enrollment until 180 days after hospital discharge

Study Arms (2)

Pharmacist-led teleconsultations

ACTIVE COMPARATOR

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.

Behavioral: Pharmacist-led teleconsultations

Usual care

NO INTERVENTION

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.

Interventions

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.

Also known as: Remote Consultation, Remote Patient Monitoring, Community Pharmacy Services, Pharmaceutical Services, Online, Pharmaceutical Services, Medication Therapy Management
Pharmacist-led teleconsultations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

MeSH Terms

Conditions

Ambulatory Care Sensitive Conditions

Interventions

Remote ConsultationRemote Patient MonitoringCommunity Pharmacy ServicesPharmaceutical Services, OnlinePharmaceutical ServicesMedication Therapy Management

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care ManagementCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicare

Study Officials

  • Diego Gnatta, PhD

    Federal University of Rio Grande do Sul

    STUDY CHAIR

Central Study Contacts

Bianca V Bianchini, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations