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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ambulatory Care Sensitive Conditions
• Intervention / Treatment: Behavioral: Pharmacist-led teleconsultations

• Study Type: Interventional
• Enrollment (Estimated): 3220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bianca V Bianchini, PhD; Phone Number: +55 51 31914125; Email: bianca@noharm.ai

Study Locations

• Brazil
  • Porto Alegre, Brazil
    • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.; Other Names: Pharmaceutical Services; Medication Therapy Management; Remote Consultation; Remote Patient Monitoring; Community Pharmacy Services; Pharmaceutical Services, Online
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who died within 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	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	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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Institute of Artificial Intelligence in Health
• Investigators: Study Chair: Diego Gnatta, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Transitional Care; Patient Discharge; Patient Readmission; Remote Patient Monitoring; Ambulatory Care Sensitive Conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Ambulatory Care Sensitive Conditions; Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Health Care Economics and Organizations; Telemedicine; Patient Care Management; Financing, Organized; Economics; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Medicare; Remote Patient Monitoring; Remote Consultation; Pharmaceutical Services; Medication Therapy Management; Pharmaceutical Services, Online; Community Pharmacy Services
• Other Study ID Numbers: 2026-0354; 99456126.3.0000.5327 (Other Identifier: Certificate of Presentation for Ethical Assessment)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No