Ambulatory Care Sensitive ConditionsNCT07789353
Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions
A study testing Pharmacist-led teleconsultations in people with Ambulatory Care Sensitive Conditions, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Care Sensitive Conditions
- What is being tested?
- Pharmacist-led teleconsultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,220 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Ambulatory Care Sensitive Conditions
- Being tested
- Pharmacist-led teleconsultations
- Keywords
- Transitional Care, Ambulatory Care Sensitive Conditions, Remote Patient Monitoring, Patient Readmission, Patient Discharge
- Medical subject headings
- Ambulatory Care Sensitive Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led teleconsultationsBehavioural
Also called Remote Consultation, Remote Patient Monitoring, Community Pharmacy Services, Pharmaceutical Services, Online
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until 180 days after hospital discharge
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: From enrollment until 180 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Care Sensitive ConditionsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Artificial Intelligence in Health
- Responsible party
- Sponsor
- Investigators
- Diego Gnatta, PhD, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789353
- Sponsor's protocol ID
- 2026-0354
- Other IDs
- 99456126.3.0000.5327
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions After Discharge: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07789353
- Acronym / sponsor ID
- 2026-0354
- Conditions
- Ambulatory Care Sensitive Conditions
- Keywords
- Transitional Care, Ambulatory Care Sensitive Conditions, Remote Patient Monitoring, Patient Readmission, Patient Discharge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,220 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Institute of Artificial Intelligence in Health
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led teleconsultations | Active comparator | Behavioral: Pharmacist-led teleconsultationsContinuous 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led teleconsultationsAlso: Remote Consultation, Remote Patient Monitoring, Community Pharmacy Services, Pharmaceutical Services, OnlineContinuous 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. | Behavioural | Pharmacist-led teleconsultations |
Primary outcome
Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge
Time frame: 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.
3 secondary outcomes
Proportion of participants who died within 180 days after hospital discharge
Time frame: From enrollment until 180 days after hospital discharge
Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan
Time frame: From enrollment until 180 days after hospital discharge
Satisfaction with continuous pharmacist-led care
Time frame: From enrollment until 180 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Ambulatory Care Sensitive Conditions
Not yet recruiting
A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology
Chronic Dermatological Conditions, Eczema
Recruiting
CMSL Ambulatory Sensitive Condition Nudge Study 2
Behavioral Intervention, Emergency Department Visits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Gnatta, PhD study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led teleconsultations in people with Ambulatory Care Sensitive Conditions, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bianca V Bianchini, PhD (+55 51 31914125, bianca@noharm.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge (time frame: From enrollment until 180 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.