- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07789353
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bianca V Bianchini, PhD
- 전화번호: +55 51 31914125
- 이메일: bianca@noharm.ai
연구 장소
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Porto Alegre, 브라질
- Hospital de Clinicas de Porto Alegre
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
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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.
다른 이름들:
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge
기간: From enrollment until 180 days after hospital discharge
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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.
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From enrollment until 180 days after hospital discharge
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of participants who died within 180 days after hospital discharge
기간: From enrollment until 180 days after hospital discharge
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Proportion of participants who died within 180 days after hospital discharge, assessed through caregiver reports and medical records.
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From enrollment until 180 days after hospital discharge
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Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan
기간: From enrollment until 180 days after hospital discharge
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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.
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From enrollment until 180 days after hospital discharge
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Satisfaction with continuous pharmacist-led care
기간: From enrollment until 180 days after hospital discharge
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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).
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From enrollment until 180 days after hospital discharge
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공동 작업자 및 조사자
수사관
- 연구 의자: Diego Gnatta, PhD, Federal University of Rio Grande do Sul
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-0354
- 99456126.3.0000.5327 (기타 식별자: Certificate of Presentation for Ethical Assessment)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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