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NCT03696875
Discharge Planning in Emergency Department for Frail Older With AHF
NA trial testing Multilevel Guided Discharge Planning in Acute Heart Failure in 1,260 participants. Status unknown.
20 December 2021
Quick facts
| Lead sponsor | F. Javier Martin Sanchez |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,260 |
| Start date | 20 May 2019 |
| Primary completion | 20 December 2021 |
| Estimated completion | 15 May 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Multilevel Guided Discharge Planning
- Standard of care
Conditions studied
- Acute Heart Failure — all drugs for Acute Heart Failure →
- Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →
Sponsor
F. Javier Martin Sanchez
Who can join
70 and older, any sex, with Acute Heart Failure or Frail Elderly Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objectives: To demonstrate the efficacy of care transition holistic intervention (Multilevel Guided Discharge Planning, MGDP) in reducing 30-day adverse outcomes among frail older patients with acute heart failure (AHF) discharged from Emergency Departments (EDs) and to validate the results of MGDP in real life. Method: Investigators will select frail patients ≥70 years with primary diagnosis of AHF discharged from EDs. The intervention will consist of MGDP implementation: 1) checklist that includes clinical recommendations and resources activations; 2) scheduling of early visit with the specialist; 3) communication with primary care; 4) providing a written instruction sheet to patient or caregiver. Phase 1: matched-pair cluster randomized clinical trial. EDs were randomly allocated to intervention (n = 10) or control (n = 10) group. Investigators will compare the outcomes between intervention and control groups. Phase 2: a quasi-experimental study. The 20 EDs will carry out the intervention. Investigators will compare the outcomes between phase 1 and phase 2 of intervention group and between phase 1 and phase 2 of control group. The main outcome is a 30-day composite endpoint (ED revisit or hospital admission for AHF and cardiovascular death) after being discharged.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03696875
- Europe PMC full search
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Related trials
Other recruiting trials for Acute Heart Failure
Currently open trials in the same condition.
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- NCT07008365 — The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure · Phase 3 · recruiting
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- NCT06597331 — Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital · recruiting
- NCT06166654 — Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03696875 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by F. Javier Martin Sanchez
- Last refreshed: 8 July 2019
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing