Acute Heart FailureNCT03696875
Discharge Planning in Emergency Department for Frail Older With AHF
A study testing Multilevel Guided Discharge Planning in people with Acute Heart Failure and Frail Elderly Syndrome, run by F. Javier Martin Sanchez at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Heart Failure, Frail Elderly Syndrome
- What is being tested?
- Multilevel Guided Discharge Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,260 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2019to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years.
- Diagnosis of descompensated chronic heart failure.
- Screening for frailty positive (ISAR ≥ 2).
- Planned discharge home from Emergency Department (included observation and short stay unit).
- Written informed consent provided by the patient or proxy.
Who cannot join
- De novo (new onset) acute heart failure (AHF).
- Severe episode of acute heart failure (≥9th decile of MEESSI-AHF Score).
- Uncorrected clinically significant primary valvular disease.
- Acute coronary syndrome currently or within 30 days prior to enrolment.
- Surgery or implanted device within 30 days prior to enrolment.
- Significant arrhythmias.
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- Uncorrected systolic blood pressure < 100 mmHg, O2 saturation baseline < 92%, heart rate < 60 or >110 bpm, serum sodium < 130 mmol/l, serum potassium >5,5 mmol/l or hemoglobin <9 g/dL prior to enrolment.
- Planned treatment with vasoactive therapies, ventricular assist device, heart surgery or transplant within 6 months.
- End stage renal disease.
- Severe disability.
- Difficulty intervention due to significant dementia, active delirium or psychiatric disorder.
- Condition with a life expectancy <1 year.
- Length of stay in Emergency Department ≥96 hours.
- Discharged to facility care.
- Inability of outpatient follow-up.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Martin Sanchez, MD, 913303750, fjjms@hotmail.com
About this study
Official title: Discharge Planning in Emergency Department to Reduce 30-day Adverse Outcomes for Frail Older Patients With Acute Heart Failure: Design and Rationale of DEED FRAIL-AHF Clinical Trial Study
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.
- Conditions
- Acute Heart Failure, Frail Elderly Syndrome
- Being tested
- Multilevel Guided Discharge Planning, Standard of care
- Keywords
- Discharge Planning, Emergency Department, Heart failure, Older, Frail
- Medical subject headings
- Emergencies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Guided Discharge PlanningOther
Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Guided Discharge Planning | Experimental | Not described Receives: Other: Multilevel Guided Discharge Planning |
| Standard of care | Active comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge
Measured: at 30 days post-discharge
Secondary outcomes (13)
All-cause emergency revisit rate
The proportion of patients who have ED revisit for all causes within 30 days after discharge
Measured: at 30 days post-discharge
Acute heart failure emergency revisit rate
The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
Measured: at 30 days post-discharge
Cardiovascular emergency revisit rate
The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge
Measured: at 30 days post-discharge
All-cause hospitalisation rate
The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Measured: at 30 days post-discharge
Acute heart failure hospitalisation rate
The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
Measured: at 30 days post-discharge
Cardiovascular hospitalisation rate
The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
Measured: at 30 days post-discharge
All-cause mortality rate
The proportion of patients who have all-cause mortality within 30 days after discharge
Measured: at 30 days post-discharge
Cardiovascular mortality rate
The proportion of patients who have cardiovascular mortality within 30 days after discharge
Measured: at 30 days post-discharge
Free-hospitalization survival
Number of days alive out of the hospital
Measured: at 30 days post-discharge
Functional impairment (assessed by self-reported Barthel index)
Barthel index measures the subject's capacity to perform ten activities of daily living (feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing). The sum score ranges from 0 (totally dependent) to 100 (totally independent).
Measured: Change from baseline to 30 days post-discharge
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)
The four-item MGLS measures pharmacological adherence. The score ranges from 0 (perfect adherence) to 4 (some level of non-adherence).
Measured: Within 30 days after discharge
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)
CTM questionnaire assesses the quality of care transitions, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.
Measured: Within 30 days after discharge
Quality of live of patients (assessed by EuroQol-5D)
EQ-5D measures of health-related quality of life. The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Measured: Within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start20 May 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
- Masking
- None (open label)
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F. Javier Martin Sanchez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, F. Javier Martin Sanchez, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696875
- Sponsor's protocol ID
- DEED FRAIL-AHF
- Status last verified
- Jul 2019
- First submitted
- 28 Sep 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Planning in Emergency Department to Reduce 30-day Adverse Outcomes for Frail Older Patients With Acute Heart Failure: Design and Rationale of DEED FRAIL-AHF Clinical Trial Study
- ClinicalTrials.gov ID
- NCT03696875
- Acronym / sponsor ID
- DEED FRAIL-AHF
- Conditions
- Acute Heart Failure, Frail Elderly Syndrome
- Keywords
- Discharge Planning, Emergency Department, Heart failure, Older, Frail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- F. Javier Martin SanchezUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 5 Oct 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
| Arm | Type | Receives |
|---|---|---|
| Multilevel Guided Discharge Planning | Experimental | Other: Multilevel Guided Discharge Planning |
| Standard of care | Active comparator | Other: Standard of care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥70 years.
- Diagnosis of descompensated chronic heart failure.
- Screening for frailty positive (ISAR ≥ 2).
- Planned discharge home from Emergency Department (included observation and short stay unit).
- Written informed consent provided by the patient or proxy.
Key exclusion criteria (15 listed)
- De novo (new onset) acute heart failure (AHF).
- Severe episode of acute heart failure (≥9th decile of MEESSI-AHF Score).
- Uncorrected clinically significant primary valvular disease.
- Acute coronary syndrome currently or within 30 days prior to enrolment.
- Surgery or implanted device within 30 days prior to enrolment.
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 |
|---|---|---|
| Multilevel Guided Discharge PlanningClinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient | Other | Multilevel Guided Discharge Planning |
| Standard of careStandard of care | Other | Standard of care |
Primary outcome
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
Time frame: at 30 days post-discharge
The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge
13 secondary outcomes
All-cause emergency revisit rate
Time frame: at 30 days post-discharge
Acute heart failure emergency revisit rate
Time frame: at 30 days post-discharge
Cardiovascular emergency revisit rate
Time frame: at 30 days post-discharge
All-cause hospitalisation rate
Time frame: at 30 days post-discharge
Acute heart failure hospitalisation rate
Time frame: at 30 days post-discharge
Cardiovascular hospitalisation rate
Time frame: at 30 days post-discharge
All-cause mortality rate
Time frame: at 30 days post-discharge
Cardiovascular mortality rate
Time frame: at 30 days post-discharge
Free-hospitalization survival
Time frame: at 30 days post-discharge
Functional impairment (assessed by self-reported Barthel index)
Time frame: Change from baseline to 30 days post-discharge
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)
Time frame: Within 30 days after discharge
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)
Time frame: Within 30 days after discharge
Quality of live of patients (assessed by EuroQol-5D)
Time frame: Within 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Guided Discharge Planning in people with Acute Heart Failure and Frail Elderly Syndrome, run by F. Javier Martin Sanchez at 1 site in Spain.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Martín-Sánchez, MD, PhD. (+34 91.330.37.50, fjjms@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge (time frame: at 30 days post-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 8 Jul 2019.