Feasibility of Implementation of Recommended Standards in Patients With Heart Failure (HFOutcomesSP)

April 2, 2024 updated by: Marisa Crespo Leiro, Fundacion Profesor Novoa Santos

Feasibility of the Use in Spanish Hospitals of Recommended Standards to Measure Results in Patients With Heart Failure (HF-Outcomes-Spain)

Longitudinal pilot study among heart failure patients from six Spanish hospitals to evaluate the feasibility of establishing and maintaining for one year the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement), as well as identifying factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. MAIN GOAL To evaluate through a pilot study the viability of establishing and maintaining for one year in selected Spanish centers the set of standards for measuring results in patients with heart failure proposed by ICHOM (International Consortium for Health Outcomes Measurement). (International Consortium for Health Outcomes Measurement).
  2. SPECIFIC GOALS To identify factors that hinder the use and applicability of this group of standards in real life, where appropriate, defined as the variables not filled in and the reason for the absence of such information To estimate the workload necessary to implement this set of variables within everyday clinical practice.
  3. STUDY DESIGN Observational pilot study with prospective follow-up with data collection at 30 days, 6 months and 1 year.

Due to the defined objective, the methods used are, to a large extent, those proposed by ICHOM, except in those sections that may be slightly modified to adapt to the local situation.

3.1. Selection of centers and patients Six centers with experience and adequate organization (heart failure unit) and with a sufficient size have been selected to guarantee the recruitment of patients in a short period of time (around three weeks). The main justification was to seek, within the usual clinical practice, centers where, due to the organization and interest in heart failure, the chances of success of this initiative were greater.

100 consecutive patients with a diagnosis of heart failure who meet inclusion criteria and with no exclusion criteria will be selected in each center.

3.2. Sample size considerations For the main outcome, success is considered if the proportion of patients followed is ≥ 70%. A random sample of 588 individuals is sufficient to estimate, with 95% confidence and a precision of +/- 3.5 percentage units, a population percentage that is expected to be around 75%. Six Spanish centers will participate and a recruitment target of 100 consecutive patients is set, for a total of 600 patients in the study. In addition, these sizes in each center offer, accepting an alpha risk of 0.05, a power greater than 80% to detect statistically significant differences between two centers, assuming that a follow-up of 75% of patients is achieved in one and 55% in the other.

3.3. Follow-up From the baseline or inclusion visit and afterwards, in newly diagnosed patients or in those recruited in an acute situation, follow-up visits at 30 days, 6 months and 1 year [Hospitalized patients (1. A recent diagnosis, that is, they did not previously have the diagnosis of HF and 2.Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF) and Outpatients (1. A recent diagnosis that is in the process of titration and/or compensation and 2.A previous diagnosis, that they have suffered a decompensation, either defined because they have had to go to the emergency room or have been seen in the outpatient clinic for that reason)].

In patients who were included in a stable situation, the 30-day visit will not be carried out (Outpatients: "Stable" patients attending a follow-up visit. A simple follow-up) since doing so would unjustifiably complicate the follow-up, giving more work and discomfort to patients and health professionals. The outcomes reported by the patient (PROMs) in the visits every six months may be collected by telephone contact if the doctor, due to the stable situation of the patient, does not consider the face-to-face visit necessary. Information will be collected at in the case of hospital admissions during follow-up, these admissions also set the "counter to zero" with regard to time for the following visits (30 days, six months…).

4. DATA COLLECTION AND MANAGEMENT A data entry application will be enabled that will include filters to detect inconsistencies and anomalous data and alarms for patient monitoring. The data will be anonymized for all the people involved in the study except for the person in charge in each center, who will be able to identify their patients to enable follow-up.

5. PLAN FOR DATA ANALYSIS Two data analyses are planned, one that includes the information from the baseline visit and the 30-day visit (in patients for whom it is indicated in the protocol) and the final one with all the information collected. In both cases, a global analysis and a comparison between centers (benchmarking) will be carried out.

In line with the main objective of this pilot study, the main variables are the proportion of patients who remain in follow-up, the proportion of patients in whom follow-up is carried out, in terms of time, as planned, and the proportion of missing data in each one of the defined outcomes.

The pilot's success criteria will be a follow-up> 70%, a proportion of missing data in the outcomes <10%.

Study Type

Observational

Enrollment (Actual)

581

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruna
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Based on the situation at the time of inclusion,5 types of patients are defined that reflect different clinical situations and influence the necessary follow-up plan.

A.Hospitalized patients:

  1. A recent diagnosis (at that admission), that is, they did not previously have the diagnosis of HF
  2. Patients with a previous diagnosis of HF and who are admitted for an episode of decompensation of HF.

B.Outpatients:

  1. A recent diagnosis that is in the process of titling and/or compensation
  2. A previous diagnosis, that they have suffered a decompensation, well defined because they have had to go to the emergency room (and the diuretic treatment has been increased) or have been seen in the outpatient clinic for that reason
  3. "Stable" patients attending a follow-up visit.A simple follow-up

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Diagnosed with heart failure: Clinical identification of signs and symptoms of heart failure and objective evidence of heart dysfunction.
  • Acute presentation (first presentation or decompensation of already known HF, whether or not it causes hospital admission) or chronic (stable outpatients) of any etiology
  • Any value of the ejection fraction.
  • Give writed informed consent to participate in the study.

Exclusion Criteria:

  • Patients whose first manifestation of heart failure is cardiogenic shock, in that first episode. Those patients who survived an initial episode of shock and remain in heart failure can be included once stabilized.
  • Heart transplant patients
  • Patients with long-lasting ventricular assist devices
  • Patients with isolated right heart failure.
  • Patients with onset of heart failure and whose cause can be corrected immediately (eg, acute ischemia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospitalized patients and outpatients
There may be different types of patients with differing follow-up plan but all will bie considered one group regarding on whether they receive their recommended follow-up plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients in follow-up
Time Frame: Up to 1 year
Proportion of patients who receive their recommended follow-up plan
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Profesor Novoa Santos

Collaborators

ODDS , S.L.
Vifor Pharma España, S.L.

Investigators

  • Principal Investigator: María G Crespo Leiro, MD, Complejo Hospitalario Universitario de A Coruña (CHUAC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-Outcomes-Spain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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