Facilitated Access to Optimized Treatment and Clinical Follow-Up for Elderly Patients by the Internal Medicine Heart Failure Outpatient Clinic - a Randomized Multicenter Prospective Study

Summary

Research problem and specific questions:

Due to lack of resources and an increasingly heavy burden placed on the primary care system, most of heart failure (HF) patients don´t receive a swift follow-up according to guideline recommendations. Our study aims to investigate if a structured and swift follow-up at a dedicated internal medicine HF out-patient clinic (IM-HF)) for older adults with HF post hospital discharge, can improve the quality of life and reduce mortality and re-hospitalization compared to current standard with follow-up within the primary care.

Data and method:

The study will be performed as a prospective, randomized controlled trial (RCT) at two sites. All patients older than 70 years admitted to a ward with new onset or chronic HF will be invited to participate. After discharge, all patients will be invited to a re-visit to the IM-HF within 2 weeks, and will thereafter be randomized to either continued follow-up on-demand at the IM-HF or within the primary care. Outcomes will be self-reported quality of life, number of days alive and out of hospital, time to death or re-hospitalization and adherence to guideline-directed medical therapy. Data collection will be performed by means of nurse-led interviews, blood sampling and review of medical records. By employing a RCT-design with a well-defined population, intervention, control and outcome, this study aims to provide high-quality evidence that could influence clinical practice.

Societal relevance and utilization:

The study is expected to give valuable insight into the effects of early and structured follow-up for older adults with HF and could improve the standard of care and lead to improved quality of life and reduced risks of re-hospitalization and mortality. Through multidisciplinary teams and cooperation with patients associations the study aspires to be evidence based and patient centered. The start-up and implementation of the study is expected during the following years and may have important implications for the care of older adults with HF.

Plan for project realization:

The study aims to start at the IM-HF at two sites in 2025 with a research nurse with a 50% position at each site. About 12 patients fulfilling the inclusion criteria are discharged from the hospital wards each week and we expect an inclusion rate of 4 patients/week. The study is expected to go on for 3.5 years.

Conditions

• Heart Failure

Interventions

OTHER

Swift follow-up

Swift and structured follow-up on-demand for 6 months at a disease-specific outpatient clinic following hospitalization for heart failure among older adults

Sponsors & Collaborators

• Region Skane

  lead OTHER

Principal Investigators

• Amra Jujic, PhD · Institution of Clinical Sciences, Lund University, Malmö

• Hannes Holm-Isholth, MD, PhD · Institution of Clinical Sciences, Lund University, Malmö

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2028-06-01

Completion

2028-12-31