Effectiveness of a Multidisciplinary Care Management Program for High-risk Patients Who Are Admitted at Hospital Because of Heart Failure (PROMIC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- Hospital readmissions because of HF
Study Overview
Brief Summary
OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management collaborative program for high-risk patients with heart failure (HF) who are admitted at hospital, based on the 6 components of the Chronic Care Model "PROMIC", in terms of reduction of a Combined event rate (readmissions / cardiac events / death / emergency department visits) and other variables, the feasibility of the program, the improvement on quality of life related to health and functional capacity of the PROMIC patients compared with control patients in usual care.
DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS: Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba, Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in New York Heart Association (NYHA) functional status II-III-IV from previous mentioned hospitals. Another 125 patients from different primary health care centers, will be the control group.
INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the time of inclusion to the first event (readmission / cardiac events / death / emergency visits). Secondary endpoints will be the quality of life related to health (MLFHQ and SF-12), functional capacity (6-Minute Walk Test), structural changes in cardiac structure (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor variables also will be collected such as sex, age, education level, co-morbidity, social risk level, dependency etc.
STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will done. A model of Cox proportional hazards will be built.
Detailed Description
INTRODUCTION In light of the increased prevalence of chronic diseases and comorbidities as a result of the increased life expectancy of the population, the need to develop care models that adequately respond to the healthcare and sociodemographic needs of the populatión in the actual context in which they are applied has been proposed. Patients with chronic and/or multiple diseases present the greatest health care needs and tend to experience the imbalances in the system with the greatest intensity. Investigators have concentrated the research on patients admitted because of HF due to the high prevalence and complexity of this disease and the fact that such patients present multiple chronic conditions. These patients are normally elderly and present high degrees of comorbidity and poly-medication, poor treatment adherence and difficulties in selfcare. The majority of patients admitted with HF are in level 3 of the Kaiser pyramid together with other patients with complex health care needs.
There is some evidence that a higher degree of multidisciplinarity results in better team coordinatión and training and more effective care for complex high-risk patients, of which HF patients are a good example.
PROMIC is an organisational care management innovation that provides a comprehensive and integrated approach to patients with a high degree of complexity, in this case, patients admitted with HF.
It promotes the integratión of care in different healthcare settings with the change of the nurses role and self-care training in patients. As such, PROMIC helps to ensure the continuity of patients care in their own environment.
The aim of the innovative care model that PROMIC is intended to provide in high-risk HF patients is to improve health outcomes and to modify the current care model for chronic diseases, thereby serving as the foundation for future interventions targetting other chronic patients with multiple comorbidities and complex health care needs. Indeed, precisely due to the presence of comorbidities in this type of patient, investigators consider coordination with consultants from other specialities to be essential. As HF patients present marked comorbidity, investigators expect that the experience acquired during this project will help them to design interventions that can be broadened to cover all complex chronic patients likely to benefit from a care management programs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted at hospital because of HF in II to IV NYHA stage
Exclusion Criteria
- •life expectancy below 3 months
- •discharge to nursing home
- •Severe cognitive impairment
Outcomes
Primary Outcomes
Hospital readmissions because of HF
Time Frame: one year
Secondary Outcomes
- professional perception of integrated care measured by the D'Amour Questionaire(one year)
- Quality of life measured by Minnesota Questionaire and SF12 Questionaire(one year)
- Cost of the program(one year)
- self management knowledge measured by the Heart Failure Self Behaviour Scale(one year)
Investigators
Cristina Domingo
Family physician
Basque Health Service
