Effectiveness of a Multidisciplinary Care Management Program for High-risk Patients With Heart Failure (PROMIC)

NCT02436161 | Completed Phase 2 DMC

• 1 other identifier: BG2010111182
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Heart Failure; Comorbidity; Patient Care Management; Primary Health Care; Delivery of Health Care, Integrated

Outcome Measures

Primary Outcomes (1)

• Hospital readmissions because of HF

  one year

Secondary Outcomes (4)

• Quality of life measured by Minnesota Questionaire and SF12 Questionaire

  one year

• self management knowledge measured by the Heart Failure Self Behaviour Scale

  one year

• Cost of the program

  one year

• professional perception of integrated care measured by the D'Amour Questionaire

  one year

Study Arms (2)

Care management program "PROMIC"

EXPERIMENTAL

care management program provided by a multidisciplinary team that optimizes care with the main role of nurses acting as coaches of patients and carers, within the primary care teams

Behavioral: Care management program "PROMIC"

Usual care

NO INTERVENTION

Patients in the control group belongs to different Primary health care centres from the intervention group and are treated as usual by their Primary Care team and by cardiologists different from the intervention group

Interventions

Care management program "PROMIC" BEHAVIORAL

intensive coaching intervention to optimize care and prevent readmissions, using educational selfcare and worsening symptoms recognition by patients and carers

Care management program "PROMIC"

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted at hospital because of HF in II to IV NYHA stage

You may not qualify if:

• life expectancy below 3 months
• discharge to nursing home
• Severe cognitive impairment

Sponsors & Collaborators

• Basque Health Service: lead

Related Links

• phase 0 and 1 of the PROMIC care management program

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Cristina Domingo, MD, FAM PHY

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family physician

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: May 6, 2015
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05