Integrated Disease Management of Heart Failure in Primary Care

NCT04066907 | Unknown

• 1 other identifier: LawsonHRI03
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The study population includes primary care physicians and heart failure (HF) patients attending one of over 100 family physicians in seven family health teams in Southwestern Ontario. Study purpose is to measure the effect of an integrated disease management (IDM) program for people diagnosed with HF and receiving treatment at a primary care facility. Components of IDM include HF specific patient education and self care management skills training by a heart failure educator. Study outcomes include health service use, HF symptoms, quality of life, and HF knowledge assessment compared to the usual care group. The primary objective of this study is composite and will measure the effect of integrated disease management (IDM) on all cause hospitalizations, ED visits and mortality events. Secondary outcomes will include HF related hospitalizations, HF related ED visits, quality of life, mortality, other health service utilization, acute HF episodes, NYHA class. We hypothesize HF specific IDM implemented in primary care will be superior to usual physician-based care measured by a combined reduction in the total number of all cause hospitalizations and ED visit events.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Composite of all cause mortality, hospital admissions and emergency department visits

  The primary outcome will be a composite of the total number of all-cause mortality, hospital admissions, and ED visits events. This measure will be the rate of events per person year at risk. The ED visits will be visits that do not lead to hospitalization.

  1 year

Secondary Outcomes (12)

• Quality of Life using KCCQ

  6 months and 1 year

• Mortality

  1 year (rate number of events per person year of follow-up)

• Health Status using EQ-5D

  6 months and 1 year

• Health Status using SF-12

  6 months and 1 year

• Health Service Use - Hospitalization

  1 year (rate number of events per person year of follow-up)

Study Arms (2)

Integrated Disease Management

EXPERIMENTAL

Physicians randomized to intervention will attend a training session on the program standards and details of the IDM. Following the initial baseline interview a heart failure educator (HFE) will meet with subjects to obtain a detailed history of their HF, provide education, self-care management strategies (medication adherence, symptoms monitoring, dietary adherence, fluid restriction, exercise, weight management, smoking cessation) and review immunization status. A self-management action plan will be developed with the study physician and HFE to enable monitoring and management of HF by the participant.

Other: Integrated Disease Management

Usual Care

NO INTERVENTION

Subjects will receive HF care as usually provided by their physician as advised or as needed. Study commitments for the control group include the initial interview, the expected time allotment for this initial visit is 1 hour. Telephone follow-up will occur at 3 months and 9 months to collect exacerbation data and maintain contact with participant. At 6 months and 12 months telephone follow-up will be conducted by the research assistant and the questionnaires will be completed.

Interventions

Integrated Disease Management OTHER

Multidisciplinary intervention comprising of patient education, self management strategies and medication optimization

Integrated Disease Management

Eligibility Criteria

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

You may qualify if:

• New York Heart Association (NYHA) classification of stage II, III or IV
• a clinical diagnosis of HF and a supporting diagnostic echocardiogram
• HF or cardiovascular related hospitalization and/or ED visit in the 24 months prior to recruitment
• Patients with HF with a preserved ejection fraction and HF with a reduced ejection fraction (\<45%) will be included.

You may not qualify if:

• hemodynamic instability
• awaiting cardiac surgery
• expected survival rate of \<1 year due to terminal illness
• lack of English language skills
• reduced cognitive function that affects the ability to complete the questionnaires
• enrolment in other cardiac trials
• formalized HF education (e.g. Telehomecare) in the six months prior to enrolment
• scheduled for cardiac rehabilitation
• severely impaired renal function requiring dialysis.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Science Center, Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Hussey AJ, McKelvie RS, Ferrone M, To T, Fisk M, Singh D, Faulds C, Licskai C. Primary care-based integrated disease management for heart failure: a study protocol for a cluster randomised controlled trial. BMJ Open. 2022 May 12;12(5):e058608. doi: 10.1136/bmjopen-2021-058608.

  PMID: 35551078 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christopher Licskai

  Lawson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A blinded research assistant will collect questionnaire data and perform NYHA assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 26, 2019
• Study Start: May 25, 2021
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)