Integrated Disease Management of Heart Failure in Primary Care

Heart Failure Clinical Trial

Official title:

Integrated Disease Management of Heart Failure in Primary Care; A Cluster Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04066907
• Other study ID #: LawsonHRI03
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: August 5, 2024

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study population will be identified through patients attending one of 100 family physicians from 10 different family health teams (FHTs) or family health organizations (FHOs) in the Southwestern Ontario.

Study Design: A parallel cluster randomized trial design has been chosen comparing the intervention arm (patients entered on the IDM) to the control arm (patients receiving usual care). A multi-level study design is proposed, level 3 the FHT/FHO, level 2 the physician and level 1 the HF patient. We have chosen to randomize at level 2, the physician and implement the intervention at both level 2 and 1, the physician and the individual. Outcomes will be measured at individual level. Stratified randomization of physicians will be performed by FHT/FHO, giving greater balance between arms and increased power and precision by reduction of between cluster variability.

Recruitment: Physicians from the FHTs/FHOs will be invited to participate and informed consent will be obtained. The physician will be randomized to either the control or intervention group and randomization will be computer generated by FHT/FHO strata. Allocation for overall study will be 1:1 as will allocation by FHT/FHO. Each participating primary care site will identify all individuals with a HF diagnosis in their care suitable for the trial and a simple random sample will be taken from this group to obtain the desired cluster size. An initial telephone call will be arranged with the patient to discuss study details, obtain informed consent, further determine eligibility, and complete questionnaires.

Data management: As a part of the objectives of this study a POSS electronic tool has been developed, all data collected about the participants will be entered by heart failure educators and stored in a central server. Access is restricted to authorized personnel only. The POSS has been designed not only as a secure storage depot but also as a tool to standardize the data collected minimizing information bias. There is extensive data checking at the time of data entry. Data definitions are incorporated to support quality data inputs.

Sample Size: With a minimum recruitment of 50 physicians recruited and 4 participants per physician, this study would be powered to detect a minimum 36% reduction in the rate of number of hospitalizations or ED visits per person year with an attrition rate of 20%. This calculation is based on 80% power to 5% significance with an ICC of 0.05.

If 100 physicians are recruited with 2 to 3 participants per physician (and a total sample size of 280) the study will have 90% power to detect a 35% reduction in the primary outcome.

Statistical Analysis: Analysis will be on an intention to treat basis. Baseline data will be used to characterize the study population, to identify any imbalances between arms. Continuous data will be displayed as mean ±standard deviation and count (percent) for categorical variables (variables to be presented will be predetermined in an analysis plan). Due to over dispersion that occurs in this type of count data the primary outcome (and health service utilization secondary outcomes) will be analyzed using a negative binomial distribution with random effects to account for clustering and for individuals experiencing multiple events. The results will be presented as rate ratios. The secondary outcomes (change in KCCQ at 6 months and other knowledge and QoL metrics) will be analyzed at individual level using logistic regression, results will be presented as odds ratios. Reliability will be assessed by using a quadrature check and in the event of failure a generalizing estimating equation (GEE) model will be fitted.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: August 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Integrated Disease Management
Multidisciplinary intervention comprising of patient education, self management strategies and medication optimization

Locations

Country	Name	City	State
Canada	London Health Science Center, Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life using KCCQ	Quality of life measure using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An improvement in total score will indicate an improvement in health status and quality of life. The range is score is from 0-100	6 months and 1 year
Secondary	Mortality	All cause mortality rate	1 year (rate number of events per person year of follow-up)
Secondary	Health Status using EQ-5D	Measure health status of health for clinical and economic appraisal using the EQ-5D. The EQ-5D is a self-administered questionnaire and is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An decrease in total score will indicate an improvement in health status. The range of the scale is from 5-25.	6 months and 1 year
Secondary	Health Status using SF-12	Measure overall health status using the SF-12. The SF-12 is a self-administered questionnaire that measures physical and mental health composite scores with twelve questions that range from 0-100. An improvement in score will indicate an improvement in health status.	6 months and 1 year
Secondary	Health Service Use - Hospitalization	Number of heart failure related hospitalizations during study. Number of all-cause hospitalizations during study.	1 year (rate number of events per person year of follow-up)
Secondary	Health Service Use - Emergency Department visit	Number of heart failure related emergency department visits. Number of all-cause emergency department visits during study.	1 year (rate number of events per person year of follow-up)
Secondary	Atlanta Heart Failure Knowledge Questionnaire	The Atlanta Heart Failure Knowledge Questionnaire (AHFKQ) consists of 30 questions and was developed to ascertain knowledge about HF, treatment, and self-care.	1 year
Secondary	The Mediterranean Diet Questionnaire	The Mediterranean Diet is a 14-item questionnaire to assess adhesion to a Mediterranean diet, proven to be beneficial to people with heart failure	1 year
Secondary	NYHA	NYHA: The NYHA is a classification system for the extent of HF. It classifies patients in one of four categories based on limitations during physical activity due to symptoms of HF	1 year
Secondary	Health Service Use -unscheduled physician visits	Number of heart failure related unscheduled physician visits	1 year (rate number of events per person year of follow-up)
Secondary	Health Service Use -urgent care facility visits	Number of heart failure related urgent care facility visits	1 year (rate number of events per person year of follow-up)
Secondary	Acute Heart Failure Episodes	An acute HF episode will be recorded if the participant experiences any of the following: i. Worsening signs or symptoms of HF leading to an unscheduled physician visit and/or urgent care facility.; ii. Worsening signs or symptoms of HF leading to a visit to an ED. iii. Worsening signs or symptoms of HF leading to hospitalization. iv. Worsening signs or symptoms of HF leading to an activation of action plan	1 year (rate number of events per person year of follow-up)