Community Vascular and Multiple Chronic Conditions Intervention Study

Recruiting

Phase N/A Results N/A

Trial Description

Patients with vascular and multiple chronic conditions (MCC) move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Recent Canadian studies and reports identify significant gaps in the delivery of effective care to patients with multiple chronic conditions in community-based settings.
The overall goal of the program is to promote successful management of chronic conditions, enhance quality of life, reduce the on-demand use of expensive health services and support primary caregivers (i.e. family or friends) who provide physical, emotional or financial care to an older adult with vascular conditions and MCC. This research program will leverage the tremendous potential to reduce the burden of vascular and vascular-related diseases by enhancing community-based prevention and chronic disease management.
This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of an interprofessional intervention on health-related quality of life (HRQOL), depression, anxiety, physical functioning, and the costs of use of health services for stroke survivors with MCC receiving home care and their family caregivers. The results will inform: (1) the development of national standards for community-based care for patients with multiple chronic conditions and (2) the development of a new and innovative community-based model for the management of multiple chronic conditions that can be scaled up and spread across Canada.

Detailed Description

Research Question:
What is the acceptability and effects of a six-month community navigation and management program compared to usual home care services for older adults with vascular conditions with MCC and their primary caregivers?
Methods:
The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly referred to home care services. The intervention is a 6-month community navigation and management program for patients with vascular conditions and multiple chronic conditions. It will be provided by an interprofessional team of home care providers and will consist of three components: (1) intensive case management to facilitate access to services across the care continuum, provide psychosocial support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN), three visits by the physiotherapist (PT) or occupational therapist (OT), and six visits by a Personal Support Worker (PSW) over 6 months in addition to usual home care services. The in-home visit schedule and team composition will be tailored to client need and will be determined in collaboration with the home care providers. The interprofessional (IP) team will conduct comprehensive screening and assessments for chronic conditions, utilize strengths-based practice to encourage self-care and foster behavioural change, provide education for multiple chronic conditions, medication review, in-home exercise, and caregiver support; and (3) monthly interprofessional team case conferences to develop an IP evidence-based, patient-centred care plan.
Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables. Analysis of covariance will be used to compare study groups, while adjusting for baseline measurements and potential confounding variables. Subgroup analyses will be conducted based on sex/gender and region.
Expected Outcomes:
It is expected that patients with vascular conditions and multiple chronic conditions receiving the intervention will show greater improvements in health-related quality of life, at no additional cost, compared with usual care.

Conditions

Interventions

  • Community-Based Interprofessional Care Behavioral
    Intervention Desc: Individuals in the Community-Based Interprofessional Care group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a minimum of three in-home visits by the care coordinator and three in-home visits by the Occupational therapist or Physiotherapist over 6 months in addition to usual home care services; and (3) monthly interprofessional team conferences to develop an evidence-based, patient-centred community reintegration plan.
    ARM 1: Kind: Experimental
    Label: Community-Based Interprofessional Care
    Description: Individuals in the Community-Based Interprofessional Care group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a minimum of three in-home visits by the care coordinator and three in-home visits by the Occupational therapist or Physiotherapist over 6 months in addition to usual home care services; and (3) monthly interprofessional team conferences to develop an evidence-based, patient-centred community reintegration plan.
  • Community Navigation and Rehabilitation Intervention Behavioral
    Intervention Desc: Individuals in the Community Navigation and Rehabilitation group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
    ARM 1: Kind: Experimental
    Label: Community Navigation and Rehabilitation Intervention
    Description: Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
  • ACHRU - Community Partnership Program Behavioral
    Intervention Desc: Individuals in the ACHRU - CPP for Older Adults with Multiple Chronic Conditions group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
    ARM 1: Kind: Experimental
    Label: ACHRU - Community Partnership Program
    Description: Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Short-Form 12 Health Survey, Version 2 (SF-12v2) Baseline and end of study (6 months from baseline) No
Secondary Generalized Anxiety Disorder Screener (GAD-7) Scale Baseline and end of study (6 months from baseline) No
Secondary Centre for Epidemiological Studies in Depression (CES-D) - Shortened version Baseline and end of study (6 months from baseline) No
Secondary Re-Integration to Normal Living Index (RNLI) Baseline and end of study (6 months from baseline) No
Secondary Stroke Impact Scale - 16 (SIS-16) Baseline and end of study (6 months from baseline) No
Secondary Health and Social Services Utilization Inventory (HSSUI) Baseline and end of study (6 months from baseline) No
Secondary Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10) Baseline and end of study (6 months from baseline) No
Secondary Modified 2003 Caregiver Strain Index (CSI) Baseline and end of study (6 months from baseline) No
Secondary Collaborative Practice Assessment Tool (CPAT) At 3 months and at 9 months after the start of the study No
Secondary Team Climate Inventory-19 (TCI-19) At 3 months and at 9 months after the start of the study No

Sponsors