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Community Vascular and Multiple Chronic Conditions Intervention Study

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ClinicalTrials.gov Identifier: NCT02209285
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Maureen Markle-Reid, McMaster University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Chronic Conditions Behavioral: ACHRU - Community Partnership Program Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: (Aging, Community and Health Research Unit) ACHRU - Community Partnership Program for Older Adults With Multiple Chronic Conditions
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
No Intervention: Control group
The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis.
Active Comparator: ACHRU - Community Partnership Program
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.
Behavioral: ACHRU - Community Partnership Program
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.




Primary Outcome Measures :
  1. Short-Form 12 Health Survey, Version 2 (SF-12v2) [ Time Frame: Baseline and end of study (6 months from baseline) ]
    The Short-Form 12 Health Survey will be administered to the participants and caregivers to measure health-related quality of life.


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder Screener (GAD-7) Scale [ Time Frame: Baseline and end of study (6 months from baseline) ]
    The GAD-7 will be administered to study participants at baseline and 6 months to assess anxiety.

  2. Centre for Epidemiological Studies in Depression (CES-D) - Shortened version [ Time Frame: Baseline and end of study (6 months from baseline) ]
    The CES-D shortened version will be administered to study participants at baseline and 6 months to assess depression.

  3. Health and Social Services Utilization Inventory (HSSUI) [ Time Frame: Baseline and end of study (6 months from baseline) ]
    The HSSUI will be administered to every study participant and participating family caregivers at baseline and 6 months to assess healthcare utilization costs.

  4. Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10) [ Time Frame: Baseline and end of study (6 months from baseline) ]

    The CES-D-10 will be administered to study participants' family caregiver at baseline and 6 months to assess caregiver depressive symptoms.

    It is estimated that approximately 70% of the study participants will have a family caregiver.


  5. Modified 2003 Caregiver Strain Index (CSI) [ Time Frame: Baseline and end of study (6 months from baseline) ]

    The Modified CSI will be administered to every study participant's family caregiver at baseline and 6 months to assess change in burden associated with caregiving.

    It is estimated that approximately 70% of the study participants will have a family caregiver.


  6. Collaborative Practice Assessment Tool (CPAT) [ Time Frame: At 3 months and at 9 months after the start of the study ]
    The CPAT will be administered to participating home care providers at 3 months and 9 months after initiation of the study to assess changes in collaborative practice.

  7. Team Climate Inventory-19 (TCI-19) [ Time Frame: At 3 months and at 9 months after the start of the study ]
    The TCI-19 will be administered to participating home care providers at 3 months and 9 months after initiation of the study to assess level of team functioning.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 years of age and older;
  • One of the four vascular conditions: Stroke and TIA, Hypertension, Cardiovascular disease and Heart failure
  • Newly referred (following initiation of the study) for home care services and living in the community, including supportive housing, retirement homes, and lodging homes and excluding long-term care;
  • At least 1 comorbid conditions;
  • Able to speak English or have access to a translator;
  • Not planning to move away from the CCAC catchment area in the next 6 months;
  • Be mentally competent to provide informed consent, either independently or by a substitute decision maker.

Exclusion Criteria:

  • Participants will be excluded if they are unable to read and understand English and do not have access to their own translator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209285


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Maureen Markle-Reid, RN, PhD McMaster University School of Nursing
Principal Investigator: Jenny Ploeg, RN, PhD McMaster University School of Nursing

Responsible Party: Maureen Markle-Reid, Associate Professor and Canada Research Chair, Co-Scientific Director of Aging, Community and Health Research Unit (ACHRU), McMaster University
ClinicalTrials.gov Identifier: NCT02209285     History of Changes
Other Study ID Numbers: STRCT- 06669
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maureen Markle-Reid, McMaster University:
Older adults
Home and community care
Effectiveness
Cost analysis
Stroke
TIA
Hypertension
Cardiovascular disease

Additional relevant MeSH terms:
Disease
Multiple Chronic Conditions
Pathologic Processes
Chronic Disease
Disease Attributes