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Quality of Life Assessment and Practice Support System in Home Care Services for Older Adults

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ClinicalTrials.gov Identifier: NCT02940951
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Richard Sawatzky, Trinity Western University

Brief Summary:

Older adults living with incurable and advancing life-limiting illness frequently desire to spend as much time as possible comfortably at home, rather than in hospital. They often have complex problems that not only affect their ability to function, but also their and their family caregivers' overall quality of life (QOL). Routine assessment of their perceived health care needs and their self-reported QOL is necessary to ensure that patients' and family caregivers' concerns are visible to home care clinicians so that they can be effectively monitored and addressed. These types of assessments involve asking people to respond to questions about their symptoms, their physical, psychological, social and existential/spiritual wellbeing, and their experiences with the care provided. Handheld electronic information systems are increasingly used and recommended to facilitate such QOL assessments. However, there is a need for information about how such systems are best translated into practice improvements that ultimately may improve patient- and family-centred outcomes.

This study is about the implementation of an electronic tablet-based innovative health care information system, the Quality of life Assessment and Practice Support System (QPSS), into routine care provided by home care services for older adults with life-limiting illnesses and their family caregivers. Nine home care sites in Canada are participating. At each site the investigators will first adapt the QPSS to the local context and develop a plan for its local implementation. Then home care staff will be asked to use it in practice and the investigators will evaluate the process of using the QPSS and its effect on patient and family caregiver quality of life, health, and satisfaction with care as well as the cost consequences of its integration into practice. The effect of its use will be studied in a randomized trial, which is the part of the study described in this registry. Patients and their family caregivers will be randomly assigned to 1) have their home care team use the QPSS in their care or 2) not to use it, instead receiving care as usual. The effect of using the QPSS will be measured using questionnaires completed by the participating patients and family caregivers every two months. If using the QPSS improves quality of life, health, or satisfaction with care, the last stage will explore how to scale up use of the QPSS in practice and its integration with existing health information systems.


Condition or disease Intervention/treatment Phase
Chronic Disease Life-limiting Illness Palliative Care Other: QPSS Other: Usual care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Integrating a Quality of Life Assessment and Practice Support System in Home Care Services for Older Adults With Chronic Life-limiting Illness and Their Families
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Usual home care provided by clinicians
Usual care provided by the home health clinicians. This may or may not include use of some standardized forms of quality of life assessment that were in place prior to the study beginning.
Other: Usual care
Home healthcare services provided by nurses and, where applicable, multi-professional teams.

Experimental: Use of QPSS by home health clinicians
Usual home care plus the use of the Quality of Life Assessment and Practice Support System (QPSS) at point of care to document, monitor and address the quality of life concerns of patients and family caregivers.
Other: QPSS
Home care providers use an electronic tablet-based system (QPSS) that includes standardized instruments for assessing patient and family caregiver quality of life and satisfaction with care in routine care. In addition to instant calculation of scores, the QPSS allows for tracking scores over time and sharing them with other registered users from that home care service.
Other Name: Quality of Life Assessment and Practice Support System

Other: Usual care
Home healthcare services provided by nurses and, where applicable, multi-professional teams.




Primary Outcome Measures :
  1. Change in MQOL-R [McGill Quality of Life Questionnaire -Revised] Total Score [ Time Frame: Every 2 months from start of enrollment for 6 months, or until discharge from home care services or death ]
  2. Change in QOLLTI-F [Quality of Life in Life-Threatening Illness- Family] version 2 Total Score [ Time Frame: Every 2 months from start of enrollment for 6 months, or until discharge from home care services or death ]

Secondary Outcome Measures :
  1. Change in Canadian Health Care Evaluation Project Questionnaire [CANHELP] Lite Patient version Total Score [ Time Frame: Every 2 months from start of enrollment for 6 months, or until discharge from home care services or death ]
  2. Change in Canadian Health Care Evaluation Project Questionnaire [CANHELP] Lite Family version Total Score [ Time Frame: Every 2 months from start of enrollment for 6 months, or until discharge from home care services or death ]
  3. Change in VR-12 (Veterans Rand 12 based on a nearly identical to the SF-12) mental and physical health status scores [ Time Frame: Every 2 months from start of enrollment for 6 months, or until discharge from home care services or death ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients:

    • >= 55 years of age
    • receiving ongoing home care because of having one or more advancing life-limiting illnesses
    • able to speak English
    • able to provide informed consent
  2. Family caregivers:

    • identified as eligible and competent by the patient, or by a clinician if the patient is unable to do so, as the person most involved in the care of a patient who meets the eligibility criteria just above (#1). No more than one caregiver per patient will be recruited
    • able to speak English
    • able to provide informed consent

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): NCT02940951


Contacts
Contact: Joyce Lee (604) 513-2121 ext 3559 Joyce.Lee@twu.ca

Locations
Canada, British Columbia
Alberta Health Services Edmonton Zone Home Living Not yet recruiting
Edmonton, British Columbia, Canada
Contact: Coral Paul       Coral.Paul@albertahealthservices.ca   
Contact: Janet Carlson       Janet.Carlson@albertahealthservices.ca   
Fraser Health Home Health Offices Recruiting
Surrey, British Columbia, Canada
Contact: Lisa Zetes-Zanatta, MSc       Lisa.Zetes-Zanatta@fraserhealth.ca   
Contact: Neil Hilliard, MD       Neil.Hilliard@fraserhealth.ca   
Island Health Home Health Offices Withdrawn
Victoria, British Columbia, Canada
Sponsors and Collaborators
Trinity Western University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Richard Sawatzky, Ph.D. Trinity Western University

Publications:
Sawatzky R, Cohen SR, Laforest E, Voth J, Stajduhar K. The Development and Use of Tablet-Based Quality Of Life Assessment Instruments in Clinical Practice. Paper presented at the 20th International Congress on Palliative Care, Montreal, Canada, 2014.

Responsible Party: Richard Sawatzky, Associate Professor, Trinity Western University
ClinicalTrials.gov Identifier: NCT02940951     History of Changes
Other Study ID Numbers: FH-REB 2015-139
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As part of the project, the investigators will explore the possibility of using the tablets (intervention) as part of routine care. The tablet would be used to administer the questionnaires to patients and families as part of their care and to obtain a report of the assessment data that will drive the clinical team to service/care improvement, for clinical purposes. This generation of the report will happen in real time, will contain the patient's name and personal health identifier, and can be placed in the patient's chart as part of care services delivered to that patient. No other individual participant data collected for research is shared.

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes