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

NCT02940951 | Completed

• 1 other identifier: FH-REB 2015-139
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 2

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 health care. 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 innovative, electronic health care information and practice support 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. Eight 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.

Conditions

Chronic Disease; Life-limiting Illness; Palliative Care

Outcome Measures

Primary Outcomes (2)

• Differences in trajectories of change between groups in McGill Quality of Life Questionnaire -Expanded [MQOL-E] Total Score

  The McGill Quality of Life Questionnaire -Expanded has 20 items covering Physical, Psychological, Existential, Social, Feeling like a burden, Environment, Cognition and Quality of health care domains. The total score is the mean of the domain scores, with possible values ranging from 0 (worst possible quality of life) to 10 (best possible quality of life).

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months)

• Differences in trajectories of change between groups in Quality of Life in Life-Threatening Illness- Family (QOLLTI-F) (version 3) Total Score

  Quality of Life in Life-Threatening Illness- Family (version 3) includes 16 items measuring 7 domains that contribute to quality of life: Environment; Patient Condition; Caregiver's Own Condition (formerly called Own State); Caregiver's Outlook; Quality of Care; Relationships; and Financial Worries. The total score is the mean of the 7 domain scores, with possible values ranging from 0 (worst possible quality of life) to 10 (best possible quality of life).

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

Secondary Outcomes (5)

• Differences in trajectories of change between groups in McGill Quality of Life Questionnaire -Expanded [MQOL-E] domains

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

• Differences in trajectories of change between groups in Quality of Life in Life-Threatening Illness- Family (version 3) domains

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

• Differences in trajectories of change between groups in Canadian Health Care Evaluation Project Questionnaire [CANHELP] Lite Patient version Total Satisfaction Score

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

• Differences in trajectories of change between groups in Canadian Health Care Evaluation Project Questionnaire [CANHELP] Lite Family version Total Satisfaction Score

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

• Differences in trajectories of change between groups in VR-12 (Veterans Rand 12) Physical Component Score (PCS) and a Mental Component Score (MCS).

  Trajectories over 12 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))

Study Arms (2)

Usual home care provided by clinicians

OTHER

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

Use of QPSS by home health clinicians

EXPERIMENTAL

Usual home care plus the use of the Quality of Life Assessment and Practice Support System (QPSS) to document, monitor and address the quality of life concerns of patients and family caregivers.

Other: QPSS; Other: Usual care

Interventions

QPSS OTHER

Home care providers use the QPSS that includes standardized instruments for assessing patient and family caregiver quality of life 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.

Also known as: Quality of Life Assessment and Practice Support System

Use of QPSS by home health clinicians

Usual care OTHER

Home healthcare services provided by nurses and, where applicable, multi-professional teams.

Use of QPSS by home health clinicians; Usual home care provided by clinicians

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Patients who are less than 55 years old and are not identified as having one or more advancing life-limiting illnesses.

Sponsors & Collaborators

• Trinity Western University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Alberta Health Services Edmonton Zone Home Living

Edmonton, British Columbia, Canada

Location

BC Home Health Offices

Surrey, British Columbia, Canada

Location

Related Publications (1)

• Sawatzky R, Schick-Makaroff K, Ratner PA, Kwon JY, Whitehurst DGT, Ohlen J, Maybee A, Stajduhar K, Zetes-Zanatta L, Cohen SR. Did a digital quality of life (QOL) assessment and practice support system in home health care improve the QOL of older adults living with life-limiting conditions and of their family caregivers? A mixed-methods pragmatic randomized controlled trial. PLoS One. 2025 May 6;20(5):e0320306. doi: 10.1371/journal.pone.0320306. eCollection 2025.

  PMID: 40327663 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Sawatzky, Ph.D.

  Trinity Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: October 21, 2016
• Study Start: March 12, 2018
• Primary Completion: May 6, 2020
• Study Completion: August 6, 2021
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Immediately following publication and up to 5 years after
• Access Criteria: Anyone who wishes to access the data can do so through the Trinity Western University Dataverse (site currently under development - to be updated when link available). Data will be made available for any purpose.

Locations

CA (2)