- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02940951
Quality of Life Assessment and Practice Support System in Home Care Services for Older Adults (QPSS)
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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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 will try to improve patient and family caregiver QOL while improving the efficacy of the health care system by studying the implementation of an 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.
Research aims and questions:
This integrated knowledge translation project involves working with clinicians, patients, and family caregivers to answer the following aims and research questions.
Aim 1: To examine the efficacy of the QPSS in home care for older adults who have advancing life-limiting illnesses.
• Does the routine use of the QPSS in home care improve quality of care, as indicated by patients' and family caregivers' reports of enhanced QOL and experiences with the care provided?
Aim 2: To evaluate the cost consequences of implementing the QPSS in home care.
Aim 3: To understand the process of implementing the QPSS in home care.
• How can the integration and routine use of the QPSS in the home care for older adults who have advancing life-limiting illnesses and their family caregivers be best facilitated?
Aim 4: To examine how integration of the QPSS with health information systems will meet the needs of administrators for quality improvement and accreditation.
Design:
This project will be conducted in 3 stages at 8 home care service sites:
Stage 1: The local adaptation stage will use qualitative methods (user-centered design focus groups and interviews with clinicians, managers, patients, and family caregivers) to adapt the QPSS to the unique context of each home care service site and develop site-specific protocols for its routine integration in daily practice. For evaluative purposes, this stage will also include (a) measurement of patient and family caregiver QOL and their health care experiences prior to integrating routine use of the QPSS into home care to serve as a pre-intervention comparator group (Aim 1) and (b) data collection regarding the cost of local adaptation of and training to use the QPSS (Aim 2).
Stage 2: During the evaluation stage, the investigators will (a) conduct a randomized controlled trial to evaluate the impact of using the QPSS on the QOL and care experiences of patients and their family caregivers (Aim 1); (b) conduct an economic evaluation to estimate the cost consequences of implementing the QPSS in home care (Aim 2); and (c) apply qualitative and quantitative methods to examine the process of using the QPSS in home health care (Aim 3). The investigators aim to recruit 540 patients and 540 family caregivers. Patient participants will be 55 years of age and older who are receiving ongoing home care due to advancing life-limiting illnesses. Family caregiver participants are identified as eligible and competent by the patient, or by a clinician if the patient is unable to do so, and as the person most involved in the care of a patient who meets the abovementioned eligibility criteria. No more than one caregiver per patient will be recruited. Patient and family caregiver participants must have the ability to speak English and capacity to provide informed consent.
STAGE 3: The sustainability stage will focus on (a) whether the results warrant sustained and widespread integration of the QPSS into practice, and if so, (b) how to scale this up, (c) how to further integrate the QPSS with other health information systems to facilitate use by health care administrators for continuous quality improvement and accreditation (Aim 4) and (d) dissemination of results.
The start and end dates and recruitment information for this registration pertains only to the randomized controlled trial in stage 2 (evaluation).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
British Columbia
-
Edmonton, British Columbia, Canada
- Alberta Health Services Edmonton Zone Home Living
-
Surrey, British Columbia, Canada
- BC Home Health Offices
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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
Exclusion criteria:
Patients who are less than 55 years old and are not identified as having one or more advancing life-limiting illnesses.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
|
Home healthcare services provided by nurses and, where applicable, multi-professional teams.
|
Eksperimentell: Use of QPSS by home health clinicians
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.
|
Home healthcare services provided by nurses and, where applicable, multi-professional teams.
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Differences in trajectories of change between groups in McGill Quality of Life Questionnaire -Expanded [MQOL-E] Total Score
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
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 of up to 24 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
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
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 of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Differences in trajectories of change between groups in McGill Quality of Life Questionnaire -Expanded [MQOL-E] domains
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
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.
Domain scores are calculated using the mean of the item scores assigned to each domain.
Each domain has possible values ranging from 0 (worst possible) to 10 (best).
|
Trajectories of up to 24 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
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
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.
Domain scores are calculated using the mean of the item scores assigned to each domain.
Each domain has possible values ranging from 0 (worst possible) to 10 (best).
|
Trajectories of up to 24 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
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
The patient version has 20 items and covers the following domains: Relationship with Doctors, Illness Management, Communication, Decision-Making, Your Well-being, and Overall Satisfaction.
Three items on relationships with home health professionals adapted from the questions on relationships with doctors are added to the CANHELP-LITE assessment for patients to be used in this study.
The Total Satisfaction score is the unweighted average of all answered questions.
Each item has possible values ranging from 1 (worst possible) to 5 (best possible).
|
Trajectories of up to 24 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
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
The family caregiver version has 21 items representing the following domains: Relationship with Doctors, Characteristics of Doctors and Nurses, Illness Management, Communication and Decision-Making, Your Involvement, and Overall Satisfaction.
Three items on relationships with home health professionals adapted from the questions on relationships with doctors are added to the CANHELP-LITE assessment for family caregivers to be used in this study.
The Total Satisfaction score is the unweighted average of all answered questions.
Each item has possible values ranging from 1 (worst possible) to 5 (best possible).
|
Trajectories of up to 24 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).
Tidsramme: Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
VR-12 is a widely-used generic PROM which will be included for the measurement of general physical and mental health status and for cost-effectiveness analysis. VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). Each question has possible values ranging from 1 (best possible) to 5 (worst possible). |
Trajectories of up to 24 months from start of enrollment in Stage 2 until study completion (assessments completed every two months))
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Richard Sawatzky, Ph.D., Trinity Western University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FH-REB 2015-139
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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