Palliative CareNCT03267706
Introducing the Palliative Care Comprehensive Tool in Family Medicine
A study testing Palliative Care Comprehensive Tool in people with Palliative Care and Primary Care, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to pilot the introduction of a newly developed palliative care tool to clinicians in a family health team. The intent of the tool is to improve the quality and comprehensiveness of palliative care, which effects caregiver and patient satisfaction with care received, as well as clinician… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Primary Care, Satisfaction
- What is being tested?
- Palliative Care Comprehensive Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusive sample of all clinicians employed at Stonechurch Family Health Centre
- Inclusive sample of all patients over 18 years of age, registered as palliative within Stonechurch Family Health Centre and who are English speaking
- Exclusion Criteria: Patients younger than 18 years of age, patients who are non-English speaking
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stonechurch Family Health Centre, Department of Family Medicine McMaster University
Hamilton, Ontario, L8W3J6
Sarah Xu, MD, 9055751300, sarah.xu@medportal.ca
Amanpaul Bhamber, MD, 9055751300, amanpaul.bhamber@medportal.ca
About this study
Official title: Introducing the Comprehensive Palliative Care Tool in Family Medicine : A Pilot Randomized Controlled Trial
The purpose of this study is to pilot the introduction of a newly developed palliative care tool to clinicians in a family health team. The intent of the tool is to improve the quality and comprehensiveness of palliative care, which effects caregiver and patient satisfaction with care received, as well as clinician satisfaction with their delivery of care. Tool effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and clinicians who receive training and access to the tool compared to caregivers, patients and clinicians providing usual care (without the tool). Uptake of the tool and user feedback will be collected
Read the detailed description
A newly developed tool to guide clinicians in best palliative care practices was developed based on a combination of published tools and consultation with primary care, end users (clinicians). The tool will be introduced as a pilot to clinicians who will receive training on use of the tool and access to the tool within a family health team in Ontario, Canada. The tool will be applied in a controlled study environment that randomly assigns clinicians to one of two groups. One group will receive training and access to the tool and the other group of clinicians will continue to provide usual care.The tool will be evaluated based on validated satisfaction surveys completed by caregivers, patients and clinicians. Satisfaction scores of those randomly assigned to care enhanced by the tool will be compared to those receiving usual care at the beginning and end of the study. Uptake of the tool will be measured, as well as user experience with the tool (feasibility and acceptability)
- Conditions
- Palliative Care, Primary Care, Satisfaction
- Being tested
- Palliative Care Comprehensive Tool
- Keywords
- Primary care, Palliative care
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care Comprehensive ToolOther
Also called PaCCT
Clinicians assigned to the newly developed Palliative Care Comprehensive Tool will be trained during a 1 hour period on the application of the tool; Including rationale for tool development, objective of the tool and demonstration of the tool in action
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Comprehensive Tool | Active comparator | Clinicians within the study will be randomly assigned and trained on the use of the Palliative Care Comprehensive Tool Receives: Other: Palliative Care Comprehensive Tool |
| Usual Care | No intervention | Clinicians within the study will be randomly assigned to usual palliative care (without the newly introduced tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver satisfaction
FAMCARE-2 survey to measure caregiver satisfaction
Measured: 3 months
Secondary outcomes (4)
Patient satisfaction
FAMCARE-P13
Measured: 3 months
Clinician satisfaction
Physician Satisfaction with Aspects of Chronic Care (modified)
Measured: 3 months
User feedback
Acceptability and feasibility of the Palliative Care Comprehensive Tool will be sought using the Clinical Sensibility Questionnaire
Measured: 3 months
Uptake of tool
Tool implementation will be (rate of tool uptake by clinician)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ainsley Moore, McMaster University
- Investigators
- Ainsley Moore, MD, Principal investigator, Department of Family Medicine McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267706
- Sponsor's protocol ID
- PaCCT
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data. Data will be stored on secured facility servers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing the Comprehensive Palliative Care Tool in Family Medicine : A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03267706
- Acronym / sponsor ID
- PaCCT
- Conditions
- Palliative Care, Primary Care, Satisfaction
- Keywords
- Primary care, Palliative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot the introduction of a newly developed palliative care tool to clinicians in a family health team. The intent of the tool is to improve the quality and comprehensiveness of palliative care, which effects caregiver and patient satisfaction with care received, as well as clinician satisfaction with their delivery of care. Tool effectiveness will be evaluated by measuring satisfaction scores of caregivers, patients and clinicians who receive training and access to the tool compared to caregivers, patients and clinicians providing usual care (without the tool). Uptake of the tool and user feedback will be collected
Detailed description
A newly developed tool to guide clinicians in best palliative care practices was developed based on a combination of published tools and consultation with primary care, end users (clinicians). The tool will be introduced as a pilot to clinicians who will receive training on use of the tool and access to the tool within a family health team in Ontario, Canada. The tool will be applied in a controlled study environment that randomly assigns clinicians to one of two groups. One group will receive training and access to the tool and the other group of clinicians will continue to provide usual care.The tool will be evaluated based on validated satisfaction surveys completed by caregivers, patients and clinicians. Satisfaction scores of those randomly assigned to care enhanced by the tool will be compared to those receiving usual care at the beginning and end of the study. Uptake of the tool will be measured, as well as user experience with the tool (feasibility and acceptability)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pilot prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Comprehensive Tool | Active comparator | Other: Palliative Care Comprehensive ToolClinicians within the study will be randomly assigned and trained on the use of the Palliative Care Comprehensive Tool |
| Usual Care | No intervention | –Clinicians within the study will be randomly assigned to usual palliative care (without the newly introduced tool) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inclusive sample of all clinicians employed at Stonechurch Family Health Centre
- Inclusive sample of all patients over 18 years of age, registered as palliative within Stonechurch Family Health Centre and who are English speaking
- Exclusion Criteria: Patients younger than 18 years of age, patients who are non-English speaking
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Care Comprehensive ToolAlso: PaCCTClinicians assigned to the newly developed Palliative Care Comprehensive Tool will be trained during a 1 hour period on the application of the tool; Including rationale for tool development, objective of the tool and demonstration of the tool in action | Other | Palliative Care Comprehensive Tool |
Primary outcome
Caregiver satisfaction
Time frame: 3 months
FAMCARE-2 survey to measure caregiver satisfaction
4 secondary outcomes
Patient satisfaction
Time frame: 3 months
Clinician satisfaction
Time frame: 3 months
User feedback
Time frame: 3 months
Uptake of tool
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No. No plan to share data. Data will be stored on secured facility servers.
Related trials for Palliative Care
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Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ainsley Moore, MD principal investigator
Department of Family Medicine McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Comprehensive Tool in people with Palliative Care and Primary Care, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Xu, MD (9055751300, sarah.xu@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.