Introducing the Palliative Care Comprehensive Tool in Fam... | NCT03267706

Studies
Introducing the Palliative Care Comprehensive Tool in Family Medicine

NCT03267706

Sponsor

McMaster University

Status

Unknown status

Last Update Posted

Aug 30, 2017Actual

Enrollment

149Estimated

Phase

Not Applicable

Conditions

Palliative Care
Primary Care
Satisfaction

Interventions

Palliative Care Comprehensive Tool

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2017Estimated

Primary Completion Date

Mar 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Aug 29, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2017

Last Update Posted Date

Aug 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ainsley Moore, Associate Professor of Family Medicine, McMaster UniversityPrincipal Investigator

Lead Sponsor

McMaster UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Palliative Care Comprehensive Tool	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caregiver satisfaction	FAMCARE-2 survey to measure caregiver satisfaction	3 months

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	FAMCARE-P13	3 months
Clinician satisfaction	Physician Satisfaction with Aspects of Chronic Care (modified)	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Xu, MD	Contact	9055751300		sarah.xu@medportal.ca
Amanpaul Bhamber, MD	Contact	9055751300		amanpaul.bhamber@medportal.ca

Overall Officials

Name	Affiliation	Role
Ainsley Moore, MD	Department of Family Medicine McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stonechurch Family Health Centre, Department of Family Medicine McMaster University		Hamilton	Ontario	L8W3J6	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share data. Data will be stored on secured facility servers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

Patients and caregivers are blinded as to whether their clinician received training and access to the newly introduced comprehensive palliative care tool. Clinicians delivering care are not blinded to use of the tool, outcome assessors are not blinded to the data

Who Masked

Participant