Introducing the Palliative Care Comprehensive Tool in Family Medicine

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

Study Overview

• Status: Unknown
• Conditions: Palliative Care; Satisfaction; Primary Care
• Intervention / Treatment: Other: Palliative Care Comprehensive Tool

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 Type: Interventional
• Enrollment (Anticipated): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8W3J6
      • Stonechurch Family Health Centre, Department of Family Medicine McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palliative Care Comprehensive Tool; Clinicians within the study will be randomly assigned and trained on the use of the Palliative Care Comprehensive Tool	Other: Palliative Care Comprehensive Tool; 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; Other Names: PaCCT
No Intervention: Usual Care; Clinicians within the study will be randomly assigned to usual palliative care (without the newly introduced tool)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	FAMCARE-P13	3 months
Clinician satisfaction	Physician Satisfaction with Aspects of Chronic Care (modified)	3 months
User feedback	Acceptability and feasibility of the Palliative Care Comprehensive Tool will be sought using the Clinical Sensibility Questionnaire	3 months
Uptake of tool	Tool implementation will be (rate of tool uptake by clinician)	3 month

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Ainsley Moore, MD, Department of Family Medicine McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Primary care; Palliative care
• Other Study ID Numbers: PaCCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data. Data will be stored on secured facility servers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No