An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
medication reviews, assessment, recommendations, education.
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or older
- Baseline average pain intensity using Brief Pain Inventory is 6 or higher
- Ambulatory and able to attend the intervention
- Complaining of pain for 3 months or longer
Exclusion Criteria:
- Patients with malignant or cancer pain
- Patients who are unable to communicate in English
- Non-ambulatory and unable to attend the intervention at the participating site
- Unable to give informed consent.
Sites / Locations
- The PharmaShoppe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacist intervention
Arm Description
Within the pharmacist intervention arm, pharmacists will do medication reviews, assessment, recommendations, education.
Outcomes
Primary Outcome Measures
Pain intensity change
Pain intensity will be measured with Brief Pain Inventory pain intensity subscale, and will be measured 3 times in total
Secondary Outcome Measures
Pain interference
Pain interference will be measured with Brief Pain Inventory pain interference subscale, and will be measured 3 times in total
Quality of life change
quality of life will be measured using Short Form-36, and will be measured twice in total.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03087331
Brief Title
An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
Official Title
An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, pre post, pilot cohort study to be conducted in patients with chronic pain, which is defined as pain that lasts beyond 3 months. To accomplish the primary and secondary objectives of the study, three phrases will be designed and completed during three months
Detailed Description
This study will evaluate the effectiveness of community-based pharmacist interventions on the quality of life of patients with chronic pain as determined by self-reported pain levels using an established scoring system. Participating pharmacists will enroll chronic pain patients from their normal practice to receive a consultation, which consists of an assessment of their current pain, a medication review, and education about their condition. Based on the information provided by the patient, the pharmacist will prepare a care plan, contact the patient's prescriber, and, in conjunction with the prescriber, implement the plan to help relieve their pain. Follow-up assessments will be done after 2 weeks, and 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist intervention
Arm Type
Experimental
Arm Description
Within the pharmacist intervention arm, pharmacists will do medication reviews, assessment, recommendations, education.
Intervention Type
Other
Intervention Name(s)
medication reviews, assessment, recommendations, education.
Primary Outcome Measure Information:
Title
Pain intensity change
Description
Pain intensity will be measured with Brief Pain Inventory pain intensity subscale, and will be measured 3 times in total
Time Frame
baseline, 2 weeks follow-up, 3 months follow-up
Secondary Outcome Measure Information:
Title
Pain interference
Description
Pain interference will be measured with Brief Pain Inventory pain interference subscale, and will be measured 3 times in total
Time Frame
baseline, 2 weeks follow-up, 3 months follow-up
Title
Quality of life change
Description
quality of life will be measured using Short Form-36, and will be measured twice in total.
Time Frame
baseline, 3 months follow-up
Other Pre-specified Outcome Measures:
Title
patient adherence
Description
Patient adherence will be measured using Morisky medication adherence scale-8, and will be measured at 2 weeks and 3 months follow-up.The Morisky medication adherence scale-8 will be used as supplementary data to further elucidate potential factors behind the observed outcomes.
Time Frame
2 weeks follow-up and 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 or older
Baseline average pain intensity using Brief Pain Inventory is 6 or higher
Ambulatory and able to attend the intervention
Complaining of pain for 3 months or longer
Exclusion Criteria:
Patients with malignant or cancer pain
Patients who are unable to communicate in English
Non-ambulatory and unable to attend the intervention at the participating site
Unable to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Chang
Organizational Affiliation
University of Waterloo
Official's Role
Study Director
Facility Information:
Facility Name
The PharmaShoppe
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G4X6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
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