- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03087331
An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
November 15, 2017 updated by: University of Waterloo
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Kitchener, Ontario, Canada, N2G4X6
- The PharmaShoppe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmacist intervention
Within the pharmacist intervention arm, pharmacists will do medication reviews, assessment, recommendations, education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity change
Time Frame: baseline, 2 weeks follow-up, 3 months follow-up
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Pain intensity will be measured with Brief Pain Inventory pain intensity subscale, and will be measured 3 times in total
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baseline, 2 weeks follow-up, 3 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain interference
Time Frame: baseline, 2 weeks follow-up, 3 months follow-up
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Pain interference will be measured with Brief Pain Inventory pain interference subscale, and will be measured 3 times in total
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baseline, 2 weeks follow-up, 3 months follow-up
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Quality of life change
Time Frame: baseline, 3 months follow-up
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quality of life will be measured using Short Form-36, and will be measured twice in total.
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baseline, 3 months follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient adherence
Time Frame: 2 weeks follow-up and 3 months follow-up
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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.
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2 weeks follow-up and 3 months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Feng Chang, University of Waterloo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
May 10, 2016
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 15, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21092 (Other Identifier: City of Hope Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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