Chronic PainNCT03087331
An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
A study testing medication reviews, assessment, recommendations, education. in people with Chronic Pain, run by University of Waterloo at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- medication reviews, assessment, recommendations, education.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to May 2017
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- medication reviews, assessment, recommendations, education.
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication reviews, assessment, recommendations, education.Other
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist intervention | Experimental | Within the pharmacist intervention arm, pharmacists will do medication reviews, assessment, recommendations, education. Receives: Other: medication reviews, assessment, recommendations, education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity change
Pain intensity will be measured with Brief Pain Inventory pain intensity subscale, and will be measured 3 times in total
Measured: baseline, 2 weeks follow-up, 3 months follow-up
Secondary outcomes (2)
Pain interference
Pain interference will be measured with Brief Pain Inventory pain interference subscale, and will be measured 3 times in total
Measured: baseline, 2 weeks follow-up, 3 months follow-up
Quality of life change
quality of life will be measured using Short Form-36, and will be measured twice in total.
Measured: baseline, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startFeb 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Chang, Study director, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087331
- Sponsor's protocol ID
- 21092
- Status last verified
- Nov 2017
- First submitted
- 10 May 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of Community-based Pharmacist Intervention on Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT03087331
- Acronym / sponsor ID
- 21092
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 Mar 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist intervention | Experimental | Other: medication reviews, assessment, recommendations, education.Within the pharmacist intervention arm, pharmacists will do medication reviews, assessment, recommendations, education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| medication reviews, assessment, recommendations, education. | Other | Pharmacist intervention |
Primary outcome
Pain intensity change
Time frame: baseline, 2 weeks follow-up, 3 months follow-up
Pain intensity will be measured with Brief Pain Inventory pain intensity subscale, and will be measured 3 times in total
2 secondary outcomes
Pain interference
Time frame: baseline, 2 weeks follow-up, 3 months follow-up
Quality of life change
Time frame: baseline, 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Feng Chang study director
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication reviews, assessment, recommendations, education. in people with Chronic Pain, run by University of Waterloo 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 4 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: finished, as of the sponsor's last update on 17 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity change (time frame: baseline, 2 weeks follow-up, 3 months follow-up). 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 17 Nov 2017.