Chronic PainNCT04716621
Computerized Decision Support Tool for Pain Management in Primary Care
A study testing Early intervention and Delayed intervention in people with Chronic Pain, run by MJHS Institute for Innovation in Palliative Care.
Trial summary
Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. 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?
- Early intervention and Delayed intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2013to Apr 2016
- 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
- Treated at the Institute for Family Health
- Spoke English or Spanish
- Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
- Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
- Willingness to complete questionnaires three times
- A commitment to return to the practice
- Reachable by phone
- No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments
Who cannot join
- -
About this study
Official title: Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.
The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.
Read the detailed description
This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.
- Conditions
- Chronic Pain
- Being tested
- Early intervention, Delayed intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early interventionOther
The Pain Management Support System for Primary Care (PMSS-PC) generated "best practice alerts" and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain.
Delayed interventionOther
Delayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record. Receives: Other: Early intervention |
| Delayed intervention | Other | Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm. Receives: Other: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst Pain Intensity
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Measured: From baseline to 6 months following intervention implementation
Average Pain Intensity
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Measured: From baseline to 6 months following intervention implementation
Pain Interference with Function
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Measured: From baseline to 6 months following intervention implementation
Secondary outcomes (4)
Worst Pain Intensity
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Measured: From 6 to 12 months following intervention implementation
Average Pain Intensity
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Measured: From 6 to 12 months following intervention implementation
Pain Interference with Function
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Measured: From 6 to 12 months following intervention implementation
Uptake of the PMSS-PC intervention tool
Use of the PMSS-PC decision support tool by primary care providers
Measured: From baseline to 12 months following intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start11 Nov 2013
- Primary completionApr 2016
- Study completionApr 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- MJHS Institute for Innovation in Palliative Care
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, The Institute for Family Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716621
- Sponsor's protocol ID
- 8408357
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
- ClinicalTrials.gov ID
- NCT04716621
- Acronym / sponsor ID
- 8408357
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- MJHS Institute for Innovation in Palliative CareUniversity, hospital or other
- Collaborators
- Pfizer, The Institute for Family Health
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Jan 2021 (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.
Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.
The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.
Detailed description
This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Other: Early interventionThree sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record. |
| Delayed intervention | Other | Other: Delayed interventionDelayed wait-list control group. Three additional sites received the intervention 6 months after the first arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Treated at the Institute for Family Health
- Spoke English or Spanish
- Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
- Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
- Willingness to complete questionnaires three times
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Early interventionThe Pain Management Support System for Primary Care (PMSS-PC) generated "best practice alerts" and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain. | Other | Early intervention |
| Delayed interventionDelayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm. | Other | Delayed intervention |
Primary outcome
Worst Pain Intensity
Time frame: From baseline to 6 months following intervention implementation
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Average Pain Intensity
Time frame: From baseline to 6 months following intervention implementation
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Pain Interference with Function
Time frame: From baseline to 6 months following intervention implementation
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
4 secondary outcomes
Worst Pain Intensity
Time frame: From 6 to 12 months following intervention implementation
Average Pain Intensity
Time frame: From 6 to 12 months following intervention implementation
Pain Interference with Function
Time frame: From 6 to 12 months following intervention implementation
Uptake of the PMSS-PC intervention tool
Time frame: From baseline to 12 months following intervention implementation
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 22 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention and Delayed intervention in people with Chronic Pain, run by MJHS Institute for Innovation in Palliative Care.
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 8 inclusion and 1 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Worst Pain Intensity (time frame: From baseline to 6 months following intervention implementation). The study lists 3 primary outcomes in all. 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 22 Jan 2021.