Pain, PostoperativeNCT05252767
Patient Engagement in Perioperative Pain Management Project
A study testing Patient Engagement Tools and Educational Guide in people with Pain, Postoperative and Opioid Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Opioid Use Disorder
- What is being tested?
- Patient Engagement Tools and Educational Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Aug 2023
- 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
- All patients in Johns Hopkins Personalized Pain Program Clinic
Who cannot join
- Active suicidal ideation at study entry
- Primary psychotic disorder
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management
Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.
- Conditions
- Pain, Postoperative, Opioid Use Disorder
- Being tested
- Patient Engagement Tools, Educational Guide
- Keywords
- Patient engagement, Patient activation
- Medical subject headings
- Pain, Postoperative, Opioid-Related Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Engagement ToolsBehavioural
Experimental participants will receive the patient engagement tools or the educational guide after randomization. The participants in the experimental cohort will utilize the tools between visits with their clinic providers. During visits, clinic providers will review the completed tools with participants.
Educational GuideBehavioural
Control participants will receive a brief educational guide about pain management.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Patient Engagement Tools | Experimental | Participants will be enrolled from the a pain management clinic. Participants randomized into the experimental cohort will receive access to a clinic brochure, clinic website, as well as 'My Pain Passport' and 'My Treatment Plan' tools. Receives: Behavioral: Patient Engagement Tools |
| Cohort B - Educational Guide | Sham comparator | Participants randomized into the control cohort will receive a brief educational guide on general pain management. Receives: Behavioral: Educational Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient engagement as assessed by a patient engagement survey
Patient engagement survey measures level of patient engagement on five-point Likert scale
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Secondary outcomes (6)
Opioid consumption as assessed by daily morphine milligram equivalents
Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Brief Pain Inventory
Brief Pain Inventory assesses pain severity and impact of pain on functional status on 10-point scale (1=no pain, no interference and 10 = worst pain, complete interference)
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire
Present Pain Intensity scale of the McGill Pain Questionnaire measures pain intensity on 4-point scale (0 = none, 3 = severe)
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Pain Catastrophizing Scale
Pain Catastrophizing Scale measures level of pain catastrophizing (0 = not at all, 4 = all the time)
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Functional status as assessed by the Insomnia Severity Index
Insomnia Severity Index measures severity of insomnia on five-point scale (0=none, 4=severe, were score of 0-7 indicates no clinically significant insomnia and score of 22-28 indicates clinical or severe insomnia)
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Functional status as assessed by the 36-Item Short Form Health Survey
36-Item Short Form Health Survey measures overall health status (converted into 0-100 scale, were lower score indicates more disability)
Measured: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Anping Xie, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252767
- Sponsor's protocol ID
- IRB00307176
- Other IDs
- R01CE003150
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management
- ClinicalTrials.gov ID
- NCT05252767
- Acronym / sponsor ID
- IRB00307176
- Conditions
- Pain, Postoperative, Opioid Use Disorder
- Keywords
- Patient engagement, Patient activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 23 Feb 2022 (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.
Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Patient Engagement Tools | Experimental | Behavioral: Patient Engagement ToolsParticipants will be enrolled from the a pain management clinic. Participants randomized into the experimental cohort will receive access to a clinic brochure, clinic website, as well as 'My Pain Passport' and 'My Treatment Plan' tools. |
| Cohort B - Educational Guide | Sham comparator | Behavioral: Educational GuideParticipants randomized into the control cohort will receive a brief educational guide on general pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in Johns Hopkins Personalized Pain Program Clinic
Key exclusion criteria (3 listed)
- Active suicidal ideation at study entry
- Primary psychotic disorder
- Non-English speaker
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 |
|---|---|---|
| Patient Engagement ToolsExperimental participants will receive the patient engagement tools or the educational guide after randomization. The participants in the experimental cohort will utilize the tools between visits with their clinic providers. During visits, clinic providers will review the completed tools with participants. | Behavioural | Cohort A - Patient Engagement Tools |
| Educational GuideControl participants will receive a brief educational guide about pain management. | Behavioural | Cohort B - Educational Guide |
Primary outcome
Patient engagement as assessed by a patient engagement survey
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Patient engagement survey measures level of patient engagement on five-point Likert scale
6 secondary outcomes
Opioid consumption as assessed by daily morphine milligram equivalents
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Brief Pain Inventory
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Pain level as assessed by the Pain Catastrophizing Scale
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Functional status as assessed by the Insomnia Severity Index
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Functional status as assessed by the 36-Item Short Form Health Survey
Time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
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 8 Feb 2024.
- 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.
Anping Xie, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Engagement Tools and Educational Guide in people with Pain, Postoperative and Opioid Use Disorder, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 3 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 8 Feb 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Patient engagement as assessed by a patient engagement survey (time frame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment). 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 8 Feb 2024.