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| ID | Type | Description | Link |
|---|---|---|---|
| R01CE003150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cohort B - Educational Guide | Sham Comparator | Participants randomized into the control cohort will receive a brief educational guide on general pain management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Engagement Tools | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient engagement as assessed by a patient engagement survey | Patient engagement survey measures level of patient engagement on five-point Likert scale | Time of each participant's standard of care clinic visit, up to 1 year from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption as assessed by daily morphine milligram equivalents | Daily morphine milligram equivalents (MME) indicates potency of an opioid dosage compared to morphine | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anping Xie, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009293 | Opioid-Related Disorders |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Educational Guide | Behavioral | Control participants will receive a brief educational guide about pain management. |
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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) |
| 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) | 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) | 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) | 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) | Time of each participant's standard of care clinic visit, up to 1 year from enrollment |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |