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| Name | Class |
|---|---|
| George Washington University | OTHER |
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The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Education Delivery | Experimental | The participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log. |
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| Standard verbal and written education | Placebo Comparator | The control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Education Delivery | Other | Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in self-reported pain scores | Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain. | Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain management knowledge | Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome. | Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
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Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Amber M Stitz | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2017 | Sep 25, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2017 | Sep 25, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.
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| Standard Verbal and Written Education | Other | Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need. |
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| Difference in self-reported participation in pain management | Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation. | Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
| Difference in post-operative opioid requirements | Total opioid requirements, converted to morphine milligram equivalents | Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
| Difference in usefulness of education | Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness. | Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
| Difference in use of non-pharmacologic pain modalities | Results are tabulated for a descriptive selection list for patients to report what interventions were used. | Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |