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Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.
Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.
These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.
Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.
The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound Care Video | Active Comparator | Wound Care Patient Education Video |
|
| Pain Management Video Group | Experimental | Pain Management Patient Education Video |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Management Patient Education Video | Behavioral | Patient education video that were created in-house specifically for this project. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery 15 Score | Score on the standardized Quality of Recovery 15 questionnaire How have you been feeling in the last 24 hours? (0 to 10, where 0= none of the time [poor] and 10=all of the time [excellent]) 0 1 2 3 4 5 6 7 8 9 10
| 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS | PROMIS short forms administered on POD 3 - (GI belly pain 5a, GI nausea and vomiting 4a, Pain Intensity 3a, Pain Interference 4a, Sleep Disturbance 4a, Cognitive Function 4a) | 3 days after surgery |
| number of narcotic pills used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cassandra Mierisch, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Orthopedics and Neurosciences | Roanoke | Virginia | 24014 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2017 | Nov 29, 2017 |
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prospective, randomized clinical trial
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Care provider is not informed of which patient education video(s) the patient was provided, unless that patient initiates a conversation with the provider regarding the video.
| Wound Care Patient Education Video | Behavioral | Patient education video that were created in-house specifically for this project. |
|
number of narcotic pills used
| 7 days after surgery |
| daily pain level | 0-10 rating scale | 7 days after surgery |
| patient-reported satisfaction and feeling of control - pain management | Today, I feel in control of my pain management.
| 7 days after surgery |
| patient-reported satisfaction and feeling of control- wound care | Today, I feel in confident about how I am caring for my wound.
| 7 days after surgery |
| patient-reported satisfaction and feeling of control - pain management satisfaction | Today, I would rate my satisfaction with my pain control as (circle)
| 7 days after surgery |
| number of pain-related calls/visits to a healthcare provider | patient-reported | 7 days after surgery |
| use of non-narcotic adjunct pain relief medication and modalities | 7 days after surgery |
| incidence of high risk activities - sedating medication polytherapy | combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications | 7 days after surgery |
| incidence of high risk activities - NSAID polytherapy | combining prn NSAIDs with regularly dosed prescription NSAIDs | 7 days after surgery |
| incidence of high risk activities - overdosing | exceeding daily recommended doses of pain medication | 7 days after surgery |
| incidence of side effects and adverse events - Nausea/V omitting | Nausea/Vomiting | 7 days after surgery |
| incidence of side effects and adverse events - Dizziness/balance problems | Dizziness/balance problems | 7 days after surgery |
| incidence of side effects and adverse events - fatigue or sedation | fatigue or sedation | 7 days after surgery |
| incidence of side effects and adverse events - headache | headache | 7 days after surgery |
| incidence of side effects and adverse events - visual changes | visual changes | 7 days after surgery |
| incidence of side effects and adverse events - stomach pain | stomach pain | 7 days after surgery |
| incidence of side effects and adverse events - constipation | constipation | 7 days after surgery |
| incidence of side effects and adverse events - diarrhea | diarrhea | 7 days after surgery |
| incidence of side effects and adverse events - fever | fever | 7 days after surgery |
| incidence of side effects and adverse events - rash | rash | 7 days after surgery |
| incidence of side effects and adverse events - hives | hives | 7 days after surgery |
| incidence of side effects and adverse events - swelling | swelling | 7 days after surgery |
| incidence of side effects and adverse events - difficulty breathing/shortness of breath | difficulty breathing/shortness of breath | 7 days after surgery |
| incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing | heart palpitations/arrythmia/heart racing | 7 days after surgery |
| incidence of side effects and adverse events - anaphylaxis | anaphylaxis | 7 days after surgery |
| incidence of side effects and adverse events - ringing in ears | ringing in ears | 7 days after surgery |
| incidence of side effects and adverse events - other | other | 7 days after surgery |
| demonstrated patient knowledge | as measured by score on the follow-up quiz | 7 days after surgery |
| prevalence of chronic opioid use | patient reported | 1 year after surgery |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2017 | Nov 29, 2017 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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