Ambulatory Surgery, Analgesics, Opioid, Education, Patient, Injuries and Wounds, Orthopedic Surgery
Conditions
Keywords
opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPain Management Patient Education Video
Patient education video that were created in-house specifically for this project.
BEHAVIORALWound Care Patient Education Video
Patient education video that were created in-house specifically for this project.
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
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.
Intervention model description
prospective, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
Exclusion criteria
1. Patients unable or unwilling to provide informed consent 2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation) 3. Patients who are or suspect they may be pregnant. 4. Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 15 Score | 2 days after surgery | 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 1. Able to breath easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with family or friends 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being Have you had any of the following in the last 24 hours? (10 to 0, where: 10=none of the time \[excellent\] and 0=all of the time \[poor\]) 10 9 8 7 6 5 4 3 2 1 0 11. Moderate pain 12. severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of narcotic pills used | 7 days after surgery | number of narcotic pills used |
| daily pain level | 7 days after surgery | 0-10 rating scale |
| patient-reported satisfaction and feeling of control - pain management | 7 days after surgery | Today, I feel in control of my pain management. 1. Strongly agree 2. Agree 3. Neither agree nor disagree 4. Disagree 5. Strongly disagree |
| patient-reported satisfaction and feeling of control- wound care | 7 days after surgery | Today, I feel in confident about how I am caring for my wound. 1. Strongly agree 2. Agree 3. Neither agree nor disagree 4. Disagree 5. Strongly disagree |
| patient-reported satisfaction and feeling of control - pain management satisfaction | 7 days after surgery | Today, I would rate my satisfaction with my pain control as (circle) 1. Very satisfied 2. Somewhat satisfied 3. Neutral 4. Somewhat dissatisfied 5. Very dissatisfied |
| number of pain-related calls/visits to a healthcare provider | 7 days after surgery | patient-reported |
| use of non-narcotic adjunct pain relief medication and modalities | 7 days after surgery | — |
| incidence of high risk activities - sedating medication polytherapy | 7 days after surgery | combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications |
| incidence of high risk activities - NSAID polytherapy | 7 days after surgery | combining prn NSAIDs with regularly dosed prescription NSAIDs |
| incidence of high risk activities - overdosing | 7 days after surgery | exceeding daily recommended doses of pain medication |
| incidence of side effects and adverse events - Nausea/V omitting | 7 days after surgery | Nausea/Vomiting |
| incidence of side effects and adverse events - Dizziness/balance problems | 7 days after surgery | Dizziness/balance problems |
| incidence of side effects and adverse events - fatigue or sedation | 7 days after surgery | fatigue or sedation |
| incidence of side effects and adverse events - headache | 7 days after surgery | headache |
| PROMIS | 3 days after surgery | 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) |
| incidence of side effects and adverse events - stomach pain | 7 days after surgery | stomach pain |
| incidence of side effects and adverse events - constipation | 7 days after surgery | constipation |
| incidence of side effects and adverse events - diarrhea | 7 days after surgery | diarrhea |
| incidence of side effects and adverse events - fever | 7 days after surgery | fever |
| incidence of side effects and adverse events - rash | 7 days after surgery | rash |
| incidence of side effects and adverse events - hives | 7 days after surgery | hives |
| incidence of side effects and adverse events - swelling | 7 days after surgery | swelling |
| incidence of side effects and adverse events - difficulty breathing/shortness of breath | 7 days after surgery | difficulty breathing/shortness of breath |
| incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing | 7 days after surgery | heart palpitations/arrythmia/heart racing |
| incidence of side effects and adverse events - anaphylaxis | 7 days after surgery | anaphylaxis |
| incidence of side effects and adverse events - ringing in ears | 7 days after surgery | ringing in ears |
| incidence of side effects and adverse events - other | 7 days after surgery | other |
| demonstrated patient knowledge | 7 days after surgery | as measured by score on the follow-up quiz |
| prevalence of chronic opioid use | 1 year after surgery | patient reported |
| incidence of side effects and adverse events - visual changes | 7 days after surgery | visual changes |
Countries
United States
Outcome results
None listed