Clinical trial NCT03366805: A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
Official title: A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesics, Opioid
Orthopedic Surgery
Ambulatory Surgery
Education, Patient
Injuries and Wounds
Keywords: opioid
analgesic
ambulatory
orthopedic
surgery
patient education
video
medication diary
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality of Recovery 15 Score
timeFrame: 2 days after surgery
Secondary outcomes:
measure: PROMIS
timeFrame: 3 days after surgery
measure: number of narcotic pills used
timeFrame: 7 days after surgery
measure: daily pain level
timeFrame: 7 days after surgery
measure: patient-reported satisfaction and feeling of control - pain management
timeFrame: 7 days after surgery
measure: patient-reported satisfaction and feeling of control- wound care
timeFrame: 7 days after surgery
measure: patient-reported satisfaction and feeling of control - pain management satisfaction
timeFrame: 7 days after surgery
measure: number of pain-related calls/visits to a healthcare provider
timeFrame: 7 days after surgery
measure: use of non-narcotic adjunct pain relief medication and modalities
timeFrame: 7 days after surgery
measure: incidence of high risk activities - sedating medication polytherapy
timeFrame: 7 days after surgery
measure: incidence of high risk activities - NSAID polytherapy
timeFrame: 7 days after surgery
measure: incidence of high risk activities - overdosing
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - Nausea/V omitting
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - Dizziness/balance problems
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - fatigue or sedation
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - headache
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - visual changes
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - stomach pain
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - constipation
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - diarrhea
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - fever
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - rash
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - hives
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - swelling
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - difficulty breathing/shortness of breath
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - anaphylaxis
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - ringing in ears
timeFrame: 7 days after surgery
measure: incidence of side effects and adverse events - other
timeFrame: 7 days after surgery
measure: demonstrated patient knowledge
timeFrame: 7 days after surgery
measure: prevalence of chronic opioid use
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Institute for Orthopedics and Neurosciences
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Cassandra Mierisch, MD
role: PRINCIPAL_INVESTIGATOR
References: