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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03366805
Other study ID # 2266
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2017
Est. completion date June 12, 2020

Study information

Verified date September 2019
Source Carilion Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 221
Est. completion date June 12, 2020
Est. primary completion date November 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Behavioral:
Pain Management Patient Education Video
Patient education video that were created in-house specifically for this project.
Wound Care Patient Education Video
Patient education video that were created in-house specifically for this project.

Locations

Country Name City State
United States Institute for Orthopedics and Neurosciences Roanoke Virginia

Sponsors (1)

Lead Sponsor Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Able to breath easily
Been able to enjoy food
Feeling rested
Have had a good sleep
Able to look after personal toilet and hygiene unaided
Able to communicate with family or friends
Getting support from hospital doctors and nurses
Able to return to work or usual home activities
Feeling comfortable and in control
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
Moderate pain
severe pain
Nausea or vomiting
Feeling worried or anxious
Feeling sad or depressed
2 days after surgery
Secondary 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
Secondary number of narcotic pills used number of narcotic pills used 7 days after surgery
Secondary daily pain level 0-10 rating scale 7 days after surgery
Secondary patient-reported satisfaction and feeling of control - pain management Today, I feel in control of my pain management.
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
7 days after surgery
Secondary patient-reported satisfaction and feeling of control- wound care Today, I feel in confident about how I am caring for my wound.
Strongly agree
Agree
Neither agree nor disagree
Disagree
Strongly disagree
7 days after surgery
Secondary patient-reported satisfaction and feeling of control - pain management satisfaction Today, I would rate my satisfaction with my pain control as (circle)
Very satisfied
Somewhat satisfied
Neutral
Somewhat dissatisfied
Very dissatisfied
7 days after surgery
Secondary number of pain-related calls/visits to a healthcare provider patient-reported 7 days after surgery
Secondary use of non-narcotic adjunct pain relief medication and modalities 7 days after surgery
Secondary incidence of high risk activities - sedating medication polytherapy combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications 7 days after surgery
Secondary incidence of high risk activities - NSAID polytherapy combining prn NSAIDs with regularly dosed prescription NSAIDs 7 days after surgery
Secondary incidence of high risk activities - overdosing exceeding daily recommended doses of pain medication 7 days after surgery
Secondary incidence of side effects and adverse events - Nausea/V omitting Nausea/Vomiting 7 days after surgery
Secondary incidence of side effects and adverse events - Dizziness/balance problems Dizziness/balance problems 7 days after surgery
Secondary incidence of side effects and adverse events - fatigue or sedation fatigue or sedation 7 days after surgery
Secondary incidence of side effects and adverse events - headache headache 7 days after surgery
Secondary incidence of side effects and adverse events - visual changes visual changes 7 days after surgery
Secondary incidence of side effects and adverse events - stomach pain stomach pain 7 days after surgery
Secondary incidence of side effects and adverse events - constipation constipation 7 days after surgery
Secondary incidence of side effects and adverse events - diarrhea diarrhea 7 days after surgery
Secondary incidence of side effects and adverse events - fever fever 7 days after surgery
Secondary incidence of side effects and adverse events - rash rash 7 days after surgery
Secondary incidence of side effects and adverse events - hives hives 7 days after surgery
Secondary incidence of side effects and adverse events - swelling swelling 7 days after surgery
Secondary incidence of side effects and adverse events - difficulty breathing/shortness of breath difficulty breathing/shortness of breath 7 days after surgery
Secondary incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing heart palpitations/arrythmia/heart racing 7 days after surgery
Secondary incidence of side effects and adverse events - anaphylaxis anaphylaxis 7 days after surgery
Secondary incidence of side effects and adverse events - ringing in ears ringing in ears 7 days after surgery
Secondary incidence of side effects and adverse events - other other 7 days after surgery
Secondary demonstrated patient knowledge as measured by score on the follow-up quiz 7 days after surgery
Secondary prevalence of chronic opioid use patient reported 1 year after surgery
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