Analgesics, OpioidNCT03366805
A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery
A study testing Pain Management Patient Education Video and Wound Care Patient Education Video in people with Analgesics, Opioid and Orthopedic Surgery, run by Carilion Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery
- What is being tested?
- Pain Management Patient Education Video and Wound Care Patient Education Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
Who cannot join
- Patients unable or unwilling to provide informed consent
- Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
- Patients who are or suspect they may be pregnant.
- Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, 24014
About this study
Official title: A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
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.
Read the 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.
- Conditions
- Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery, Education, Patient, Injuries and Wounds
- Being tested
- Pain Management Patient Education Video, Wound Care Patient Education Video
- Keywords
- opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Management Patient Education VideoBehavioural
Patient education video that were created in-house specifically for this project.
Wound Care Patient Education VideoBehavioural
Patient education video that were created in-house specifically for this project.
| Study group | Role | What they receive |
|---|---|---|
| Wound Care Video | Active comparator | Wound Care Patient Education Video Receives: Behavioral: Wound Care Patient Education Video |
| Pain Management Video Group | Experimental | Pain Management Patient Education Video Receives: Behavioral: Pain Management Patient Education Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days after surgery
Secondary outcomes (30)
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)
Measured: 3 days after surgery
number of narcotic pills used
number of narcotic pills used
Measured: 7 days after surgery
daily pain level
0-10 rating scale
Measured: 7 days after surgery
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
Measured: 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.
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: 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)
- Very satisfied
- Somewhat satisfied
- Neutral
- Somewhat dissatisfied
- Very dissatisfied
Measured: 7 days after surgery
number of pain-related calls/visits to a healthcare provider
patient-reported
Measured: 7 days after surgery
use of non-narcotic adjunct pain relief medication and modalities
Measured: 7 days after surgery
incidence of high risk activities - sedating medication polytherapy
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
Measured: 7 days after surgery
incidence of high risk activities - NSAID polytherapy
combining prn NSAIDs with regularly dosed prescription NSAIDs
Measured: 7 days after surgery
incidence of high risk activities - overdosing
exceeding daily recommended doses of pain medication
Measured: 7 days after surgery
incidence of side effects and adverse events - Nausea/V omitting
Nausea/Vomiting
Measured: 7 days after surgery
incidence of side effects and adverse events - Dizziness/balance problems
Dizziness/balance problems
Measured: 7 days after surgery
incidence of side effects and adverse events - fatigue or sedation
fatigue or sedation
Measured: 7 days after surgery
incidence of side effects and adverse events - headache
headache
Measured: 7 days after surgery
incidence of side effects and adverse events - visual changes
visual changes
Measured: 7 days after surgery
incidence of side effects and adverse events - stomach pain
stomach pain
Measured: 7 days after surgery
incidence of side effects and adverse events - constipation
constipation
Measured: 7 days after surgery
incidence of side effects and adverse events - diarrhea
diarrhea
Measured: 7 days after surgery
incidence of side effects and adverse events - fever
fever
Measured: 7 days after surgery
incidence of side effects and adverse events - rash
rash
Measured: 7 days after surgery
incidence of side effects and adverse events - hives
hives
Measured: 7 days after surgery
incidence of side effects and adverse events - swelling
swelling
Measured: 7 days after surgery
incidence of side effects and adverse events - difficulty breathing/shortness of breath
difficulty breathing/shortness of breath
Measured: 7 days after surgery
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
heart palpitations/arrythmia/heart racing
Measured: 7 days after surgery
incidence of side effects and adverse events - anaphylaxis
anaphylaxis
Measured: 7 days after surgery
incidence of side effects and adverse events - ringing in ears
ringing in ears
Measured: 7 days after surgery
incidence of side effects and adverse events - other
other
Measured: 7 days after surgery
demonstrated patient knowledge
as measured by score on the follow-up quiz
Measured: 7 days after surgery
prevalence of chronic opioid use
patient reported
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start30 Nov 2017
- Primary completion29 Nov 2018
- Study completion12 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassandra Mierisch, Carilion Clinic
- Investigators
- Cassandra Mierisch, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366805
- Sponsor's protocol ID
- 2266
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery
- ClinicalTrials.gov ID
- NCT03366805
- Acronym / sponsor ID
- 2266
- Conditions
- Analgesics, Opioid, Orthopedic Surgery, Ambulatory Surgery, Education, Patient, Injuries and Wounds
- Keywords
- opioid, analgesic, ambulatory, orthopedic, surgery, patient education, video, medication diary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 12 Jun 2020 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- prospective, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Wound Care Video | Active comparator | Behavioral: Wound Care Patient Education VideoWound Care Patient Education Video |
| Pain Management Video Group | Experimental | Behavioral: Pain Management Patient Education VideoPain Management Patient Education Video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.
Key exclusion criteria (4 listed)
- Patients unable or unwilling to provide informed consent
- Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
- Patients who are or suspect they may be pregnant.
- Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Management Patient Education VideoPatient education video that were created in-house specifically for this project. | Behavioural | Pain Management Video Group |
| Wound Care Patient Education VideoPatient education video that were created in-house specifically for this project. | Behavioural | Wound Care Video |
Primary outcome
Quality of Recovery 15 Score
Time frame: 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
30 secondary outcomes
PROMIS
Time frame: 3 days after surgery
number of narcotic pills used
Time frame: 7 days after surgery
daily pain level
Time frame: 7 days after surgery
patient-reported satisfaction and feeling of control - pain management
Time frame: 7 days after surgery
patient-reported satisfaction and feeling of control- wound care
Time frame: 7 days after surgery
patient-reported satisfaction and feeling of control - pain management satisfaction
Time frame: 7 days after surgery
number of pain-related calls/visits to a healthcare provider
Time frame: 7 days after surgery
use of non-narcotic adjunct pain relief medication and modalities
Time frame: 7 days after surgery
incidence of high risk activities - sedating medication polytherapy
Time frame: 7 days after surgery
incidence of high risk activities - NSAID polytherapy
Time frame: 7 days after surgery
incidence of high risk activities - overdosing
Time frame: 7 days after surgery
incidence of side effects and adverse events - Nausea/V omitting
Time frame: 7 days after surgery
incidence of side effects and adverse events - Dizziness/balance problems
Time frame: 7 days after surgery
incidence of side effects and adverse events - fatigue or sedation
Time frame: 7 days after surgery
incidence of side effects and adverse events - headache
Time frame: 7 days after surgery
incidence of side effects and adverse events - visual changes
Time frame: 7 days after surgery
incidence of side effects and adverse events - stomach pain
Time frame: 7 days after surgery
incidence of side effects and adverse events - constipation
Time frame: 7 days after surgery
incidence of side effects and adverse events - diarrhea
Time frame: 7 days after surgery
incidence of side effects and adverse events - fever
Time frame: 7 days after surgery
incidence of side effects and adverse events - rash
Time frame: 7 days after surgery
incidence of side effects and adverse events - hives
Time frame: 7 days after surgery
incidence of side effects and adverse events - swelling
Time frame: 7 days after surgery
incidence of side effects and adverse events - difficulty breathing/shortness of breath
Time frame: 7 days after surgery
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing
Time frame: 7 days after surgery
incidence of side effects and adverse events - anaphylaxis
Time frame: 7 days after surgery
incidence of side effects and adverse events - ringing in ears
Time frame: 7 days after surgery
incidence of side effects and adverse events - other
Time frame: 7 days after surgery
demonstrated patient knowledge
Time frame: 7 days after surgery
prevalence of chronic opioid use
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassandra Mierisch, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Management Patient Education Video and Wound Care Patient Education Video in people with Analgesics, Opioid and Orthopedic Surgery, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 15 Score (time frame: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.