Distal Radius FractureNCT05237531
Preoperative Education in Hand and Wrist Surgery
A study testing Standardized Preoperative Education and Preoperative and postoperative questionnaires in people with Distal Radius Fracture, run by Emory University at 1 site in United States.
Trial summary
This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Standardized Preoperative Education and Preoperative and postoperative questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 16 Jun 2023
- 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
- Any patient over the age of 18 years with a closed carpal, metacarpal, or distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent.
Who cannot join
- Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the carpal, metacarpal, or distal radius fracture. Patients with open fractures. Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). Non-English speaking patients will be excluded.
- Adults who are unable to consent will not be included.
- Individuals who are not yet adults will not be included.
- Pregnant women will not be included.
- Prisoners will not be included.
- Cognitively impaired individuals or individuals with impaired decision-making capacity will not be included.
- Individuals who speak English will be included. Individuals who have limited English proficiency but speak Spanish as a primary language will not be eligible for inclusion. Spanish-speaking patients will be excluded because the components of the educational protocol (video, questionnaires, surveys) are not available in Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital
This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital.
Read the detailed description
The proposed research aims to study the impact of preoperative education on postoperative pain control after outpatient surgery for traumatic wrist fractures. The impact of preoperative education will be studied through patient questionnaires and by tracking postoperative opioid consumption as well as instances of unscheduled healthcare contact after surgery. The study will be a randomized controlled trial. This study imposes no more than minimal risk to study participants. Loss of privacy and breach of confidentiality are risks of this study. All data will be stored securely on Microsoft One Drive, a password-protected, encrypted database which requires two-factor authorization. The study population will be patients aged 18-99 years who are undergoing outpatient surgical management of distal radius fractures at Grady Memorial Hospital. No vulnerable populations will be included. Contact will be made with potential study participants at their preoperative clinic visit. Written informed consent will be obtained. Data will not be publicly available. Data will be deidentified, and no members of the team will have access to the code that identifies patients. Data will be collected in the plastic surgery clinic, orthopedic surgery clinic, and preoperative area at Grady Memorial Hospital. The total respondent burden will be 30 minutes.
- Conditions
- Distal Radius Fracture
- Being tested
- Standardized Preoperative Education, Standard of care, Preoperative and postoperative questionnaires
- Keywords
- ORIF
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Preoperative EducationBehavioural
The standardized preoperative education includes a brief video, an interactive quiz, and a written handout.
The video will provide information on the proper use and common side effects of opioid pain medications, the expected effects of a peripheral nerve block, and the concept of multimodal postoperative pain management with non-opioid medications and non-pharmaceutical pain management strategies. The interactive quiz will reinforce the critical components of the video in a question-and-answer format which requires active participation. The written handout will summarize the educational content in a form which can be easily referenced by patients at home.
Standard of careBehavioural
Education per provider preference (no standardization, current standard of care)
Preoperative and postoperative questionnairesBehavioural
Preoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Patients in the experimental arm will receive standardized preoperative education in the form of a brief video, interactive quiz, and written handout.
All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects. Receives: Behavioral: Standardized Preoperative Education; Behavioral: Preoperative and postoperative questionnaires |
| Control Arm | Active comparator | Patients in the control arm will receive education per the provider's preference (current standard of care).
All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects. Receives: Behavioral: Standard of care; Behavioral: Preoperative and postoperative questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared.
Measured: Day of surgery, postoperative day 10
Secondary outcomes (8)
Total opioid consumption during the postoperative course
Total opioid consumption in mg during the postoperative course taken from the pain diary and postoperative questionnaire.
Measured: Up to postoperative day 10
Total number of opioid refills in the postoperative period
Number of opioid refills in the postoperative period based on postoperative questionnaire and prescription drug monitoring program (PDMP) database.
Measured: Up to postoperative day 10
Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms
Average visual analog scale (VAS) pain score will be collected for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period from the pain diary, and results will be compared between both study arms. Total score ranges between 1-10 and 10 correlates with worse pain.
Measured: Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10
Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery
UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital
Measured: Up to 30 days after surgery
Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery
UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital. The reason will be collected from the day of surgery until 30 days after surgery.
Measured: Up to 30 days after surgery
Change in results of Pain Management quiz after education
Change in results of Pain Management Quiz before and after education. Answers to the questions on the quiz are either correct or incorrect. Total number questions are 11. It will be measured as total number of correct answers/total number of questions (number of correct/11). This will be converted to a percentage correct. Range of score will be 0% - 100% correct. Higher change in percentage correct is a better outcome. Change in percentage correct from preoperative appointment to day of surgery will help determine the effectiveness of the educational protocol.
Measured: Preoperative, day of surgery
Postoperative Satisfaction score with education
Based on the postoperative questionnaire, participants will answer a question about satisfaction with 5 possible answers: Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied and Very dissatisfied.
Results will be in percentage, based on number of participants in each category. "Very satisfied" correlates with better outcome with lower level of satisfaction until "very dissatisfied" that correlates with worse outcome.
Measured: Postoperative (up to 2 weeks after surgery)
Percentage of participants with adequate postoperative pain control
Based on the postoperative questionnaire, participants will answer a question about pain control:
"Do you feel like your pain was adequately controlled after surgery?" Possible answers include:Yes, No and Somewhat.
Number of participants who answer "Yes" will be counted per randomization group. A higher result correlates with better outcome (better pain control).
Measured: Postoperative (Up to 2 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Mar 2022
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Why it stopped: Due to difficulty enrolling participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Responsible party
- Principal investigator, Paul A Ghareeb, MD, Emory University
- Investigators
- Paul Ghareeb, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237531
- Sponsor's protocol ID
- STUDY00003074
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital
- ClinicalTrials.gov ID
- NCT05237531
- Acronym / sponsor ID
- STUDY00003074
- Conditions
- Distal Radius Fracture
- Keywords
- ORIF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty enrolling participants.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 14 Feb 2022 (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.
This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital.
Detailed description
The proposed research aims to study the impact of preoperative education on postoperative pain control after outpatient surgery for traumatic wrist fractures. The impact of preoperative education will be studied through patient questionnaires and by tracking postoperative opioid consumption as well as instances of unscheduled healthcare contact after surgery. The study will be a randomized controlled trial. This study imposes no more than minimal risk to study participants. Loss of privacy and breach of confidentiality are risks of this study. All data will be stored securely on Microsoft One Drive, a password-protected, encrypted database which requires two-factor authorization. The study population will be patients aged 18-99 years who are undergoing outpatient surgical management of distal radius fractures at Grady Memorial Hospital. No vulnerable populations will be included. Contact will be made with potential study participants at their preoperative clinic visit. Written informed consent will be obtained. Data will not be publicly available. Data will be deidentified, and no members of the team will have access to the code that identifies patients. Data will be collected in the plastic surgery clinic, orthopedic surgery clinic, and preoperative area at Grady Memorial Hospital. The total respondent burden will be 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Standardized Preoperative Education, Behavioral: Preoperative and postoperative questionnairesPatients in the experimental arm will receive standardized preoperative education in the form of a brief video, interactive quiz, and written handout. All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects. |
| Control Arm | Active comparator | Behavioral: Standard of care, Behavioral: Preoperative and postoperative questionnairesPatients in the control arm will receive education per the provider's preference (current standard of care). All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient over the age of 18 years with a closed carpal, metacarpal, or distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent.
Key exclusion criteria (7 listed)
- Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the carpal, metacarpal, or distal radius fracture. Patients with open fractures. Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). Non-English speaking patients will be excluded.
- Adults who are unable to consent will not be included.
- Individuals who are not yet adults will not be included.
- Pregnant women will not be included.
- Prisoners will not be included.
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 |
|---|---|---|
| Standardized Preoperative EducationThe standardized preoperative education includes a brief video, an interactive quiz, and a written handout. The video will provide information on the proper use and common side effects of opioid pain medications, the expected effects of a peripheral nerve block, and the concept of multimodal postoperative pain management with non-opioid medications and non-pharmaceutical pain management strategies. The interactive quiz will reinforce the critical components of the video in a question-and-answer format which requires active participation. The written handout will summarize the educational content in a form which can be easily referenced by patients at home. | Behavioural | Experimental Arm |
| Standard of careEducation per provider preference (no standardization, current standard of care) | Behavioural | Control Arm |
| Preoperative and postoperative questionnairesPreoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education | Behavioural | Control Arm, Experimental Arm |
Primary outcome
Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
Time frame: Day of surgery, postoperative day 10
Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared.
8 secondary outcomes
Total opioid consumption during the postoperative course
Time frame: Up to postoperative day 10
Total number of opioid refills in the postoperative period
Time frame: Up to postoperative day 10
Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms
Time frame: Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10
Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery
Time frame: Up to 30 days after surgery
Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery
Time frame: Up to 30 days after surgery
Change in results of Pain Management quiz after education
Time frame: Preoperative, day of surgery
Postoperative Satisfaction score with education
Time frame: Postoperative (up to 2 weeks after surgery)
Percentage of participants with adequate postoperative pain control
Time frame: Postoperative (Up to 2 weeks after surgery)
Results and safety
The study was stopped early (reason given: Due to difficulty enrolling participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Paul Ghareeb, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Preoperative Education and Preoperative and postoperative questionnaires in people with Distal Radius Fracture, run by Emory University 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 7 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: stopped early, as of the sponsor's last update on 22 Feb 2024. 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?
The study was stopped early (reason given: Due to difficulty enrolling participants.). 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?
Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10 (time frame: Day of surgery, postoperative day 10). 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 22 Feb 2024.