Upper Extremity Orthopedic Surgery PatientsNCT04401891
Formal Pre-Operative Education
A study testing Formal pre-operative education in people with Upper Extremity Orthopedic Surgery Patients, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Orthopedic Surgery Patients
- What is being tested?
- Formal pre-operative education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2020to 2 Aug 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
- 18 years or older,
- English as Primary language,
- scheduled to have orthopedic upper extremity surgery.
Who cannot join
- less than 18 years
- Conservative management or non operative management of orthopedic upper extremity surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63130
About this study
Official title: The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function
The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.
- Being tested
- Formal pre-operative education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal pre-operative educationBehavioural
One group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office.
| Study group | Role | What they receive |
|---|---|---|
| Routine Pre-Operative Education in MD office prior to surgery | No intervention | Not described |
| Formal Pre-operative education/therapy prior to surgery | Experimental | Not described Receives: Behavioral: Formal pre-operative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed
Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
Measured: prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed
Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety
Measured: prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed
Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.
Measured: prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed
Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain
Measured: prior to surgery and two weeks post surgery
PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed
Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
Measured: prior to surgery and two weeks post surgery
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
Measured: prior to surgery
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative
1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
Measured: 2 weeks post surgery
Pain Scale
0 to 10 likert scale. 0 being no pain and 10 being worst pain possible
Measured: prior to surgery and 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start5 Feb 2020
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity Orthopedic Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Logan Berlet, OTD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401891
- Sponsor's protocol ID
- 201911175
- Status last verified
- Apr 2024
- First submitted
- 13 May 2020
- Last updated
- 25 Apr 2024
- Results posted
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function
- ClinicalTrials.gov ID
- NCT04401891
- Acronym / sponsor ID
- 201911175
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 26 May 2020 (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.
The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Pre-Operative Education in MD office prior to surgery | No intervention | – |
| Formal Pre-operative education/therapy prior to surgery | Experimental | Behavioral: Formal pre-operative education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older,
- English as Primary language,
- scheduled to have orthopedic upper extremity surgery.
Key exclusion criteria (2 listed)
- less than 18 years
- Conservative management or non operative management of orthopedic upper extremity surgery
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 |
|---|---|---|
| Formal pre-operative educationOne group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office. | Behavioural | Formal Pre-operative education/therapy prior to surgery |
Primary outcome
PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed
Time frame: prior to surgery and two weeks post surgery
Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed
Time frame: prior to surgery and two weeks post surgery
Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed
Time frame: prior to surgery and two weeks post surgery
Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed
Time frame: prior to surgery and two weeks post surgery
Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain
PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed
Time frame: prior to surgery and two weeks post surgery
Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
Time frame: prior to surgery
1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative
Time frame: 2 weeks post surgery
1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
Pain Scale
Time frame: prior to surgery and 2 weeks post surgery
0 to 10 likert scale. 0 being no pain and 10 being worst pain possible
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Logan Berlet, OTD principal investigator
Washington University in Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal pre-operative education in people with Upper Extremity Orthopedic Surgery Patients, run by Washington University School of Medicine 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 3 inclusion and 2 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 25 Apr 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: Difficulty with recruitment). 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?
PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed (time frame: prior to surgery and two weeks post surgery). The study lists 8 primary outcomes in all. 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 25 Apr 2024.