Orthopaedic Decision MakingNCT02440529
Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery
A study testing Intervention and Verbal Group in people with Orthopaedic Decision Making, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Decision Making
- What is being tested?
- Intervention and Verbal Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2018
- 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
- Patients 18 year old or older,
- daily smoker
- inpatient post fracture operation,
- patient that have never received an orthopaedic related smoking cessation discussion
Who cannot join
- Younger than 18,
- patients unable to provide consent
- patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.
- Conditions
- Orthopaedic Decision Making
- Being tested
- Intervention, Verbal Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Discussion
Verbal GroupBehavioural
Detailed Discussion
| Study group | Role | What they receive |
|---|---|---|
| (Intervention Group) | Active comparator | The discussion about how smoking cigarettes impacts patient orthopaedic management plus aid Receives: Behavioral: Intervention |
| (Control Group) | Active comparator | The discussion about how smoking cigarettes impacts patient orthopaedic management. Receives: Behavioral: Verbal Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Comprehension
Knowledge-Based Question
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Research staff decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic Decision MakingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nkemakolam Egekeze, University of Missouri, Kansas City
- Investigators
- Nkem Egekeze, MD, Principal investigator, UMKC DEPT OF ORTHOPAEDIC SURGERYJonathan Dubin, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERYKaren Williams, PhD, Study director, UMKC DEPT OF BIOINFORMATICSAkin Cil, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERYMark Bernhardt, MD, Study chair, UMKC DEPT OF ORTHOPAEDIC SURGERYDane Church, MD, Study director, UMKC DEPT OF ORTHOPAEDIC SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440529
- Sponsor's protocol ID
- 15-248
- Status last verified
- Apr 2018
- First submitted
- 7 May 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery
- ClinicalTrials.gov ID
- NCT02440529
- Acronym / sponsor ID
- 15-248
- Conditions
- Orthopaedic Decision Making
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research staff decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Intervention Group) | Active comparator | Behavioral: InterventionThe discussion about how smoking cigarettes impacts patient orthopaedic management plus aid |
| (Control Group) | Active comparator | Behavioral: Verbal GroupThe discussion about how smoking cigarettes impacts patient orthopaedic management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 year old or older,
- daily smoker
- inpatient post fracture operation,
- patient that have never received an orthopaedic related smoking cessation discussion
Key exclusion criteria (3 listed)
- Younger than 18,
- patients unable to provide consent
- patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker
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 |
|---|---|---|
| InterventionDiscussion | Behavioural | (Intervention Group) |
| Verbal GroupDetailed Discussion | Behavioural | (Control Group) |
Primary outcome
Patient Comprehension
Time frame: 20 minutes
Knowledge-Based Question
Results and safety
The study was stopped early (reason given: Research staff decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
Nkem Egekeze, MD principal investigator
UMKC DEPT OF ORTHOPAEDIC SURGERY
Jonathan Dubin, MD study director
UMKC DEPT OF ORTHOPAEDIC SURGERY
Karen Williams, PhD study director
UMKC DEPT OF BIOINFORMATICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Verbal Group in people with Orthopaedic Decision Making, run by University of Missouri, Kansas City 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 4 inclusion and 3 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 26 Apr 2018. 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: Research staff decision). 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?
Patient Comprehension (time frame: 20 minutes). 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 26 Apr 2018.