Hand InjuriesNCT03557073
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures
A study testing Postoperative phone call in people with Hand Injuries and Trauma, run by Indiana University at 1 site in United States.
Trial summary
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries, Trauma, Hand Injuries and Disorders
- What is being tested?
- Postoperative phone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Dec 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 with isolated injuries of the hand who present to a specific level 1 trauma center in the Midwestern United States
- Patients who have planned surgical treatment by a pre-specified group of surgeons
Who cannot join
- Patients who have significant trauma to other organ systems proximal to the wrist
- Patients who have open ("compound") fractures (i.e., bone is exposed)
- Children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: a Single-blinded, Prospective, Randomized Controlled Trial
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.
Read the detailed description
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. Patients who require operative treatment of hand and wrist fractures are randomly assigned to a group that receives a postoperative phone call or the control group that receives the standard postoperative care. Patient reported and medical outcomes are observed starting at 1 month postoperatively.
- Conditions
- Hand Injuries, Trauma, Hand Injuries and Disorders
- Being tested
- Postoperative phone call
- Keywords
- Hand injuries, Hand trauma, Patient reported outcomes
- Medical subject headings
- Hand Injuries, Wounds and Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative phone callBehavioural
The intervention is a phone call on the day following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Phone Call | Experimental | Subjects in this study arm receive a post-operative phone call by a physician. Receives: Behavioral: Postoperative phone call |
| No Phone call | No intervention | Subjects in this study arm do not receive an additional post-operative phone call by a physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Michigan Hand Questionnaire Score Difference
A patient reported measure of hand function on a scale of 1 to 100. 100 indicates better hand function and 1 indicates worse hand function. The measure is obtained form a survey that has been published in multiple peer reviewed articles. This score can be subtracted from preoperative score to obtain a difference in score of preoperative compared to postoperative.
Measured: 1 month postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Model description
- Participants are randomized to receiving a postoperative phone call or not receiving a postoperative phone call by a physician.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Adkinson, Indiana University
- Investigators
- Joshua M Adkinson, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557073
- Sponsor's protocol ID
- 1712309601
- Status last verified
- Feb 2019
- First submitted
- 4 Jun 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: a Single-blinded, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03557073
- Acronym / sponsor ID
- 1712309601
- Conditions
- Hand Injuries, Trauma, Hand Injuries and Disorders
- Keywords
- Hand injuries, Hand trauma, Patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jun 2018 (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 seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.
Detailed description
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. Patients who require operative treatment of hand and wrist fractures are randomly assigned to a group that receives a postoperative phone call or the control group that receives the standard postoperative care. Patient reported and medical outcomes are observed starting at 1 month postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to receiving a postoperative phone call or not receiving a postoperative phone call by a physician.
| Arm | Type | Receives |
|---|---|---|
| Phone Call | Experimental | Behavioral: Postoperative phone callSubjects in this study arm receive a post-operative phone call by a physician. |
| No Phone call | No intervention | –Subjects in this study arm do not receive an additional post-operative phone call by a physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with isolated injuries of the hand who present to a specific level 1 trauma center in the Midwestern United States
- Patients who have planned surgical treatment by a pre-specified group of surgeons
Key exclusion criteria (3 listed)
- Patients who have significant trauma to other organ systems proximal to the wrist
- Patients who have open ("compound") fractures (i.e., bone is exposed)
- Children
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 |
|---|---|---|
| Postoperative phone callThe intervention is a phone call on the day following surgery. | Behavioural | Phone Call |
Primary outcome
Brief Michigan Hand Questionnaire Score Difference
Time frame: 1 month postoperatively.
A patient reported measure of hand function on a scale of 1 to 100. 100 indicates better hand function and 1 indicates worse hand function. The measure is obtained form a survey that has been published in multiple peer reviewed articles. This score can be subtracted from preoperative score to obtain a difference in score of preoperative compared to postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Joshua M Adkinson, M.D. principal investigator
Indiana 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 Postoperative phone call in people with Hand Injuries and Trauma, run by Indiana 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 2 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: finished, as of the sponsor's last update on 28 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Michigan Hand Questionnaire Score Difference (time frame: 1 month postoperatively.). 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 28 Feb 2019.