Intention - Mental ProcessSternalNCT02209558
The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions
A study testing Visual Sternal Precautions in people with Intention - Mental Process and Readmission Rates, run by Northwell Health at 1 site in United States.
Trial summary
Sternal precautions are standard patient education protocol disseminated to post-operative open heart surgery patients . While this "best practice" safety measure is widely distributed to patients, the origin of said precautions is unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intention - Mental Process, Readmission Rates
- What is being tested?
- Visual Sternal Precautions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-surgical adult patients who had a median or midline sternotomy incision during cardiac surgery at North-Shore University Hospital.
Who cannot join
- Patients with dementia or those that are cognitively impaired will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Sternal precautions are standard patient education protocol disseminated to post-operative open heart surgery patients . While this "best practice" safety measure is widely distributed to patients, the origin of said precautions is unknown. Statewide hospitals vary on their parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities, biomechanical movements to be avoided. In addition, the medium in which sternal precautions are taught varies, thus complicating patient adherence to these vital post-operative measures.
The primary objective of this study is to use a randomized pre-post test design to compare two different training procedures. One training group examines current standard of care (providing verbal instruction using teach back and written sternal precautions). The second training group provides subjects with visual depiction of sternal precautions, in addition to standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned patients. Finally, the study will assess changes in behavior intentions from before training to after training in both groups via behavioral analysis survey consisting of 8 questions.
Read more
Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal precautions, in addition to standard of care, will have a lower 30 and 60 day readmission rate when compared to subjects in the standard of care group
Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward sternal precautions will be greater from before training to after training in the visual SPs in addition to standard of care group than the standard of care only group.
Read the detailed description
Eligible subjects will be identified by the Senior Cardiothoracic Physical Therapist (Dr. Craig D. Feinman, PT, DPT) on staff at North Shore University Hospital. Dr. Feinman will provide basic study information to potential subjects and refer those that are interested in the study to the research team who will then provide a copy of the consent form and more information about the study. Inclusion Criteria represents post-surgical adult patients who had a median or midline sternotomy incision during cardiac surgery at North-Shore University Hospital. Exclusion Criteria represents patients with dementia or those that are cognitively impaired will be excluded from the study.
A T-test or Mann Whitney U test will be use to compare group differences on continuous variables, e.g. age. Beta regression or logistic regression model will be developed for the outcomes of adherence and readmission proportions/rates. To assess changes from pre to post training on behavioral intentions a paired t-test or Wilcoxon signed rank for matched pairs will be used. A result will be considered statistically significant at the p<0.05 level of significance. All analyses will be performed using SAS version 9.3 (SAS Institute, Cary, NC).
- Conditions
- Intention - Mental Process, Readmission Rates
- Being tested
- Visual Sternal Precautions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Sternal PrecautionsBehavioural
Visual depiction of SPs in addition to "standard of care" written precautions
| Study group | Role | What they receive |
|---|---|---|
| Standard Written Sternal Precautions | No intervention | Patients will receive education that is the "standard of care" at North Shore Long Island Jewish Health Systems in their post-operative sternal precautions. |
| Visual Sternal Precautions | Experimental | Patients will receive both "standard of care" written sternal precautions, as well as visual sternal precautions. Receives: Behavioral: Visual Sternal Precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient behavioral intentions post visual training strategies
The intervention group will receive "standard of care" sternal precautions delivered via written medium. In addition, printed visual depictions of sternal precautions will be provided. During completion of the initial Physical Therapy evaluation, patients will be asked to provide baseline knowledge of sternal precautions via "teach back," an important tool in assessing patients' knowledge of important points delivered during clinical practice. Patients will then perform teach back of sternal precautions upon second Physical Therapy encounter to ensure understanding and post-operative anesthesia effects have waned. Prior to discharge (when patient deemed medically appropriate by the medical/surgical team), the patient will receive a survey consisting of 8 behavioral intention questions with "yes," "no," or "not sure" responses. Questions posed on the surveys assess if patients will/will not perform certain behaviors that may/may not predispose a risk to the patient's sternum.
Measured: Post-operative day one when patient medically cleared for PT evaluation, 2nd session, and prior to discharge from hospital (approximately 1-10 days)
Secondary outcomes (1)
30 and 60 day readmission rates
Re-admission rates of enrolled subjects is integral in determining if patients adhere to sternal precautions after discharge. Resumption of regular activities is cleared by the medical/surgical team. The study team will review the medical records of the subjects 60 days after enrollment to determine if and why they were re-admitted to the hospital. Since there is a possibility for subjects to be re-admitted to facilities outside of the health system, the study team will also call the enrolled subjects 60 days after enrollment to obtain this information.
Measured: 30-60 days post patient discharge from hospital setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intention - Mental ProcessStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- North Shore University Hospital
- Responsible party
- Principal investigator, Craig Feinman, Northwell Health
- Investigators
- Craig D Feinman, Doctor of Physical Therapy, Principal investigator, North Shore University Hospital, NSLIJ Health SystemRenee Pekmezaris, PhD, Study director, North Shore University Hospital, NSLIJ Health SystemAndrzej Kozikowski, PhD, Study director, North Shore University Hospital, NSLIJ Health SystemJonathan Dropkin, ScD, PT, Study director, North Shore University Hospital, NSLIJ Health SystemJoanna Steinn, MPH, Study director, North Shore University Hospital, NSLIJ Health SystemAlan Hartman, MD, Study director, North Shore University Hospital, NSLIJ Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209558
- Sponsor's protocol ID
- 14-305B
- Acronym
- Sternal
- Status last verified
- Apr 2015
- First submitted
- 1 Aug 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions
- ClinicalTrials.gov ID
- NCT02209558
- Acronym / sponsor ID
- Sternal / 14-305B
- Conditions
- Intention - Mental Process, Readmission Rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- North Shore University Hospital
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Aug 2014 (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.
Sternal precautions are standard patient education protocol disseminated to post-operative open heart surgery patients . While this "best practice" safety measure is widely distributed to patients, the origin of said precautions is unknown. Statewide hospitals vary on their parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities, biomechanical movements to be avoided. In addition, the medium in which sternal precautions are taught varies, thus complicating patient adherence to these vital post-operative measures.
The primary objective of this study is to use a randomized pre-post test design to compare two different training procedures. One training group examines current standard of care (providing verbal instruction using teach back and written sternal precautions). The second training group provides subjects with visual depiction of sternal precautions, in addition to standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned patients. Finally, the study will assess changes in behavior intentions from before training to after training in both groups via behavioral analysis survey consisting of 8 questions.
Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal precautions, in addition to standard of care, will have a lower 30 and 60 day readmission rate when compared to subjects in the standard of care group
Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward sternal precautions will be greater from before training to after training in the visual SPs in addition to standard of care group than the standard of care only group.
Detailed description
Eligible subjects will be identified by the Senior Cardiothoracic Physical Therapist (Dr. Craig D. Feinman, PT, DPT) on staff at North Shore University Hospital. Dr. Feinman will provide basic study information to potential subjects and refer those that are interested in the study to the research team who will then provide a copy of the consent form and more information about the study. Inclusion Criteria represents post-surgical adult patients who had a median or midline sternotomy incision during cardiac surgery at North-Shore University Hospital. Exclusion Criteria represents patients with dementia or those that are cognitively impaired will be excluded from the study.
A T-test or Mann Whitney U test will be use to compare group differences on continuous variables, e.g. age. Beta regression or logistic regression model will be developed for the outcomes of adherence and readmission proportions/rates. To assess changes from pre to post training on behavioral intentions a paired t-test or Wilcoxon signed rank for matched pairs will be used. A result will be considered statistically significant at the p<0.05 level of significance. All analyses will be performed using SAS version 9.3 (SAS Institute, Cary, NC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Written Sternal Precautions | No intervention | –Patients will receive education that is the "standard of care" at North Shore Long Island Jewish Health Systems in their post-operative sternal precautions. |
| Visual Sternal Precautions | Experimental | Behavioral: Visual Sternal PrecautionsPatients will receive both "standard of care" written sternal precautions, as well as visual sternal precautions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-surgical adult patients who had a median or midline sternotomy incision during cardiac surgery at North-Shore University Hospital.
Key exclusion criteria (1 listed)
- Patients with dementia or those that are cognitively impaired will be excluded from the study.
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 |
|---|---|---|
| Visual Sternal PrecautionsVisual depiction of SPs in addition to "standard of care" written precautions | Behavioural | Visual Sternal Precautions |
Primary outcome
Patient behavioral intentions post visual training strategies
Time frame: Post-operative day one when patient medically cleared for PT evaluation, 2nd session, and prior to discharge from hospital (approximately 1-10 days)
The intervention group will receive "standard of care" sternal precautions delivered via written medium. In addition, printed visual depictions of sternal precautions will be provided. During completion of the initial Physical Therapy evaluation, patients will be asked to provide baseline knowledge of sternal precautions via "teach back," an important tool in assessing patients' knowledge of important points delivered during clinical practice. Patients will then perform teach back of sternal precautions upon second Physical Therapy encounter to ensure understanding and post-operative anesthesia effects have waned. Prior to discharge (when patient deemed medically appropriate by the medical/surgical team), the patient will receive a survey consisting of 8 behavioral intention questions with "yes," "no," or "not sure" responses. Questions posed on the surveys assess if patients will/will not perform certain behaviors that may/may not predispose a risk to the patient's sternum.
1 secondary outcome
30 and 60 day readmission rates
Time frame: 30-60 days post patient discharge from hospital setting
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 14 Apr 2015.
Related trials for Intention - Mental Process
Not yet recruiting
Quit and Screen Project
Knowledge, Attitudes
Active, not recruitingPhase 3
Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
Hematopoietic and Lymphoid System Neoplasm
Not yet recruitingObservational study
Expression Intensity Modulates Social Intention Understanding in ASD Children
Autism Spectrum Disorder (ASD)
Not yet recruitingPhase 4
Skin Subs vs Secondary Intention
Skin Substitutes, Secondary Intention Healing
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
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.
Craig D Feinman, Doctor of Physical Therapy principal investigator
North Shore University Hospital, NSLIJ Health System
Renee Pekmezaris, PhD study director
North Shore University Hospital, NSLIJ Health System
Andrzej Kozikowski, PhD study director
North Shore University Hospital, NSLIJ Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Sternal Precautions in people with Intention - Mental Process and Readmission Rates, run by Northwell Health 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 1 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 14 Apr 2015. 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?
Patient behavioral intentions post visual training strategies (time frame: Post-operative day one when patient medically cleared for PT evaluation, 2nd session, and prior to discharge from hospital (approximately 1-10 days)). 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 14 Apr 2015.