Clinical trial NCT02209558: The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions
Official title: The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intention - Mental Process
Readmission Rates
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: North Shore University Hospital
First posted: 2014-08-06
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Post-surgical adult patients who had a median or midline sternotomy incision during cardiac surgery at North-Shore University Hospital.

Exclusion Criteria:

* Patients with dementia or those that are cognitively impaired will be excluded from the study.

Primary outcomes:
measure: Patient behavioral intentions post visual training strategies
timeFrame: 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:
measure: 30 and 60 day readmission rates
timeFrame: 30-60 days post patient discharge from hospital setting
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital, NSLIJ Health System
name: Craig D Feinman, Doctor of Physical Therapy
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore University Hospital, NSLIJ Health System
name: Renee Pekmezaris, PhD
role: STUDY_DIRECTOR
affiliation: North Shore University Hospital, NSLIJ Health System
name: Andrzej Kozikowski, PhD
role: STUDY_DIRECTOR
affiliation: North Shore University Hospital, NSLIJ Health System
name: Jonathan Dropkin, ScD, PT
role: STUDY_DIRECTOR
affiliation: North Shore University Hospital, NSLIJ Health System
name: Joanna Steinn, MPH
role: STUDY_DIRECTOR
affiliation: North Shore University Hospital, NSLIJ Health System
name: Alan Hartman, MD
role: STUDY_DIRECTOR
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