Clinical Trials Directory

Trials / Completed

CompletedNCT02209558

The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Northwell Health · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALVisual Sternal PrecautionsVisual depiction of SPs in addition to "standard of care" written precautions

Timeline

Start date
2014-08-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2014-08-06
Last updated
2015-04-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02209558. Inclusion in this directory is not an endorsement.