The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions

NCT ID: NCT02209558

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-04-30

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).

Conditions

Intention - Mental Process; Readmission Rates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Written Sternal Precautions

Patients will receive education that is the "standard of care" at North Shore Long Island Jewish Health Systems in their post-operative sternal precautions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Visual Sternal Precautions

Patients will receive both "standard of care" written sternal precautions, as well as visual sternal precautions.

Group Type: EXPERIMENTAL

Visual Sternal Precautions

Intervention Type: BEHAVIORAL

Visual depiction of SPs in addition to "standard of care" written precautions

Interventions

Visual Sternal Precautions

Visual depiction of SPs in addition to "standard of care" written precautions

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

North Shore University Hospital

OTHER

Sponsor Role: collaborator

Responsible Party

Craig Feinman

Senior Cardiothoraic Physical Therapist, Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig D Feinman, Doctor of Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital, NSLIJ Health System

Renee Pekmezaris, PhD

Role: STUDY_DIRECTOR

North Shore University Hospital, NSLIJ Health System

Andrzej Kozikowski, PhD

Role: STUDY_DIRECTOR

North Shore University Hospital, NSLIJ Health System

Jonathan Dropkin, ScD, PT

Role: STUDY_DIRECTOR

North Shore University Hospital, NSLIJ Health System

Joanna Steinn, MPH

Role: STUDY_DIRECTOR

North Shore University Hospital, NSLIJ Health System

Alan Hartman, MD

Role: STUDY_DIRECTOR

North Shore University Hospital, NSLIJ Health System

Locations

North Shore University Hospital

Manhasset, New York, United States

Countries

United States

Other Identifiers

14-305B

Identifier Type: -

Identifier Source: org_study_id