The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions

NCT02209558 | Completed DMC

• 1 other identifier: 14-305B
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Intention - Mental Process; Readmission Rates

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  30-60 days post patient discharge from hospital setting

Study Arms (2)

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.

Behavioral: Visual Sternal Precautions

Interventions

Visual Sternal Precautions BEHAVIORAL

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

Visual Sternal Precautions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead
• North Shore University Hospital: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Study Officials

• Craig D Feinman, Doctor of Physical Therapy

  North Shore University Hospital, NSLIJ Health System

  PRINCIPAL INVESTIGATOR

• Renee Pekmezaris, PhD

  North Shore University Hospital, NSLIJ Health System

  STUDY DIRECTOR

• Andrzej Kozikowski, PhD

  North Shore University Hospital, NSLIJ Health System

  STUDY DIRECTOR

• Jonathan Dropkin, ScD, PT

  North Shore University Hospital, NSLIJ Health System

  STUDY DIRECTOR

• Joanna Steinn, MPH

  North Shore University Hospital, NSLIJ Health System

  STUDY DIRECTOR

• Alan Hartman, MD

  North Shore University Hospital, NSLIJ Health System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Cardiothoraic Physical Therapist, Physical Therapy

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 6, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)