Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients

Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study

This randomized pilot clinical trial studies tailored patient educational intervention or standard education in assessing perceived risk for falls in hospitalized oncology patients. A tailored patient educational intervention may be more beneficial than standard education in preventing patients from falling by increasing the patient's knowledge of the risk factors for falling routinely and then providing education in deficit areas. Making patients more aware of the risk factors for falling may lead to greater engagement in preventative activities.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Tailored education intervention; Other: Standard fall care

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients.

II. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on confidence to minimize falls in hospitalized hematology-oncology patients.

III. To evaluate the relationship between patients' perceived risk for falling and their willingness to call for assistance with ambulation.

SECONDARY OBJECTIVES:

I. To evaluate the relationship between patients' perceived risk for falls and nursing risk assessments when using the standard hospital assessment tool and the investigator-designed perceived risk survey.

II. To evaluate the relationship between a patients' perceived risk for falls and sustaining a fall.

III. To evaluate patient satisfaction with the intervention.

OUTLINE:

All participants complete the Perceived Risk Survey comprising the participants' perceived risk for falls, their confidence to prevent a fall, and their willingness to ask for assistance at baseline and at 24 and 72 hours (or at discharge if stay is less than 72 hours) post-intervention. Patients are then randomized to 1 of 2 arms.

ARM I: Participants receive tailored education comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive printed education sheets based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.

ARM II: Participants receive a generic educational instruction sheet on falls prevention and receive standard care by nurses comprising a falls risk assessment and verbal education.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of cancer
• Admitted to the third floor of Seidman Cancer Center (SCC)
• Cognitively intact (alert, oriented to self, place, and time, and able to participate in the intervention)
• Ability to speak, read, and comprehend English

Exclusion Criteria:

• Nonmalignant diagnosis
• Actively dying
• Patients with a physician order for bed rest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Tailored education intervention); Participants receive a tailored educational intervention on the risk of falls comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive tailored printed educational information concerning hospital falls based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk. Participants also complete an investigator-constructed satisfaction survey at 24 and 72 hours post-intervention.	Other: Tailored education intervention; Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
Active Comparator: Arm II (standard fall care); Participants receive standard care by nurses comprising a falls risk assessment and verbal education and receive an educational instruction sheet on falls prevention.	Other: Standard fall care; Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool	Changes in pre vs post survey for the High Risk/Low Perception group will be compared to all others using a paired McNemar's test for both those receiving the intervention and controls. Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.	Up to 8 weeks
Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)	Pre vs post survey changes will be compared in confidence group using a paired McNemar's test for both those receiving the intervention and controls. Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.	Up to 8 weeks
Willingness to call for assistance	An eight-point Likert scale will be used. Pre vs post survey changes in willingness group will be compared using a paired McNemars test. Relationship between Risk/Perception group status and Willingness group will be assessed using a chi-square test stratified by pre or post survey results for both those receiving the intervention and controls.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between patients perceived risk for falls and nurses risk assessments	Descriptive statistics will be used to compare scores self-perceived risks of falling with a nurse's assessment of a patient falling	Up to 8 weeks
Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey	Descriptive statistics will be used by the distribution of pre vs post perceived risk values.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Megan Kuhlenschmidt, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CASE18Z13; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00388 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 18Z13 (Other Identifier: Case Comprehensive Cancer Center)