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

NCT02081794 | Completed DMC

• 4 other identifiers: CASE18Z13NCI-2014-00388CASE 18Z13P30CA043703
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Relationship between patients perceived risk for falls and nurses risk assessments

  Up to 8 weeks

• Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey

  Up to 8 weeks

Study Arms (2)

Arm I (Tailored education intervention)

EXPERIMENTAL

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

Arm II (standard fall care)

ACTIVE COMPARATOR

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

Interventions

Tailored education intervention OTHER

Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks

Arm I (Tailored education intervention)

Standard fall care OTHER

Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education

Arm II (standard fall care)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Megan Kuhlenschmidt

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

US (1)