Malignant NeoplasmNCT02081794
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients
A study testing Tailored education intervention and Standard fall care in people with Malignant Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies tailored patient educational intervention or standard education in assessing perceived risk for falls in hospitalized oncology patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Tailored education intervention and Standard fall care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nonmalignant diagnosis
- Actively dying
- Patients with a physician order for bed rest
Trial locations and contacts
1 site in 1 country.
United States1 site
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Tailored education intervention, Standard fall care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored education interventionOther
Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
Standard fall careOther
Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard fall care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Megan Kuhlenschmidt, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081794
- Sponsor's protocol ID
- CASE18Z13
- Other IDs
- NCI-2014-00388, CASE 18Z13, P30CA043703
- Status last verified
- Oct 2015
- First submitted
- 5 Mar 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02081794
- Acronym / sponsor ID
- CASE18Z13
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Tailored education intervention) | Experimental | Other: Tailored education interventionParticipants 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. |
| Arm II (standard fall care) | Active comparator | Other: Standard fall careParticipants receive standard care by nurses comprising a falls risk assessment and verbal education and receive an educational instruction sheet on falls prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Nonmalignant diagnosis
- Actively dying
- Patients with a physician order for bed rest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored education interventionReceive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks | Other | Arm I (Tailored education intervention) |
| Standard fall carePatient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education | Other | Arm II (standard fall care) |
Primary outcome
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Time frame: Up to 8 weeks
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.
Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)
Time frame: Up to 8 weeks
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.
Willingness to call for assistance
Time frame: Up to 8 weeks
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.
2 secondary outcomes
Relationship between patients perceived risk for falls and nurses risk assessments
Time frame: Up to 8 weeks
Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Kuhlenschmidt principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored education intervention and Standard fall care in people with Malignant Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.