Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00632944 |
| Other study ID # |
5529 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 3, 2008 |
| Last updated |
June 4, 2015 |
| Start date |
January 2007 |
| Est. completion date |
March 2008 |
Study information
| Verified date |
March 2008 |
| Source |
State University of New York - Upstate Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to determine the effects of hourly rounding on patient falls,
patient satisfaction, and patient call light usage. This is a replication of research which
determined that hourly rounds conducted by nursing personnel decreased patient falls and
call light usage and increased patient satisfaction. The study design is quasi-
experimental. One unit will be used as its own control (4S). On this unit, hourly nursing
rounds will be implemented by Registered Nurses, Licensed Practical Nurses, and Nursing
Assistants. A second unit, 6S, will maintain current practices and data from this unit will
be used to determine if there are any hospital-wide fluctuations for fall rates, patient
satisfaction, or call light usage. Data for patient falls, patient satisfaction, call light
usage, and reasons for call light use will be collected on both units using fall rate
reports, patient satisfaction survey data, and the call light system.
Falls among hospital patients are a persistent problem, with 2.3 to 7 falls occurring in
U.S. hospitals every 1000 patient days. Approximately 30-48% percent of these falls result
in injury and 5 to 10 percent of them result in serious injury. Fall related deaths occurred
at a rate of 46.2 per 100,000 in 2003. Hospital falls affect both young and old patients and
many of them occur when the patient is alone or involved in elimination-related activities.
Falls that result in injury may lead to an extended hospitalization and increased costs.
Patients who fall and sustain injury are reported to have hospital charges of more than
$4,200 higher than patients who do not fall. Hourly nursing rounds have been shown to
decrease falls by 52%.
Hospitalized patients often require assistance with basic self-care tasks, such as using the
toilet, ambulating, and eating; they ask for assistance by using the call light. Therefore,
a patient's level of satisfaction with nursing care depends principally upon the patient's
perception of how well the nursing staff has been able to meet his or her needs. The call
light can be a lifeline for hospitalized patients, but it can also impose considerable
demands on nurses' time. Several studies have documented the unfavorable effects of
patients' frequent use of call lights on the effectiveness of patient-care management on
inpatient units, which may already be compromised by staffing shortages.
Description:
Falls among hospital patients are a persistent problem, with 2.3 to 7 falls occurring in
U.S. hospitals every 1000 patient days. Approximately 30-48% percent of these falls result
in injury and 5 to 10 percent of them result in serious injury. Fall related deaths occurred
at a rate of 46.2 per 100,000 in 2003. Hospital falls affect both young and old patients and
many of them occur when the patient is alone or involved in elimination-related activities.
Falls that result in injury may lead to an extended hospitalization and increased costs .
Patients who fall and sustain injury are reported to have hospital charges of more than
$4,200 higher per admission than patients who do not fall. Hourly nursing rounds have been
shown to decrease falls by 52% .
Hospitalized patients often require assistance with basic self-care tasks, such as using the
toilet, ambulating, and eating; they ask for assistance by using the call light. Therefore,
a patient's level of satisfaction with nursing care depends principally upon the patient's
perception of how well the nursing staff has been able to meet his or her needs. The call
light can be a lifeline for hospitalized patients, but it can also impose considerable
demands on nurses' time. Several studies have documented the unfavorable effects of
patients' frequent use of call lights on the effectiveness of patient-care management on
inpatient units, which may already be compromised by staffing shortages.
Current data at Crouse Hospital show that the fall rate on 4S is 5.05 per 1000 patient days,
demonstrating significant opportunity for improvement. Data from the 6S shows a fall rate of
5.26 per 1000 patient days. As far as patient satisfaction, the percentage of patients who
gave the 4S a 9 or 10 out of a possible score of 10 for overall rating of care was 56.29%.
Likewise the number of patients who would definitely recommend Crouse Hospital to others was
56.25%. Both satisfaction questions (Core IP Key Results: I would prefer to return to X
without hesitation, if care is needed and I would recommend X without hesitation to others)
show significant opportunities for improvement. Preliminary call light usage gathered from
the Hill Rom call light system, which is currently available only on 6S, showed 6,909
individual uses of the call light within a 4-week period. One can surmise from this number
that patient issues are not being addressed in a timely manner and therefore significant
opportunities for improvement exist. Only aggregate data will be collected. No subjects will
be identified directly or through any identifiers.
The objectives of the study are to:
1. Correlate the effects of hourly nursing rounds, if any, to patient falls and call light
use.
2. Determine if there are any changes in patient satisfaction levels
All subjects 18 years and over admitted to 4 South Irving (Oncology/OBGYN) or 6 South Irving
(Orthopedic/Neurology) during the twelve month study will be included as research subjects.
Exclusion Criteria: Any patient not admitted to 4 South Irving or 6 South Irving at Crouse
Hospital will be excluded from the study. Patients under the age of 18 years are not
admitted to these units.
Sample sizes for the study were determined for call light usage rates, patient satisfaction
scores, and fall rates. Current process averages for sample size calculations were obtained
as follows: 1) fall rates from existing fall rate reports 2) patient satisfaction from
Avatar surveys, and 3) call bell usage from preliminary Hill Rom system data. For all sample
size calculations, α=0.05 and β=0.10 were used. Based on these calculations, the study
baseline data for patient satisfaction will be calculated using Avatar patient satisfaction
data from the six-month period prior to study initiation. The baseline data for falls will
be collected from existing fall rate reports using the six months of data prior to study
initiation. Data for these variables will continue to be collected for 6 months after the
implementation of nursing rounds. For call bell usage rates the data for 2 weeks prior to
rounding implementation will be collected as baseline data. Data will be collected for 4
weeks following the implementation of nursing rounds. Data for average patient age, length
of stay, and severity of illness for both units will be obtained from Transition Systems,
Inc. TSI, a financial data base is a type of Decision Support System. In order to get the
information on a patient's age a query will be made of TSI. It will then print up average
ages of a particular unit within a specified time. Measures of central tendency and spread
will be calculated for these variables to compare both units. Chi-square tests, rank sum
tests, and tests of means will be used to compare baseline and post-intervention demographic
characteristics and reasons for call light usage on both units. Rate ratios comparing post-
to pre-intervention fall rates and call rates will be calculated on both. For both fall
rates and call rates, significance tests will be conducted to determine whether the rate
ratios differ between the two units. The change in the proportion of patients who indicated
they were satisfied with their care in each unit before and after the intervention will also
be calculated and compared. The data will be analyzed using SAS®9. No data involving
individual patient identifiers will be presented with the analysis. Findings from this study
will potentially be used to change nursing practice at Crouse Hospital.
4-South Irving, the experimental unit, will be used as its own control. A second unit, 6S,
will maintain current practices and data from this unit will be used to determine if there
are any hospital-wide fluctuations for fall rates, patient satisfaction, or call light
usage. Age, gender, and severity of illness of subjects on the control and experimental
units will be compared. Because the patient populations differ from the experimental to
control unit, the reasons why patients use the call light will be collected to verify that
these two groups use the call lights for similar reasons.
The principal and co-investigators of this study will be educating all nursing personnel on
both units on how to collect and document call light data 1 week prior to the start of the
data collection process. Baseline call light data for the reasons why patients use the call
light and number of patient calls will then be collected for 2 weeks. After baseline call
light data are collected the principal and co-investigators will be educating all nursing
personnel on 4 South Irving on how to round on patients. Education will last for 2 weeks and
includes what questions to ask of the patient while in the room, what tasks need to be done
each time they are in the room, when to round on patients, and how to document rounds. An
hourly rounding toolkit purchased from the authors of the original study, which includes an
educational video, will be used to assist in this education phase. Nursing leadership, which
includes the nurse manager, Director of Medical-Surgical Nursing, the Chief Nursing Officer
and Clinical Nurse Specialists, will be educated on techniques to ensure rounding is
consistently completed by nursing personnel. The implementation of nursing rounds will begin
after the two weeks of rounding education is completed.
One member of the nursing staff, including RNs, LPNs, and Nursing Assistants, will be
required to perform nursing rounds every hour on 4 South Irving Patients will not be
awakened if they are sleeping unless it is necessary for treatment. During nursing rounds,
nursing personnel will assess pain levels using a pain-assessment scale, offer toileting
assistance, assess the patient's position and position comfort, make sure the call light is
within the patients reach, put the television remote control and bed light switch within the
patients reach, put the bedside table next to the bed, put the tissue box and water within
the patient's reach and prior to leaving the room ask "Is there anything I can do for you
before I leave? I have time while I am here in the room." Nursing personnel will also tell
the patient that a member of the nursing staff (name will be written on white board in room)
will be back in an hour to round again. Nursing staff members are expected to complete all
patient-care tasks, unless they are not authorized to dispense medication or work with IVs.
Laminated pocket cards will be given to nursing staff so they are continually reminded of
the actions to perform on the rounds. Patients will not be awakened to check for pain,
positioning, or the need to use the bathroom; however the environmental check can be
completed during rounds. Members of the nursing leadership team including the nurse manager,
Director of Medical-Surgical Nursing, Chief Nursing Officer, and Clinical Nurse Specialists
will be making frequent observations of staff, using rounding documentation sheets and
patient interviews, to verify that rounding is occurring as expected.
Call light usage will be collected through the use of the Hill Rom call light system.
Recently, Hill Rom Beds were added to 4 South. Now the two units are equipped with Hill Rom
Beds and corresponding Hill Rom call lights. All call lights placed from individual patient
rooms are recorded on a central server located in each nursing station. The central server
can generate and print reports for all call lights used in a user specified time frame.
Reports include the time a call light was placed, area it was placed from and call light
response time. Reasons for call light usage will be documented by bedside nursing personnel
on a standard sheet. The documentation forms will be collected every day at 7a.m. by the
principal investigator or co-investigators of the study. New documentation forms will be
posted daily at 7a.m. Inter-rater reliability will be performed by comparing manual call
light data to the computerized call light data collected within the Hill Rom call light
system. Documentation of rounding times and frequency will also be documented by nursing
personnel on a standard form . This form will be collected every day at 7a.m. by either the
principal investigator or co-investigator of the study. New rounding documentation forms
will be posted daily. Rounding documentation forms will be used to calculate the percentage
of rounds completed as expected.
On both units, baseline data collection for falls and patient satisfaction will be collected
for 6 months prior to the start of nursing rounds and 6 months after the start of the
implementation of nursing rounds. Fall rates will be collected through pre-existing fall
rate reports and reported as falls per 1000 patient days. Patient satisfaction will be
collected through pre-existing Avatar patient satisfaction surveys that are randomly sent to
discharged patients. All data will be analyzed to determine if statistically significant
differences in patient fall rates, satisfaction, or call light usage occurred.
A limitation in this study is that nurses from the medical surgical float pool may work on 4
South and subsequently be assigned to 6 South within the 6 month post-intervention time
period. This potential movement of nurses between the control and experimental unit may
influence the results on the control unit. This will be addressed by limiting the number of
float pool nurses who are scheduled to work on both the experimental unit and the control
unit for the six months following the education phase of the study.
