Research Application Sample

Sample of An Effective Application for a Research Study

Following is a sample of a well-written, effective application for funding of a Clinical Research Study. It is here to provide you with an example of the kind of thinking and detail our reviewers are looking for as they consider your application. If you are applying for funding for another type of study, such as survey research, this is conceptually the kind of application we hope you will write.

We hope you find this helpful as you draft your own application!

Abstract (250 words)

Summarize the main points of the grant proposal (aims, methods, outcome measures)

• Specific Aims: To determine bias and precision of temporal artery and axillary temperature measurements compared to oral temperature in oncology patients undergoing bone marrow transplant who develop a fever (oral temperature > 38.3°C).
• Background: Accurate temperature measurement is critical in cancer patients undergoing treatments that destroy the white blood cells, as fever may be the only indication of an infection. Standard methods for temperature measurement are oral or axillary routes. However, these methods have limitations. Temporal artery temperature (TAT) may be an alternative. There are no studies comparing these various methods in high risk oncology patients, particularly those patients with a fever.
• Methods: A repeated measures design will be used to evaluate the bias and precision of the three temperature measurement methods in 60 patients undergoing bone marrow transplant. Baseline temperature measurements will be obtained using calibrated thermometers at the time of study enrollment and repeated measures will be obtained if the patient becomes febrile (oral temperature > 38.3°C) and four hours later. Temperatures will be taken within a one minute period in a random order. Intra and interrater reliability will be established. Bland Altman analysis will be used to describe the bias and precision of the methods. Oral temperature will be used as the value for comparison.

Specific Aims and/or Hypothesis (Maximum 100 words):

Your aims or hypothesis should be specific (Example: Less strong: we want to determine if a patient/family education program works - Stronger: Determine if there is an improvement in patient/family satisfaction with discharge education after implementation of a computer based medication education program).

To determine bias and precision of temporal artery and axillary temperature measurements compared to oral temperature in oncology patients undergoing bone marrow transplant who develop a fever (oral temperature > 38.3°C). This research is consistent with the goals of the J. Patrick Barnes research program as patients undergoing bone marrow transplant represent some of the most vulnerable oncology patients.

Significance/Background (Maximum 750 words):

Briefly describe the background of your proposal, including a critical evaluation of the existing body of knowledge about the problem. Identify the importance of this study by relating it to existing knowledge. Summarize how the proposed research addresses the priorities of the J. Patrick Barnes Grant program. Include a list of references as an appendix.

Accurate temperature measurement is critical in cancer patients undergoing treatments that destroy the white blood cells. White blood cells fight infection and create the signs and symptoms of an infection. In a patient whose bone marrow has been depleted of white blood cells, the only sign of infection may be a fever. Our current standard is to obtain oral temperature. An axillary temperature is obtained if the patient cannot have an oral temperature due to oral lesions.

Although there is adequate literature demonstrating the accuracy of oral temperature as an indicator of core temperature there are limitations to the use of oral measurements and currently axillary is the only option. The temporal artery thermometer (TAT) offers a potential alternative. However, there are no studies comparing these methods in our patient population. Before we can change our method of assessment, research is needed to evaluate the accuracy and precision of TAT compared to the standard methods of measurement in this high risk group of patients.

Oral temperature measurement is a standard in healthcare. Factors that may affect oral temperature include the ingestion of hot/cold liquids, tachypnea and oral lesions or trauma. Administration of oxygen and open versus closed mouth breathing do not affect oral temperature measurements.1,2 Oxygen administered via a face mask has a statistically but not clinically significant effect (<0.3°C decrease) on oral temperature measurements.3-5 Axillary temperature is a skin temperature from an area that is somewhat protected from ambient air. The axillary temperature varies from the core temperature. For example, in 38 critically ill cardiovascular patients, 10 the axillary temperature was lower than core temperature by a 0.68°C ± 0.57°C. In 42 critically ill patients with sepsis, 22 the axillary temperature was higher than PA temperature (0.27°C ±0.45°C). The TAT offers an alternative method for patients who cannot have an oral measurement or for who axillary is not accurate enough. The temporal artery measurement is noninvasive and does not require contact with mucous membranes. The temporal artery is not significantly affected by thermoregulatory changes.REF. Because of the high perfusion rate of the temporal artery the TAT may be an accurate indicator of core temperature.REF

In a study, REF of 60 adult ICU patients, PA temperature (core) was 37.1°C ±0.6°C (range 35.3°C-39.4°C). Mean ± SD offset from core temperature and 95% confidence limits were 0.09°C ±0.43°C; (95% CL = -0.75°C to 0.93°C) for oral measurements, -0.36°C ± 0.56°C (95% CL = -0.92°C to 0.88°C) for temporal artery measurements, and 0.23°C ± 0.44°C (95% CL = -0.64°C to 1.12°C) for axillary measurements. Oral and TAT measurements were most accurate and precise, while axillary measurements underestimated core temperature. This study provides justification for the use of oral temperature as the method of comparison for our proposed study. However, a limitation of this study was the small number of patients who were febrile. Thus, we propose to conduct a method comparison study of oral, axillary and TAT measurements in oncology patients who develop a fever (oral temperature > 38.3°C).

Methods (Maximum 1,000 words):

Describe the methods you will use for the research. Identify sample (characteristics, sample size, provide power analysis as appropriate). Specify the protocols and instruments you will use. If you are using a particular instrument, provide a copy as an attachment. As appropriate, provide information on the psychometric properties of the instrument you are proposing to use. Describe outcome variables in detail. Describe data analysis plan.

A repeated-measures design with participants serving as their own control will be used. The oral temperature will be used as the measurement for comparison. The thermometers have been loaned by the companies for research purposes and will be returned upon study completion.

Upon enrollment the patient will have the first set of temperature measurements obtained. If during the hospitalization the patient develops a fever (oral temperature > 38.3) the RN caring for the patient will notify the study nurse on the unit and a set of temperature measurements will be obtained. The patient’s temperature will be repeated four hours later.

Sample: A convenience sample of 60 adult (age > 18) oncology patients undergoing bone marrow transplant will be studied. Subjects must be able to read/speak English and provide informed consent. Exclusion criteria: alteration in skin integrity (forehead/axilla).

The investigators will be trained to perform the procedures for each measurement. Intrarater reliability: each investigator will perform each measurement as described in the methods section until he/she achieves repeated temperature measurements for a given site that are within 0.1ºC. Interrater reliability: having 2 investigators obtain temperature measurements from a specified site that are within 0.1°C. A refresher will be performed monthly.

The temperature measurements will be obtained in a random order within a 1-minute period. The temperatures will be measured at each site on the same side of the body and only if the site was fully exposed.

Oral Temperature. Medichoice Digital Thermometer (Karma Medical Products, Portsmouth VA). The thermometer has a temperature range of 26.6ºC - 43.3ºC, with an accuracy of ±0.1ºC. The probe, will be placed in the posterior sublingual pocket. Patients who are tachypneic or mouth breathers will be encouraged to form the best seal possible around the thermometer. A note regarding each patient’s ability to make an adequate seal will be made on the study record. Nasal cannula or face masks for oxygen delivery will be left in place. No attempt will be made to close a patient’s mouth around the probe if they are unable to spontaneously accomplish this action.6

Temporal Temperature. Exergen TemporalScanner Temporal Artery Thermometer TAT-5000A (Exergen Corp, Watertown, Massachusetts). This thermometer has a reported accuracy of ±0.1°C. The temperature measurement will be obtained by sliding the thermometer probe midline straight across the forehead. To control for the effects of perspiration on the measurement, an additional temperature measurement behind the earlobe will be obtained (continuation of the temporal measurement). If a patient is in a lateral position, the temperature will be measured on the “up” (nondependent) side of the forehead. The lens will be inspected and cleaned as needed before each measurement. To avoid temperature drawdown, a minimum 30-second delay will be used if a measurement has to be repeated.

Axillary Temperature. Axillary temperature will be measured with the same thermometer used for oral measurements. The temperature probe requires direct contact with the skin, although no shaving or clipping of hair is required. Temperature measurements will be obtained in the following manner: With the axillary mode indicator flashing, the patient’s arm will be lifted so that the entire axilla is easily seen. The probe will be placed as high as possible in the axilla. The probe tip will not come into contact with the patient until the probe is placed in the measurement site. Verification that the probe tip is completely surrounded by axillary tissue will be accomplished, after which the patient’s arm will be placed snugly at their side. The patient’s arm will be held in this position to avoid movement of the arm or the probe during the measurement cycle.

To control for the effect of fluid ingestion, temperature measurements will be delayed for at least 15 minutes after a patient has ingested hot or cold liquids.

Equipment Calibration. The clinical engineering department will calibrate all thermometers before the start of the study, monthly during data collection, and upon completion of the study. The calibration will be done in accordance with manufacturers’ recommendations. The thermometers will be considered calibrated if they are within 0.2°C of the standard. A thermometer will be recalibrated if it is more than 0.2°C different from the standard.

Data Analysis Plan: The difference between the temperature measurements at each time point will be calculated and plotted as described by Bland and Altman.(Ref)) A clinically significant difference is defined as greater than ±0.5°C and the number of data pairs outside the ±0.5°C limits will be analyzed. For all analyses a will be set at .05.

Timetable: Detail your proposed step-by-step timeline in the following chart. (Your J. Patrick Barnes Grant application will have a different format, but this provides an idea of the detail your timeline should have.)

Budget: Funds are available for direct expenses only. Institutional overhead may not be included. Provide budget using the following chart, and describe/provide justification for how you will use the grant funding to support your project (e.g., cost for reproduction of booklets - 500 booklets @ $2/booklet = $1000). If the funding level offered by The DAISY Foundation is not adequate for your project, please email bonniebarnes@DAISYFoundation.org to discuss.

Equipment/Supplies: Nonreplacable probe covers are required (Total $340). The digital thermometers are a routine part of patient care and there is no charge for their use beyond normal care costs. The temporal artery thermometers are on loan from the company and will be returned upon completion of the study.