1 – Introduction
The introduction should cover the following:
● Why is this topic important
● What do we know (what’s been done before)
● What don’t we know (gap)
● What do we want to do
Each of these points can be covered in a couple of sentences or each can have a paragraph
dedicated to it.
Make sure you conclude the introduction with a couple of sentences (or a paragraph)
providing a high-level overview of your proposed study.
Sample: With a surge of COVID-19 patients needing care, HMH hospitals adopted the
Society of Critical Care Medicine tiered staffing model for ICU, telemetry, and
medical-surgical units. After the 2009 Australian H1N1 pandemic, researchers explored the
lived experience of ICU nurses revealing themes related to staffing such as the challenge of
having the appropriate skill mix, the need to work overtime, and staff having to take on new
roles (Corley, Hammond, & Fraser, 2010). There is a gap in the literature regarding nurse
staffing or how staffing ratios were altered in hospitals during pandemics, epidemics or
illness outbreaks. The purpose of this study is to describe the staffing models used in acute
care hospitals during the COVID-19 pandemic. With a better understanding of experiences
during the COVID-19 pandemic, the results from this study will assist nurse leaders and
healthcare administrators in developing a systematic action plan with evidence-based staffing
models for future outbreaks and epidemics.
Each of these points can be covered in a couple of sentences or each can have a paragraph
dedicated to it.
Make sure you conclude the introduction with a couple of sentences (or a paragraph)
providing a high-level overview of your proposed study.
Sample: With a surge of COVID-19 patients needing care, HMH hospitals adopted the
Society of Critical Care Medicine tiered staffing model for ICU, telemetry, and
medical-surgical units. After the 2009 Australian H1N1 pandemic, researchers explored the
lived experience of ICU nurses revealing themes related to staffing such as the challenge of
having the appropriate skill mix, the need to work overtime, and staff having to take on new
roles (Corley, Hammond, & Fraser, 2010). There is a gap in the literature regarding nurse
staffing or how staffing ratios were altered in hospitals during pandemics, epidemics or
illness outbreaks. The purpose of this study is to describe the staffing models used in acute
care hospitals during the COVID-19 pandemic. With a better understanding of experiences
during the COVID-19 pandemic, the results from this study will assist nurse leaders and
healthcare administrators in developing a systematic action plan with evidence-based staffing
models for future outbreaks and epidemics.
2 – Background
2.1. Background/literature review (Please provide references and add references in APA
format in the reference list at the end of this document)
The background should offer an overview of the available literature.
Please make sure that you discuss the literature that supports YOUR proposed study. You
can discuss 1-2 more general reference papers in the beginning but make sure that you
focus on similar studies or studies demonstrating a gap.
You might also want to:
2.1. Background/literature review (Please provide references and add references in APA
format in the reference list at the end of this document)
The background should offer an overview of the available literature.
Please make sure that you discuss the literature that supports YOUR proposed study. You
can discuss 1-2 more general reference papers in the beginning but make sure that you
focus on similar studies or studies demonstrating a gap.
You might also want to:
● Describe and provide the results of animal studies, laboratory studies and pilot
studies done in the USA or elsewhere, and clinical studies conducted abroad.
studies done in the USA or elsewhere, and clinical studies conducted abroad.
● Summarize the known and potential risks and benefits, if any, to human subjects.
Conclude your background by identifying the gap and explaining in one sentence how you
are going to fill it.
Make sure your background is not unnecessarily long (such as a thesis) as long. A protocol
only needs to include the background to allow the reader/reviewer to familiarize with the
area.
Conclude your background by identifying the gap and explaining in one sentence how you
are going to fill it.
Make sure your background is not unnecessarily long (such as a thesis) as long. A protocol
only needs to include the background to allow the reader/reviewer to familiarize with the
area.
Review of Literature (ROL)
● Include existing literature published within the past 3-5 years.
● The literature review can include peer-reviewed scientific journal articles,
new/revised standards of practice/clinical practice guidelines/best practices, and
statutes/regulations if applicable.
new/revised standards of practice/clinical practice guidelines/best practices, and
statutes/regulations if applicable.
● Citations/references older than 5 years may be included if it is a landmark study
or theoretical framework.
or theoretical framework.
● Discuss literature that supports your proposed study.
● Discuss 1-2 more general reference papers in the beginning but make sure that
you focus on similar studies or studies demonstrating a gap.
you focus on similar studies or studies demonstrating a gap.
● Try to avoid a structure where each paragraph summarizes one single study.
● Summarize and present studies reporting similar findings or studies on similar
populations together
populations together
● Try to be critical and discuss their limitations especially if you are planning to
base your study on doing something already done but better!
base your study on doing something already done but better!
● The ROL should be succinct for proposal submission. It is not a school
project/dissertation that requires a 10-15 page long literature review.
project/dissertation that requires a 10-15 page long literature review.
● Summarize the known and potential risks and benefits, if any, to human
subjects.
subjects.
● Conclude your ROL by identifying the gap and explaining in one sentence how
you intend to address it with this work. This will give you a good justification for
why you are proposing a study
you intend to address it with this work. This will give you a good justification for
why you are proposing a study
3 – Rationale, Objectives and Hypothesis
The rationale for the study, the investigator’s goals, and/or the hypothesis to be tested
should be stated here. Objectives should be broken down by primary and secondary which
will then lead to your primary/secondary variables.
3.1. Study Rationale/Problem Statement/Research question or Study significance
Explain in one sentence what the need you intend to cover is.
3.2. Hypothesis (if applicable) (Generally not applicable in nursing social-behavioral
studies.)
A statement that can be tested with an experiment (usually suggests a relationship).
Scientists generally base scientific hypotheses on previous observations that cannot
satisfactorily be explained with available scientific theory/ data.
studies.)
A statement that can be tested with an experiment (usually suggests a relationship).
Scientists generally base scientific hypotheses on previous observations that cannot
satisfactorily be explained with available scientific theory/ data.
3.3. Primary Objective
The main goal you are trying to achieve. It derives from the research question.
The main goal you are trying to achieve. It derives from the research question.
3.4. Primary Outcome Variable(s)/Measure(s) (outcomes corresponding to the stated
objective above)
Quantitative measures deriving from the objective(s). Defines the outcomes that the study
will measure. Try to have no more than 2-3 primary outcomes. The rest can be secondary or
explanatory.
objective above)
Quantitative measures deriving from the objective(s). Defines the outcomes that the study
will measure. Try to have no more than 2-3 primary outcomes. The rest can be secondary or
explanatory.
Primary Outcome Measure 1
Title:
Description: [Description of the metric used to characterize the specific primary outcome
measure, if not included in the primary outcome measure title. If a scale is used to assess
the outcome, please list the name of the scale and its range e.g. knowledge will be assessed
using a 9-item scale ranging from 0-9 with 0 being “no previous knowledge” and 9 being
“expert knowledge”.]
Timeframe: [Time point(s) at which the measurement is assessed for the specific metric
used. The description of the time point(s) of assessment must be specific to the outcome
measure and is generally the specific duration of time over which each participant is
assessed (not the overall duration of the study).]
Primary Outcome Measure 2
Title/Description/Timeframe
3.5. Secondary Objective(s) (if applicable)
3.6. Secondary Outcome Variable(s)/Measure(s) (if applicable)
Secondary Outcome Measures [N/A if not applicable]
Secondary Outcome Measure 1 [for clinical trials, “Secondary outcome measure” means an
outcome measure that is of lesser importance than a primary outcome measure, but is part
of a pre-specified analysis plan for evaluating the effects of the intervention or interventions
under investigation in a clinical study and is not specified as an exploratory or other
measure. A clinical study may have more than one secondary outcome measure.]
Title/Description/Timeframe
3.6. Secondary Outcome Variable(s)/Measure(s) (if applicable)
Secondary Outcome Measures [N/A if not applicable]
Secondary Outcome Measure 1 [for clinical trials, “Secondary outcome measure” means an
outcome measure that is of lesser importance than a primary outcome measure, but is part
of a pre-specified analysis plan for evaluating the effects of the intervention or interventions
under investigation in a clinical study and is not specified as an exploratory or other
measure. A clinical study may have more than one secondary outcome measure.]
Title/Description/Timeframe
3.7. Exploratory objective(s) (if applicable) [N/A if not applicable]
3.8. Exploratory outcome variable(s) [N/A if not applicable]
Exploratory outcome measure 1
Title/Description/Timeframe
Exploratory outcome measure 1
Title/Description/Timeframe
4 – Study Design
4.1 General Design
Describe in a sentence or two the general design of the study. If applicable, make sure you
mention whether this is a study with a retrospective AND prospective component, or only
prospective, and the type of the protocol (e.g. prospective data / sample collection /clinical
trial/survey-based/ quantitative and/or qualitative), and list control or comparison groups, as
applicable.
Please ensure there is a clear distinction between what is taking place as standard of
care (SOC) versus what is done for research purposes.
You might also want to:
4.1 General Design
Describe in a sentence or two the general design of the study. If applicable, make sure you
mention whether this is a study with a retrospective AND prospective component, or only
prospective, and the type of the protocol (e.g. prospective data / sample collection /clinical
trial/survey-based/ quantitative and/or qualitative), and list control or comparison groups, as
applicable.
Please ensure there is a clear distinction between what is taking place as standard of
care (SOC) versus what is done for research purposes.
You might also want to:
Include a schematic diagram of the study design, procedures and stages as applicable.
Describe the measures taken to minimize/avoid bias (randomization, blinding).
If data is to be collected, make sure the list of datapoints is listed here or is provided in the
appendix (or as a separate attachment).
4.1.1 Study Duration
Describe how long the study is going to last. Take into consideration the time you will need
for the data collection and the time needed for data analysis. Recommend that you allocate
extra time for your study because if you have an end date and you have not finished data
collection you will need to submit an amendment to the IRB.
If this is a clinical trial in which patients will be actively involved, make sure you specify the
duration for which they will be involved and the time needed to analyze the data collected.
When indicating duration, try to use days, months, years, not specific dates as this may
change depending on when you obtain IRB approval.
Describe how long the study is going to last. Take into consideration the time you will need
for the data collection and the time needed for data analysis. Recommend that you allocate
extra time for your study because if you have an end date and you have not finished data
collection you will need to submit an amendment to the IRB.
If this is a clinical trial in which patients will be actively involved, make sure you specify the
duration for which they will be involved and the time needed to analyze the data collected.
When indicating duration, try to use days, months, years, not specific dates as this may
change depending on when you obtain IRB approval.
4.1.2 Participant duration
Explain how long each participant will remain in the study, including follow-up.
Explain how long each participant will remain in the study, including follow-up.
4.1.3 Number of Study Sites
Mention the site(s) that will be involved in this study. Include their name and location and
specify if they are HMH/non-HMH sites.
This is also entered into eResearch in “Local Research Locations.”
Mention the site(s) that will be involved in this study. Include their name and location and
specify if they are HMH/non-HMH sites.
This is also entered into eResearch in “Local Research Locations.”
4.2 Study Population
Describe the participant pool you will choose your participants from and their general
characteristics. Make sure you specify the type of the participant population (e.g.
patients/students, etc.).
Describe the participant pool you will choose your participants from and their general
characteristics. Make sure you specify the type of the participant population (e.g.
patients/students, etc.).
4.2.1. Number of Participants
Specify the number of participants that will be recruited for your proposed study.
For quantitative studies, recommend that you consult with the statistician to determine the
number of participants and need for power analysis.
For qualitative studies, typically the number of participants is based on data saturation.
Specify the number of participants that will be recruited for your proposed study.
For quantitative studies, recommend that you consult with the statistician to determine the
number of participants and need for power analysis.
For qualitative studies, typically the number of participants is based on data saturation.
4.2.2. Eligibility Criteria
Inclusion Criteria: All eligibility criteria should be listed. (Medical criteria, age, demonstration
of disease, ailment, proof of failure using standard therapy, laboratory assessments for
eligibility, etc.).
Exclusion Criteria: As applicable: Age limits; minors, pregnant women, mental
incompetents; use of other medications concomitantly; subjects with other diseases, severity
of illness, etc.
Inclusion Criteria: All eligibility criteria should be listed. (Medical criteria, age, demonstration
of disease, ailment, proof of failure using standard therapy, laboratory assessments for
eligibility, etc.).
Exclusion Criteria: As applicable: Age limits; minors, pregnant women, mental
incompetents; use of other medications concomitantly; subjects with other diseases, severity
of illness, etc.
A comprehensive study cohort inclusion/exclusion criteria is essential to capture the correct
population. A good example for a study that used data collected within the SOC would be
(especially if you will collaborate with DTS to pull data):
Study Title Example: Investigation of Surgical Outcomes for Patients with Knee
Osteoarthritis
Inclusion Criteria:
population. A good example for a study that used data collected within the SOC would be
(especially if you will collaborate with DTS to pull data):
Study Title Example: Investigation of Surgical Outcomes for Patients with Knee
Osteoarthritis
Inclusion Criteria:
● Age: Adults aged 50 to 75 years at time of surgery.
● Diagnosis Codes: Patients with a confirmed diagnosis of knee osteoarthritis based
on ICD-10 code M17 (Unilateral primary osteoarthritis of knee) or M18 (Bilateral
primary osteoarthritis of knee) as primary or secondary diagnosis.
on ICD-10 code M17 (Unilateral primary osteoarthritis of knee) or M18 (Bilateral
primary osteoarthritis of knee) as primary or secondary diagnosis.
● Payor: N/A
● Procedure Codes: Patients who have undergone knee arthroscopy for osteoarthritis
(CPT code: 29881)
(CPT code: 29881)
● Medications: N/A
● Test/Lab results: N/A
● Study sites: HUMC
● Service: Inpatient or Outpatient
● Date Range: Surgeries performed Jan 1, 2021-Dec 31,2021
Exclusion Criteria:
● Date Range: Surgeries performed Jan 1, 2021-Dec 31,2021
Exclusion Criteria:
● Age:Patients below 50 years or above 75 years.
● Diagnosis Codes:
○ Patients with rheumatoid arthritis (ICD-10 code M05 or M06) primary or
secondary OR
○ Patients with post-traumatic knee osteoarthritis (ICD-10 code M17.1) primary
or secondary OR
○ Patients with secondary osteoarthritis due to other conditions (ICD-10 code
M19) as secondary code.
○ Patients with rheumatoid arthritis (ICD-10 code M05 or M06) primary or
secondary OR
○ Patients with post-traumatic knee osteoarthritis (ICD-10 code M17.1) primary
or secondary OR
○ Patients with secondary osteoarthritis due to other conditions (ICD-10 code
M19) as secondary code.
● Payor: N/A
● Procedure Codes: Patients who have undergone knee replacement surgery (CPT
codes: 27447, 27486)
codes: 27447, 27486)
4.2.3. Vulnerable populations (if applicable). Vulnerable populations include children,
prisoners, cognitively impaired individuals, economically or educationally disadvantaged
individuals, employees, students. When vulnerable populations are included, indicate what
safeguards are in place to minimize coercion or undue influence to participate.
prisoners, cognitively impaired individuals, economically or educationally disadvantaged
individuals, employees, students. When vulnerable populations are included, indicate what
safeguards are in place to minimize coercion or undue influence to participate.
4.3 Withdrawal criteria
● When and how to withdraw subjects from the study
● The type and timing of the data to be collected for withdrawn subjects
● Whether and how subjects are to be replaced
● The follow-up for subjects withdrawn e.g. procedures that will be followed when
subjects withdraw from the research, including partial withdrawal from procedures
with continued data collection or surveillance (if applicable)
subjects withdraw from the research, including partial withdrawal from procedures
with continued data collection or surveillance (if applicable)
4.4. Study procedures
All procedures that are STUDY-RELATED must be described here.
Recruitment, consent and any research interventions must be described here. Interventions
might include, but are not limited to: Clinical procedures, surveys, interviews, focus groups
and educational interventions. Also include plans to return results to participants and/or their
treating physician and explain where lab tests will take place (CLIA vs. non-CLIA certified
lab).
All procedures that are STUDY-RELATED must be described here.
Recruitment, consent and any research interventions must be described here. Interventions
might include, but are not limited to: Clinical procedures, surveys, interviews, focus groups
and educational interventions. Also include plans to return results to participants and/or their
treating physician and explain where lab tests will take place (CLIA vs. non-CLIA certified
lab).
● Describe and explain the study design, including control or comparison groups as
applicable.
applicable.
● Provide a description of all research procedures being performed and when they are
performed, including procedures being performed to monitor subjects for safety or
minimize risks.
performed, including procedures being performed to monitor subjects for safety or
minimize risks.
● Describe:
o Procedures performed to lessen the probability or magnitude of risks.
o The source records that will be used to collect data about subjects.
(Attach all surveys, scripts, and data collection forms.)
o Procedures performed to lessen the probability or magnitude of risks.
o The source records that will be used to collect data about subjects.
(Attach all surveys, scripts, and data collection forms.)
● What data will be collected during the study and how that data will be obtained.
● If there are plans for long-term follow-up (once all research related procedures are
complete), what data will be collected during this period.
complete), what data will be collected during this period.
● If you will conduct genetic or genomic testing as part of your study, please make sure
you specify if you will be using targeted analysis or whole exome/genome
sequencing and ensure consistency between the protocol and the consent form.
Please avoid long explanations of procedures that are standard of care unless it is to explain
your research activities. Please make sure there is a clear distinction between what is the
standard of care and what is done for research purposes.
4.4.1. Study discontinuation (if applicable)
you specify if you will be using targeted analysis or whole exome/genome
sequencing and ensure consistency between the protocol and the consent form.
Please avoid long explanations of procedures that are standard of care unless it is to explain
your research activities. Please make sure there is a clear distinction between what is the
standard of care and what is done for research purposes.
4.4.1. Study discontinuation (if applicable)
4.4.2. Concomitant medication (if applicable)
4.5. Risks and Benefits
4.5.1. Risks
● List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the
subjects related to the subjects’ participation in the research. Include a description of
the probability, magnitude, duration, and reversibility of the risks considering physical,
psychological, social, legal, and economic risks.
subjects related to the subjects’ participation in the research. Include a description of
the probability, magnitude, duration, and reversibility of the risks considering physical,
psychological, social, legal, and economic risks.
● If applicable, indicate which procedures may have risks to the subjects that are
currently unforeseeable.
currently unforeseeable.
● If applicable, indicate which procedures may have risks to an embryo or fetus should
the subject be or become pregnant.
the subject be or become pregnant.
● If applicable, describe risks to others who are not subjects.
● Risks related to breach of confidentiality or data must be described
4.5.2. Benefits
Indicate whether there is the prospect of direct benefit to participants or whether there are no
direct benefits to participants. If there are no direct benefits to participants, the potential
benefits to society should be mentioned. Do not include compensation as a benefit to the
subject.
Indicate whether there is the prospect of direct benefit to participants or whether there are no
direct benefits to participants. If there are no direct benefits to participants, the potential
benefits to society should be mentioned. Do not include compensation as a benefit to the
subject.
5 – Methods All methods that will be used in the study procedures described above have to be explained
here. The statistical analysis plan has to be included here, including the timing of any
planned interim analysis and the criteria for termination of the trial. In the statistical section
you might also need to include procedures for accounting for missing, unused, or spurious
data and for reporting deviations from the original statistical plan.
If this is a treatment/diagnostic/prevention (non drug/device/biologic) study, the investigator
should explain the treatment /diagnosis/prevention plan and describe any control or
comparison group, as applicable. Baseline diagnostic tests, initial laboratory assessments
for eligibility, any EKGs, physical exams, etc., should be noted. The use of participant
diaries should be noted, the number of visits etc..
here. The statistical analysis plan has to be included here, including the timing of any
planned interim analysis and the criteria for termination of the trial. In the statistical section
you might also need to include procedures for accounting for missing, unused, or spurious
data and for reporting deviations from the original statistical plan.
If this is a treatment/diagnostic/prevention (non drug/device/biologic) study, the investigator
should explain the treatment /diagnosis/prevention plan and describe any control or
comparison group, as applicable. Baseline diagnostic tests, initial laboratory assessments
for eligibility, any EKGs, physical exams, etc., should be noted. The use of participant
diaries should be noted, the number of visits etc..
The PI (same as quality improvement) should indicate if subjects are to be
hospitalized for any part of the study.
If this is not a treatment study, the PI should list measures to be used, tests, interviews,
videotaping, and the amount of time the participant will be involved in each component of the
hospitalized for any part of the study.
If this is not a treatment study, the PI should list measures to be used, tests, interviews,
videotaping, and the amount of time the participant will be involved in each component of the
study. All tools, surveys etc. that are going to be used should be explained here. Also include
how they have been created and validated.
The PI should make clear which methodologies are standard clinical care and which are
experimental: e.g. if lumbar punctures are to be performed, it should be clear which, if any,
would have been performed off study.
experimental: e.g. if lumbar punctures are to be performed, it should be clear which, if any,
would have been performed off study.
Any monitoring should be described. The PI should also discuss reasons for dropping any
participant from the study. (Relapse, lack of patient compliance, etc.).
If applicable also include:
● Assessment of efficacy (specification of the efficacy parameters; methods and timing
for assessing, recording, and analyzing efficacy parameters).
for assessing, recording, and analyzing efficacy parameters).
● Assessment of safety (specification of safety parameters; the methods and timing for
assessing, recording, and analyzing safety parameters; procedures for eliciting
reports of and for recording and reporting adverse events and intercurrent illnesses;
the type and duration of the follow-up of subjects after adverse events).
assessing, recording, and analyzing safety parameters; procedures for eliciting
reports of and for recording and reporting adverse events and intercurrent illnesses;
the type and duration of the follow-up of subjects after adverse events).
5.1. Screening
5.2. Recruitment, enrollment and retention (including screen failures as applicable)
Flyers, patient handouts, etc. require IRB approval and should be attached as an Appendix.
Flyers, patient handouts, etc. require IRB approval and should be attached as an Appendix.
5.3. Study intervention (including schedule of events and study visits)
5.4. Assignment / randomization (if applicable)
5.5. Section of instruments (to include for all studies with a social behavioral
intervention)
intervention)
Describe the tools that will be used, validation/piloting and applicable copyright.
If the tool was home developed, explain if and how it was piloted. If the tool is copyright
protected, please make sure you have obtained permission before using it for research
purposes.
If the tool was home developed, explain if and how it was piloted. If the tool is copyright
protected, please make sure you have obtained permission before using it for research
purposes.
Describe the purpose of each tool/instrument/scale, number of items, scale of
measurement, reliability and validity. Include who created the tool and if you have
permission to utilize. Include a sample of each tool/instrument/scale in Appendix
measurement, reliability and validity. Include who created the tool and if you have
permission to utilize. Include a sample of each tool/instrument/scale in Appendix
5.6. Follow-up and end-of study (if applicable)
5.7. Statistical Method
5.7.1. Sample size calculation and justification
Justification can include a statistical sample size calculation (with methods and results) or a
description of the number of eligible participants seen in your practice during the study
period.
description of the number of eligible participants seen in your practice during the study
period.