Determine focus of study: What will the study address? How is this different from previous research, in the literature or your organization?
Establish concrete goal(s) for the study: What is trying to be accomplished? (not the outcome, but what will be measured.)
Three factors for a successful research project include recruiting and sustaining a qualified research workgroup, addressing financial needs, and developing a solid research plan.
Develop a research workgroup based on:
- What is the goal of the research?
- What systems/organizations/providers are impacted by this project? Include prescribers, departments of health, hospitals and/or clinics, healthcare providers, academia, community organizations, other pharmacies, transportation providers, community leaders, board members, etc.
- Workgroup should include members familiar with the subject being addressed, including front-line workers, administrators, providers, volunteers, students and any others involved with the processes.
- Have an executive sponsor or principal investigator who takes responsibility for the study.
Inclusion in research workgroup
- Contribution of skills needed to complete the study. Interest in goal, statistics, administrative, professional
- Review curricula vitae, resumes and biographies of potential interested members
- Availability and willingness to dedicate time for conducting research. Develop an approximate ask time for specific tasks for study – hours/week, number of weeks. Will time be voluntary or paid, available as regular or additional staffing hours?
Responsibilities of workgroup members
- Establishing study design and goals; consider use of Stages of Change Model
- Identify benefits and risks to participants and community
- Investigate need of Investigational Review Board (IRB) (usually through hospital or academic institution) See Determining if IRB approval is needed
Develop a research team
This is the team who will be conducting the research and the ongoing analysis. Key will be determining those within the organization (volunteers, staff, students) with the appropriate skills and abilities to conduct and/or support the study. See Inclusion in research workgroup above.
Training those conducting research:
- Act (HIPAA) including signed agreement with organization(s) involved
- National Institute of Health (NIH) Protection of Human Subjects Education Note: tutorials are no longer updated as of September 2018, but site includes informatics defining Human Subject Research and tutorial prior to September 2018 with quiz.
- If you think your study does NOT constitute research involving human subjects, consult Comparison: Characteristics of Human Subject Research Versus Other Project Types
- Develop training materials that include clear procedures and processes (as in Standard Operating Procedures) to ensure consistency of tasks by all team members. Competency with performing tasks should be measured.
- A check list verifying training and competency is beneficial for analysis, liability and stakeholders. Materials should be signed and dated by both researcher and trainee to be kept with research materials.
Develop a Research Plan
- This is a business plan for the project
- Create a budget based on direct (e.g. office and medical supplies) and indirect costs (space, utilities, technology, staff compensation).
- Other factors besides financial include legal, Investigational Review Board (IRB) processes, facility or designated space requirements, and time limits and expenditures.
Steps for Research Project
Not required to be completed in sequential order, but all items should be completed prior to implementation of project.Define focus and goal of project. Can your research provide evidence to change practice within the scope of practice (Evidence Based)? Is there a pattern of evidence emerging from the organization’s practice that may not be described in current literature? Is there a gap in current literature that this research may fill?
Develop a research statement based on the question the study will address. Statement should be specific, not be too general, too vague, or too ambitious. Example: Impact of pharmacist-led Medication Therapy Management in collaboration with healthcare providers on patient reported health outcomes.
Review relevant literature. Does project meet a gap? Are there methodologies that could be used for this project?
Develop study design: randomized or non-randomized; control or no-control; double blinded.
Develop subject participation criteria (age, disease state, length or severity of illness, literacy, income, language, other).
Establish ethics of research. Participants should not be coerced to participate. Consent is obtained. Written or verbal information is in language and literacy level appropriate to participants. Risks are minimized and there is a potential for benefits (risk benefit ratio). HIPAA permission is obtained, stored and compliance is maintained.
Determine methods and data to be collected From this, design policies and procedures for research team.
Construct research proposal based on Research Plan. This is used for community and organization support, collaboration and funding.
Receive IRB approval if needed.
- Those conducting research are trained in their roles, methodologies, data to be collected, etc. Methods should be clear, repeatable and consistent by all researchers.
- Data should be collected clearly and accurately, utilizing technology whenever possible.
- As well as clinical data, monitor: subject recruitment process, time commitments, follow-up, and dropout rate.
- Pilot study may be used evaluate processes, collection of data relevant to project, time commitment, and quality and quantity of data
- Team meets frequently to evaluate processes See Improving Care Delivery through Lean for a model of implementation.
- Utilize Plan, Do, Study, Act (PDSA) to refine processes, such as setting upper limits of participants/team member, reasons for non-participation or return for follow-up, etc. Review study documentation for accuracy, streamlining, and compliance with local health officials, external sponsors, ethics committees or academic institutions.
- Research Workgroup oversees project.
Analysis and Interpretation
- As much as possible, determine data points prior to beginning study or as soon as points become apparent to ensure necessary quantity and quality of data.
- Minimum of 50 study participants are required to achieve statistical significance
- Clear and accurate interpretation of data can be done by a statistician or using medical statistics software.
- Analysis is a time-consuming process; allow time for this.