week 15 research
MC17
Tappen2eChapter26.pptxChapter 26
Patient Safety and Quality Research
Patient Safety and Quality Research
To Err is Human: Building a Safer Health Systems is a report by the Institute of Medicine and has been the impetus for a great increase in research on improving the safety and quality of patient care
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Patient Safety and Quality Research
More than 15 years after the Institute of Medicine report was released, the quality of care provided in the United States is still uneven and patients are still at risk of harm from medication errors, healthcare-associated infections, obstetrical adverse effects, and so on (Kronick, 2014)
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Research Study Versus Quality Improvement Project
Quality improvement projects are institution based and the ensuing investigation is oriented toward identifying gaps in safety procedures and policies in that institution and taking corrective action
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Research Study Versus Quality Improvement Project
A research study is a systematic investigation of phenomena that is designed to contribute new knowledge
A research study protocol needs to be reviewed by an institutional review board (IRB)
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Research Study Versus Quality Improvement Project
Whether a research study or quality improvement project, attention to the design of the study, adequacy of data collection, and appropriate data analysis are necessary
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Examples of Patient Safety Research
Schoonover and colleagues (2014) conducted a secondary analysis of data from a study of medication discrepancies found when patients transition from acute care to home
They found that the odds of unplanned hospital readmission was 5.45 times greater for those with higher medication regimen complexity
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Examples of Patient Safety Research
Taber and colleagues (2014) looked at contributions to a hospitalization for patients with a transplanted kidney
64% of participants experienced at least one medication error
12% experienced a clinically significant medication error
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Examples of Patient Safety Research
Nationwide Children’s Hospital instituted a hospital-wide culture transformation using the Institute of Healthcare Improvement (IHI) model of improvement and expanded its quality improvement program, which lowered the hospital’s serious safety event rate by 83%
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Design Challenges in Patient Safety Research
Placing specific boundaries around the event of concern
Identifying the event in existing patient records, especially in the qualitative portions of the record
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Design Challenges in Patient Safety Research
Noting the sequence of events and the date the event of interest occurred
Comparing populations across different facilities
Measuring the degree of baseline adherence
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Design Challenges in Patient Safety Research
Using organization-wide interventions
Encompassing the contextual complexity of system change
Analyzing complex data
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Ethical Research Considerations
It is often very difficult to obtain the consent of every patient to be included in the study; however, individual patients need to be given the opportunity whether they want to be part of the study or not
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Ethical Research Considerations
The Office for Human Research Protections has issued guidelines when considering a request for waiver of consent:
Research involves no more than minimal risk
Only the minimum information necessary to conduct the research will be collected
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Ethical Research Considerations
The Office for Human Research Protections has issued guidelines when considering a request for waiver of consent:
Confidentiality must be maintained; particular attention needs to be paid to collection of any identifying information
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Ethical Research Considerations
Situations that may qualify for a waiver of consent are:
The research cannot be reasonably carried out unless consent is waived
Scientific rigor of the research would be threatened by consent procedures
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Ethical Research Considerations
Baker and Persell (2015) made a few additional considerations to waivers:
If consent cannot be obtained from every subject then the research should only pose minimal risk to the subjects of the research
Consider if the intervention can ethically be withheld from the comparison group
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Ethical Research Considerations
Baker and Persell (2015) made a few additional considerations to waivers:
Data obtained under waiver of consent should be collected as part of routine care, but if this cannot be done then consent may be necessary
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Guidelines for Publishing Safety and Quality Study Results
Indicate in the title that some type of improvement in the quality of care was the purpose of the study
Be sure the review of the literature is balanced
Provide sufficient detail about implementation of the improvement intervention
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Guidelines for Publishing Safety and Quality Study Results
Description of the environment should include organization and patient characteristics and factors likely to influence the improvement project
Use appropriate analyses
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Guidelines for Publishing Safety and Quality Study Results
When analyzing the outcomes, report the strength of the intervention effect
When reporting outcomes, include both benefits and harms, successes and failures, and lessons learned
Include estimates of cost factors
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Guidelines for Publishing Safety and Quality Study Results
Describe the local problem and the intended improvement
Write a description of the individuals or groups involved in the project and characteristics of the setting in which the study was done
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