REVIEW ARTICLE
A Systematic Review of the Unintended Consequences of Clinical Interventions to Reduce Adverse Outcomes Milisa Manojlovich, PhD, RN, CCRN,* Soohee Lee, MSN,* and Deborah Lauseng, AMLSÞ
Abstract: This is a systematic review of the literature on unintended consequences of clinical interventions to reduce falls, catheter-related urinary tract infection, and vascular catheter-related infections in hospitalized patients. A systematic search of the literature was conducted in CINAHL and PubMed. We developed a screening tool and a two-stage screening process to identify relevant articles. Nine articles met inclusion criteria, and of those, 8 reported on interventions to reduce patient falls. Four studies reported a positive, unexpected benefit; 3 studies reported a negative, unexpected detriment; and 4 reported a perverse effect (different from what was expected). Three studies reported both positive and perverse effects arising from the intervention. In 4 of the studies, despite fall prevention interventions, patients fell while trying to get to the bathroom, suggesting that interventions to reduce one adverse outcome (i.e., CAUTI) may be associated with another outcome (i.e., patient falls). In some cases, there were positive outcomes for those who implemented and/or evaluated interventions. We encourage colleagues to collect and report data on possible unintended consequences of their interventions to allow a fuller picture of the relationship between intervention and all outcomes to emerge. Key Words: quality assurance, health care, quality improvement, patient safety, outcome assessment, inpatients, intervention studies, unintended consequences (J Patient Saf 2014;00: 00Y00)
I
nterventions to improve quality and patient safety should be subjected to the same standards as clinical trials in other fields of study.1 Clinical trials on human subjects are required to report unintended adverse effects, but the assessment of possible unintended effects in evaluations of safety practices is often ignored.2 Researchers acknowledge that reducing infections and other complications acquired by patients as a result of clinical interventions while in the hospital is a complex problem. Part of the problem exists because we do not understand the complex mechanisms by which clinical interventions aimed at reducing some adverse outcomes may inadvertently increase others, leading to unintended consequences. Adverse patient outcomes include health careYassociated infections, events such as falls, and the development of pressure ulcers, deep vein thrombosis, malnutrition, deconditioning, pain, and delirium. Interventions to reduce these outcomes have become multi-faceted but largely targeted to reducing one outcome at a time while neglecting other outcomes that may co-occur. As a result, unintended consequences of clinical interventions are no longer the exception but becoming the norm.3 From the *University of Michigan School of Nursing; and †University of Michigan Taubman Health Sciences Library Ann Arbor, Michigan. Correspondence: Milisa Manojlovich, PhD, RN, CCRN, University of Michigan School of Nursing, 400 N. Ingalls, Room 4306, Ann Arbor, MI 48109 (e
A Systematic Review of the Unintended Consequences of Clinical Interventions to Reduce Adverse Outcomes Milisa Manojlovich, PhD, RN, CCRN,* Soohee Lee, MSN,* and Deborah Lauseng, AMLSÞ
Abstract: This is a systematic review of the literature on unintended consequences of clinical interventions to reduce falls, catheter-related urinary tract infection, and vascular catheter-related infections in hospitalized patients. A systematic search of the literature was conducted in CINAHL and PubMed. We developed a screening tool and a two-stage screening process to identify relevant articles. Nine articles met inclusion criteria, and of those, 8 reported on interventions to reduce patient falls. Four studies reported a positive, unexpected benefit; 3 studies reported a negative, unexpected detriment; and 4 reported a perverse effect (different from what was expected). Three studies reported both positive and perverse effects arising from the intervention. In 4 of the studies, despite fall prevention interventions, patients fell while trying to get to the bathroom, suggesting that interventions to reduce one adverse outcome (i.e., CAUTI) may be associated with another outcome (i.e., patient falls). In some cases, there were positive outcomes for those who implemented and/or evaluated interventions. We encourage colleagues to collect and report data on possible unintended consequences of their interventions to allow a fuller picture of the relationship between intervention and all outcomes to emerge. Key Words: quality assurance, health care, quality improvement, patient safety, outcome assessment, inpatients, intervention studies, unintended consequences (J Patient Saf 2014;00: 00Y00)
I
nterventions to improve quality and patient safety should be subjected to the same standards as clinical trials in other fields of study.1 Clinical trials on human subjects are required to report unintended adverse effects, but the assessment of possible unintended effects in evaluations of safety practices is often ignored.2 Researchers acknowledge that reducing infections and other complications acquired by patients as a result of clinical interventions while in the hospital is a complex problem. Part of the problem exists because we do not understand the complex mechanisms by which clinical interventions aimed at reducing some adverse outcomes may inadvertently increase others, leading to unintended consequences. Adverse patient outcomes include health careYassociated infections, events such as falls, and the development of pressure ulcers, deep vein thrombosis, malnutrition, deconditioning, pain, and delirium. Interventions to reduce these outcomes have become multi-faceted but largely targeted to reducing one outcome at a time while neglecting other outcomes that may co-occur. As a result, unintended consequences of clinical interventions are no longer the exception but becoming the norm.3 From the *University of Michigan School of Nursing; and †University of Michigan Taubman Health Sciences Library Ann Arbor, Michigan. Correspondence: Milisa Manojlovich, PhD, RN, CCRN, University of Michigan School of Nursing, 400 N. Ingalls, Room 4306, Ann Arbor, MI 48109 (e
