Measuring Harm in Health Care: Optimizing Adverse Event Review.

OBJECTIVE: The objective of this study was to identify modifiable factors that improve the reliability of ratings of severity of health care-associated harm in clinical practice improvement and research. METHODS: A diverse group of clinicians rated 8 types of adverse events: blood product, device or medical/surgical supply, fall, health care-associated infection, medication, perinatal, pressure ulcer, surgery. We used a generalizability theory framework to estimate the impact of number of raters, rater experience, and rater provider type on reliability. RESULTS: Pharmacists were slightly more precise and consistent in their ratings than either physicians or nurses. For example, to achieve high reliability of 0.83, 3 physicians could be replaced by 2 pharmacists without loss in precision of measurement. If only 1 rater was available for rating, ∼5% of the reviews for severe harm would have been incorrectly categorized. Reliability was greatly improved with 2 reviewers. CONCLUSIONS: We identified factors that influence the reliability of clinician reviews of health care-associated harm. Our novel use of generalizability analyses improved our understanding of how differences affect reliability. This approach was useful in optimizing resource utilization when selecting raters to assess harm and may have similar applications in other settings in health care.

Home medication support for childhood cancer: family-centered design and testing.

PURPOSE: Errors in the use of medications at home by children with cancer are common, and interventions to support correct use are needed. We sought to (1) engage stakeholders in the design and development of an intervention to prevent errors in home medication use, and (2) evaluate the acceptability and usefulness of the intervention. METHODS: We convened a multidisciplinary team of parents, clinicians, technology experts, and researchers to develop an intervention using a two-step user-centered design process. First, parents and oncologists provided input on the design. Second, a parent panel and two oncology nurses refined draft materials. In a feasibility study, we used questionnaires to assess usefulness and acceptability. Medication error rates were assessed via monthly telephone interviews with parents. RESULTS: We successfully partnered with parents, clinicians, and IT experts to develop Home Medication Support (HoMeS), a family-centered Web-based intervention. HoMeS includes a medication calendar with decision support, a communication tool, adverse effect information, a metric conversion chart, and other information. The 15 families in the feasibility study gave HoMeS high ratings for acceptability and usefulness. Half recorded information on the calendar to indicate to other caregivers that doses were given; 34% brought it to the clinic to communicate with their clinician about home medication use. There was no change in the rate of medication errors in this feasibility study. CONCLUSION: We created and tested a stakeholder-designed, Web-based intervention to support home chemotherapy use, which parents rated highly. This tool may prevent serious medication errors in a larger study.

Medication errors in the home: a multisite study of children with cancer.

OBJECTIVE: As home medication use increases, medications previously managed by nurses are now managed by patients and their families. Our objective was to describe the types of errors occurring in the home medication management of children with cancer. METHODS: In a prospective observational study at 3 pediatric oncology clinics in the northeastern and southeastern United States, patients undergoing chemotherapy and their parents were recruited from November 2007 through April 2011. We reviewed medical records and checked prescription doses. A trained nurse visited the home, reviewed medication bottles, and observed administration. Two physicians independently made judgments regarding whether an error occurred and its severity. Overall rates of errors were weighted to account for clustering within sites. RESULTS: We reviewed 963 medications and observed 242 medication administrations in the homes of 92 patients. We found 72 medication errors. Four errors led to significant patient injury. An additional 40 errors had potential for injury: 2 were life-threatening, 13 were serious, and 25 were significant. Error rates varied between study sites (40-121 errors per 100 patients); the weighted overall rate was 70.2 errors per 100 patients (95% confidence interval [CI]: 58.9-81.6). The weighted rate of errors with injury was 3.6 (95% CI: 1.7-5.5) per 100 patients and with potential to injure the patient was 36.3 (95% CI: 29.3-43.3) per 100 patients. Nonchemotherapy medications were more often involved in an error than chemotherapy. CONCLUSIONS: Medication errors were common in this multisite study of outpatient pediatric cancer care. Rates of preventable medication-related injuries in this outpatient population were comparable or higher than those found in studies of hospitalized patients.

Multisite parent-centered risk assessment to reduce pediatric oral chemotherapy errors.

PURPOSE: Observational studies describe high rates of errors in home oral chemotherapy use in children. In hospitals, proactive risk assessment methods help front-line health care workers develop error prevention strategies. Our objective was to engage parents of children with cancer in a multisite study using proactive risk assessment methods to identify how errors occur at home and propose risk reduction strategies. METHODS: We recruited parents from three outpatient pediatric oncology clinics in the northeast and southeast United States to participate in failure mode and effects analyses (FMEA). An FMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, brainstorm and prioritize failure modes (places where things go wrong), and propose risk reduction strategies. We focused on home oral chemotherapy administration after a change in dose because prior studies identified this area as high risk. RESULTS: Parent teams consisted of four parents at two of the sites and 10 at the third. Parents developed a 13-step process map, with two to 19 failure modes per step. The highest priority failure modes included miscommunication when receiving instructions from the clinician (caused by conflicting instructions or parent lapses) and unsafe chemotherapy handling at home. Recommended risk assessment strategies included novel uses of technology to improve parent access to information, clinicians, and other parents while at home. CONCLUSION: Parents of pediatric oncology patients readily participated in a proactive risk assessment method, identifying processes that pose a risk for medication errors involving home oral chemotherapy.

Assessing patient-centered communication in cancer care: stakeholder perspectives.

PURPOSE: Patient-centered communication is critical to quality cancer care. Effective communication can help patients and family members cope with cancer, make informed decisions, and effectively manage their care; suboptimal communication can contribute to care breakdowns and undermine clinician-patient relationships. The study purpose was to explore stakeholders' views on the feasibility and acceptability of collecting self-reported patient and family perceptions of communication experiences while receiving cancer care. The results were intended to inform the design, development, and implementation of a structured and generalizable patient-level reporting system. METHODS: This was a formative, qualitative study that used semistructured interviews with cancer patients, family members, clinicians, and leaders of health care organizations. The constant comparative method was used to identify major themes in the interview transcripts. RESULTS: A total of 106 stakeholders were interviewed. Thematic saturation was achieved. All stakeholders recognized the importance of communication and endorsed efforts to improve communication during cancer care. Patients, clinicians, and leaders expressed concerns about the potential consequences of reports of suboptimal communication experiences, such as damage to the clinician-patient relationship, and the need for effective improvement strategies. Patients and family members would report good communication experiences in order to encourage such practices. Practical and logistic issues were identified. CONCLUSION: Patient reports of their communication experiences during cancer care could increase understanding of the communication process, stimulate improvements, inform interventions, and provide a basis for evaluating changes in communication practices. This qualitative study provides a foundation for the design and pilot testing of such a patient reporting system.