Prospective Evaluation of a Multifaceted Intervention to Improve Outcomes in Intensive Care: The Promoting Respect and Ongoing Safety Through Patient Engagement Communication and Technology Study* Patricia C. Dykes, PhD, RN1,2; Ronen Rozenblum, PhD1,2; Anuj Dalal, MD1,2; Anthony Massaro, MD1,2; Frank Chang, MSE1; Marsha Clements, MSN, RN1; Sarah Collins, PhD, RN1,2; Jacques Donze, MD1; Maureen Fagan, DNP, RN1; Priscilla Gazarian PhD, RN1; John Hanna, BS1; Lisa Lehmann, MD1,2; Kathleen Leone, MBA, RN1; Stuart Lipsitz, ScD1,2; Kelly McNally, BS1; Conny Morrison, BA1; Lipika Samal, MD, MSc1,2; Eli Mlaver, BA1; Kumiko Schnock, PhD1,2; Diana Stade BA1; Deborah Williams, BA1; Catherine Yoon, MPH1; David W. Bates, MD, MSc1,2 *See also p. 1424. Center for Patient Safety, Research and Practice, Brigham and Women’s Hospital, Boston, MA. Assignment Healthcare Information Technology Trends Paper.
2 Harvard Medical School, Boston, MA. Registration: ClinicalTrials.gov, number NCT02258594. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal). Supported, in part, by The Gordon and Betty Moore Foundation. Dr. Dykes’s institution received funding from the Gordon and Betty Moore Foundation (GBMF). Assignment Healthcare Information Technology Trends Paper.
Dr. Rozenblum’s institution received funding from the GBMF; he disclosed that he is a cofounder of Hospitech Respiration; and he disclosed work for hire. Dr. Dalal’s institution received funding from the GBMF. Dr. Massaro’s institution received funding from the GBMF and from Risk Management Foundation Insurance Company. Dr. Chang received support for article research from the National Institutes of Health. Assignment Healthcare Information Technology Trends Paper.
Dr. Clements’ institution received funding from the GBMF. Dr. Collins’ institution received funding from the GBMF, from research grants funded by Agency for Healthcare Research & Quality, and research contracts funded by the Food and Drug Administration and ASPR. Assignment: Healthcare Information Technology Trends Paper.
Dr. Donze’s institution received funding from the GBMF, and he received funding from Swiss National Science Foundation. Dr. Gazarian’s institution received funding from the GBMF. Dr. Hanna disclosed work for hire. Dr. Lehmann’s institution received funding from the GBMF. Dr. Morrison’s institution received funding from the GBMF. Dr. Samal’s institution received funding from the GBMF. Dr. Schnock’s institution received funding from the GBMF, and she received support for article research from the GBMF.
Dr. Bates’ institution received funding from the GBMF; he received funding from SEA Medical, Intensix, EarlySense, QPID, Zynx, CDI (Negev), Enelgy, ValeraHealth, and MDClone; and he disclosed that he is a coinventor on Patent No. 6029138 held by Brigham and Women’s Hospital on the use of decision support software for medical management, licensed to the Medicalis Corporation, where he holds a minority equity position. Discussion: Healthcare Information Technology Trends.
The remaining authors have disclosed that they do not have any potential conflicts of interest. 1 Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000002449 e806 www.ccmjournal.org Address requests for reprints to: Patricia C. Dykes, PhD, RN, Center for Patient Safety, Research and Practice, Brigham and Women’s Hospital, 1620 Tremont St., Boston, MA. E-mail: firstname.lastname@example.org Objectives: Studies comprehensively assessing interventions to improve team communication and to engage patients and care partners in ICUs are lacking. This study examines the effectiveness of a patient-centered care and engagement program in the medical ICU.
Design: Prospective intervention study. Setting: Medical ICUs at large tertiary care center. Patients: Two thousand one hundred five patient admissions (1,030 before and 1,075 during the intervention) from July 2013 to May 2014 and July 2014 to May 2015. Interventions: Structured patient-centered care and engagement training program and web-based technology including ICU safety checklist, tools to develop shared care plan, and messaging platform.
Patient and care partner access to online portal to view health information, participate in the care plan, and communicate with providers. Measurements and Main Results: Primary outcome was aggregate adverse event rate. Secondary outcomes included patient and care partner satisfaction, care plan concordance, and resourc e utilization. We included 2,105 patient admissions, (1,030 baseline and 1,075 during intervention periods). Discussion: Healthcare Information Technology Trends.
The aggregate rate of adverse events fell 29%, from 59.0 per 1,000 patient days (95% CI, 51.8–67.2) to 41.9 per 1,000 patient days (95% CI, 36.3–48.3; p < 0.001), during the intervention period. Satisfaction improved markedly from an overall hospital rating of 71.8 (95% CI, 61.1–82.6) to 93.3 (95% CI, 88.2–98.4; p < 0.001) for patients and from 84.3 (95% CI, 81.3– 87.3) to 90.0 (95% CI, 88.1–91.9; p < 0.001) for care partners. No change in care plan concordance or resource utilization. August 2017 • Volume 45 • Number 8 Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.
All Rights Reserved. Online Clinical Investigations Conclusions: Implementation of a structured team communication and patient engagement program in the ICU was associated with a reduction in adverse events and improved patient and care partner satisfaction. Assignment Healthcare Information Technology Trends Paper.
(Crit Care Med 2017; 45:e806–e813) Key Words: checklist; medical errors; medical informatics; patientcentered care; patient engagement I CU hospitalizations can be frightening and may have longterm consequences for patients including posttraumatic stress disorder (1). Furthermore, patients cared for in ICUs are particularly vulnerable to adverse events (AEs) (2). Discussion: Healthcare Information Technology Trends.
Although checklists have been found to be effective in reducing specific types of AEs in critical care, preventable AEs still frequently occur (2). Recent literature suggests that the ICU experience could be safer if care were more patient-centered and if patients could be engaged more effectively (3). Active partnerships among health professionals, patients, and families can improve the quality
, safety, and delivery of healthcare (4). Evidence indicates that patient engagement affects self-management, treatment adherence, satisfaction, and healthcare costs (5). However, intensive care is a difficult environment in which to engage patients—because most patients are critically ill and many are incapacitated (6). Assignment Healthcare Information Technology Trends Paper.
Yet, patients and families want to be actively involved, and many patients have a “care partner.” Care partners can be a family member or friend who works with the patient to engage with the healthcare team even when the patient is not physically able. A care partner helps with care navigation including communication with providers, asking for clarity around complex issues, letting the team know about patient preferences, and facilitating follow-up on unresolved issues (7). Assignment Healthcare Information Technology Trends Paper.
Operationally, patient engagement in the ICU may include participation in rounds, communication about values and goals, and protection of individual respect and dignity (4). Interprofessional communication related to the patient’s goals and care plan occurs during patient rounds. Assignment Healthcare Information Technology Trends Paper.
Previous studies focusing on provider members of the care team indicate that a standardized interprofessional rounding structure facilitated by electronic health record (EHR) data and checklist tools is associated with improved adherence with the standard of care, patient outcomes, and provider satisfaction (8, 9). Assignment Healthcare Information Technology Trends Paper.
Earlier work at our institution highlights the importance of engaging with patients and care partners to identify goals of care and to jointly assess the effectiveness of treatment in meeting goals and restoring life (10). However, the use of health information technology (IT) to support integrated patient-centered model of team communication in the ICU, characterized by shared checklists, health information, and goals across team members has not been reported. Patient portals are another way to promote engagement and enhance patient-provider partnerships (11). Assignment Healthcare Information Technology Trends Paper.
The type of information included in patient portals varies markedly by site (12). Portal content can range from EHR data (laboratory results, medications, problems) to patient education and self-management tools. With patient permission, Critical Care Medicine care partners can access their portal. Outpatient portals have been shown to improve patient-provider communication and patient satisfaction (13). However, the use of portals in hospitals, especially in the ICU, has been limited (14).
Despite evidence that health IT and patient-centered care can improve safety and outcomes, little research has assessed interventions that leverage health IT to improve team communication while engaging patients and care partners in the ICU. Therefore, we designed an intervention and conducted a prospective study to assess the effect of a patient-centered care and engagement program enabled by health IT on care delivered in the ICU. METHODS This prospective pre-post study was conducted in two medical ICUs (MICUs) at a large tertiary care center from July 1, 2013, through June 8, 2014 (baseline period), and from July 1, 2014, through May 29, 2015 (intervention period). Implementation of the intervention, including training, was completed by June 30, 2014. Assignment Healthcare Information Technology Trends Paper.
The institutional review board approved the study protocol. Study Unit Descriptions and Patient Eligibility Both MICUs operate using a “closed” model, whereby the critical care team maintained responsibility for all patients on the unit (15). The ICU staff (physicians and nurses) rotated on both units. Assignment Healthcare Information Technology Trends Paper.
Each unit had a physician team comprised of an attending physician, critical care fellows, interns, and residents. There was 24-hour attending-level coverage for each unit, and physician and nursing staff worked 12-hour shifts. Residents rotated in 2-week blocks. Physician and nurse staffing ratios and work schedules were the same during the 11 months of baseline and intervention data collection periods.
Any patient 18 years old or older and admitted to the ICU for 24 hours or longer was eligible to participate. Preintervention Period Attending physicians, fellows, residents, and nurses participated in daily rounds and used existing paper (safety checklist, nursing flow sheet, care plan) and electronic tools (computerized provider order entry, laboratory/test results, medication administration record). There was no preexisting standardized approach for team communication or patient engagement. During rounds, the team verbally reviewed a paper-based safety checklist that included prompts for standard safety elements (16). Intervention Discussion: Healthcare Information Technology Trends.
The Promoting Respect and Ongoing Safety through Patient Engagement Communication and Technology (PROSPECT) intervention was a systems-based patient-centered care and engagement program that was introduced to providers (physicians and nurses) to enhance their responsiveness to patients and care partners (Fig. 1; Appendix A, Supplemental Digital Content 1, http://links.lww.com/CCM/C605).
The intervention consisted of the following components: 1) a 60-minute training session that introduced the Patient SatisfActive Model that included structured patient-centered care training to enhance www.ccmjournal.org e807 Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. Dykes et al Figure 1. Assignment Healthcare Information Technology Trends Paper.
The PROSPECT (Promoting Respect and Ongoing Safety through Patient Engagement Communication and Technology) intervention included 1) a nontechnical structured patient-centered care and engagement model (Patient SatisfActive Model) and 2) a web-based technology to facilitate communication and to engage patients/care partners with providers in their care plan. Providers (physicians, nurses) received structured patient-centered care and engagement training using the Patient SatisfActive Model and a web-based patient-centered toolkit comprised of an ICU safety checklist, shared patient and provider care planning and messaging platform. Providers accessed the toolkit via mobile and desktop devices.
Patients/care partners were given access to a portal via iPads (Apple, Cupertino, CA) to view health information, participate in the care plan, and communicate with providers. Detailed information about the PROSPECT intervention components is included in Appendix A (Supplemental Digital Content 1, http://links.lww. com/CCM/C605). Assignment Healthcare Information Technology Trends Paper.
responsiveness to the needs, concerns, and expectations of patients and care partners and interactive training on the use of a web-based toolkit to facilitate team communication and patient engagement (Appendixes B1, Supplemental Digital Content 2, http://links.lww.com/CCM/C606; Appendix B2, Supplemental Digital Content 3, http://links.lww.com/CCM/ C607). 2) A web-based toolkit including a) an ICU safety checklist prepopulated with real-time EHR data, b) shared patient and provider care planning tools, and c) a messaging platform for communicating with providers and patients.
The webbased toolkit was used by providers for all patients during the intervention period. In addition, all patients and care partners received the Patient SatisfActive Model in which nurses asked patients at admission, during each shift, and at time of ICU discharge about their perceived needs, concerns, and expectations. Patient wishes were routinely discussed by the team during interprofessional rounds and were integrated into the daily care plan as needed. Assignment Healthcare Information Technology Trends Paper.
Patients capable of providing informed consent (or proxy) were eligible to use the patient portal accessible on hospital-issued iPads (iPad Air; Apple, Cupertino, CA) available at every patient’s bedside to view personal health information
, to participate in developing the care plan, and to communicate with providers. Research assistants approached eligible patients (or proxy) to participate in using the portal. The informed consent process was extensive (i.e., a 10-page informed consent and access authorization form). Once enrolled, patients/proxies were shown how to use the portal and could access the portal throughout their stay in the MICU. Main Outcome Measures
The primary outcome was the aggregate rate per 1,000 patient days of selected AEs, defined as failed processes of care and/ or unintended consequences of medical care that can lead to e808 www.ccmjournal.org patient harm (2, 17). To avoid outcomes ascertainment bias, we included only those AEs that are routinely reported within established organizational surveillance processes (and therefore captured and vetted independently of the study team): falls, pressure ulcers, catheter-associated urinary tract infections, central catheter-associated bloodstream infections, and ventilator-associated events. Secondary outcomes were patient and care partner satisfaction, care plan concordance (e.g., agreement on the care plan) between the patient and providers, and healthcare utilization.
Secondary outcome data were collected in REDCap (18) using organizational reporting systems. Validated survey instruments were administered with verbal consent to a randomly selected subsample of patients (19) care partners (20), and providers to assess care plan concordance (21, 22). Patient satisfaction data were collected through telephone using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) (23) survey 6 weeks after discharge.
Hospitalized patients (or a care partner) as well as their bedside nurse and a physician were interviewed at least 48 hours into admission using a validated care plan concordance assessment tool (22) modified to include the patient’s key recovery goal (24). Outcome measure definitions, surveys, and data sources are included in Table 1.
Process measures included the number of patients/care partners who provided informed consent to use the patient portal. Statistical Analysis Based on previously reported AE rates (2) and the effect of communication interventions (8) in critical care, we hypothesized that there would be a 28% decrease in the rate of AEs in the baseline period to the intervention group. We estimated that a total sample size of 1,800 would provide a statistical power of 80% to detect this decrease, at a two-sided significance level of 5% using a propensity-adjusted two sample Poisson test (30). Assignment Healthcare Information Technology Trends Paper.
Demographic characteristics for patient admissions are described using proportions for dichotomous variables and means for continuous variables. Demographics are compared before and during the intervention using Pearson’s chi-square test for dichotomous variables and Wilcoxon rank-sum tests for continuous variables. We used weighted propensity score methods to account for differences in observed participant characteristics between the baseline and intervention periods. Discussion: Healthcare Information Technology Trends.
For the patient/care partner surveys, the following demographics are adjusted: gender, age, education, race, selfreported health status (patient), and relationship to patient (care partner). Using the weighted propensity score method, each patient was weighted by the inverse propensity of being in the baseline or intervention period in all analyses.
The propensity was estimated using logistic regression with potential confounders as covariates. Weighted propensity score methods control for confounding factors better than regression models alone (31). Assignment: Healthcare Information Technology Trends Paper.
The robust SEs used with the weighted propensity score approach also accounted for repeated measures (stays) on the same patient (patients who had multiple stays during the study). AE rates were compared using Poisson regression, with a dichotomous covariate for before versus after the August 2017 • Volume 45 • Number 8 Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. Online Clinical Investigations Promoting Respect and Ongoing Safety Through Patient Engagement Communication and Technology Outcome Measures, Timing, Data Sources, and Methods TABLE 1. Assignment Healthcare Information Technology Trends Paper.
Measure Timing Data Source Method/Tool Ongoing (independent of Promoting Respect and Ongoing Safety through Patient Engagement Communication and Technology Project) BWH Quality and Infection Control Departments Used standard definitions (25–28) for measures that involved data routinely collected by the BWH Quality and Infection Control Departments (external to study team) and events submitted by clinicians Care partner (family) reported experience and satisfaction Prior to transfer from ICU In-person survey with care partner/family by research staff FS-ICU (20) composite score based on average of all 24 items (FSICU total, satisfaction with care, and satisfaction with decisionmaking) FS-ICU includes a 5-point Likert scale 1 (excellent) to 5 (poor). Assignment: Healthcare Information Technology Trends Paper.
All items give response option “not applicable.” 1) A random sample of care partners 2) Sample size based on power calculation Patient reported experience and satisfaction 45 d after discharge from hospital Telephone Survey of Patients by research staff Hospital Consumer Assessment of Healthcare Providers and Systems survey (29) “Top Box Score” e.g., Patients who gave their hospital a rating of 9 or 10 on a scale from 0 (lowest) to 10 (highest) 1) Random sample of care partners 2) Sample size based on power calculation Care plan concordance: The degree of agreement of patient’s overall goal for hospitalization between patient/ care partner, responding physician, and nurse. Assignment Healthcare Information Technology Trends Paper.
At time of transfer (ICU) Patients, care partner/family, physician, nurse interviews Interview based survey based on Haberle (24) 1) Random sample of care partners 2) Sample size based on power calculation Healthcare utilization (proxy) Post discharge BWH administrative data Administrative report 1) Length of stay 2) 30-d readmission Ag… Discussion:Assignment Healthcare Information Technology Trends Paper.