The Effects of a Multifaceted Intervention to Improve Care Transitions Within an Accountable Care Organization: Results of a Stepped-Wedge Cluster-Randomized Trial
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BACKGROUND: Transitions from hospital to the ambulatory setting are high risk for patients in terms of adverse events, poor clinical outcomes, and readmission.
OBJECTIVES: To develop, implement, and refine a multifaceted care transitions intervention and evaluate its effects on postdischarge adverse events.
DESIGN, SETTING, AND PARTICIPANTS: Two-arm, single-blind (blinded outcomes assessor), stepped-wedge, cluster-randomized clinical trial. Participants were 1,679 adult patients who belonged to one of 17 primary care practices and were admitted to a medical or surgical service at either of two participating hospitals within a pioneer accountable care organization (ACO).
INTERVENTIONS: Multicomponent intervention in the 30 days following hospitalization, including: inpatient pharmacist-led medication reconciliation, coordination of care between an inpatient “discharge advocate” and a primary care “responsible outpatient clinician,” postdischarge phone calls, and postdischarge primary care visit.
MAIN OUTCOMES AND MEASURES: The primary outcome was rate of postdischarge adverse events, as assessed by a 30-day postdischarge phone call and medical record review and adjudicated by two blinded physician reviewers. Secondary outcomes included preventable adverse events, new or worsening symptoms after discharge, and 30-day nonelective hospital readmission.
RESULTS: Among patients included in the study, 692 were assigned to usual care and 987 to the intervention. Patients in the intervention arm had a 45% relative reduction in postdischarge adverse events (18 vs 23 events per 100 patients; adjusted incidence rate ratio, 0.55; 95% CI, 0.35-0.84). Significant reductions were also seen in preventable adverse events and in new or worsening symptoms, but there was no difference in readmission rates.
CONCLUSION: A multifaceted intervention was associated with a significant reduction in postdischarge adverse events but no difference in 30-day readmission rates.
© 2021 Society of Hospital Medicine
Patient and Public Involvement in Research
As with all PCORI-funded studies, this study involved a patient-family advisory council (PFAC). Our PFAC included six recently hospitalized patients or caregivers of recently hospitalized patients. The PFAC participated in monthly meetings throughout the study period. They helped inform the research questions, including confirmation that the endpoints were patient centered, and provided valuable input for the design of the intervention and the patient-facing components of the data collection instruments. They also interviewed several patient participants in the study regarding their experiences with the intervention. Lastly, they helped develop plans for dissemination of study results to the public.19
We also formed a steering committee consisting of physician, nursing, pharmacy, information technology, and administrative leadership representing primary care, inpatient care, and transitional care at both hospitals and Partners Healthcare. PFAC members took turns participating in quarterly steering committee meetings.
Evolution of the Intervention and Implementation
The intervention was iteratively refined during the course of the study in response to input from the PFAC, steering committee, and members of the intervention team; cases of adverse events and readmissions from patients despite being in the intervention arm; exit interviews of patients who had recently completed the intervention; and informal feedback from inpatient and outpatient clinicians. For example, we learned that the more complicated a patient’s conditions are, the sooner the clinical team wanted them to be seen after discharge. However, these patients were also less likely to feel well enough to keep that appointment. Therefore, the timing of follow-up of appointments needed to be a negotiation among the inpatient team, the patient, any caregivers, and the outpatient provider. PFAC members also emphasized that patients wanted one person to trust and to be the “point person” during a complicated transition such as hospital discharge.
At the same time, the intervention components evolved because of factors outside our control (eg, resource limitations). In keeping with the real-world nature of the research, the aim was for the intervention to be internally supported because incentives were theoretically more aligned with improvement of care transitions under the ACO model. By design, the PCORI contract only paid for limited parts of the intervention, such as a nurse practitioner to act as the discharge advocate at one hospital, overtime costs of inpatient pharmacists, and project manager time to facilitate inpatient-outpatient provider communication. (See Table 1 of Appendix 1 for details about the modifications to the intervention.)
Lastly, in keeping with PCORI’s methodology standards for studies of complex interventions,20 we strove to standardize the intervention by function across hospitals, units, and practices, while still allowing for local adaptation in the form. In other words, rather than specifying exactly how a task (eg, medication counseling) needed to be performed, the study design offered sites flexibility in how they implemented the task given their available personnel and institutional culture.
Intervention Fidelity
To determine the extent to which each patient in the intervention arm received each intervention component, a project manager unblinded to treatment arm reviewed the electronic medical record for documentation of each component implemented by providers (eg, inpatient pharmacists, outpatient nurses). Because each intervention component produced documentation, this provided an accurate assessment of intervention fidelity, ie, the extent to which the intervention was implemented as intended.
