Impact of a Multicomponent Care Transition Intervention on Hospitalizations and Emergency Department Visits in Patients with Venous Thromboembolism Alok.

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Impact of a Multicomponent Care Transition Intervention on Hospitalizations and Emergency Department Visits in Patients with Venous Thromboembolism Alok Kapoor, MD, MSc David McManus, MD Bruce Barton, PhD Chad Darling, MD Saud Javed, MD Kathleen Mazor, EdD

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Conflicts of Interest Dr. Kapoor receives sponsored research support from Pfizer Independent Grants for Learning and Change. He is also funded by Bristol Myers Squibb for atrial fibrillation research. Dr. McManus has received research grant funding from Bristol-Myers Squibb, Boeringher-Ingelheim, Pfizer, Samsung, Philips Healthcare, Biotronik, and Apple, Inc. He has received consultancy fees from Bristol-Myers Squibb, Pfizer, Flexcon, Boston Biomedical Associates, and has inventor equity in Mobile Sense Technologies, Inc. All other authors report no conflicts. April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Background Venous Thromboembolism (VTE) is a significant health problem Annual incidence 900,000 Annual treatment cost $10 B Hospital utilization after VTE diagnosis ~20% Preventing hospital utilization after VTE diagnosis complex Initiation/maintenance of anticoagulants Need for more intensive multicomponent intervention April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Study Design RCT assessing the impact of a multicomponent intervention on hospitalizations in months after VTE diagnosis Outcome measures: Hospitalization and Emergency Department (ED) visits Determined by chart review and phone interview April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Setting and Population UMass Memorial Health Care, a multi-hospital system in central MA Inclusion Criteria VTE episode diagnosed in previous 2 weeks in hospital or ambulatory setting Prescribed warfarin, direct oral anticoagulant, or low molecular weight heparin Age 18+ English-speaking Exclusion Criterion Discharge to a nursing home April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Methods Identification Screened radiology reports and provider referrals for new cases of VTE Recruitment In-person (written consent) By phone (verbal consent + written consent via mail) Randomization Stratified on type of anticoagulant April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Methods Intervention Pharmacist home visit (within 7 days of randomization) Medication reconciliation and simulation* Assessment and education Contact with prescriber (if warranted) Illustrated medication instructions Anticoagulation expert follow-up consultation (within 30 days of randomization) *Kapoor JPS 2018 April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Illustrated Medication Instructions Kapoor et al. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2019 Jan 29. [Epub ahead of print] PMID: 30702452 April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Methods Control Standard discharge paperwork without illustrated medication instructions No contact with pharmacist or anticoagulation expert April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Methods Physicians: blinded chart review Identify hospitalization or ED visits up to 90 days post-randomization Patients: telephone interview 90-120 days post-randomization hospitalized or visited ED outside health system? When, where, reason April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Study Flow Kapoor A, Landyn V, Wagner J, Burgwinkle P, Huang W, Gore J, Spencer FA, Goldberg R, McManus DD, Darling C, Boudreaux E, Barton B, Mazor KM. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2019. April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Study Flow (Cont.) Kapoor A, Landyn V, Wagner J, Burgwinkle P, Huang W, Gore J, Spencer FA, Goldberg R, McManus DD, Darling C, Boudreaux E, Barton B, Mazor KM. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2019. April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Analysis Compared outcomes (unadjusted and unadjusted) Incidence rate of hospitalization and ED visits for each group Incidence rate = # of events / sum of time observed in each group Negative binomial distribution for multivariate regression 70% of patients had no events Examined effect of intervention using… Intention to treat (ITT) cohort Completer cohort April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Covariates Gender Patient Activation Race Charlson Comorbidity Index Ethnicity VTE Type Income Level Anticoagulant Prescribed Health Literacy Care Transition Type April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: ITT Cohort Characteristics Most covariates balanced between intervention (n=77) and control groups (n=85) Gender: more men, but even between groups Race: mostly white, both groups Education: mostly high school educated or higher Income, health literacy, patient activation, VTE type, anticoagulant prescribed, care transition type No between group differences Charlson Comorbidity Index: lower in the intervention group (p = 0.03) April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: ITT Cohort Hospitalizations Intervention (n=77) Control (n=85) Hospitalizations 11 23 Related to index: Yes 6 (of 11) 3 (of 23) Reason: Recurrent VTE Reason: Major/Clinically Relevant Bleeding 1 2 Reason: Other (SOB, Suspicion VTE, Minor Bleeding) 5 Preventable: Yes* 2 (of 11) *Preventable defined as better adherence with medication, better control of anticoagulant, avoidance of another medication that could have interfered with anticoagulant, or better education of the patient about what to expect (minor bleeding while brushing teeth, etc.). April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: ITT Cohort ED Visits Intervention (n=77) Control (n=85) ED Visits 14 15 Related to index: Yes 8 (of 14) 4 (of 15) Reason: Recurrent VTE Reason: Major/Clinically Relevant Bleeding 4 Reason: Other (SOB, Suspicion VTE, Minor Bleeding) Preventable: Yes* 3 (of 14) 0 (of 15) *Preventable defined as better adherence with medication, better control of anticoagulant, avoidance of another medication that could have interfered with anticoagulant, or better education of the patient about what to expect (minor bleeding while brushing teeth, etc.). April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: ITT Cohort All Encounters Intervention (n=77) Control (n=85) Total Number of Encounters (Hospitalizations and ED Visits) 25 38 Observation Days 5,778 6,320 Incidence rate (per 1,000 patient days followed) 4.33 6.01 Incidence rate ratio (unadjusted) 0.71 (95% CI: 0.40 – 1.27) Incidence rate ratio (adjusted)* 1.05 (95% CI 0.57-1.91) *Covariates: gender, income, race, Hispanic ethnicity, blood clot type, health literacy, patient activation, and Charlson score. April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: Completer Characteristics 54 intervention participants completed all aspects of the intervention; 23 did not Compared with controls (n=85), completers (n=54) Had greater percentages of participants who Were white (95.9% vs. 77.9%) Had DVT alone (57.1% vs. 42.9%) Transitioned from ambulatory care to home (22.5% vs. 13.0%) No significant differences on quality of care transition, knowledge, adherence Adjusted IRR = 1.05 (no different from ITT result) April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Discussion Confirmed high utilization of hospital and ED post-VTE diagnosis Multicomponent intervention did not reduce visits Intervention group had fewer visits, but most of the control group visits were unrelated to VTE, bleeding or anticoagulation Future research Testing other interventions for VTE Those that address other comorbidities and conditions of VTE patients (pain related -chest and back pain, cellulitis, dizziness) Testing our multicomponent / pharmacologic based intervention in another group of patients April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Limitations Small sample size Unable to examine effect of intervention in subgroups (e.g., patients with low health literacy) Loss to follow up Two-step process of enrollment Fidelity concerns Significant number of patients assigned to intervention did not receive all parts of it April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Acknowledgements Funding support Pfizer’s Independent Grants for Learning and Change Initiative National Center for Advancing Translational Sciences of the National Institutes of Health (UL1TR000161) Software REDCap Picture Rx April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Additional Acknowledgements Co-Investigators Robert Goldberg, PhD Joel Gore, MD Pamela Burgwinkle, MS, APN Nathan Erskine, MD/PhD Candidate Frederick Spencer, MD Wei Huang, PhD Edwin Boudreaux, PhD Abiramy Maheswaran, MD Gurkirat Singh Xiaoshuang Chen, MD Ahmed Nagy, MD Rasha Elhag, MD Edna Markaddy, MD Shoshana J. Herzig, MD, MPH Clinical Staff Recruiters / Reviewers Yoel Vega Carrasquillo, MD Emily Kaditz, MD Pharmacists Matt Silva, PharmD Ann Lynch, PharmD Dinesh Yogaratnam, PharmD, BCPS Brian Carlone, PharmD Katelyn Springer, PharmD, RPh Timothy Aungst, PharmD Donna Bartlett, PharmD, BCGP, RPh Diana Houng, PharmD, BCPS Project Manager Joann Wagner, MSW Project Staff Valentina Landyn Mary Ellen Stansky Julie St. John, MA, LADCI Yanhua Zhou, MS Timothy Konola, BA April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Author Contact Information Alok Kapoor, MD, MSc Alok.Kapoor@umassmemorial.org Kathy Mazor, EdD Kathy.Mazor@Meyersprimary.org April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Impact of Multicomponent Care Transition Intervention on VTE Outcomes Thank You! April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: Completers Cohort Hospitalizations Outcome: Hospitalizations Intervention (n=54) Control (n=85) Hospitalizations 5 23 Related to index: Yes 4 3 Reason: Recurrent VTE Reason: Major/Clinically Relevant Bleeding 1 2 Reason: Other (SOB, Suspicion VTE, Minor Bleeding) Preventable: Yes April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: Completers Cohort ED Visits Outcome: ED Visits Intervention (n=54) Control (n=85) ED Visits 12 15 Related to index: Yes 7 4 Reason: Recurrent VTE Reason: Major/Clinically Relevant Bleeding 3 Reason: Other (SOB, Suspicion VTE, Minor Bleeding) Preventable: Yes April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes

Results: Completers Cohort Incidence Rate Outcome: All Encounters (Hospitalizations and ED Visits) Intervention (n=54) Control (n=85) Total Number of Encounters 17 38 Days of Observation 4,179 6,320 Incidence rate (per 1,000 patient days followed) 4.07 6.01 Incidence rate ratio unadjusted for covariates 0.71 (95% CI: 0.37 – 1.35) Incidence rate ratio adjusted for covariates* 1.05 (95% CI 0.57-1.91) *Covariates: gender, income, race, Hispanic ethnicity, blood clot type, health literacy, patient activation, and Charlson score. April 9, 2019 Impact of Multicomponent Care Transition Intervention on VTE Outcomes