Boston, Massachusetts 02130


Purpose:

Medication discrepancies, defined as unintentional differences found between patients' medical records and patients' reports of the medication they are taking, occur frequently after hospital discharge, predisposing to adverse drug events (ADEs), emergency department visits and readmissions. Resolving medication discrepancies - medication reconciliation - is mandated at every care transition, but little is known about intervention strategies to improve medication reconciliation in the post-discharge period, when patients may lack prompt access to primary care and are at high risk for ADEs. To address this gap, the investigators developed and pilot tested the Secure Messaging for Medication Reconciliation Tool (SMMRT), with a pharmacist communicating with Veterans to review medications and reconcile discrepancies after hospital discharge via Secure Messaging (SM), within My HealtheVet (MHV), VA's patient portal. The objectives of The SMMRT Trial are therefore To optimize the end-users' experience with SMMRT through usability testing and refinement of the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices and, specifically, on Veterans' interactions with their primary care providers.


Study summary:

Study Procedure of Work Done at Richard L. Roudebush VAMC in Indianapolis Aim 1 of SMMRT will be conducted at the Human-Computer Interaction & Simulation Laboratory within the HSR&D Center for Health Information and Communication at the Richard L. Roudebush VAMC in Indianapolis, IN. The work in Indianapolis will include a formal usability test of SMMRT to access and improve usability for pharmacists, nurses, and patients. Ten VA pharmacists, 10 VA nurses, and 10 VA patients will participate in the usability tests in Indianapolis. They will assess how well the SMMRT interface supports their respective medication reconciliation tasks. Pharmacists who work for the Roudebush VAMC and have some responsibility for medication reconciliation in their normal work will be eligible to participate in the study. Roudebush VAMC nurses who work as part of a Patient Aligned Care Team (PACT) will be eligible. Eligible patients must be taking at least 5 medications and must have been discharged from the Roudebush VAMC within the last 30 days. Veterans will be excluded if they are cognitively impaired, based on the Callahan screener. Patients will be recruited regardless of prior MHV use. No patients will have previous experience with SMMRT, as it is a new feature in MHV. Usability testing sessions will be about 30 minutes and will include audio and video recordings of the computer screen movements and the participant's face. A standardized script is read to the participants to instruct them to do certain tasks that will evaluate specific usability issues in the SMMRT. The participants enter reconciled medications into the SMMRT and the completed work is sent to the research team for analysis. Although the investigators intend to complete all data collection procedures for Aim 1 at the Indianapolis VA, the investigators did note in the submitted grant proposal (Section 4.g.1) that the investigators would recruit (VA) Boston pharmacists for Aim 1 data collection in the unlikely event that the investigators cannot recruit sufficient numbers from Indianapolis. If that unlikely contingency arises (i.e., the investigators determine that there is a need to recruit pharmacists from VA Boston), the investigators will submit an amendment to the VA Boston IRB with appropriate consent and authorization forms at that time. Study Procedure of Work at VABHS A three-armed randomized controlled trial (RCT) (Aim 2) and a formative evaluation of SMMRT (Aim 3) will both be conducted at VA Boston Healthcare System's West Roxbury inpatient facility. The usability testing results from Aim 1 at Indianapolis will be incorporated to improve SMMRT before the RCT is conducted. The RCT will compare the effectiveness of (1) Usual Care (UC), (2) UC plus MyHealtheVet (MHV) enrollment and training, and (3) UC plus MHV training plus medication reconciliation with a pharmacist using SMMRT. The RCT will enroll 1,400 hospitalized Veterans at VA Boston and will assess the main outcome of hospital utilization (including hospital readmissions and emergency room) during the 30 days after discharge. Secondary outcomes that will be assessed include medication discrepancies, community tenure, and measures of patient satisfaction and self-efficacy related to medication use. Aim 2: Dr. Simon and research team members will meet with clinical teams to describe the study and patient recruitment and eligibility. Research assistants will review the daily census of hospitalized Veterans to ascertain anticipated discharge dates and to identify any Veterans with obvious exclusion criteria. After patients complete the consent-to-contact form, research assistants will introduce patients to the study. Interested patients will be screened for eligibility and those eligible will be consented for participation. Veterans will be eligible for the study if they are age 18 or older, have a VA primary care provider at a VISN-1 VA facility, are being discharged to their home, have computer and internet access, will be discharged with at least five medications, and are not cognitively impaired (based on Callahan screener). Patients will randomly be assigned to one of three study arms. Usual care (UC) includes medication reconciliation at every transition in hospitalization. At discharge, the Veteran receives a printed list of medications with instructions. After discharge, Veterans receive a "care coordination" telephone call, ideally within 2 business days of hospital discharge, from a nurse on the Patient Aligned Care Team (PACT). The call includes a review of symptoms, diet, activity, upcoming visits, and medications, but medication reconciliation does not usually occur on this call. The study arm UC with MHV includes all described in UC plus training in MHV. Veterans who are not yet enrolled in MHV will be assisted in enrolling and in completing the in-person authorization. Key features of MHV will be explained and demonstrated to the Veterans, including secure messaging (SM), the Blue Button, and how to send messages and recognize when they have received a message. They will also be instructed regarding SMMRT. Participants will be shown how to save, edit, and re-attach attachments in SM. Usual care with MHV training and SMMRT will include all previously described care as well as communication with a pharmacist after discharge through SMMRT. In this SMMRT intervention arm, a pharmacist reviews the patient chart within 3 days of discharge, reconciles medications in SMMRT and adds photographs of the patient's medications from the Medication Image Library (MIL). The SMMRT is sent to the patient after the pharmacist reviews it. The patient will be encouraged to have medications with him or her while reviewing and editing the SMMRT to reflect what he or she is actually taking. The patient then sends the SMMRT back to the pharmacist. The pharmacist records the medication reconciliation in the Computerized Patient Record Systems (CPRS) and communicates with the PCP for urgent and unclear issues. The pharmacist sends the final SMMRT to the patient. Research assistants blinded to the participants' study arm will contact all participants by phone 30 days after discharge to learn about their hospital visits since discharge. This 30-40 minute interview will follow a written protocol and will also obtain information regarding the patient's medication discrepancies, health status, satisfaction with care post-discharge, and self-efficacy relating to taking medication. Reminder letters will be sent a week before the scheduled phone interview. Letters will be sent to reschedule the phone call if the Veteran is unreachable after several attempts. A data abstraction tool will be developed and used to obtain participant's hospital utilization information, including reason, length, and whether it was planned. CPRS and CDW will be reviewed to find dates of hospital readmission or emergency department visits. The research assistant will also uncover if participant was reached for "care coordination" call and if medication reconciliation occurred during the conversation. Interview data will be recorded and analyzed in SAS. Aim 3 involves in-depth interviews of Veterans and staff within two weeks of study completion to understand the characteristics of MHV and SMMRT that users prefer. A subset of participants from Aim 2will be selected to participate in Aim 3. Twenty Veteran participants from each study arm will participate in the interviews in Aim 3. The investigators will use semi-structured interview guide that includes a core list of questions to be supplemented by prepared and spontaneous follow-up questions to seek clarification and examples. The interviews will identify factors related to successful or unsuccessful implementation of the MHV Training and SMMRT interventions. The interview will be designed to encourage Veterans to provide feedback on specific details of the intervention that they found helpful and features that were confusing or not helpful. The investigators will also recruit 15-20 PACT nurses for brief, focused interviews to explore how SMMRT influenced post-discharge calls and more generally their workflow and communication with Veterans.


Criteria:

Inclusion Criteria: - Veterans age 18 years or older - Having a VA primary care provider (PCP) at any VA facility in VISN-1 - Planned discharge home (as opposed to another facility) - Computer and internet access - Anticipated to be discharged with at least 5 medications. - Having a VA PCP will be defined as having seen the provider within the past two years - Planned discharge home will be ascertained from the Veteran's nurse; approximately 75% of VA Boston discharges are to home - The nurse will also provide number of anticipated discharge medications Exclusion Criteria: - Cognitive impairment (as determined by the Callahan screener)


NCT ID:

NCT02482025


Primary Contact:

Principal Investigator
Steven R Simon, MD MPH BS
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Steven R Simon, MD MPH BS
Phone: (857) 364-5704
Email: steven.simon2@va.gov


Backup Contact:

Email: amy.linsky@va.gov
Amy M Linsky, MD MSc
Phone: (857) 364-5467


Location Contact:

Boston, Massachusetts 02130
United States

Maria Higgins
Phone: 857-364-4802
Email: maria.higgins@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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