The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02482025
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.8
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Drug-Related Side Effects and Adverse Reactions; Adverse Drug Events	Other: SMMRT	N/A

Detailed Description

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. The Study has received approval for a Project Modification.

The essential scientific changes of the proposed modification are (1) switching from a three-arm to a two-arm RCT; (2) changing the main outcome measure from hospital utilization to medication discrepancies; and (3) reducing the sample size from 1400 to 240 subject. The second specific aim of the Project will become the following:

Aim 2. To conduct a two-arm RCT to evaluate the effect of SMMRT. This trial will compare Usual Care (UC) with UC plus the bundled MHV/SMMRT Intervention among Veterans discharged from the VA Boston Community Living Center (CLC) and from the VA Boston acute inpatient setting of West Roxbury. The primary outcome measure will be medication discrepancies detected 30 days after discharge. Secondary outcome measures will be 30-day hospital utilization (combined readmissions plus emergency department use) and Veterans' self-efficacy in medication use. The primary hypothesis is that SMMRT will result in a reduction in 30-day medication discrepancies as compared with UC.

The third specific aim of the Project remains unchanged:

Aim 3. To evaluate the SMMRT intervention for potential future implementation. In anticipation of future implementation, we will use qualitative methods to identify features of the intervention that are most and least effective, as well as elements that are most and least likely to be accepted into clinical practice.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
• Actual Study Start Date: Nov 16, 2018
• Actual Primary Completion Date: Oct 22, 2019
• Actual Study Completion Date: Jun 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care Usual care delivered at VA Boston
Active Comparator: SMMRT Receives Usual Care PLUS SMMRT Intervention	Other: SMMRT; Includes My HealtheVet registration and enrollment

Outcome Measures

Primary Outcome Measures

1. Medication Discrepancies [30 days after hospitalization]

   Medication discrepancies (discrepancies between what the patient is taking and what is in the medical record) identified 30 days after hospitalization via telephone interview and review of medical record

Secondary Outcome Measures

1. Hospital Utilization [30 days]

   Hospital utilization, defined as re-admissions or emergency department utilization, within 30 days of hospital discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Amy M Linsky, MD MSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02482025
• Other Study ID Numbers: IIR 14-059
• First Posted: Jun 25, 2015
• Last Update Posted: Nov 19, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Medications; Hospitalization; Electronic medical records
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions

Study Results

Participant Flow

Arm/Group Title	Usual Care	SMMRT
Arm/Group Description	Usual care delivered at VA Boston	Receives Usual Care PLUS SMMRT Intervention SMMRT: Includes My HealtheVet registration and enrollment
Period Title: Overall Study
STARTED	122	118
COMPLETED	122	118
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Usual Care	SMMRT	Total
Arm/Group Description	Usual care delivered at VA Boston	Receives Usual Care PLUS SMMRT Intervention SMMRT: Includes My HealtheVet registration and enrollment	Total of all reporting groups
Overall Participants	122	118	240
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (11.8)	63.4 (11.7)	64.9 (11.7)
Sex: Female, Male (Count of Participants)
Female	10 8.2%	8 6.8%	18 7.5%
Male	112 91.8%	110 93.2%	222 92.5%
Race/Ethnicity, Customized (Count of Participants)
White	104 85.2%	100 84.7%	204 85%
Non-White	18 14.8%	18 15.3%	36 15%
MyHealtheVet: Yes, No (Count of Participants)
My HealtheVet - Yes	107 87.7%	105 89%	212 88.3%
My HealtheVet - No	15 12.3%	13 11%	28 11.7%

Outcome Measures

1. Primary Outcome

Title	Medication Discrepancies
Description	Medication discrepancies (discrepancies between what the patient is taking and what is in the medical record) identified 30 days after hospitalization via telephone interview and review of medical record
Time Frame	30 days after hospitalization

Outcome Measure Data

Analysis Population Description

Intention to treat.

Arm/Group Title	Usual Care	SMMRT
Arm/Group Description	Usual care delivered at VA Boston	Receives Usual Care PLUS SMMRT Intervention SMMRT: Includes My HealtheVet registration and enrollment
Measure Participants	122	118
Mean (Standard Deviation) [Medication Discrepancies]	6.4 (4.6)	4.4 (3.2)

2. Secondary Outcome

Title	Hospital Utilization
Description	Hospital utilization, defined as re-admissions or emergency department utilization, within 30 days of hospital discharge.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intention to Treat.

Arm/Group Title	Usual Care	SMMRT
Arm/Group Description	Usual care delivered at VA Boston	Receives Usual Care PLUS SMMRT Intervention SMMRT: Includes My HealtheVet registration and enrollment
Measure Participants	122	118
Count of Participants [Participants]	41 33.6%	35 29.7%

Adverse Events

Time Frame	30-day follow-up
Adverse Event Reporting Description	30-day follow-up telephone calls
Arm/Group Title	Usual Care		SMMRT
Arm/Group Description	Usual care delivered at VA Boston		Receives Usual Care PLUS SMMRT Intervention SMMRT: Includes My HealtheVet registration and enrollment
All Cause Mortality
	Usual Care		SMMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/118 (0%)
Serious Adverse Events
	Usual Care		SMMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/118 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		SMMRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/122 (0%)		0/118 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.