Rate of Post-discharge Medication AdherencePhase 1SMMRTNCT01564446
Interactive Medication Reconciliation By Secure Messaging
A Phase 1 study testing Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen in people with Rate of Post-discharge Medication Adherence, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
Background and Significance: Adverse drug events (ADE) are the most common of all healthcare associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE and avoidable healthcare utilization affecting up to 20% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rate of Post-discharge Medication Adherence
- What is being tested?
- Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Staff at Jamaica Plain and West Roxbury VA.
- Trained in use of secure messaging.
- Inclusion Criteria for Veteran pre intervention focus groups:
- Over 18.
- Receive medical care at the Jamaica Plain or West Roxbury VA.
- Over 18.
- Inpatient at West Roxbury VA.
- Home computer access.
Who cannot join
- N/A
- Exclusion Criteria for Veteran pre intervention focus groups
- Non-ambulatory
- Not receiving medical care at Jamaica Plain or West Roxbury VA.
- Non-inpatient.
- No home computer access.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Official title: Interactive Medication Reconciliation by Secure Messaging
Background and Significance: Adverse drug events (ADE) are the most common of all healthcare associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE and avoidable healthcare utilization affecting up to 20% of patients. Insufficient monitoring has been identified as a particularly common cause of preventable and ameliorable ADE. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called for a process to "accurately and completely reconcile medications across the continuum of care." Inpatient computerized medication reconciliation tools have shown great potential, but little is known about successful medication reconciliation strategies immediately post-discharge. One promising solution to outpatient medication reconciliation is the use of secure electronic communication (SEC) between patients, accessing their personal health record via a web portal, and providers within an electronic health record. Surveys have consistently found that patients want to communicate with their primary care providers via SEC, and SEC is rapidly becoming a standard feature in electronic health records. A SEC-based approach to outpatient medication reconciliation following hospital discharge has the potential to improve patient safety, but important questions must be addressed, including: What information needs to be included in the SEC? What elements of the SEC are essential to its design? How can SEC be best incorporated into the workflow of the primary care office practice? Will patients and physicians find this approach acceptable? To address these questions, we propose a one-year pilot study at VA Boston with the following specific aims:
Aim 1: To evaluate the primary care environment's receptivity to secure electronic communication (SEC) for medication reconciliation and design a prototype SEC. We will use qualitative methods to characterize the primary care clinic environment - the physical space and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills of staff and, most importantly, the patients. Specific approaches will include in-depth interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a prototype SEC for medication reconciliation through a participatory design process, involving primary care clinicians, staff and patients working collaboratively with the research team, and to test the usability and acceptability of the prototype SEC among a sample of patients and primary care clinicians.
Research and Development Plan: With extensive experience in designing and evaluating health care informatics innovations, we have assembled a multi-disciplinary team with expertise from primary care internal medicine, clinical informatics, health services research, qualitative research, clinical pharmacy, nursing and industrial engineering. This team will carry out a formative evaluation and develop a prototype of a secure electronic message to facilitate medication reconciliation following hospital discharge. The proposed CIMIT project will leverage the resources and expertise of the e-Health QUERI (a national VA program for innovation and evaluation of the VA's e-Health programs) at VA Boston and other participating VA facilities nationwide. The figure below shows a very rough conceptualization of the SEC that will guide the qualitative research and participatory design of the prototype. This project will lay the foundation for a future rigorous evaluation of this approach to medication reconciliation and improving patient safety.
Read the detailed description
Adverse drug events (ADE) are the most common of all healthcare-associated adverse events1 and commonly occur after hospitalization when multiple changes to medication regimens take place in the context of poor patient education, inadequate information transfer and delayed continuity of care. Medication reconciliation - i.e., any intentional process to resolve discrepancies between what medications the patient is taking and what medications the health care team thinks the patient is taking - has been designated a "National Patient Safety Goal" since 2005.2-6 Recent studies examining inpatient computerized medication reconciliation tools and pharmacist-facilitated medication reconciliation programs at hospital discharge have shown promising results. However, little is known about successful medication reconciliation strategies following discharge, representing an untapped point of leverage to improve medication safety.
With recently awarded seed funding, and in collaboration with the Department of Veterans' Affairs (VA) nationwide Medication Reconciliation Initiative, we are developing an informatics-based tool for medication reconciliation following hospital discharge by secure, e-mail-like communication: the Secure Messaging for Medication Reconciliation Tool (SMMRT). In this proposed study, we plan to pilot the SMMRT prototype through My HealtheVet (MHV), the VA's secure personal health record and web portal, among 50 Veterans at VA Boston, with the following two Specific Aims:
Specific Aim 1: Refine the existing SMMRT prototype and integrate it into MHV's secure messaging web-interface, with authentication of secure two-way communication between patient and primary healthcare team. We will use a participatory and patient-centered process involving the primary care clinicians, pharmacists, nurses, other staff members and Veterans working collaboratively with the research team to establish the usability and acceptability of the prototype SMMRT.
Specific Aim 2: Pilot the SMMRT prototype, refined through Specific Aim 1, among 50 Veterans with primary care relationships and hospitalized at our facility. Veterans will be recruited prior to hospital discharge, enrolled in MHV if necessary, and trained in the use of secure messaging and specifically the SMMRT tool.
This study will benefit from a recently funded preliminary study (Veterans' Engineering Resource Center seed funding, $25,000), in enabling us to analyze the primary care environment's receptivity to SMMRT-based post-discharge medication reconciliation, focusing on staff activation and education, workflow optimization to incorporate staff and clinicians managing SMMRT's incoming and outgoing messages, and coordination with MHV staff to ensure continued successful software integration.
This proposed CIMIT-funded study will lead to a refined and strengthened intervention to enhance the preliminary use of SMMRT, as well as qualitative results that will constitute the foundation of an investigator-initiated research proposal alongside a full-scale implementation of SMMRT into MHV for Veterans nationwide.
- Being tested
- Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen
- Keywords
- medication, discharge, adherence, compliance, secure message
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive a internet based secure message confirming adherence to post-discharge medication regimenOther
Also called My HealtheVet
Participants will receive a internet based secure message via My HealtheVet (MHV), The VA's online medical record and secure messaging portal. The message will specify post-discharge prescribed medications and inquire about adherence to these medications.
| Study group | Role | What they receive |
|---|---|---|
| secure message regarding post-discharge medication | Experimental | Participants will be sent a secure message to confirm compliance with post-discharge medication. Receives: Other: Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-discharge medication adherence
The degree to which patients are adhering to the medication regimen prescribed following an inpatient stay.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of Post-discharge Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- New England Veterans Engineering Resource Center (VERC), Center for Integration of Medicine & Innovative Technology
- Responsible party
- Principal investigator, Steven Simon, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564446
- Sponsor's protocol ID
- 2580
- Acronym
- SMMRT
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2012
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Medication Reconciliation by Secure Messaging
- ClinicalTrials.gov ID
- NCT01564446
- Acronym / sponsor ID
- SMMRT / 2580
- Keywords
- medication, discharge, adherence, compliance, secure message
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- New England Veterans Engineering Resource Center (VERC), Center for Integration of Medicine & Innovative Technology
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Significance: Adverse drug events (ADE) are the most common of all healthcare associated adverse events. Transitions between inpatient and ambulatory care can lead to ADE and avoidable healthcare utilization affecting up to 20% of patients. Insufficient monitoring has been identified as a particularly common cause of preventable and ameliorable ADE. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has called for a process to "accurately and completely reconcile medications across the continuum of care." Inpatient computerized medication reconciliation tools have shown great potential, but little is known about successful medication reconciliation strategies immediately post-discharge. One promising solution to outpatient medication reconciliation is the use of secure electronic communication (SEC) between patients, accessing their personal health record via a web portal, and providers within an electronic health record. Surveys have consistently found that patients want to communicate with their primary care providers via SEC, and SEC is rapidly becoming a standard feature in electronic health records. A SEC-based approach to outpatient medication reconciliation following hospital discharge has the potential to improve patient safety, but important questions must be addressed, including: What information needs to be included in the SEC? What elements of the SEC are essential to its design? How can SEC be best incorporated into the workflow of the primary care office practice? Will patients and physicians find this approach acceptable? To address these questions, we propose a one-year pilot study at VA Boston with the following specific aims:
Aim 1: To evaluate the primary care environment's receptivity to secure electronic communication (SEC) for medication reconciliation and design a prototype SEC. We will use qualitative methods to characterize the primary care clinic environment - the physical space and facilities, the workflow, the resources, as well as the knowledge, attitudes and skills of staff and, most importantly, the patients. Specific approaches will include in-depth interviews, direct ethnographic observations, and visualization methods Aim 2. To develop a prototype SEC for medication reconciliation through a participatory design process, involving primary care clinicians, staff and patients working collaboratively with the research team, and to test the usability and acceptability of the prototype SEC among a sample of patients and primary care clinicians.
Research and Development Plan: With extensive experience in designing and evaluating health care informatics innovations, we have assembled a multi-disciplinary team with expertise from primary care internal medicine, clinical informatics, health services research, qualitative research, clinical pharmacy, nursing and industrial engineering. This team will carry out a formative evaluation and develop a prototype of a secure electronic message to facilitate medication reconciliation following hospital discharge. The proposed CIMIT project will leverage the resources and expertise of the e-Health QUERI (a national VA program for innovation and evaluation of the VA's e-Health programs) at VA Boston and other participating VA facilities nationwide. The figure below shows a very rough conceptualization of the SEC that will guide the qualitative research and participatory design of the prototype. This project will lay the foundation for a future rigorous evaluation of this approach to medication reconciliation and improving patient safety.
Detailed description
Adverse drug events (ADE) are the most common of all healthcare-associated adverse events1 and commonly occur after hospitalization when multiple changes to medication regimens take place in the context of poor patient education, inadequate information transfer and delayed continuity of care. Medication reconciliation - i.e., any intentional process to resolve discrepancies between what medications the patient is taking and what medications the health care team thinks the patient is taking - has been designated a "National Patient Safety Goal" since 2005.2-6 Recent studies examining inpatient computerized medication reconciliation tools and pharmacist-facilitated medication reconciliation programs at hospital discharge have shown promising results. However, little is known about successful medication reconciliation strategies following discharge, representing an untapped point of leverage to improve medication safety.
With recently awarded seed funding, and in collaboration with the Department of Veterans' Affairs (VA) nationwide Medication Reconciliation Initiative, we are developing an informatics-based tool for medication reconciliation following hospital discharge by secure, e-mail-like communication: the Secure Messaging for Medication Reconciliation Tool (SMMRT). In this proposed study, we plan to pilot the SMMRT prototype through My HealtheVet (MHV), the VA's secure personal health record and web portal, among 50 Veterans at VA Boston, with the following two Specific Aims:
Specific Aim 1: Refine the existing SMMRT prototype and integrate it into MHV's secure messaging web-interface, with authentication of secure two-way communication between patient and primary healthcare team. We will use a participatory and patient-centered process involving the primary care clinicians, pharmacists, nurses, other staff members and Veterans working collaboratively with the research team to establish the usability and acceptability of the prototype SMMRT.
Specific Aim 2: Pilot the SMMRT prototype, refined through Specific Aim 1, among 50 Veterans with primary care relationships and hospitalized at our facility. Veterans will be recruited prior to hospital discharge, enrolled in MHV if necessary, and trained in the use of secure messaging and specifically the SMMRT tool.
This study will benefit from a recently funded preliminary study (Veterans' Engineering Resource Center seed funding, $25,000), in enabling us to analyze the primary care environment's receptivity to SMMRT-based post-discharge medication reconciliation, focusing on staff activation and education, workflow optimization to incorporate staff and clinicians managing SMMRT's incoming and outgoing messages, and coordination with MHV staff to ensure continued successful software integration.
This proposed CIMIT-funded study will lead to a refined and strengthened intervention to enhance the preliminary use of SMMRT, as well as qualitative results that will constitute the foundation of an investigator-initiated research proposal alongside a full-scale implementation of SMMRT into MHV for Veterans nationwide.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| secure message regarding post-discharge medication | Experimental | Other: Participants will receive a internet based secure message confirming adherence to post-discharge medication regimenParticipants will be sent a secure message to confirm compliance with post-discharge medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Staff at Jamaica Plain and West Roxbury VA.
- Trained in use of secure messaging.
- Over 18.
- Receive medical care at the Jamaica Plain or West Roxbury VA.
- Over 18.
Key exclusion criteria (6 listed)
- N/A
- Exclusion Criteria for Veteran pre intervention focus groups
- Non-ambulatory
- Not receiving medical care at Jamaica Plain or West Roxbury VA.
- Non-inpatient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will receive a internet based secure message confirming adherence to post-discharge medication regimenAlso: My HealtheVetParticipants will receive a internet based secure message via My HealtheVet (MHV), The VA's online medical record and secure messaging portal. The message will specify post-discharge prescribed medications and inquire about adherence to these medications. | Other | secure message regarding post-discharge medication |
Primary outcome
post-discharge medication adherence
Time frame: one year
The degree to which patients are adhering to the medication regimen prescribed following an inpatient stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen in people with Rate of Post-discharge Medication Adherence, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-discharge medication adherence (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.