Patient SafetyNCT03544034
Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design
A study testing HomeTeam Toolkit in people with Patient Safety and Adverse Drug Event, run by Johns Hopkins University at 1 site in United States.
Trial summary
This project is to develop, implement, pilot evaluate, and disseminate a medication safety program (HomeTeam) that consolidates strategies to help patients by partnering with patients and their informal caregivers during transitions from hospital to home. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Adverse Drug Event
- What is being tested?
- HomeTeam Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Oct 2022
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 and older
- medicine patients
- hospitalized from home
- English speaking
- no cognitive problems/ can consent
Who cannot join
- surgery patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Univ Armstrong Institute
Baltimore, Maryland, 21202
About this study
This project is to develop, implement, pilot evaluate, and disseminate a medication safety program (HomeTeam) that consolidates strategies to help patients by partnering with patients and their informal caregivers during transitions from hospital to home. Care transitions, especially from hospital to home, are high-risk periods for medication errors, and are frequently associated with serious adverse drug events (ADEs) and preventable readmissions. Older adults with multi-morbid conditions who have complex medication regimes are especially prone to these risks. Patients and family caregivers may experience a dramatic transition in roles and responsibilities immediately after hospital discharge. Patients and family caregivers are relatively passive recipients in their care and medication management in the hospital, but when patients arrive at home, patients have the primary responsibility for their care and medication use (with professional care providers switching to a 'supporting' function). Although this significant transition in the nature and intensity of patient work needs to be managed actively, often patients and family members are not adequately engaged and prepared in the hospital, and not effectively supported for safe medication use after hospital discharge. More specifically, patients and family members may not understand essential steps in the management of their condition, and have difficulty contacting appropriate health care practitioners for guidance. Although most organizations deploy multiple layers of interventions for improving care transitions, reducing postdischarge adverse drug events (ADEs), 30-day readmissions and emergency department (ED) visits, their impact to date has been small, and there remains significant and urgent need to fundamentally redesign the hospital-to-home care transition process. Investigators believe that one practical and potentially effective way for this 'much-needed' redesign is through engaging and supporting patients and families in safe medication use. Investigators' proposed program 'HomeTeam' will contain evidence-based tools and methods for engaging patients and shifting culture towards a truly patient-centered care for medication safety.
Read the detailed description
The 'HomeTeam will be developed and evaluated by completing 3 specific aims:
Aim #1: Develop components of a multi-faceted program (HomeTeam) that consolidates evidence-based practices in patient and family activation and engagement related to medication safety, with the goal to adequately and reliably support transitions from the hospital to the patient home "work system" for medication management. Inpatient stays and the hospital discharge periods will be targeted as opportunities in activating, engaging, and enabling patients and family members to improve medication safety.
(1a) Identify evidence-based practices in patient and family activation and engagement related to medication safety during care transitions.
- b) Develop program components (e.g., action-oriented patient/ family education, improved medication reconciliation, patient-centered rounds, learning systems through systematic feedback from home care professionals)-including tools to assess, prioritize, streamline, and integrate existing practices- aimed at engaging patients and families and supporting medication use safety during care transitions from hospital to home with a participatory design (PD) approach. Aim #2: Refine and implement the HomeTeam program in two organizations (one academic, one community hospital), with a peer-to-peer assessment methodology to identify and refine patient and family engagement practices for transitional care medication safety.
- a) Refine HomeTeam program through participatory design approach and peer-to-peer assessment (2b) Implement and pilot test HomeTeam in all participating sites
Aim #3: Evaluate the implementation process and the impact of the toolkit 'HomeTeam' on medication safety after hospital discharge. Investigators will use a pre-post design to evaluate the impact of the toolkit over a one year period, focusing on 65 years of age and older medicine patients. The primary outcome is preventable and ameliorable adverse drug events (ADEs) after discharge. Secondary outcomes include 30-day post-discharge readmissions and ED visits due to medication-related issues process improvement assessment, patient-reported outcomes, and toolkit adoption assessment (e.g., acceptability, feasibility). Qualitative methods (post-implementation interviews with clinicians and patient/ family members) will be used as part of the evaluation.
Hypothesis: Investigators hypothesize that the HomeTeam Medication Safety Program will reduce preventable and ameliorable post-discharge 30-day ADEs in the following subpopulations: older adults with at least 5 medications discharged from hospital to home on (H01) anticoagulants, (H0b) opioids, (H0c) diabetes agents.
The project will be conducted in two hospitals: Bayview Medical Center (academic) and Howard County Medical Center (community). Dissemination plans include national medication safety organizations (e.g., Institute for Safe Medication Practices), patient safety organizations (e.g., Batz Patient Safety Foundation), and professional societies (e.g., Society of Hospital Medicine). Different dissemination modalities are planned, including story-telling through social media and short videos targeted for patients and clinicians.
- Conditions
- Patient Safety, Adverse Drug Event
- Being tested
- HomeTeam Toolkit
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeTeam ToolkitBehavioural
A multi-component intervention (8S's)
- Safety at home through partnership.
- Safety risk assessment at the admission
- Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management
- Safety tools. Cognitive tools to support patient/family after discharge
- Safety education. Enhanced Patient/ family medication safety education
- Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks.
- Safety through learning routines across the care continuum
- Safety assessment after discharge
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline |
| Post-intervention | Experimental | Hometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services. Receives: Behavioral: HomeTeam Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable adverse drug events
Preventable ADEs are injuries that could have bee n avoided, that is, an injury judged to probably be the result of an error or a system design flaw.
Measured: 30 days after hospital discharge
Ameliorable adverse drug events
Ameliorable ADEs are injuries whose severity could have been substantially reduced if different actions or procedures had been performed or followed.
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study startDec 2019 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pre-post study in two hospitals. Implementation will be done at the organization level (for all 65 and older patients admitted to hospitalist service in these two hospitals.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas at Arlington
- Responsible party
- Sponsor
- Investigators
- Ayse Gurses, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544034
- Sponsor's protocol ID
- IRB00175392
- Status last verified
- Jan 2020
- First submitted
- 17 May 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design
- ClinicalTrials.gov ID
- NCT03544034
- Acronym / sponsor ID
- IRB00175392
- Conditions
- Patient Safety, Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The University of Texas at Arlington
- Study start
- Dec 2019 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Jun 2018 (actual)
- 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.
This project is to develop, implement, pilot evaluate, and disseminate a medication safety program (HomeTeam) that consolidates strategies to help patients by partnering with patients and their informal caregivers during transitions from hospital to home. Care transitions, especially from hospital to home, are high-risk periods for medication errors, and are frequently associated with serious adverse drug events (ADEs) and preventable readmissions. Older adults with multi-morbid conditions who have complex medication regimes are especially prone to these risks. Patients and family caregivers may experience a dramatic transition in roles and responsibilities immediately after hospital discharge. Patients and family caregivers are relatively passive recipients in their care and medication management in the hospital, but when patients arrive at home, patients have the primary responsibility for their care and medication use (with professional care providers switching to a 'supporting' function). Although this significant transition in the nature and intensity of patient work needs to be managed actively, often patients and family members are not adequately engaged and prepared in the hospital, and not effectively supported for safe medication use after hospital discharge. More specifically, patients and family members may not understand essential steps in the management of their condition, and have difficulty contacting appropriate health care practitioners for guidance. Although most organizations deploy multiple layers of interventions for improving care transitions, reducing postdischarge adverse drug events (ADEs), 30-day readmissions and emergency department (ED) visits, their impact to date has been small, and there remains significant and urgent need to fundamentally redesign the hospital-to-home care transition process. Investigators believe that one practical and potentially effective way for this 'much-needed' redesign is through engaging and supporting patients and families in safe medication use. Investigators' proposed program 'HomeTeam' will contain evidence-based tools and methods for engaging patients and shifting culture towards a truly patient-centered care for medication safety.
Detailed description
The 'HomeTeam will be developed and evaluated by completing 3 specific aims:
Aim #1: Develop components of a multi-faceted program (HomeTeam) that consolidates evidence-based practices in patient and family activation and engagement related to medication safety, with the goal to adequately and reliably support transitions from the hospital to the patient home "work system" for medication management. Inpatient stays and the hospital discharge periods will be targeted as opportunities in activating, engaging, and enabling patients and family members to improve medication safety.
(1a) Identify evidence-based practices in patient and family activation and engagement related to medication safety during care transitions.
- b) Develop program components (e.g., action-oriented patient/ family education, improved medication reconciliation, patient-centered rounds, learning systems through systematic feedback from home care professionals)-including tools to assess, prioritize, streamline, and integrate existing practices- aimed at engaging patients and families and supporting medication use safety during care transitions from hospital to home with a participatory design (PD) approach. Aim #2: Refine and implement the HomeTeam program in two organizations (one academic, one community hospital), with a peer-to-peer assessment methodology to identify and refine patient and family engagement practices for transitional care medication safety.
- a) Refine HomeTeam program through participatory design approach and peer-to-peer assessment (2b) Implement and pilot test HomeTeam in all participating sites
Aim #3: Evaluate the implementation process and the impact of the toolkit 'HomeTeam' on medication safety after hospital discharge. Investigators will use a pre-post design to evaluate the impact of the toolkit over a one year period, focusing on 65 years of age and older medicine patients. The primary outcome is preventable and ameliorable adverse drug events (ADEs) after discharge. Secondary outcomes include 30-day post-discharge readmissions and ED visits due to medication-related issues process improvement assessment, patient-reported outcomes, and toolkit adoption assessment (e.g., acceptability, feasibility). Qualitative methods (post-implementation interviews with clinicians and patient/ family members) will be used as part of the evaluation.
Hypothesis: Investigators hypothesize that the HomeTeam Medication Safety Program will reduce preventable and ameliorable post-discharge 30-day ADEs in the following subpopulations: older adults with at least 5 medications discharged from hospital to home on (H01) anticoagulants, (H0b) opioids, (H0c) diabetes agents.
The project will be conducted in two hospitals: Bayview Medical Center (academic) and Howard County Medical Center (community). Dissemination plans include national medication safety organizations (e.g., Institute for Safe Medication Practices), patient safety organizations (e.g., Batz Patient Safety Foundation), and professional societies (e.g., Society of Hospital Medicine). Different dissemination modalities are planned, including story-telling through social media and short videos targeted for patients and clinicians.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre-post study in two hospitals. Implementation will be done at the organization level (for all 65 and older patients admitted to hospitalist service in these two hospitals.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline |
| Post-intervention | Experimental | Behavioral: HomeTeam ToolkitHometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 and older
- medicine patients
- hospitalized from home
- English speaking
- no cognitive problems/ can consent
Key exclusion criteria (1 listed)
- surgery patients
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 |
|---|---|---|
| HomeTeam ToolkitA multi-component intervention (8S's) 1. Safety at home through partnership. 2. Safety risk assessment at the admission 3. Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management 4. Safety tools. Cognitive tools to support patient/family after discharge 5. Safety education. Enhanced Patient/ family medication safety education 6. Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks. 7. Safety through learning routines across the care continuum 8. Safety assessment after discharge | Behavioural | Post-intervention |
Primary outcome
Preventable adverse drug events
Time frame: 30 days after hospital discharge
Preventable ADEs are injuries that could have bee n avoided, that is, an injury judged to probably be the result of an error or a system design flaw.
Ameliorable adverse drug events
Time frame: 30 days after hospital discharge
Ameliorable ADEs are injuries whose severity could have been substantially reduced if different actions or procedures had been performed or followed.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Ayse Gurses principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HomeTeam Toolkit in people with Patient Safety and Adverse Drug Event, run by Johns Hopkins University 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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Jan 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Preventable adverse drug events (time frame: 30 days after hospital discharge). The study lists 2 primary outcomes in all. 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 29 Jan 2020.