Medication SafetyNCT02781662
Improving Safety After Hospitalization in Older Persons on High-Risk Medications
A study testing Pharmacist Home-Visit in people with Medication Safety, run by University of Massachusetts, Worcester.
Trial summary
This study evaluates an intervention to reduce medication errors and adverse drug events in older adults who have recently been discharged from the hospital and prescribed anticoagulants, diabetes agents, or opioids. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Safety
- What is being tested?
- Pharmacist Home-Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2016to 20 Sep 2019
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age and having been prescribed one of the three high-risk drug categories (anticoagulants, diabetes agents, and opioids) at the time of hospital discharge and must meet one or more of following screening Items:
- Prescribed >2 high-risk medications
- Low health literacy
- Caregiver (an affirmative response to "Have you received assistance from one or more caregivers over the past 4 weeks?").
- Low adherence
- Using >7 different medications
Who cannot join
- Plans to enroll in hospice upon discharge.
- Discharged for a psychiatric condition.
- Discharged to a skilled nursing facility, rehabilitation hospital, or nursing home.
- Patient is not capable of providing informed consent, and a proxy is not available.
About this study
This study evaluates an intervention to reduce medication errors and adverse drug events in older adults who have recently been discharged from the hospital and prescribed anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the intervention, while the other half will receive usual care.
Read the detailed description
The overarching objective of this research study is to pursue a large randomized controlled trial (RCT) focused on older patients recently discharged from the hospital who have been prescribed medications within one of three high-priority, high-risk drug classes in order to reduce the risk of clinically important medication errors. The National Action Plan for Adverse Drug Event (ADE) Prevention identified three high-priority drug classes as key targets for reducing the risk of drug-related injuries: anticoagulants; diabetes agents (insulin and oral agents); and opioids. These medication classes were chosen because they account for the greatest number of measurable drug-related harms to patients, and a substantial proportion of ADEs associated with these medications is considered preventable. The clinical trial will determine the value of a multifaceted medication error and ADE reduction intervention with a special focus on in-home assessment.
Components of the intervention will include: (1) in-home assessment of high-risk patients by a clinical pharmacist; (2) best-practice, evidence-based medication safety tools and resources targeted to high-risk patients and their caregivers; (3) communication with the primary care team via the electronic health record (EHR) regarding concerns relevant to the use of high-risk medications as well as other medication safety concerns; and (4) a follow-up phone call by the pharmacist to the patient and/or caregiver within 14 days of the home visit. The primary outcome of interest will be clinically important medication errors, a composite outcome comprised of preventable or ameliorable ADEs and potential ADEs due to medication discrepancies or non-adherence. Secondary outcomes will include: (1) preventable or ameliorable ADEs; (2) potential ADEs due to discrepancies or non-adherence; and (3) preventable or ameliorable ADEs judged to be serious, life-threatening, or fatal.
The specific aims for our study are as follows:
Aim 1: To adapt and integrate existing "best-practice," evidence-based medication safety tools, resources, and approaches into a cohesive, multifaceted intervention to reduce the occurrence of clinically important medication errors in older adults recently discharged from the hospital using one or more of the three high-priority, high-risk drug classes (anticoagulants, diabetes agents, and opioids).
Aim 2: To assess the impact of the multifaceted intervention on the incidence of clinically important medication errors employing a randomized controlled trial (RCT) design.
Aim 3: To conduct a process evaluation assessing intervention fidelity, adaptation, mechanisms of impact, essential components, and the influence of contextual factors.
Aim 4: To create: 1) a plan for disseminating study findings to stakeholders who might implement the intervention or make decisions about its future use; and 2) an implementation toolkit for those who wish to implement the intervention in practice.
- Conditions
- Medication Safety
- Being tested
- Pharmacist Home-Visit
- Keywords
- Safety, Hospitalization, Older Persons, High-Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Home-VisitBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Intervention; Control Arm: Receives Written Medication Information |
| Intervention | Experimental | Behavioral: Pharmacist Home-Visit Receives: Behavioral: Pharmacist Home-Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically important medication errors (preventable drug events and potential adverse events due to medication discrepancies or non-adherence).
To assess for the occurrence of clinically important medication errors, the investigators will use methods that they have developed, tested, and validated in previous investigations relating to drug-related incidents. Two pharmacist-investigators, who will not be involved in the intervention, will screen for signals of possible clinically important medication errors in the patient's electronic health record and in a structured telephone interview. The semi-structured telephone interview will be conducted according to the approach used by Forester, et. al (Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003; 138(3):161-167).
Measured: Within 45 days subsequent to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start28 Jul 2016
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication SafetyStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Medical Group, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jerry H Gurwitz, MD, Principal investigator, Meyers Primary Care Institute, University of Massachusetts Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781662
- Sponsor's protocol ID
- R18HS023774
- Other IDs
- R18HS023774
- Status last verified
- Jun 2023
- First submitted
- 9 May 2016
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gurwitz JH, Kapoor A, Garber L, Mazor KM, Wagner J, Cutrona SL, Singh S, Kanaan AO, Donovan JL, Crawford S, Anzuoni K, Konola TJ, Zhou Y, Field TS. Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):610-618. doi: 10.1001/jamainternmed.2020.9285.
PubMed 33646267
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safety After Hospitalization in Older Persons on High-Risk Medications
- ClinicalTrials.gov ID
- NCT02781662
- Acronym / sponsor ID
- R18HS023774
- Conditions
- Medication Safety
- Keywords
- Safety, Hospitalization, Older Persons, High-Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Reliant Medical Group, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 24 May 2016 (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.
This study evaluates an intervention to reduce medication errors and adverse drug events in older adults who have recently been discharged from the hospital and prescribed anticoagulants, diabetes agents, or opioids. Half of the study participants will receive the intervention, while the other half will receive usual care.
Detailed description
The overarching objective of this research study is to pursue a large randomized controlled trial (RCT) focused on older patients recently discharged from the hospital who have been prescribed medications within one of three high-priority, high-risk drug classes in order to reduce the risk of clinically important medication errors. The National Action Plan for Adverse Drug Event (ADE) Prevention identified three high-priority drug classes as key targets for reducing the risk of drug-related injuries: anticoagulants; diabetes agents (insulin and oral agents); and opioids. These medication classes were chosen because they account for the greatest number of measurable drug-related harms to patients, and a substantial proportion of ADEs associated with these medications is considered preventable. The clinical trial will determine the value of a multifaceted medication error and ADE reduction intervention with a special focus on in-home assessment.
Components of the intervention will include: (1) in-home assessment of high-risk patients by a clinical pharmacist; (2) best-practice, evidence-based medication safety tools and resources targeted to high-risk patients and their caregivers; (3) communication with the primary care team via the electronic health record (EHR) regarding concerns relevant to the use of high-risk medications as well as other medication safety concerns; and (4) a follow-up phone call by the pharmacist to the patient and/or caregiver within 14 days of the home visit. The primary outcome of interest will be clinically important medication errors, a composite outcome comprised of preventable or ameliorable ADEs and potential ADEs due to medication discrepancies or non-adherence. Secondary outcomes will include: (1) preventable or ameliorable ADEs; (2) potential ADEs due to discrepancies or non-adherence; and (3) preventable or ameliorable ADEs judged to be serious, life-threatening, or fatal.
The specific aims for our study are as follows:
Aim 1: To adapt and integrate existing "best-practice," evidence-based medication safety tools, resources, and approaches into a cohesive, multifaceted intervention to reduce the occurrence of clinically important medication errors in older adults recently discharged from the hospital using one or more of the three high-priority, high-risk drug classes (anticoagulants, diabetes agents, and opioids).
Aim 2: To assess the impact of the multifaceted intervention on the incidence of clinically important medication errors employing a randomized controlled trial (RCT) design.
Aim 3: To conduct a process evaluation assessing intervention fidelity, adaptation, mechanisms of impact, essential components, and the influence of contextual factors.
Aim 4: To create: 1) a plan for disseminating study findings to stakeholders who might implement the intervention or make decisions about its future use; and 2) an implementation toolkit for those who wish to implement the intervention in practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Intervention; Control Arm: Receives Written Medication Information |
| Intervention | Experimental | Behavioral: Pharmacist Home-VisitBehavioral: Pharmacist Home-Visit |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 years of age and having been prescribed one of the three high-risk drug categories (anticoagulants, diabetes agents, and opioids) at the time of hospital discharge and must meet one or more of following screening Items:
Key exclusion criteria (4 listed)
- Plans to enroll in hospice upon discharge.
- Discharged for a psychiatric condition.
- Discharged to a skilled nursing facility, rehabilitation hospital, or nursing home.
- Patient is not capable of providing informed consent, and a proxy is not available.
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 |
|---|---|---|
| Pharmacist Home-Visit | Behavioural | Intervention |
Primary outcome
Clinically important medication errors (preventable drug events and potential adverse events due to medication discrepancies or non-adherence).
Time frame: Within 45 days subsequent to hospital discharge
To assess for the occurrence of clinically important medication errors, the investigators will use methods that they have developed, tested, and validated in previous investigations relating to drug-related incidents. Two pharmacist-investigators, who will not be involved in the intervention, will screen for signals of possible clinically important medication errors in the patient's electronic health record and in a structured telephone interview. The semi-structured telephone interview will be conducted according to the approach used by Forester, et. al (Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003; 138(3):161-167).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 33646267Gurwitz JH, Kapoor A, Garber L, Mazor KM, Wagner J, Cutrona SL, Singh S, Kanaan AO, Donovan JL, Crawford S, Anzuoni K, Konola TJ, Zhou Y, Field TS. Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):610-618. doi: 10.1001/jamainternmed.2020.9285.
- 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.
Jerry H Gurwitz, MD principal investigator
Meyers Primary Care Institute, University of Massachusetts Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Home-Visit in people with Medication Safety, run by University of Massachusetts, Worcester.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinically important medication errors (preventable drug events and potential adverse events due to medication discrepancies or non-adherence). (time frame: Within 45 days subsequent to hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781662, which also lists 1 linked publication.
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 5 Jun 2023.