Medication ComplianceNCT03247322
mHealth Medication Safety Intervention
A study testing Pharmacist-led medication therapy using mHealth application in people with Medication Compliance, run by Medical University of South Carolina at 1 site in United States.
Trial summary
TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Compliance
- What is being tested?
- Pharmacist-led medication therapy using mHealth application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 30 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Kidney transplant recipient between 6 and 36 months post-transplant
- At least 18 years of age
- Transplant MD agrees that patient is eligible to participate
Who cannot join
- Multi-organ recipient
- Patient is incapable of:
- Measuring their own blood pressure and glucose (if applicable)
- Self-administering medications
- Speaking, hearing and reading English
- Utilizing the mHealth application, after training
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.
- Conditions
- Medication Compliance
- Being tested
- Pharmacist-led medication therapy using mHealth application
- Keywords
- Medication Safety, Mobile Health Technology
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led medication therapy using mHealth applicationOther
This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
| Study group | Role | What they receive |
|---|---|---|
| mHealth Group | Experimental | Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable). Receives: Other: Pharmacist-led medication therapy using mHealth application |
| Usual Care Group | No intervention | Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Medication Errors
Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
Measured: 1 year
Incidence and Severity of Adverse Drug Events
Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care.
Rates of Events Per Patient Year by AE Grade
Measured: 1 year
Severity of Medication Errors
Severity of Medication Errors were measured using the Overhage criteria
Measured: 1 year
Secondary outcomes (1)
Hospitalization Rate
Number of hospitalizations per patient-year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start11 Oct 2017
- Primary completion3 Feb 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication ComplianceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- David Taber, PharmD,MS, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247322
- Sponsor's protocol ID
- Pro00068746
- Status last verified
- Feb 2021
- First submitted
- 9 Aug 2017
- Last updated
- 25 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829Gonzales HM, Fleming JN, Gebregziabher M, Posadas Salas MA, McGillicuddy JW, Taber DJ. A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial. Ann Pharmacother. 2022 Jun;56(6):685-690. doi: 10.1177/10600280211044792. Epub 2021 Sep 8.
PubMed 34496669Taber DJ, Fleming JN, Su Z, Mauldin P, McGillicuddy JW, Posadas A, Gebregziabher M. Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients. Am J Transplant. 2021 Oct;21(10):3428-3435. doi: 10.1111/ajt.16737. Epub 2021 Jul 14.
PubMed 34197699Fleming JN, Treiber F, McGillicuddy J, Gebregziabher M, Taber DJ. Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol. JMIR Res Protoc. 2018 Mar 2;7(3):e59. doi: 10.2196/resprot.9078.
PubMed 29500161
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
- ClinicalTrials.gov ID
- NCT03247322
- Acronym / sponsor ID
- Pro00068746
- Conditions
- Medication Compliance
- Keywords
- Medication Safety, Mobile Health Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Group | Experimental | Other: Pharmacist-led medication therapy using mHealth applicationPatients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable). |
| Usual Care Group | No intervention | –Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant recipient between 6 and 36 months post-transplant
- At least 18 years of age
- Transplant MD agrees that patient is eligible to participate
Key exclusion criteria (6 listed)
- Multi-organ recipient
- Patient is incapable of:
- Measuring their own blood pressure and glucose (if applicable)
- Self-administering medications
- Speaking, hearing and reading English
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-led medication therapy using mHealth applicationThis cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable). | Other | mHealth Group |
Primary outcome
Number of Medication Errors
Time frame: 1 year
Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
Incidence and Severity of Adverse Drug Events
Time frame: 1 year
Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care. Rates of Events Per Patient Year by AE Grade
Severity of Medication Errors
Time frame: 1 year
Severity of Medication Errors were measured using the Overhage criteria
1 secondary outcome
Hospitalization Rate
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Derived from this study: PubMed 34496669Gonzales HM, Fleming JN, Gebregziabher M, Posadas Salas MA, McGillicuddy JW, Taber DJ. A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial. Ann Pharmacother. 2022 Jun;56(6):685-690. doi: 10.1177/10600280211044792. Epub 2021 Sep 8.
- Derived from this study: PubMed 34197699Taber DJ, Fleming JN, Su Z, Mauldin P, McGillicuddy JW, Posadas A, Gebregziabher M. Significant hospitalization cost savings to the payer with a pharmacist-led mobile health intervention to improve medication safety in kidney transplant recipients. Am J Transplant. 2021 Oct;21(10):3428-3435. doi: 10.1111/ajt.16737. Epub 2021 Jul 14.
- Derived from this study: PubMed 29500161Fleming JN, Treiber F, McGillicuddy J, Gebregziabher M, Taber DJ. Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol. JMIR Res Protoc. 2018 Mar 2;7(3):e59. doi: 10.2196/resprot.9078.
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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.
David Taber, PharmD,MS principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led medication therapy using mHealth application in people with Medication Compliance, run by Medical University of South Carolina 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 3 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: finished, as of the sponsor's last update on 25 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Medication Errors (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT03247322, which also lists 4 linked publications.
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 25 Feb 2021.