Medication Administered in ErrorNCT03181906
Effectiveness of Pre-Consultation Medication Reconciliation Service in Reducing Unintentional Medication Discrepancies During Transition of Care From Hospital Discharge to Primary Care Setting
A study testing Pre-Consultation Medication Reconciliation in people with Medication Administered in Error and Medication Adherence, run by National Healthcare Group, Singapore.
Trial summary
This study evaluates the the effectiveness of pre-consultation Medication Reconciliation Service in reducing unintentional medication discrepancies among patients who discharged from hospital to primary care. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Administered in Error, Medication Adherence
- What is being tested?
- Pre-Consultation Medication Reconciliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2016to 30 Apr 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years and older
- Patient or primary caregiver was able to provide informed consent
- Patient or primary caregiver was English, Mandarin or Malay speaking
- Patient was able to self-administer medications, or accompanied by a caregiver who assisted in administering medications
- Patient was prescribed 5 or more chronic medications
- The day of the study visit was the first follow-up visit in National Healthcare Group Polyclinics for chronic disease management after recent discharge from a local public hospital
Who cannot join
- Residents of nursing home
- The day of the study visit was for acute illness consult
- Unwilling to consent to a 30-day follow-up phone call.
About this study
Official title: Effectiveness of Pre-Consultation Medication Reconciliation Service in Reducing Unintentional Medication Discrepancies During Transition of Care From Hospital Discharge to Primary Care Setting- A Randomised Controlled Trial
This study evaluates the the effectiveness of pre-consultation Medication Reconciliation Service in reducing unintentional medication discrepancies among patients who discharged from hospital to primary care.
Read the detailed description
Medication discrepancies during care transition were common. Many factors contribute to the risk of medication discrepancies. Despite medication reconciliation service being practiced in the hospital setting, there was limited knowledge on its effectiveness in the primary care setting. This study aims to evaluate the effectiveness of a pre-consultation medication reconciliation service in reducing medication discrepancies in patients who transit from hospital to primary care. Adult patients who made their first visit to the polyclinics following a recent hospital discharge and were prescribed with 5 or more chronic medications were randomised to 2 groups. Pre-consultation medication reconciliation by a pharmacist was carried out for the intervention group. Outcome was assessed by a different pharmacist who was blinded to the randomised allocation. The control group underwent usual care without a pre-consultation medication reconciliation.
- Being tested
- Pre-Consultation Medication Reconciliation
- Keywords
- medication discrepancy, primary care, transition of care
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Consultation Medication ReconciliationOther
Medication reconciliation service to be done for participants randomised to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Pre-Consultation Medication Reconciliation | Experimental | Participants underwent medication reconciliation service before their consultation with the attending doctor. A best possible medication history (BPMH) was created and saved as an electronic draft in the electronic medical record system. Receives: Other: Pre-Consultation Medication Reconciliation |
| Control | No intervention | Participants in the control group proceeded with usual care, where the doctor reviewed the patient's condition and ordered an electronic prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintentional medication discrepancies
Any unintentional medication discrepancies after doctor's consultation
Measured: 1 day
Secondary outcomes (4)
Types of medication discrepancies
Type of medication discrepancies, by a validated instrument by Claeys et al, (Claeys C, Neve J, Tulkens PM, Spinewine A. Content Validity and Inter-Rater Reliability of an Instrument to Characterize Unintentional Medication Discrepancies.Drugs \& Aging. 2012 July; 29(7): 577-91.)
Measured: 1 day
Causes of medication discrepancies
Causes of medication discrepancies, by a validated instrument by Claeys et al, (Claeys C, Neve J, Tulkens PM, Spinewine A. Content Validity and Inter-Rater Reliability of an Instrument to Characterize Unintentional Medication Discrepancies.Drugs \& Aging. 2012 July; 29(7): 577-91.)
Measured: 1 day
Medication adherence
Medication adherence by The 8-item Morisky Medication Adherence Scale
Measured: 30 days
30-day re-hospitalisation
rate of re-hospitalisation 30 days after the study visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start11 Mar 2016
- Primary completion28 Feb 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Administered in ErrorStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kee Kok Wai, National Healthcare Group, Singapore
- Investigators
- Kok Wai Kee, MMED, Principal investigator, National Healthcare Group Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181906
- Sponsor's protocol ID
- DSRB2015/01219
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre-Consultation Medication Reconciliation Service in Reducing Unintentional Medication Discrepancies During Transition of Care From Hospital Discharge to Primary Care Setting- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03181906
- Acronym / sponsor ID
- DSRB2015/01219
- Keywords
- medication discrepancy, primary care, transition of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 9 Jun 2017 (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 study evaluates the the effectiveness of pre-consultation Medication Reconciliation Service in reducing unintentional medication discrepancies among patients who discharged from hospital to primary care.
Detailed description
Medication discrepancies during care transition were common. Many factors contribute to the risk of medication discrepancies. Despite medication reconciliation service being practiced in the hospital setting, there was limited knowledge on its effectiveness in the primary care setting. This study aims to evaluate the effectiveness of a pre-consultation medication reconciliation service in reducing medication discrepancies in patients who transit from hospital to primary care. Adult patients who made their first visit to the polyclinics following a recent hospital discharge and were prescribed with 5 or more chronic medications were randomised to 2 groups. Pre-consultation medication reconciliation by a pharmacist was carried out for the intervention group. Outcome was assessed by a different pharmacist who was blinded to the randomised allocation. The control group underwent usual care without a pre-consultation medication reconciliation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Consultation Medication Reconciliation | Experimental | Other: Pre-Consultation Medication ReconciliationParticipants underwent medication reconciliation service before their consultation with the attending doctor. A best possible medication history (BPMH) was created and saved as an electronic draft in the electronic medical record system. |
| Control | No intervention | –Participants in the control group proceeded with usual care, where the doctor reviewed the patient's condition and ordered an electronic prescription |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21 years and older
- Patient or primary caregiver was able to provide informed consent
- Patient or primary caregiver was English, Mandarin or Malay speaking
- Patient was able to self-administer medications, or accompanied by a caregiver who assisted in administering medications
- Patient was prescribed 5 or more chronic medications
Key exclusion criteria (3 listed)
- Residents of nursing home
- The day of the study visit was for acute illness consult
- Unwilling to consent to a 30-day follow-up phone call.
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 |
|---|---|---|
| Pre-Consultation Medication ReconciliationMedication reconciliation service to be done for participants randomised to the intervention group | Other | Pre-Consultation Medication Reconciliation |
Primary outcome
Unintentional medication discrepancies
Time frame: 1 day
Any unintentional medication discrepancies after doctor's consultation
4 secondary outcomes
Types of medication discrepancies
Time frame: 1 day
Causes of medication discrepancies
Time frame: 1 day
Medication adherence
Time frame: 30 days
30-day re-hospitalisation
Time frame: 30 days
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 9 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kok Wai Kee, MMED principal investigator
National Healthcare Group Polyclinics
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Consultation Medication Reconciliation in people with Medication Administered in Error and Medication Adherence, run by National Healthcare Group, Singapore.
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 3 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 9 Jun 2017. 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?
Unintentional medication discrepancies (time frame: 1 day). 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 9 Jun 2017.