Medication-related ProblemsNCT07719907
Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance
A study testing Clinical Pharmacist-Led Bundled Care in people with Medication-related Problems, run by Sultan Qaboos University.
Trial summary
This study aims to evaluate whether a clinical pharmacist-led bundled care model can improve medication use and health outcomes in hospitalized adult patients with preventable polypharmacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication-related Problems
- What is being tested?
- Clinical Pharmacist-Led Bundled Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Admitted under an adult medical specialty at one of the participating hospitals.
- Receiving five or more regular medications at the time of hospital admission.
- Expected hospital stay of at least 48 hours.
- Able and willing to provide written informed consent.
Who cannot join
- Admission under obstetric, pediatric, or psychiatric services.
- Admission to an intensive care unit.
- Terminal illness with an expected survival of less than three months.
- Unable to provide informed consent and without an available legal representative.
- Declines participation in the study.
About this study
Official title: Impact of a Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance Among Hospitalized Adults in Oman: A Prospective Randomized Controlled Study
This study aims to evaluate whether a clinical pharmacist-led bundled care model can improve medication use and health outcomes in hospitalized adult patients with preventable polypharmacy. Preventable polypharmacy refers to the use of multiple medications when some may no longer be necessary, may be inappropriate, or may increase the risk of medication-related harm.
Participants will be randomly assigned to receive either the pharmacist-led bundled care intervention in addition to usual hospital care or usual hospital care alone. The intervention includes comprehensive medication reconciliation, assessment of medication appropriateness, identification of potentially inappropriate medications, individualized deprescribing recommendations when appropriate, patient and caregiver education, discharge medication reconciliation, and follow-up after hospital discharge.
The study will compare important clinical outcomes between the two groups, including hospital readmissions, emergency department visits, adverse drug events, medication appropriateness, quality of prescribing, and healthcare costs. The findings will help determine whether integrating a clinical pharmacist-led bundled care model into routine hospital practice can improve patient safety, optimize medication use, and reduce unnecessary healthcare utilization.
- Conditions
- Medication-related Problems
- Being tested
- Clinical Pharmacist-Led Bundled Care, Control Arm (Usual Care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist-Led Bundled CareOther
Participants randomized to the intervention arm will receive a structured clinical pharmacist-led bundled care model in addition to usual hospital care. The intervention includes medication reconciliation at admission, comprehensive medication review, identification and resolution of medication-related problems, assessment of medication appropriateness using validated tools, deprescribing of potentially inappropriate medications when clinically indicated, dose optimization, evaluation of drug-drug interactions and medication safety, individualized pharmaceutical care planning, participation in multidisciplinary care with recommendations to the treating team, patient and caregiver medication counseling, discharge medication reconciliation, provision of an updated medication list, and post-discharge follow-up to reinforce medication adherence, identify medication-related problems, and optimize ongoing therapy. All interventions will be delivered according to a standardized study protocol
Control Arm (Usual Care)Other
Participants randomized to the control arm will receive usual hospital care provided according to the standard practices of the participating institutions. This includes routine medical and nursing care, medication prescribing and review by the treating healthcare team, and standard discharge processes. No structured clinical pharmacist-led bundled care intervention, standardized comprehensive medication review, protocol-driven deprescribing, or post-discharge pharmacist follow-up will be provided as part of the study. Clinical pharmacy services that are routinely available at the participating hospitals may be provided as part of usual care but will not follow the standardized intervention protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Usual Care | Active comparator | Not described Receives: Other: Control Arm (Usual Care) |
| Intervention Arm: Clinical Pharmacist-Led Bundled Care | Active comparator | Not described Receives: Other: Clinical Pharmacist-Led Bundled Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Healthcare Cost Avoidance per Participant
The difference between the intervention and control groups in total healthcare cost avoidance per participant associated with the clinical pharmacist-led bundled care model. Total cost avoidance will include direct medication and investigation cost reductions and indirect costs avoided through prevention of adverse drug events, reduced hospital length of stay, and reductions in unplanned hospital readmissions and emergency department visits.
Cost avoidance will be calculated using institutional healthcare utilization and costing data and standardized cost-avoidance values for accepted pharmacist interventions.
Measured: 90 days after hospital discharge
Prevalence of Preventable Polypharmacy at Hospital Discharge
The proportion of participants with one or more unnecessary, inappropriate, duplicative, or potentially harmful medications at hospital discharge, compared between the pharmacist-led bundled care group and the usual-care group. Preventable polypharmacy will be assessed using predefined clinical criteria, comprehensive medication review, and validated medication-appropriateness tools.
Measured: through study completion, an average of 1 week during admission
Secondary outcomes (3)
Number of Medications Deprescribed per Participant
The number of unnecessary, inappropriate, duplicative, or potentially harmful medications discontinued following medication review. Only deprescribing recommendations accepted and implemented by the treating medical team will be counted.
Measured: through study completion, an average of 1 week during admission
Incidence of Adverse Drug Events
During the index hospitalization and at 90 days after hospital discharge
Measured: From hospital admission through 90 days after discharge
All-Cause Hospital Readmission
The proportion of participants with at least one unplanned all-cause hospital readmission following discharge, compared between the intervention and control groups.
Measured: 30 days and 90 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 posted22 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-related ProblemsStudies 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
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Juhaina Al Maqbali, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719907
- Sponsor's protocol ID
- 188/2026
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance Among Hospitalized Adults in Oman: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07719907
- Acronym / sponsor ID
- 188/2026
- Conditions
- Medication-related Problems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jul 2026 (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 aims to evaluate whether a clinical pharmacist-led bundled care model can improve medication use and health outcomes in hospitalized adult patients with preventable polypharmacy. Preventable polypharmacy refers to the use of multiple medications when some may no longer be necessary, may be inappropriate, or may increase the risk of medication-related harm.
Participants will be randomly assigned to receive either the pharmacist-led bundled care intervention in addition to usual hospital care or usual hospital care alone. The intervention includes comprehensive medication reconciliation, assessment of medication appropriateness, identification of potentially inappropriate medications, individualized deprescribing recommendations when appropriate, patient and caregiver education, discharge medication reconciliation, and follow-up after hospital discharge.
The study will compare important clinical outcomes between the two groups, including hospital readmissions, emergency department visits, adverse drug events, medication appropriateness, quality of prescribing, and healthcare costs. The findings will help determine whether integrating a clinical pharmacist-led bundled care model into routine hospital practice can improve patient safety, optimize medication use, and reduce unnecessary healthcare utilization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Usual Care | Active comparator | Other: Control Arm (Usual Care) |
| Intervention Arm: Clinical Pharmacist-Led Bundled Care | Active comparator | Other: Clinical Pharmacist-Led Bundled Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Admitted under an adult medical specialty at one of the participating hospitals.
- Receiving five or more regular medications at the time of hospital admission.
- Expected hospital stay of at least 48 hours.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Admission under obstetric, pediatric, or psychiatric services.
- Admission to an intensive care unit.
- Terminal illness with an expected survival of less than three months.
- Unable to provide informed consent and without an available legal representative.
- Declines participation in the study.
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 |
|---|---|---|
| Clinical Pharmacist-Led Bundled CareParticipants randomized to the intervention arm will receive a structured clinical pharmacist-led bundled care model in addition to usual hospital care. The intervention includes medication reconciliation at admission, comprehensive medication review, identification and resolution of medication-related problems, assessment of medication appropriateness using validated tools, deprescribing of potentially inappropriate medications when clinically indicated, dose optimization, evaluation of drug-drug interactions and medication safety, individualized pharmaceutical care planning, participation in multidisciplinary care with recommendations to the treating team, patient and caregiver medication counseling, discharge medication reconciliation, provision of an updated medication list, and post-discharge follow-up to reinforce medication adherence, identify medication-related problems, and optimize ongoing therapy. All interventions will be delivered according to a standardized study protocol | Other | Intervention Arm: Clinical Pharmacist-Led Bundled Care |
| Control Arm (Usual Care)Participants randomized to the control arm will receive usual hospital care provided according to the standard practices of the participating institutions. This includes routine medical and nursing care, medication prescribing and review by the treating healthcare team, and standard discharge processes. No structured clinical pharmacist-led bundled care intervention, standardized comprehensive medication review, protocol-driven deprescribing, or post-discharge pharmacist follow-up will be provided as part of the study. Clinical pharmacy services that are routinely available at the participating hospitals may be provided as part of usual care but will not follow the standardized intervention protocol. | Other | Control Arm: Usual Care |
Primary outcome
Total Healthcare Cost Avoidance per Participant
Time frame: 90 days after hospital discharge
The difference between the intervention and control groups in total healthcare cost avoidance per participant associated with the clinical pharmacist-led bundled care model. Total cost avoidance will include direct medication and investigation cost reductions and indirect costs avoided through prevention of adverse drug events, reduced hospital length of stay, and reductions in unplanned hospital readmissions and emergency department visits. Cost avoidance will be calculated using institutional healthcare utilization and costing data and standardized cost-avoidance values for accepted pharmacist interventions.
Prevalence of Preventable Polypharmacy at Hospital Discharge
Time frame: through study completion, an average of 1 week during admission
The proportion of participants with one or more unnecessary, inappropriate, duplicative, or potentially harmful medications at hospital discharge, compared between the pharmacist-led bundled care group and the usual-care group. Preventable polypharmacy will be assessed using predefined clinical criteria, comprehensive medication review, and validated medication-appropriateness tools.
3 secondary outcomes
Number of Medications Deprescribed per Participant
Time frame: through study completion, an average of 1 week during admission
Incidence of Adverse Drug Events
Time frame: From hospital admission through 90 days after discharge
All-Cause Hospital Readmission
Time frame: 30 days and 90 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist-Led Bundled Care in people with Medication-related Problems, run by Sultan Qaboos University.
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 5 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: opening soon, as of the sponsor's last update on 22 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total Healthcare Cost Avoidance per Participant (time frame: 90 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 22 Jul 2026.