Chronic DiseaseNCT03803033
Cost-benefit Analysis of a Clinical Pharmacist Intervention
A study testing Clinical pharmacy-based home medication management review service in people with Chronic Disease, run by Applied Science Private University at 1 site in Jordan.
Trial summary
Clinical pharmacy services are vital in the prevention of adverse drug events (ADEs) in clinical practice, extending beyond the hospital to chronic disease management in outpatient settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Clinical pharmacy-based home medication management review service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteJordan
- Study dates
- Jul 2015to Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old;
- with at least one chronic disease, defined as a condition requiring prolonged management for a minimum of 3 months;
- living in Jordan for the past year;
- intention to remain in Jordan for the 3-month study duration;
- met at least one of the following criteria:
- taking ≥5 medications, taking ≥12 doses a day, discharged from the hospital within the past 4 weeks, exposed to significant changes in medication regimens within the past 3 months, demonstrating symptoms of potential adverse drug reactions, or demonstrating a poor therapeutic response to medication therapy. A significant change to medication regimen was defined as discontinuing a medication, starting new medications, or stepping up because of actual or potential therapy failure or guideline recommendations. A poor therapeutic response was defined as persistence of symptoms despite treatment.
Who cannot join
- Patients who don't have a chronic disease
- Cognitive or sensory impairment that may prevent conducting the interview
- Pregnant patients
- Patients who are planning to travel within the next 3 months after the baseline visit to the clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-benefit Analysis of a Clinical Pharmacist Intervention in Preventing Adverse Drug Events in the General Chronic Diseases Outpatients
Clinical pharmacy services are vital in the prevention of adverse drug events (ADEs) in clinical practice, extending beyond the hospital to chronic disease management in outpatient settings. This study sought to evaluate the cost-benefit of a clinical pharmacy intervention in resolving treatment-related problems (TRPs) among hospital outpatients with chronic diseases. From the hospital system perspective, the cost-benefit analysis was based on a randomized clinical trial in the general outpatients of the major hospital in Jordan. Eligible patients were randomly assigned to either an intervention or a control group. TRPs were identified in both study groups, but interventions were delivered only to the intervention group via a home medication management review (HMMR) by a clinical pharmacist. A follow-up in both groups took place 3 months after recruitment. The total economic benefit was the sum of (i) cost savings due to intervention and (ii) cost avoidance associated with preventable ADEs. The primary outcome measures were the net benefit and benefit-to-cost ratio with the clinical pharmacist-based HMMR. Based on both of the annual net benefit and benefit-to-cost ratio, the study intervention demonstrated to be cost beneficial. Sensitivity analyses confirmed the robustness of results. The RCT-based cost-benefit evaluation provided evidence-based insight into the economic benefit of a clinical pharmacist-provided HMMR for preventing ADEs in the general chronic diseases outpatients. This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the healthcare hospital payer in Jordan.
Read the detailed description
Economic evaluation The total economic benefit of the intervention was calculated as the sum of the cost savings and the cost avoidance associated with the intervention.
Cost savings Cost savings based on the intervention were the reduced cost of therapy associated with treatment changes due to the intervention. Cost savings were therefore calculated as (the reduced cost of therapy in the intervention arm) minus (the reduced cost of therapy in the control arm).
Cost avoidance Cost avoidance was the cost avoided by eliminating the occurrence of ADEs as a consequence of the pharmacist interventions.
- Based on the method of Nesbit et al., utilizing an expert panel of four specialist clinical pharmacists, the likelihood of an ADE in the absence of the intervention was set. The intervention with the potential to prevent an ADE was assessed for cost avoidance.
- The cost of an ADE was calculated on the assumption that an ADE in an outpatient will lead to a single admission to an internal medicine ward via an emergency department visit.
- For each intervention with the potential to prevent an ADE, cost avoidance was calculated by multiplying the probability of an ADE in the absence of the intervention (calculated via the Nesbit method) by the average cost of an ADE. The overall cost avoidance was the sum of avoided cost with all interventions for TRPs.
Cost-benefit analysis The net benefit was calculated as (cost saving) + (cost avoidance). It was assumed that no intervention would increase the probability of a preventable ADE.
- Calculating monthly cost savings and avoidance was based on a capacity on the part of the pharmacist to perform three HMMRs in a day, for an underestimated average of 21 working days a month, summing to a total of 63 patients per month. The need for a monthly outcome cost stems from the fact that outpatient pharmacists are paid monthly in Jordan. The assumption of three HMMRs per day is based on the expectation that a single home visit will last a maximum of 1 hour, as discussed earlier, and that up to 2 to 3 hours are needed to identify TRPs, write the physician letter, contact the physician, and implement the recommendations.
- The cost of the intervention was calculated as (the salary of a regular outpatient pharmacist) + (any increased cost of therapy in the intervention arm, measured as -ve cost saving). Here, the increased cost of therapy with intervention is referred to as '-ve cost saving' in contrast to +ve cost saving, which indicates the reduction in the cost of therapy because of treatment changes in the intervention group, as discussed above.
- The benefit-to-cost ratio was the (sum of cost savings and cost avoidance) divided by (cost of the intervention). The net benefit of the intervention was the (sum of cost savings and cost avoidance) minus (cost of the intervention).
Only direct medical costs were considered in calculations, and all costs were adjusted based on the Jordanian consumer price index to the financial year 2017/18.
- Conditions
- Chronic Disease
- Being tested
- Clinical pharmacy-based home medication management review service
- Keywords
- Treatment-related problems, Cost saving, Clinical pharmacy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pharmacy-based home medication management review serviceOther
A baseline interview by the clinical pharmacist was conducted with patients at their homes to assess their use of treatment and to collect all relevant information needed to identify TRPs. Upon TRP identification at baseline, the clinical pharmacist generated a written report of findings and recommendations, which was delivered directly to the patient's physician in a sealed envelope. Patients were asked to refer back to their physicians if they required confirmation of any changes in treatment. Physicians maintained the blinding of patients with regard to whether changes were based on recommendations by the pharmacist. In both the intervention and the control groups, the clinical pharmacist performed a follow-up interview with patients 3 months after the initial interview, during a regular follow-up visit to their physician at the hospital. Assessments in the follow-up interview, regardless of the study group, involved changes in treatment and number of TRPs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The objective of the group was to introduce an experimental clinical pharmacy-based home medication review service in the outpatient clinic setting of the Jordan University Hospital in Amman, Jordan. The intervention under evaluation in the study is the pharmacy-based home medication review service. Receives: Other: Clinical pharmacy-based home medication management review service |
| Control | No intervention | The objective of the control group was to identify changes in treatment and associated costs that take place in patients as part of the usual practice, as compared to the intervention arm, regardless of the clinical pharmacist service intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-benefit analysis
The benefit-to-cost ratio was the (sum of cost savings and cost avoidance) divided by (cost of the intervention). The net benefit of the intervention was the (sum of cost savings and cost avoidance) minus (cost of the intervention).
The scope of this is limited to cost consequences of TRPs and interventions addressing them, and does not include humanistic and clinical outcomes of interventions. Net benefit and benefit-to-cost ratio with the clinical pharmacist-based home-based service.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study startJul 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Model description
- Chronic diseases patients were initially assigned to either 3 months of routine care service (control group) or to an experimental clinical pharmacy-based HMMR service (intervention group) in the outpatient clinic setting of the Jordan University Hospital in Amman, Jordan.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803033
- Sponsor's protocol ID
- 1IRB/2014/50
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-benefit Analysis of a Clinical Pharmacist Intervention in Preventing Adverse Drug Events in the General Chronic Diseases Outpatients
- ClinicalTrials.gov ID
- NCT03803033
- Acronym / sponsor ID
- 1IRB/2014/50
- Conditions
- Chronic Disease
- Keywords
- Treatment-related problems, Cost saving, Clinical pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jan 2019 (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.
Clinical pharmacy services are vital in the prevention of adverse drug events (ADEs) in clinical practice, extending beyond the hospital to chronic disease management in outpatient settings. This study sought to evaluate the cost-benefit of a clinical pharmacy intervention in resolving treatment-related problems (TRPs) among hospital outpatients with chronic diseases. From the hospital system perspective, the cost-benefit analysis was based on a randomized clinical trial in the general outpatients of the major hospital in Jordan. Eligible patients were randomly assigned to either an intervention or a control group. TRPs were identified in both study groups, but interventions were delivered only to the intervention group via a home medication management review (HMMR) by a clinical pharmacist. A follow-up in both groups took place 3 months after recruitment. The total economic benefit was the sum of (i) cost savings due to intervention and (ii) cost avoidance associated with preventable ADEs. The primary outcome measures were the net benefit and benefit-to-cost ratio with the clinical pharmacist-based HMMR. Based on both of the annual net benefit and benefit-to-cost ratio, the study intervention demonstrated to be cost beneficial. Sensitivity analyses confirmed the robustness of results. The RCT-based cost-benefit evaluation provided evidence-based insight into the economic benefit of a clinical pharmacist-provided HMMR for preventing ADEs in the general chronic diseases outpatients. This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the healthcare hospital payer in Jordan.
Detailed description
Economic evaluation The total economic benefit of the intervention was calculated as the sum of the cost savings and the cost avoidance associated with the intervention.
Cost savings Cost savings based on the intervention were the reduced cost of therapy associated with treatment changes due to the intervention. Cost savings were therefore calculated as (the reduced cost of therapy in the intervention arm) minus (the reduced cost of therapy in the control arm).
Cost avoidance Cost avoidance was the cost avoided by eliminating the occurrence of ADEs as a consequence of the pharmacist interventions.
- Based on the method of Nesbit et al., utilizing an expert panel of four specialist clinical pharmacists, the likelihood of an ADE in the absence of the intervention was set. The intervention with the potential to prevent an ADE was assessed for cost avoidance.
- The cost of an ADE was calculated on the assumption that an ADE in an outpatient will lead to a single admission to an internal medicine ward via an emergency department visit.
- For each intervention with the potential to prevent an ADE, cost avoidance was calculated by multiplying the probability of an ADE in the absence of the intervention (calculated via the Nesbit method) by the average cost of an ADE. The overall cost avoidance was the sum of avoided cost with all interventions for TRPs.
Cost-benefit analysis The net benefit was calculated as (cost saving) + (cost avoidance). It was assumed that no intervention would increase the probability of a preventable ADE.
- Calculating monthly cost savings and avoidance was based on a capacity on the part of the pharmacist to perform three HMMRs in a day, for an underestimated average of 21 working days a month, summing to a total of 63 patients per month. The need for a monthly outcome cost stems from the fact that outpatient pharmacists are paid monthly in Jordan. The assumption of three HMMRs per day is based on the expectation that a single home visit will last a maximum of 1 hour, as discussed earlier, and that up to 2 to 3 hours are needed to identify TRPs, write the physician letter, contact the physician, and implement the recommendations.
- The cost of the intervention was calculated as (the salary of a regular outpatient pharmacist) + (any increased cost of therapy in the intervention arm, measured as -ve cost saving). Here, the increased cost of therapy with intervention is referred to as '-ve cost saving' in contrast to +ve cost saving, which indicates the reduction in the cost of therapy because of treatment changes in the intervention group, as discussed above.
- The benefit-to-cost ratio was the (sum of cost savings and cost avoidance) divided by (cost of the intervention). The net benefit of the intervention was the (sum of cost savings and cost avoidance) minus (cost of the intervention).
Only direct medical costs were considered in calculations, and all costs were adjusted based on the Jordanian consumer price index to the financial year 2017/18.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Chronic diseases patients were initially assigned to either 3 months of routine care service (control group) or to an experimental clinical pharmacy-based HMMR service (intervention group) in the outpatient clinic setting of the Jordan University Hospital in Amman, Jordan.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Clinical pharmacy-based home medication management review serviceThe objective of the group was to introduce an experimental clinical pharmacy-based home medication review service in the outpatient clinic setting of the Jordan University Hospital in Amman, Jordan. The intervention under evaluation in the study is the pharmacy-based home medication review service. |
| Control | No intervention | –The objective of the control group was to identify changes in treatment and associated costs that take place in patients as part of the usual practice, as compared to the intervention arm, regardless of the clinical pharmacist service intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old;
- with at least one chronic disease, defined as a condition requiring prolonged management for a minimum of 3 months;
- living in Jordan for the past year;
- intention to remain in Jordan for the 3-month study duration;
- met at least one of the following criteria:
Key exclusion criteria (4 listed)
- Patients who don't have a chronic disease
- Cognitive or sensory impairment that may prevent conducting the interview
- Pregnant patients
- Patients who are planning to travel within the next 3 months after the baseline visit to the clinic
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 pharmacy-based home medication management review serviceA baseline interview by the clinical pharmacist was conducted with patients at their homes to assess their use of treatment and to collect all relevant information needed to identify TRPs. Upon TRP identification at baseline, the clinical pharmacist generated a written report of findings and recommendations, which was delivered directly to the patient's physician in a sealed envelope. Patients were asked to refer back to their physicians if they required confirmation of any changes in treatment. Physicians maintained the blinding of patients with regard to whether changes were based on recommendations by the pharmacist. In both the intervention and the control groups, the clinical pharmacist performed a follow-up interview with patients 3 months after the initial interview, during a regular follow-up visit to their physician at the hospital. Assessments in the follow-up interview, regardless of the study group, involved changes in treatment and number of TRPs. | Other | Intervention |
Primary outcome
Cost-benefit analysis
Time frame: Three months
The benefit-to-cost ratio was the (sum of cost savings and cost avoidance) divided by (cost of the intervention). The net benefit of the intervention was the (sum of cost savings and cost avoidance) minus (cost of the intervention). The scope of this is limited to cost consequences of TRPs and interventions addressing them, and does not include humanistic and clinical outcomes of interventions. Net benefit and benefit-to-cost ratio with the clinical pharmacist-based home-based service.
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 14 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pharmacy-based home medication management review service in people with Chronic Disease, run by Applied Science Private University at 1 site in Jordan.
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 14 Jan 2019. 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 Jordan. 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 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?
Cost-benefit analysis (time frame: Three months). 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 14 Jan 2019.