Cost-benefit Analysis of a Clinical Pharmacist Intervention

NCT03803033 | Completed

• 1 other identifier: 1IRB/2014/50
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Disease

Keywords

Treatment-related problems; Cost saving; Clinical pharmacy

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months

Study Arms (2)

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.

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.

Interventions

Clinical pharmacy-based home medication management review service OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (1)

Prof. Iman Basheti

Amman, 11931, Jordan

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A prospective single-blind randomized control trial (RCT) for evaluating the economic impact of a clinical pharmacist's identifying and managing of TRPs as part of an home medication management review
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 14, 2019
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 14, 2019

Record last verified: 2018-12

Locations

JO (1)