Medication Review in Women With Depression and Anxiety

Assessing the Impact of Medication Management Review Service for Females Diagnosed With Depression and Anxiety

This study sought to assess the impact of the MMR service on identifying and resolving TRPs, improving adherence, depression and anxiety scores in females diagnosed with depression and anxiety in Jordan

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety; Adherence, Patient
• Intervention / Treatment: Other: Medication management review

Detailed Description

Participants were recruited into this single-blind parallel randomized controlled trial and randomized into active and control groups. A clinical pharmacist identified TRPs for all participants. Adherence, depression and anxiety scores were assessed. Active group patients received the MMR service: pharmacist-delivered counseling and a letter with recommended changes in the patient's treatment plan was sent to the patient's psychiatrist to be applied. Control group participants did not receive the intervention. Follow-up assessments were completed for all patients at 3 months from baseline. Main outcome measures were TRPs, adherence, depression and anxiety scores.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Jordanian females or residents in Jordan for the last 12 months and planning to stay in Jordan for 6 months (the study follow-up period),
• above the age of 18 years
• diagnosed with depression and/or anxiety for at least 4 weeks duration
• taking medications for depression and/or anxiety

Exclusion Criteria:

• presence of a cognitive problem or sensory impairment which may prevent communication with the patient (reported by the patient's psychiatrist)
• being not able to speak or write Arabic (reported by the patient)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; All pharmacist level counseling and education regarding treatment, adherence and self-care activities were delivered to the active group patients only (planned to take 15 minutes). Patient level TRPs (any TRP that could be resolved via patient education and counseling) were resolved directly with the patient by the clinical pharmacist. A letter with the identified TRPs (prioritized from most important to least important) for each patient in the active group was sent to the patient's psychiatrist by the researcher in sealed envelopes. The psychiatrist either accepted or rejected the recommendations. In case the recommendations were accepted, the psychiatrist implemented the recommended changes. Patients were informed by a phone call by the pharmacist to visit their psychiatrist soon after the recommendations were approved for the changes to be applied. If the recommendations were rejected, the psychiatrist stated the reason of rejection and discussed it with the pharmacist.	Other: Medication management review; The researcher screened each completed an MMR template and verified that all information in each patient template was complete. A classification system was then used to identify the TRPs which either actually or potentially interfered with the clinical outcomes for each patient.[19] This system was explained in detail and applied successfully in many previous studies.[10, 14, 20] The researcher then identified TRPs for each patient in both groups using evidence-based medicine. The TRPs including unneeded drug treatment, untreated condition/s, efficacy/effectiveness issues, safety issues, inadequate knowledge, inappropriate adherence to pharmacological therapy, inappropriate adherence to self-care activities and miscellaneous problems.
Active Comparator: Control; Control group patients also underwent the baseline interview with the researcher at the psychiatric clinic, TRPs were identified and documented. No intervention was provided by the pharmacist and no letter was sent to the patients' psychiatrists. In case a patient was found to have a life-threatening TRP, the patient was excluded from the study and reported to the psychiatrist due to ethical considerations. After study completion, all patients in the control group received the MMR service, and a letter with their TRPs and recommendations to resolve them was sent by the pharmacist to their psychologist	Other: Medication management review; The researcher screened each completed an MMR template and verified that all information in each patient template was complete. A classification system was then used to identify the TRPs which either actually or potentially interfered with the clinical outcomes for each patient.[19] This system was explained in detail and applied successfully in many previous studies.[10, 14, 20] The researcher then identified TRPs for each patient in both groups using evidence-based medicine. The TRPs including unneeded drug treatment, untreated condition/s, efficacy/effectiveness issues, safety issues, inadequate knowledge, inappropriate adherence to pharmacological therapy, inappropriate adherence to self-care activities and miscellaneous problems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of the medication management review service delivered to females living in Jordan and diagnosed with depression and anxiety	the medication management review service will be measured by the reduction of treatment related number after providing the service	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction with the medication management review service	satisfaction will be measured by the willingness of patients to pay for the provided services	6 months

Collaborators and Investigators

• Sponsor: Applied Science Private University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Medication management review service; Pharmaceutical care; Clinical pharmacist
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 1IRB/2016/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No