Medication Review in Women With Depression and Anxiety

NCT04082871 | Completed DMC

• 1 other identifier: 1IRB/2016/04
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression, Anxiety; Adherence, Patient

Keywords

Medication management review service; Pharmaceutical care; Clinical pharmacist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient's satisfaction with the medication management review service

  6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Medication management review OTHER

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Females diagnosed with depression and/or anxiety and attending the psychiatric clinics at Jordan University Hospital (JUH)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Applied Science Private University: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders; Patient Compliance

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This single-blind parallel randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following recruitment, participants were randomized into two groups (1:1 randomization), active and control, using the computer-generated randomization program (www.randomization.com). The researcher generated the allocation sequence, and assigned the participants to their group. Participant who came into the clinic during the clinic's working hours (Sunday to Thursday, from 9 am to 1 pm) were approached consecutively and allocated to the active or control group. Participants were not aware of which study group they were assigned to; only the researcher was aware of each patient's group assignment. Participants in the active and control groups completed a baseline and follow-up (3 months from baseline) visits at the same outpatient psychiatric clinic with the researcher conducting the interview using the study tool to complete the MMR process.

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 9, 2019
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 10, 2017
• Last Updated: September 9, 2019

Record last verified: 2019-09