Patient-Centered Pharmacist Care in the Hemodialysis Unit: A Quasi-Experimental Interrupted Time Series Study

Medication Adherence Clinical Trial

Official title:

The Impact of Comprehensive Medication Review by Pharmacist in Hemodialysis Patients: A Quasi Experimental Interrupted Time Series Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576404
• Other study ID #: SP16/099/J
• Status: Completed
• Phase: N/A
• Start date: October 13, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: April 2018
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nonadherence to medications by patients requiring hemodialysis (HD) leads to unfavorable clinical outcomes.Limited data exist on the influence of pharmacists on pharmacoadherence by patients requiring HD. Therefore, we assessed the impact of patient-centered pharmacist care through the implementation of concepts of Medication Therapy Management (MTM) and motivational interview (MI) on pharmacoadherence and its outcomes in patients requiring HD.

Description:

Patients were assessed at baseline for baseline characteristics, dialysis-related factors, and medications records

1. Pharmacists conducted brief monthly interview for patients to assess the medications they are receiving

2. A comprehensive interview for patients occurred at month 3 and 5 including concepts of MTM and MI

3. MTM included a review of each participant's medications and personal medication record to identify the use of any over-the-counter medications, design of their medication-related action plan, formulation of specific therapeutic interventions, and referrals for discussion with their physician and subsequent documentation and follow-up. The therapeutic interventions accepted by the physician were further discussed with each patient/caregiver using the MI technique to encourage adherence and this discussion was documented in each patient's medication record.

4. MI incorporated the main components reported in the literature: rolling with resistance; expressing empathy; avoiding argumentative behavior; highlighting the discrepancy between patients' current attitudes compared with the desired therapeutic goals; and empowering patients' self-efficacy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 30, 2017
• Est. primary completion date: April 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (=18 years of age)

• Outpatient HD for at least 3 months before the study period

Exclusion Criteria:

• Patients who refused to participate in the study

• Patients without the capacity to understand or take responsibility for their medications

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Patient-Centered Pharmacist Care
A comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	Harvard University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pharmacoadherence of patients requiring HD using electronic medication refill from baseline	Comparing changes in self-reporting of number of medications with electronic prescribing during each of the six interviews	Monthly and up to 6 months
Primary	Changes in pharmacoadherence of patients requiring HD through the control of serum phosphate level (mmol/L) from baseline	Changes in surrogate laboratory pre-HD serum phosphate level (mmol/L) from baseline	Monthly and up to 6 months
Secondary	Changes in Systolic blood pressure (SBP) control in mmHg from baseline as a independent surrogate marker for administration of medications	Changes in Systolic blood pressure (SBP) control in mmHg from baseline and on a monthly basis	Monthly and up to 6 months
Secondary	Changes in serum low-density lipoprotein (LDL) levels in mmol/L from baseline as an independent surrogate marker for the administration of medications	Changes in serum low-density lipoprotein (LDL) levels in mmol/L from baseline and on a monthly basis	Monthly and up to 6 months
Secondary	Changes in Number of Medication-related problems (MRPs) from baseline at month 3 and month 5	Number	At month 3 and month 5 of the study
Secondary	Types of Medication-related problems (MRPs)	Types of Medication-related problems included in the study as identified in literature: improper drug dosing or selection; initiation of medication without indication; adverse drug events; failure to receive drugs; indication without treatment; suggested alternative therapeutic options; and inappropriate monitoring or laboratory tests required	Total study duration: from month 1 to month 6
Secondary	Number of accepted therapeutic interventions by the pharmacist	Number of Therapeutic interventions suggested by the pharmacists to alter medication regimen suggested by pharmacist based on discussion and approval of prescribing physicians	Monthly and up to 6 months

External Links

•   An abstract of the study was accepted as poster presentation at the National Kidney foundation Spring Clinical Meeting, Austin, Texas on April 2018