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

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

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: Patient-Centered Pharmacist Care

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible participants; The intervention of patient-centered pharmacist care included a comprehensive interview patients conducted at month 3 and 5 ,which included and reviewing all their medications using concepts of MTM and MI All study participants were assessed at baseline and on monthly basis for the changes in the study outcomes.	Other: Patient-Centered Pharmacist Care; A comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: Harvard University
• Investigators: Principal Investigator: Sherine E Ismail, PharmD, MPH, KAIMRC, King Saud bin Abdulaziz University for Health Sciences, Pharmaceutical Care Department, King Khalid Hospital, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia, Harvard T. H. Chan School of Public Health, Boston, MA, USA

Publications and helpful links

General Publications

• Ismail S, Al-Subhi A, Youssif E, Ahmed M, Almalki A, Seger DL, Seger AC, Cook E. Patient-centered Pharmacist Care in the Hemodialysis Unit: a quasi-experimental interrupted time series study. BMC Nephrol. 2019 Nov 13;20(1):408. doi: 10.1186/s12882-019-1577-6.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2016
• Primary Completion (Actual): April 23, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: July 1, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SP16/099/J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: I plan to share the listed below data regarding my study for public upon request
• IPD Sharing Time Frame: After publication, I can share all the supporting information
• IPD Sharing Access Criteria: After publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No