Clinical trial NCT03576404: Patient-Centered Pharmacist Care in the Hemodialysis Unit: A Quasi-Experimental Interrupted Time Series Study
Official title: The Impact of Comprehensive Medication Review by Pharmacist in Hemodialysis Patients: A Quasi Experimental Interrupted Time Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2018-07-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Quasi-Experimental Interrupted Time Series Study
Primary purpose: OTHER

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in pharmacoadherence of patients requiring HD using electronic medication refill from baseline
timeFrame: Monthly and up to 6 months
measure: Changes in pharmacoadherence of patients requiring HD through the control of serum phosphate level (mmol/L) from baseline
timeFrame: Monthly and up to 6 months
Secondary outcomes:
measure: Changes in Systolic blood pressure (SBP) control in mmHg from baseline as a independent surrogate marker for administration of medications
timeFrame: Monthly and up to 6 months
measure: Changes in serum low-density lipoprotein (LDL) levels in mmol/L from baseline as an independent surrogate marker for the administration of medications
timeFrame: Monthly and up to 6 months
measure: Changes in Number of Medication-related problems (MRPs) from baseline at month 3 and month 5
timeFrame: At month 3 and month 5 of the study
measure: Types of Medication-related problems (MRPs)
timeFrame: Total study duration: from month 1 to month 6
measure: Number of accepted therapeutic interventions by the pharmacist
timeFrame: Monthly and up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: 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
name: Sherine E Ismail, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.