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

NCT03576404 | Completed

• 1 other identifier: SP16/099/J
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in Systolic blood pressure (SBP) control in mmHg from baseline as a independent surrogate marker for administration of medications

  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

  Monthly and up to 6 months

• Changes in Number of Medication-related problems (MRPs) from baseline at month 3 and month 5

  At month 3 and month 5 of the study

• Types of Medication-related problems (MRPs)

  Total study duration: from month 1 to month 6

• Number of accepted therapeutic interventions by the pharmacist

  Monthly and up to 6 months

Study Arms (1)

Eligible participants

EXPERIMENTAL

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

Interventions

Patient-Centered Pharmacist Care OTHER

A comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI)

Eligible participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (≥18 years of age)
• Outpatient HD for at least 3 months before the study period

You may not qualify if:

• Patients who refused to participate in the study
• Patients without the capacity to understand or take responsibility for their medications

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• Harvard University: collaborator

Related Publications (1)

• 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.

  PMID: 31722680 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Quasi-Experimental Interrupted Time Series Study

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: July 3, 2018
• Study Start: October 13, 2016
• Primary Completion: April 23, 2017
• Study Completion: April 30, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication, I can share all the supporting information
• Access Criteria: After publication