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Completed

NCT Number: NCT03576404

Patient-Centered Pharmacist Care in the Hemodialysis Unit: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

  • Pharmacists conducted brief monthly interview for patients to assess the medications they are receiving
  • A comprehensive interview for patients occurred at month 3 and 5 including concepts of MTM and MI
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Centered Pharmacist Care

Other

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

Primary outcomes

  1. Changes in pharmacoadherence of patients requiring HD using electronic medication refill from baseline

    Time frame: Monthly and up to 6 months

    Comparing changes in self-reporting of number of medications with electronic prescribing during each of the six interviews

  2. Changes in pharmacoadherence of patients requiring HD through the control of serum phosphate level (mmol/L) from baseline

    Time frame: Monthly and up to 6 months

    Changes in surrogate laboratory pre-HD serum phosphate level (mmol/L) from baseline

Secondary outcomes

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

    Time frame: Monthly and up to 6 months

    Changes in Systolic blood pressure (SBP) control in mmHg from baseline and on a monthly basis

  2. Changes in serum low-density lipoprotein (LDL) levels in mmol/L from baseline as an independent surrogate marker for the administration of medications

    Time frame: Monthly and up to 6 months

    Changes in serum low-density lipoprotein (LDL) levels in mmol/L from baseline and on a monthly basis

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

    Time frame: At month 3 and month 5 of the study

    Number

  4. Types of Medication-related problems (MRPs)

    Time frame: Total study duration: from month 1 to month 6

    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

  5. Number of accepted therapeutic interventions by the pharmacist

    Time frame: Monthly and up to 6 months

    Number of Therapeutic interventions suggested by the pharmacists to alter medication regimen suggested by pharmacist based on discussion and approval of prescribing physicians

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Collaborators

  • Harvard University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 3, 2018
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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