Medication AdherenceNCT03576404
Patient-Centered Pharmacist Care in the Hemodialysis Unit: A Quasi-Experimental Interrupted Time Series Study
A study testing Patient-Centered Pharmacist Care in people with Medication Adherence, run by King Abdullah International Medical Research Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Patient-Centered Pharmacist Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2016to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (≥18 years of age)
- Outpatient HD for at least 3 months before the study period
Who cannot join
- Patients who refused to participate in the study
- Patients without the capacity to understand or take responsibility for their medications
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Medication Adherence
- Being tested
- Patient-Centered Pharmacist Care
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Pharmacist CareOther
A comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient-Centered Pharmacist Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Changes in Systolic blood pressure (SBP) control in mmHg from baseline and on a monthly basis
Measured: 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
Measured: Monthly and up to 6 months
Changes in Number of Medication-related problems (MRPs) from baseline at month 3 and month 5
Number
Measured: 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
Measured: 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
Measured: Monthly and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start13 Oct 2016
- Primary completion23 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Quasi-Experimental Interrupted Time Series Study
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Sponsor
- Investigators
- Sherine E Ismail, PharmD, MPH, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576404
- Sponsor's protocol ID
- SP16/099/J
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share the listed below data regarding my study for public upon request
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.
PubMed 31722680
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Medication Review by Pharmacist in Hemodialysis Patients: A Quasi Experimental Interrupted Time Series Study
- ClinicalTrials.gov ID
- NCT03576404
- Acronym / sponsor ID
- SP16/099/J
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 23 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Quasi-Experimental Interrupted Time Series Study
| Arm | Type | Receives |
|---|---|---|
| Eligible participants | Experimental | Other: Patient-Centered Pharmacist CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (≥18 years of age)
- Outpatient HD for at least 3 months before the study period
Key exclusion criteria (2 listed)
- Patients who refused to participate in the study
- Patients without the capacity to understand or take responsibility for their medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Centered Pharmacist CareA comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI) | Other | Eligible participants |
Primary outcome
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
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
5 secondary outcomes
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 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 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
Types of Medication-related problems (MRPs)
Time frame: Total study duration: from month 1 to month 6
Number of accepted therapeutic interventions by the pharmacist
Time frame: Monthly and up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Derived from this study: PubMed 31722680Ismail 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.
- An abstract of the study was accepted as poster presentation at the National Kidney foundation Spring Clinical Meeting, Austin, Texas on April 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. I plan to share the listed below data regarding my study for public upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine E Ismail, PharmD, MPH principal investigator
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
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Pharmacist Care in people with Medication Adherence, run by King Abdullah International Medical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pharmacoadherence of patients requiring HD using electronic medication refill from baseline (time frame: Monthly and up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.