End Stage Renal DiseaseNCT05952388
Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients
A study testing Behavioral Patient care in people with End Stage Renal Disease, run by University of New Mexico.
Trial summary
The purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. Cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (DRPs), improve the cost-effectiveness of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Behavioral Patient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jan 2003
- 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 are eligible for inclusion in the study if they have been on HD for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. Informed consent will be obtained on eligible patients. The study is to be approved by the Human Research Review Committee prior to initiation.
Who cannot join
- Patients will be excluded if they have been on HD for less than three months, decline the opportunity to participate, or are less than 18 years of age.
About this study
The purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. Cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (DRPs), improve the cost-effectiveness of therapeutic regimens and prevent hospitalizations.
Read the detailed description
Approximately 350,000 end-stage renal disease (ESRD) patients in the United States utilized over $17.9 billion Medicare dollars in 1999. The ESRD population and cost is projected to double by 2010. ESRD patients have a mean of 5 comorbidities per patient and are prescribed a median of eight medications. The average monthly medication cost per patient is approximately $1,200.00. For every dollar spent on medication an additional $1.77 is spent on drug-related problems (DRPs). Dialysis patients are at high risk for DRPs. It is unknown if continued pharmacist intervention in hemodialysis patients will improve patient care, reduce medication utilization and cost, and prevent hospitalization as seen in other populations. The purpose of this study is to investigate the impact of continued pharmacist intervention in ambulatory hemodialysis patients.
- Conditions
- End Stage Renal Disease
- Being tested
- Behavioral Patient care
- Keywords
- Document the number, type, and severity of DRPs, in HD patients., Determine the rates and categorization of, DRPs-associated hospitalizations in HD patients., Document the number and types of pharmaceutical, Care Interventions., Determine the outcomes of pharmaceutical care, Intervention, Determine the rate of acceptance of pharmaceutical, Care Interventions ., Assign significance rank to pharmaceutical, Determine annual drug cost in HD patients., Determine drug cost associated for treatment, of each HD patient comorbidity., Determine Quality of Life (QoL) using a renal, -specific instrument
- Medical subject headings
- Kidney Failure, Chronic, Limb-girdle muscular dystrophy, type 2C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Patient careOther
Also called Chart review
chart review
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Patient Care | No intervention | Chart review Receives: Other: Behavioral Patient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in at home medications
Behavioral: Patent care
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startJan 2003
- Primary completionJan 2003
- Study completionJan 2003
Why it stopped: PI left the institution \& this is not an applicable clinical trial (ACT).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy B Pai, Pharm.D, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952388
- Sponsor's protocol ID
- HRRC # 02-423
- Status last verified
- Mar 2024
- First submitted
- 9 Jul 2008
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacy Services on Medication Cost and Hospitalization Rates in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05952388
- Acronym / sponsor ID
- HRRC # 02-423
- Conditions
- End Stage Renal Disease
- Keywords
- Document the number, type, and severity of DRPs, in HD patients., Determine the rates and categorization of, DRPs-associated hospitalizations in HD patients., Document the number and types of pharmaceutical, Care Interventions., Determine the outcomes of pharmaceutical care, Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution \& this is not an applicable clinical trial (ACT).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2003 (actual)
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 19 Jul 2023 (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.
The purpose of this study is to evaluate the effects of pharmaceutical care interventions in the ambulatory hemodialysis patients over a one-year period. Cost containment occurs through pharmaceutical care interventions designed to identify and ameliorate drug-related problems (DRPs), improve the cost-effectiveness of therapeutic regimens and prevent hospitalizations.
Detailed description
Approximately 350,000 end-stage renal disease (ESRD) patients in the United States utilized over $17.9 billion Medicare dollars in 1999. The ESRD population and cost is projected to double by 2010. ESRD patients have a mean of 5 comorbidities per patient and are prescribed a median of eight medications. The average monthly medication cost per patient is approximately $1,200.00. For every dollar spent on medication an additional $1.77 is spent on drug-related problems (DRPs). Dialysis patients are at high risk for DRPs. It is unknown if continued pharmacist intervention in hemodialysis patients will improve patient care, reduce medication utilization and cost, and prevent hospitalization as seen in other populations. The purpose of this study is to investigate the impact of continued pharmacist intervention in ambulatory hemodialysis patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Patient Care | No intervention | Other: Behavioral Patient careChart review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are eligible for inclusion in the study if they have been on HD for greater than three months, greater than 18 years of age, those who plan to be continuously enrollment in therapy at the same dialysis center throughout the duration of the study. Informed consent will be obtained on eligible patients. The study is to be approved by the Human Research Review Committee prior to initiation.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have been on HD for less than three months, decline the opportunity to participate, or are less than 18 years of age.
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 |
|---|---|---|
| Behavioral Patient careAlso: Chart reviewchart review | Other | Behavioral Patient Care |
Primary outcome
Reduction in at home medications
Time frame: through study completion, an average of 1 year
Behavioral: Patent care
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
Amy B Pai, Pharm.D principal investigator
University of New Mexico
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Patient care in people with End Stage Renal Disease, run by University of New Mexico.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in at home medications (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.