Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation

Study Overview
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Brief Summary
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This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.

Detailed Description
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This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. As a result, the Committee on Nutrition of the American Academy of Pediatrics (AAP) recommends daily oral iron supplementation, of at least 2-4 mg/kg/day from 2 weeks of age, to prevent iron deficiency in extremely premature infants. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.

Official Title
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Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation

Conditions
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Preterm Infants, Clinical Outcome, Pharmaceutical Care

Intervention / Treatment
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* Other: pharmacists involved PPMTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NICU inpatients between 26 and 32 weeks of gestation Infants older than two week of age and Iron dosing will be adjusted for weight at weekly intervals to maintain dosing at 4mg/kg/day. Parental permission obtained prior to start of study Exclusion Criteria: In extremis during consent window (as judged by primary attending provider) Known or suspected genetic disorder Small for gestational age (birth weight below the 10th percentile for gestational age) Unable to return for follow-up evaluation at 6 months of age

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Involvement of pharmacists in improving medication<br>Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up | Other: pharmacists involved PPMTM<br>* This was an open labelled randomised study. Preterm Infants With iron supplementation were recruited and arbitrarily divided into the intervention group (usual care plus PPMTM) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.<br>|
| No Intervention: usual care only<br>Patients were provided with usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ferritin level | Iron insufficiency will be determined by ferritin level less than 70 ng/mL | At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months | 
| hemoglobin level | Iron insufficiency will be determined by hemoglobin level less than 8 g/dL | At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months | 
| reticulocyte hemoglobin equivalent (Ret-He, pg) | Iron insufficiency will be determined by Ret-He less than 27.2 pg | At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months | 
| reticulocyte count (%) | Iron insufficiency will be determined by reticulocyte count less than 2% | At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical Care, Medication Adherence, Iron Supplementation