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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Involvement of pharmacists in improving medication | Experimental | Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up |
|
| usual care only | No Intervention | Patients were provided with usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacists involved PPMTM | Other | 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. |
| 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 |
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Inclusion Criteria:
Parental permission obtained prior to start of study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renjie Xu, PhD | Shaoxing Maternity and Child Health Care Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoxing Maternity and Child Care hospital | Shaoxing | Zhejiang | 312000 | China |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| D001519 | Behavior |