Self-management of Low Molecular Weight Heparin Therapy

Study Overview
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Brief Summary
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There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a SOP for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment. Hypothesis: Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

Detailed Description
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Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients. Data collection: telephone interviews with structured questionnaires at the beginning and at the end of the therapy monitored self-injection in the study center or at patient's home (direct observation technique [DOT]) compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue pill count), measuring residual volume in recycled syringes recording of the fine motor skills by the adapted Disabilities of the Arm, Shoulder and Hand questionnaire (DASH questionnaire)

Official Title
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Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care

Conditions
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Thromboembolism

Intervention / Treatment
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* Behavioral: patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment. self-application of the LMWH german / english speaking -> clinical setting: Dalteparin -> daily life setting: all LMWH (ready-to-use syringes) control group: self-application or application by another person (family member, medical person, etc.) Exclusion Criteria: - patient's home far away from study center

Ages Eligible for Study
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Minimum Age: 18 Years

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: clinical setting: intervention<br>Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital. Intervention: patient education | Behavioral: patient education<br>* Possible, individualized interventions: Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes) Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom First self-injection under control of a specially trained pharmacist<br>|
| No Intervention: clinical setting: standard care<br>Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) | |
| Experimental: daily life setting: intervention<br>Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists. Intervention: patient education | Behavioral: patient education<br>* Possible, individualized interventions: Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes) Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom First self-injection under control of a specially trained pharmacist<br>|
| No Intervention: daily life setting: standard care<br>Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Use Problems | During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes. | during the individual drug therapy, an average of 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks). | at the end of the individual drug therapy, an average of 18 days | 
| Patient Satisfaction |  | at the end of the individual drug therapy, an average of 18 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical Services, Heparin, Low-Molecular-Weight, compliance, drug safety, self-administration, ambulatory Care