Thromboembolism
Conditions
Keywords
Heparin, Low-Molecular-Weight, compliance, drug safety, self-administration, ambulatory Care, Pharmaceutical Services
Brief summary
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
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)
Interventions
BEHAVIORALpatient education
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
Sponsors
Pfizer
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Use Problems | during the individual drug therapy, an average of 18 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | at the end of the individual drug therapy, an average of 18 days | objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks). |
| Patient Satisfaction | at the end of the individual drug therapy, an average of 18 days | — |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinical Setting: Intervention 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.
patient education: 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 | 33 |
| Clinical Setting: Standard Care Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) | 32 |
| Daily Life Setting: Intervention Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
patient education: 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 | 40 |
| Daily Life Setting: Standard Care Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) | 34 |
| Total | 139 |
Baseline characteristics
| Characteristic | Clinical Setting: Intervention | Clinical Setting: Standard Care | Daily Life Setting: Intervention | Daily Life Setting: Standard Care | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56 years | 56 years | 51 years | 54 years | 54 years |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 17 Participants | 18 Participants | 70 Participants |
| Sex: Female, Male Male | 17 Participants | 13 Participants | 23 Participants | 16 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 36 | 29 / 36 | 37 / 44 | 17 / 38 |
| serious Total, serious adverse events | 0 / 36 | 1 / 36 | 0 / 44 | 0 / 38 |
Outcome results
Primary
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.
Time frame: during the individual drug therapy, an average of 18 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Setting: Intervention | Drug Use Problems | 1.25 scores on a scale | Standard Deviation 0.27 |
| Clinical Setting: Standard Care | Drug Use Problems | 0.86 scores on a scale | Standard Deviation 0.33 |
| Daily Life Setting: Intervention | Drug Use Problems | 1.20 scores on a scale | Standard Deviation 0.41 |
| Daily Life Setting: Standard Care | Drug Use Problems | 1.17 scores on a scale | Standard Deviation 0.4 |
Secondary
Compliance
objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).
Time frame: at the end of the individual drug therapy, an average of 18 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Setting: Intervention | Compliance | 94.5 percentage of syringes | Standard Deviation 10.5 |
| Clinical Setting: Standard Care | Compliance | 96.2 percentage of syringes | Standard Deviation 10.6 |
| Daily Life Setting: Intervention | Compliance | 95.1 percentage of syringes | Standard Deviation 10 |
| Daily Life Setting: Standard Care | Compliance | 97.5 percentage of syringes | Standard Deviation 4.2 |
Secondary
Patient Satisfaction
Time frame: at the end of the individual drug therapy, an average of 18 days