Potential subjects for the study were identified from pharmacy medication records. Patients were considered eligible if they were receiving either baclofen or dantrolene or both. It was initially thought that the study should exclude any patients who had had recent (in the previous 6 months) dose changes of baclofen or dantrolene, a switch from one agent to the other, or an unsuccessful withdrawal trial, but the physicians felt that these criteria were too restrictive and they wanted to include these patients for consideration as well. A list of their potentially eligible patients was developed for each physician. The research assistant met with each physician to review the list and determine the appropriateness of baclofen or dantrolene withdrawal for each patient. At that time, the physician’s reasons for recommending patients for study inclusion or exclusion were documented. The physician was also asked who should be approached for consent: the patient or a substitute decision maker or both.
The physician consent process happened at the beginning of the study, when the patient lists were reviewed. The patient consent process occurred gradually during the study, as staff wanted to only enroll a few patients at a time. The research assistant sought each patient’s consent just before medication withdrawal for that patient began. At the time of seeking patient consent, the patient’s pharmacist introduced the research assistant and described the project concept; the research assistant then explained the study and requested written consent.
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The baseline data collected for each consenting patient were age, sex, main diagnosis related to use of baclofen and/or dantrolene, and current dose of baclofen and/or dantrolene.
Once patient consent had been obtained, the patient’s physiotherapist, occupational therapist, pharmacist, and nursing representative (and occasionally the physician, if he or she was present in the institution that day) met with the research assistant to develop an individualized monitoring plan and to determine the frequency of monitoring. The interdisciplinary team incorporated tools and approaches already in use with the patient (such as the Ashworth or clonus score) or provided useful information to guide decision-making (e.g., pain assessment, because most patients experienced pain in association with spasticity). Each team was also able to identify individualized monitoring parameters related to function. Because spasticity always affects function, at least one important functional parameter was included for each patient. The patient and/or lay caregiver also had an opportunity to contribute to the development of the monitoring plan. The monitoring documentation forms were kept in convenient locations for the nurses (with the medication administration record), therapists (with other patient documentation), and the patients or caregivers (at the bedside). Dates for starting the medication withdrawal, the decision about which drug to withdraw first (for patients who were taking both medications), and subsequent decisions regarding the magnitude and frequency of dose changes (and other changes in therapy) were made by the health care team and were based on the data in the individual monitoring plans.
The team for each patient met regularly (once or twice a week initially, then as needed) to discuss the patient’s progress, to inform each other of adaptations made to patient care to manage changes in spasticity or other resolving adverse effects, and to determine whether tapering should continue. Each team member shared his or her knowledge of the patient’s progress, and the group used a shared decision-making approach to determine whether further dose changes were appropriate. The physician was contacted as appropriate to convey information about the patient’s condition and to suggest drug changes. The dose of the drug being withdrawn was reduced until spasticity reappeared or became worse, tone increased, and/or function decreased. If any of these endpoints occurred, the dose was then increased gradually to a point where there was an improvement in spasticity, tone, and/or function. The pharmacists worked closely with the physicians to provide individualized pharmacological information to aid in decision-making regarding alternative medication for spasticity. These individualized recommendations varied according to the patient’s disease, the stage and severity of the condition, other medications and disease states, previous medication responses, and acceptability to the patient. canadian antibiotics
Monitoring and documentation continued for 4 months after the drug was withdrawn or a maintenance dose had been established. At the end of this period, the patient’s chart was reviewed to document other changes in therapy related to spasticity treatment.