- Email: [email protected]
Comparing the Pharmacokinetics of Rectally Administered Phenobarbital Tablets in Microenema Form Versus Suppository (S706)
Vol. 51 No. 2 February 2016
Poster Abstracts
Results. 121 women/160 men, mean age 64.1416.3. The aggravated chronic conditions were neurological diseases (116, 41%), advanced cancer (72; 25%), dementia (23, 8%), multiple comorbidities (18, 6%), serious chronic liver disease (7, 2%), chronic obstructive pulmonary disease (10; 3%), and others (35, 12%). We noted an increase of the number of patients evaluated since the beginning of the project (13 until 45/month). Lower IT was strongly associated with lower SI (p<0.01). Conclusion. Palliative care interconsultation strategy during emergency department admission is associated with lower length of ED stay for patients admitted with acute aggravated, chronic conditions.
Implications for Research, Policy or Practice. These findings showed the need to train emergency physicians on palliative care since awareness of the importance of an early palliative care team intervention in ER was associated with shorter length of stay.
Sustaining Large-Scale, Direct-Observation Research in the Natural Setting: The Palliative Care Communication Research Initiative Cohort Study (S705) Robert Gramling, MD DSc, University of Rochester, Rochester, NY. Sally Norton, RN PhD FPCN FAAN, University of Rochester, Rochester, NY. Wendy Anderson, MD MS, University of California San Francisco, San Francisco, CA. Elizabeth Gajary-Coots University of Rochester, Rochester, NY. Jenica Cimino, BA, University of California San Francisco, San Francisco, CA. PCCRI Study Group. Objectives Acquire increased awareness of direct-observation research. Identify one approach for sustaining researchclinical team collaboration in direct-observation research. Original Research Background. Understanding the characteristics of communication that foster patientcentered outcomes amid serious illness is essential for the science of palliative care. However, epidemiological cohort studies that directly observe clinical conversations can be challenging to conduct in the natural hospital setting. Research Objectives. We describe the successful enrollment, observation and data collection methods of the ongoing Palliative Care Communication Research Initiative (PCCRI). Methods. The PCCRI is a multi-site (Rochester, NY and San Francisco, CA) cohort study of naturally occurring inpatient palliative care consultations. The 6-month cohort data includes directly observed and
409
audio-recorded palliative care consultations (up to the first three visits); patient/proxy/clinician selfreport questionnaires both before and the day after consultation; post-consultation, in-depth interviews; and medical/administrative records. Results. One hundred seventy patients (10% by proxy) and 45 palliative care clinicians enrolled in PCCRI during the first 18 months of enrollment. Seventy percent of eligible patients (adults with advanced solid cancer, English speaking, and not enrolled in hospice at time of referral) were invited to participate, and 60% of them ultimately enrolled, resulting in an overall 42% sampling proportion. The PCCRI successfully oversamples for minority/under-represented patient populations. Conclusion. Epidemiologic study of patient-familyclinician communication in palliative care settings is feasible and acceptable to patients, proxies and clinicians. We detail the successful PCCRI methods for enrollment, direct observation, and data collection for this complex ‘‘field’’ environment.
Implications for Research, Policy or Practice. Results from this work will provide the empirical basis for understanding, measuring and disseminating high-quality communication in palliative care settings. Dr. Gramling is representing the full PCCRI Writing Group on this abstract solely due to limitations in space for multiple-authorship. This work is funded by a Research Scholar Grant from the American Cancer Society (PI: R. Gramling)
Comparing the Pharmacokinetics of Rectally Administered Phenobarbital Tablets in Microenema Form Versus Suppository (S706) Bradford Macy, BSN RN CHPN, Kaiser Permanente Hospice, Concord, CA. Y. W. Francis Lam, PharmD, University of Texas Health Science Center at San Antonio, San Antonio, TX. Anson Lam, MD, WCCT Global, Fullerton, CA. Objectives Describe this research study including the objectives, methods, results and conclusions. Describe the implications of this study within the context of clinical practice and need for future research. Original Research Background. The oral route is compromised for nearly all patients approaching death. When agitation or other intractable symptoms occur, an effective, reliable and comfortable alternate route for medication delivery that is easy to administer in the home setting is highly desirable.
410
Poster Abstracts
Vol. 51 No. 2 February 2016
Research Objectives. To characterize the early ab-
Original Research Background. Despite physicians
sorption profile, variability, and comfort of phenobarbital tablets given in a microenema suspension delivered via the Macy CatheterÒ (MC) versus the same dose given via suppository. Methods. This was a randomized, open-label, crossover study comparing the early absorption profile of equal doses of phenobarbital administered rectally in three treatment phases: phenobarbital suppository and two different microenemas with phenobarbital tablets crushed and suspended in 6ml (MC-6) and 20ml (MC-20) of tap water. Results. Mean plasma phenobarbital concentrations at 10 min were 12x higher for MC-20 and 8x higher for MC-6 compared to suppository. Concentrations achieved in 30 minutes via MC-20 took almost 3 hours to achieve with suppository. Mean AUC values were higher for MC-20 and MC-6 (82% and 46%, respectively) vs. suppository (P < 0.05). There was less variability in absorption for MC-20 and MC-6 (1.4 to 1.9-fold difference) compared to a 4.4-fold difference via suppository. MC administrations were reported as ‘‘not uncomfortable’’ compared to suppositories, which were reported as ‘‘mildly uncomfortable’’ (P < 0.05). Conclusion. The absorption kinetics of Macy Catheter-administered phenobarbital microenemas were superior to compounded phenobarbital suppositories, including rate of early absorption, overall absorption, variability, and comfort of administration. Implications for Research, Policy or Practice. The administration of micro-enemas with a rectal access device such as the Macy Catheter could play an important role in the rapid control of symptoms related to agitation, seizures, and intractable suffering in the home setting, allowing more patients to die peacefully in the environment of their choice. Further research would be beneficial to better understand the potential role of microenema-delivered medications in symptom control.
attempts to select the ‘‘fittest’’ of subjects for phase I oncology trials using rigorous inclusion/exclusion criteria, many patients still suffer from serious adverse events (SAEs) that lead to increased morbidity and mortality. Research Objectives. To assess whether baseline quality-of-life (QoL) scores can predict increased likelihood of SAEs in patients and hence aid investigator judgment in deciding patient fitness for phase I studies. Methods. 92 patients with solid tumors were included in this analysis after enrolling in one of 23 phase I solid tumor clinical trials at a comprehensive cancer center in Buffalo, NY. QoL questionnaires (FACT-G, EORTC QLQ-C30 and Medical Outcomes Study Social Support Survey) were administered at baseline. All SAEs that occurred within the first four cycles of treatment were recorded. Fisher’s exact test was used to study the association between categorical variables. A linear transformation was used to standardize QoL scores. P-value # 0.05 was considered statistically significant. Results. Mean age of the patients was 61 years, and 41% were male. Baseline EORTC QLQ-C30 scores were poorer among patients who encountered SAEs (p ¼ 0.01). When EORTC QLQ-C30 scores were further analyzed according to specific domains, worse global health status, functional, and symptom scores were each associated with occurrence of SAEs (p ¼ 0.05, 0.03 and 0.02, respectively). Conclusion. Baseline EORTC QLQ-C30 score is associated with risk of SAEs during phase I trial therapy in patients with advanced solid malignancies. Additional studies are needed to validate this observation and assess efficacy of interventions, such as early palliative care, that might mitigate the risk for SAE in this population.
Quality-of-Life (QoL) in Patients with Advanced Solid Tumors as a Screening Tool During Phase I Clinical Trial RecruitmentdProspective Pilot Study on Implications on Eligibility (S707) Sidra Anwar, MD, State University of New York at Buffalo, Buffalo, NY. Grace Dy, MD, Roswell Park Cancer institute, Buffalo, NY. Wei Tan, MA, Roswell Park Cancer Institute, Buffalo, NY. Objectives Recognize QoL as a predictor for serious adverse effect (SAE) occurrence in patients enrolled in phase I oncology clinical trials. Recognize the importance of interdisciplinary approach when dealing with the oncology patient.
Implications for Research, Policy or Practice. Patients with otherwise favorable ’’traditional’’ inclusion criteria may still be at an increased risk for SAEs due to their baseline QoL, a previously unrecognized predictor of adverse events in these trials. This study supports change in current phase I eligibility protocols used for enrollment.
Ethnic Differences in Advance Directive Completion and Care Preferences Over Time (S708) Jaclyn Portanova, BS, University of Southern California Davis School of Gerontology, Los Angeles, CA. Susan Enguidanos, MPH PhD, University of Southern California, Los Angeles, CA. Objectives Identify differences in advance directive completion rates among ethnic minority groups.
Poster Abstracts
Results. 121 women/160 men, mean age 64.1416.3. The aggravated chronic conditions were neurological diseases (116, 41%), advanced cancer (72; 25%), dementia (23, 8%), multiple comorbidities (18, 6%), serious chronic liver disease (7, 2%), chronic obstructive pulmonary disease (10; 3%), and others (35, 12%). We noted an increase of the number of patients evaluated since the beginning of the project (13 until 45/month). Lower IT was strongly associated with lower SI (p<0.01). Conclusion. Palliative care interconsultation strategy during emergency department admission is associated with lower length of ED stay for patients admitted with acute aggravated, chronic conditions.
Implications for Research, Policy or Practice. These findings showed the need to train emergency physicians on palliative care since awareness of the importance of an early palliative care team intervention in ER was associated with shorter length of stay.
Sustaining Large-Scale, Direct-Observation Research in the Natural Setting: The Palliative Care Communication Research Initiative Cohort Study (S705) Robert Gramling, MD DSc, University of Rochester, Rochester, NY. Sally Norton, RN PhD FPCN FAAN, University of Rochester, Rochester, NY. Wendy Anderson, MD MS, University of California San Francisco, San Francisco, CA. Elizabeth Gajary-Coots University of Rochester, Rochester, NY. Jenica Cimino, BA, University of California San Francisco, San Francisco, CA. PCCRI Study Group. Objectives Acquire increased awareness of direct-observation research. Identify one approach for sustaining researchclinical team collaboration in direct-observation research. Original Research Background. Understanding the characteristics of communication that foster patientcentered outcomes amid serious illness is essential for the science of palliative care. However, epidemiological cohort studies that directly observe clinical conversations can be challenging to conduct in the natural hospital setting. Research Objectives. We describe the successful enrollment, observation and data collection methods of the ongoing Palliative Care Communication Research Initiative (PCCRI). Methods. The PCCRI is a multi-site (Rochester, NY and San Francisco, CA) cohort study of naturally occurring inpatient palliative care consultations. The 6-month cohort data includes directly observed and
409
audio-recorded palliative care consultations (up to the first three visits); patient/proxy/clinician selfreport questionnaires both before and the day after consultation; post-consultation, in-depth interviews; and medical/administrative records. Results. One hundred seventy patients (10% by proxy) and 45 palliative care clinicians enrolled in PCCRI during the first 18 months of enrollment. Seventy percent of eligible patients (adults with advanced solid cancer, English speaking, and not enrolled in hospice at time of referral) were invited to participate, and 60% of them ultimately enrolled, resulting in an overall 42% sampling proportion. The PCCRI successfully oversamples for minority/under-represented patient populations. Conclusion. Epidemiologic study of patient-familyclinician communication in palliative care settings is feasible and acceptable to patients, proxies and clinicians. We detail the successful PCCRI methods for enrollment, direct observation, and data collection for this complex ‘‘field’’ environment.
Implications for Research, Policy or Practice. Results from this work will provide the empirical basis for understanding, measuring and disseminating high-quality communication in palliative care settings. Dr. Gramling is representing the full PCCRI Writing Group on this abstract solely due to limitations in space for multiple-authorship. This work is funded by a Research Scholar Grant from the American Cancer Society (PI: R. Gramling)
Comparing the Pharmacokinetics of Rectally Administered Phenobarbital Tablets in Microenema Form Versus Suppository (S706) Bradford Macy, BSN RN CHPN, Kaiser Permanente Hospice, Concord, CA. Y. W. Francis Lam, PharmD, University of Texas Health Science Center at San Antonio, San Antonio, TX. Anson Lam, MD, WCCT Global, Fullerton, CA. Objectives Describe this research study including the objectives, methods, results and conclusions. Describe the implications of this study within the context of clinical practice and need for future research. Original Research Background. The oral route is compromised for nearly all patients approaching death. When agitation or other intractable symptoms occur, an effective, reliable and comfortable alternate route for medication delivery that is easy to administer in the home setting is highly desirable.
410
Poster Abstracts
Vol. 51 No. 2 February 2016
Research Objectives. To characterize the early ab-
Original Research Background. Despite physicians
sorption profile, variability, and comfort of phenobarbital tablets given in a microenema suspension delivered via the Macy CatheterÒ (MC) versus the same dose given via suppository. Methods. This was a randomized, open-label, crossover study comparing the early absorption profile of equal doses of phenobarbital administered rectally in three treatment phases: phenobarbital suppository and two different microenemas with phenobarbital tablets crushed and suspended in 6ml (MC-6) and 20ml (MC-20) of tap water. Results. Mean plasma phenobarbital concentrations at 10 min were 12x higher for MC-20 and 8x higher for MC-6 compared to suppository. Concentrations achieved in 30 minutes via MC-20 took almost 3 hours to achieve with suppository. Mean AUC values were higher for MC-20 and MC-6 (82% and 46%, respectively) vs. suppository (P < 0.05). There was less variability in absorption for MC-20 and MC-6 (1.4 to 1.9-fold difference) compared to a 4.4-fold difference via suppository. MC administrations were reported as ‘‘not uncomfortable’’ compared to suppositories, which were reported as ‘‘mildly uncomfortable’’ (P < 0.05). Conclusion. The absorption kinetics of Macy Catheter-administered phenobarbital microenemas were superior to compounded phenobarbital suppositories, including rate of early absorption, overall absorption, variability, and comfort of administration. Implications for Research, Policy or Practice. The administration of micro-enemas with a rectal access device such as the Macy Catheter could play an important role in the rapid control of symptoms related to agitation, seizures, and intractable suffering in the home setting, allowing more patients to die peacefully in the environment of their choice. Further research would be beneficial to better understand the potential role of microenema-delivered medications in symptom control.
attempts to select the ‘‘fittest’’ of subjects for phase I oncology trials using rigorous inclusion/exclusion criteria, many patients still suffer from serious adverse events (SAEs) that lead to increased morbidity and mortality. Research Objectives. To assess whether baseline quality-of-life (QoL) scores can predict increased likelihood of SAEs in patients and hence aid investigator judgment in deciding patient fitness for phase I studies. Methods. 92 patients with solid tumors were included in this analysis after enrolling in one of 23 phase I solid tumor clinical trials at a comprehensive cancer center in Buffalo, NY. QoL questionnaires (FACT-G, EORTC QLQ-C30 and Medical Outcomes Study Social Support Survey) were administered at baseline. All SAEs that occurred within the first four cycles of treatment were recorded. Fisher’s exact test was used to study the association between categorical variables. A linear transformation was used to standardize QoL scores. P-value # 0.05 was considered statistically significant. Results. Mean age of the patients was 61 years, and 41% were male. Baseline EORTC QLQ-C30 scores were poorer among patients who encountered SAEs (p ¼ 0.01). When EORTC QLQ-C30 scores were further analyzed according to specific domains, worse global health status, functional, and symptom scores were each associated with occurrence of SAEs (p ¼ 0.05, 0.03 and 0.02, respectively). Conclusion. Baseline EORTC QLQ-C30 score is associated with risk of SAEs during phase I trial therapy in patients with advanced solid malignancies. Additional studies are needed to validate this observation and assess efficacy of interventions, such as early palliative care, that might mitigate the risk for SAE in this population.
Quality-of-Life (QoL) in Patients with Advanced Solid Tumors as a Screening Tool During Phase I Clinical Trial RecruitmentdProspective Pilot Study on Implications on Eligibility (S707) Sidra Anwar, MD, State University of New York at Buffalo, Buffalo, NY. Grace Dy, MD, Roswell Park Cancer institute, Buffalo, NY. Wei Tan, MA, Roswell Park Cancer Institute, Buffalo, NY. Objectives Recognize QoL as a predictor for serious adverse effect (SAE) occurrence in patients enrolled in phase I oncology clinical trials. Recognize the importance of interdisciplinary approach when dealing with the oncology patient.
Implications for Research, Policy or Practice. Patients with otherwise favorable ’’traditional’’ inclusion criteria may still be at an increased risk for SAEs due to their baseline QoL, a previously unrecognized predictor of adverse events in these trials. This study supports change in current phase I eligibility protocols used for enrollment.
Ethnic Differences in Advance Directive Completion and Care Preferences Over Time (S708) Jaclyn Portanova, BS, University of Southern California Davis School of Gerontology, Los Angeles, CA. Susan Enguidanos, MPH PhD, University of Southern California, Los Angeles, CA. Objectives Identify differences in advance directive completion rates among ethnic minority groups.