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Poster 294: Outpatient Clinics Wait Time
E116
ACADEMY ANNUAL ASSEMBLY ABSTRACTS
Poster 292 Fibromyalgia Relapse Evaluation and Efficacy for Durability of Meaningful Relief (FREEDOM) Trial: A 6-Month Discontinuation Trial of Pregabalin for the Pain of Fibromyalgia. Jeannette A. Barrett, PhD (Pfizer Global Pharmaceuticals, New York, NY); Lynne Pauer; Bernhardt G. Zeiher, MD. Disclosure: J.A. Barrett, Pfizer Inc., employment, stock options or bond holdings; L. Pauer, Pfizer Inc., employment, stock options or bond holdings; B.G. Zeiher, Pfizer, employment . Objective: Pregabalin has shown efficacy for reducing pain associated with fibromyalgia. We investigated the durability of pregabalin’s treatment effect in patients with fibromyalgia. Design: Randomized, double-blind, placebo-controlled design: 1-week screening; 6-week open-label (OL) (individualized dosage of pregabalin monotherapy: 300, 450, or 600mg/d); 26-week double blind (DB). Setting: Primary care and specialty centers. Participants: Randomized patients had 50% or higher reduction in mean Pain VAS score from OL baseline and Patient Global Impression of Change rating of at least “much improved” at the end of OL and received pregabalin (optimized OL dosage of 300, 450, or 600mg/d) or placebo. Interventions: Individualized pregabalin dosage optimization to 300, 450, or 600mg/d. Main Outcome Measures: Primary endpoint: time to loss of therapeutic response (LTR), defined as less than 30% reduction in pain VAS score (from OL baseline) during 2 consecutive visits or subjective worsening of fibromyalgia (eg, patient needs alternative therapy). Primary analysis evaluated all pregabalin dosages versus placebo. Results: 1051 patients entered OL; 663 completed; 566 (85%) met DB inclusion criteria and were randomized to pregabalin (n⫽279) or placebo (n⫽287). Time to LTR was significantly longer for pregabalin (P⬍.0001): 25% of placebo patients had LTR by day 7, compared with day 34 for pregabalin patients. Nearly twice as many placebo patients (61%) had LTR by end of DB as compared with pregabalin patients (32%; P⬍.0001). The most common AEs during OL were dizziness (36%) and somnolence (22%); during DB, most common AEs exceeding placebo were sinusitis (pregabalin, 5% vs placebo, 3%) and arthralgia and anxiety (5% vs 2%). Conclusions: Pregabalin monotherapy demonstrated superior durability of efficacy in fibromyalgia response in this 32-week treatment study. Key Words: Fibromyalgia; Pain; Rehabilitation. Poster 293 Infections During Interdisciplinary Inpatient Cardiac Rehabilitation. Heather K. Vincent, PhD, MS (University of Florida, Gainesville, FL); Kevin R. Vincent, MD, PhD. Disclosure: H.K. Vincent, none; K.R. Vincent, none. Objective: To examine the type and prevalence of infections present, and complications related to infections present during inpatient cardiac rehabilitation. Design: Observational study of the natural course of care. Setting: Inpatient rehabilitation facility. Participants: A total of 241 consecutive patients with a major cardiac admission diagnosis were included (71.8y, 43.7% ejection fraction, 45% women, 35% living alone). Intervention: Comprehensive interdisciplinary inpatient rehabilitation. Main Outcome Measures: Infection profile, length of stay (LOS), medical complications, readmissions to acute care, charges for rehabilitation stay. Results: The preponderance of infections included pneumonia (30.8%), urinary tract infections (14.3%), wound infections (14.3%), and antibiotic-resistant staphylococcus (8.8%). LOS was 28.5⫾42.2 versus 19.3⫾5.0 days for patients with and without an infection at admission. Changes in Motor FIM scores were 3 points higher by discharge in patients with infections than those without (22% vs 19%; P⫽0.024). The frequency of readmissions to acute care was not different between those with infection (15 out of 92 cases) and those without (20 out of 149 cases). Common Arch Phys Med Rehabil Vol 89, November 2008
complications incurred were cardiac symptoms (37– 41%) and desaturation (11–21%) in patients with and without infections. Stasis and pressure ulcer incidences were 5.1% to 11.8% higher in patients with infections. Infections were related to a 12.1% higher rate of falling and injury, and 16.9% more nutrition risks (swallowing difficulty, nausea, unintentional weight loss). Infections were correlated with number of readmissions to acute care (r⫽0.544, P⬍0.0001) than not having an infection. A total of 9.8% versus 4.0% of cases resulted in death during rehabilitation. Rehabilitation charges were $20,609 versus $14,812 for patients with and without infections (P⫽0.024); presence of infections at admission was correlated with therapy and pharmacy charges (all correlation coefficients ⬎0.563; P⬍0.001). Conclusions: While infections did not preclude functional gain, rehabilitation programs should consider methods to reduce medical complications and increase awareness of the risk of falls and repeat readmissions to acute care in cardiac patients with infection. Key Words: Cardiac; Infection; Rehabilitation. Poster 294 Outpatient Clinics Wait Time. Improvement Strategy. Hany R. Nosir, MD (Advanced Pain Management, Greenfield, WI). Disclosure: H.R. Nosir, none. Objective: The tolerance by the patients for waiting more than 30 minutes is diminished. The “waiting time,” measured in minutes, is the time between an appointment and the start of the consultation or treatment. The objective is to reduce patient wait time in an outpatient practice setting by implementing improvement strategies. Design: A time study is designed to record the time data over 4 weeks. The total wait time is measured before and after implementing the improvement strategies. Statistical analysis to determine the median, the range, the mean and standard deviation, is used. Setting: Private practice. Participants: The study team included the attending physician as well as the clinic staff. Interventions: Improvement strategies: staff meeting; focus improvement efforts on paper form, entering patient data, length of the office visit for both new and continuing patients; use simple scheduling template; incorporate a checklist mailed to patients; diplomatically worded telephone reminder; change the time necessary for the visit time; the clinic start time redefined to 15 minutes before first patient appointment for all staff; a checklist for clinic organization; the patients dispatching rule to replace the first-come, first-served rule— the physician sees patients in the sequence of their notes in a pile. Main Outcome Measures: The number of patients seen within 30 minutes from their arrival time rose by 62%. Results: The wait time before the changes ranged from 33 to 80 minutes, with mean ⫾ SD of 58.28⫾12.40 minutes, median of 60 minutes. The wait time after implementing the improvement strategies ranged from 20 to 39 minutes, with a mean ⫾ SD 29.58⫾4.50 minutes, and median of 30 minutes. Conclusions: The standard of performance in an outpatient clinic is that all patients should be seen within a short period of time prior to their appointment. A patient attitude or satisfaction is attracting more attention within the framework of total quality management in health services provision. Patient appointment system is needed to monitor waiting time standards in the clinic. Key Words: Practice management; Rehabilitation. Poster 295 Pregabalin As Long-Term Treatment of Fibromyalgia Pain. Bernhardt G. Zeiher, MD (Pfizer Research and Development, Ann Arbor, MI); Jeannette A. Barrett, PhD; Teresa Leon; Lynne Pauer; Ed Whalen. Disclosure: J.A. Barrett, Pfizer Inc., employment, stock options or bond holdings; L. Pauer, Pfizer Inc., employment, stock options or
ACADEMY ANNUAL ASSEMBLY ABSTRACTS
Poster 292 Fibromyalgia Relapse Evaluation and Efficacy for Durability of Meaningful Relief (FREEDOM) Trial: A 6-Month Discontinuation Trial of Pregabalin for the Pain of Fibromyalgia. Jeannette A. Barrett, PhD (Pfizer Global Pharmaceuticals, New York, NY); Lynne Pauer; Bernhardt G. Zeiher, MD. Disclosure: J.A. Barrett, Pfizer Inc., employment, stock options or bond holdings; L. Pauer, Pfizer Inc., employment, stock options or bond holdings; B.G. Zeiher, Pfizer, employment . Objective: Pregabalin has shown efficacy for reducing pain associated with fibromyalgia. We investigated the durability of pregabalin’s treatment effect in patients with fibromyalgia. Design: Randomized, double-blind, placebo-controlled design: 1-week screening; 6-week open-label (OL) (individualized dosage of pregabalin monotherapy: 300, 450, or 600mg/d); 26-week double blind (DB). Setting: Primary care and specialty centers. Participants: Randomized patients had 50% or higher reduction in mean Pain VAS score from OL baseline and Patient Global Impression of Change rating of at least “much improved” at the end of OL and received pregabalin (optimized OL dosage of 300, 450, or 600mg/d) or placebo. Interventions: Individualized pregabalin dosage optimization to 300, 450, or 600mg/d. Main Outcome Measures: Primary endpoint: time to loss of therapeutic response (LTR), defined as less than 30% reduction in pain VAS score (from OL baseline) during 2 consecutive visits or subjective worsening of fibromyalgia (eg, patient needs alternative therapy). Primary analysis evaluated all pregabalin dosages versus placebo. Results: 1051 patients entered OL; 663 completed; 566 (85%) met DB inclusion criteria and were randomized to pregabalin (n⫽279) or placebo (n⫽287). Time to LTR was significantly longer for pregabalin (P⬍.0001): 25% of placebo patients had LTR by day 7, compared with day 34 for pregabalin patients. Nearly twice as many placebo patients (61%) had LTR by end of DB as compared with pregabalin patients (32%; P⬍.0001). The most common AEs during OL were dizziness (36%) and somnolence (22%); during DB, most common AEs exceeding placebo were sinusitis (pregabalin, 5% vs placebo, 3%) and arthralgia and anxiety (5% vs 2%). Conclusions: Pregabalin monotherapy demonstrated superior durability of efficacy in fibromyalgia response in this 32-week treatment study. Key Words: Fibromyalgia; Pain; Rehabilitation. Poster 293 Infections During Interdisciplinary Inpatient Cardiac Rehabilitation. Heather K. Vincent, PhD, MS (University of Florida, Gainesville, FL); Kevin R. Vincent, MD, PhD. Disclosure: H.K. Vincent, none; K.R. Vincent, none. Objective: To examine the type and prevalence of infections present, and complications related to infections present during inpatient cardiac rehabilitation. Design: Observational study of the natural course of care. Setting: Inpatient rehabilitation facility. Participants: A total of 241 consecutive patients with a major cardiac admission diagnosis were included (71.8y, 43.7% ejection fraction, 45% women, 35% living alone). Intervention: Comprehensive interdisciplinary inpatient rehabilitation. Main Outcome Measures: Infection profile, length of stay (LOS), medical complications, readmissions to acute care, charges for rehabilitation stay. Results: The preponderance of infections included pneumonia (30.8%), urinary tract infections (14.3%), wound infections (14.3%), and antibiotic-resistant staphylococcus (8.8%). LOS was 28.5⫾42.2 versus 19.3⫾5.0 days for patients with and without an infection at admission. Changes in Motor FIM scores were 3 points higher by discharge in patients with infections than those without (22% vs 19%; P⫽0.024). The frequency of readmissions to acute care was not different between those with infection (15 out of 92 cases) and those without (20 out of 149 cases). Common Arch Phys Med Rehabil Vol 89, November 2008
complications incurred were cardiac symptoms (37– 41%) and desaturation (11–21%) in patients with and without infections. Stasis and pressure ulcer incidences were 5.1% to 11.8% higher in patients with infections. Infections were related to a 12.1% higher rate of falling and injury, and 16.9% more nutrition risks (swallowing difficulty, nausea, unintentional weight loss). Infections were correlated with number of readmissions to acute care (r⫽0.544, P⬍0.0001) than not having an infection. A total of 9.8% versus 4.0% of cases resulted in death during rehabilitation. Rehabilitation charges were $20,609 versus $14,812 for patients with and without infections (P⫽0.024); presence of infections at admission was correlated with therapy and pharmacy charges (all correlation coefficients ⬎0.563; P⬍0.001). Conclusions: While infections did not preclude functional gain, rehabilitation programs should consider methods to reduce medical complications and increase awareness of the risk of falls and repeat readmissions to acute care in cardiac patients with infection. Key Words: Cardiac; Infection; Rehabilitation. Poster 294 Outpatient Clinics Wait Time. Improvement Strategy. Hany R. Nosir, MD (Advanced Pain Management, Greenfield, WI). Disclosure: H.R. Nosir, none. Objective: The tolerance by the patients for waiting more than 30 minutes is diminished. The “waiting time,” measured in minutes, is the time between an appointment and the start of the consultation or treatment. The objective is to reduce patient wait time in an outpatient practice setting by implementing improvement strategies. Design: A time study is designed to record the time data over 4 weeks. The total wait time is measured before and after implementing the improvement strategies. Statistical analysis to determine the median, the range, the mean and standard deviation, is used. Setting: Private practice. Participants: The study team included the attending physician as well as the clinic staff. Interventions: Improvement strategies: staff meeting; focus improvement efforts on paper form, entering patient data, length of the office visit for both new and continuing patients; use simple scheduling template; incorporate a checklist mailed to patients; diplomatically worded telephone reminder; change the time necessary for the visit time; the clinic start time redefined to 15 minutes before first patient appointment for all staff; a checklist for clinic organization; the patients dispatching rule to replace the first-come, first-served rule— the physician sees patients in the sequence of their notes in a pile. Main Outcome Measures: The number of patients seen within 30 minutes from their arrival time rose by 62%. Results: The wait time before the changes ranged from 33 to 80 minutes, with mean ⫾ SD of 58.28⫾12.40 minutes, median of 60 minutes. The wait time after implementing the improvement strategies ranged from 20 to 39 minutes, with a mean ⫾ SD 29.58⫾4.50 minutes, and median of 30 minutes. Conclusions: The standard of performance in an outpatient clinic is that all patients should be seen within a short period of time prior to their appointment. A patient attitude or satisfaction is attracting more attention within the framework of total quality management in health services provision. Patient appointment system is needed to monitor waiting time standards in the clinic. Key Words: Practice management; Rehabilitation. Poster 295 Pregabalin As Long-Term Treatment of Fibromyalgia Pain. Bernhardt G. Zeiher, MD (Pfizer Research and Development, Ann Arbor, MI); Jeannette A. Barrett, PhD; Teresa Leon; Lynne Pauer; Ed Whalen. Disclosure: J.A. Barrett, Pfizer Inc., employment, stock options or bond holdings; L. Pauer, Pfizer Inc., employment, stock options or