1. A Prospective Observational Pilot Study: Evaluating the Impact of a Breakthrough Pain Action Plan on the Use of Breakthrough Medications Luzhi Yan, BSc(Pharm); Donna K Buna, BSc(Pharm), PharmD Methods Results Discussion Conclusion References available on request Pain is multi-factorial involving both physical and psychosocial factors. Breakthrough pain (BTP) -Occurs in 48-70% of patients with chronic noncancer pain -Contributes to pain-related distress, functional impairment, depression and relatively poor quality of life -Often treated with short-acting analgesics (usually opioids) -Typical episode peaks at 3 minutes, lasts approximately 30 minutes -Strategies such as heat and ice therapy, music, relaxation, distraction, cognitive reframing and massage therapy have been described in the literature to have beneficial effects for both pain and anxiety → Promoted at VIHA Pain Program – Victoria Site Potential downfalls of breakthrough medications use -Pharmacokinetics of short-acting analgesics does not correlate well with BTP -Higher peaks, theoretically equating to more acute adverse effects -Opioid tolerance (tachyphylaxis) and dose escalation over time -Overutilization of breakthrough medications past the titration phase -Risk of abuse Objective 1: To evaluate the effectiveness of an individualized BTP Action Plan Outcome Measures: - Average number of breakthrough medication doses per day - Overall pain/function as reported by the pain outcomes questionnaire (POQ)* - Preferred behavioural interventions as per BTP Action Plan and patient report Objective 2: To determine the long-term sustainability of a BTP Action Plan in chronic pain patients Objective 3: To determine the feasibility of conducting a larger, more robust study in this area * POQ is a 20-point questionnaire used to assess pain and function (both physical and psychosocial) and is validated in both acute and chronic pain syndromes Introduction Study Objectives Results Figure 4: Nondrug intervention breakdown Recruitment and Baseline Demographics Figure 2: Average daily doses of breakthrough medications used ParameterN=5 Type of pain No. (%) Lower back pain1 (20) Neuropathic3 (60) Mixed1 (20) Avg duration of chronic pain (mo) 141.6 Avg age (yrs) 46.4 Male (%) 40 Comorbid psychiatric illness (%) 40 Pain score at baseline - numerical rating scale (NRS) 7 Reasons for Exclusion: Regimen change 4 No BTP meds 2 No pain series 1 Declined/withdrew 3 N=15 N=10 N=5 Screening Exclusions Baseline interview Consent, demographics, medication history, primary pain diagnosis, duration of chronic pain, comorbidities, set-up one week self-assessment phase Baseline interview Consent, demographics, medication history, primary pain diagnosis, duration of chronic pain, comorbidities, set-up one week self-assessment phase One-week baseline daily self-assessment Patient intervention One-week post-intervention daily self-assessment Post-study follow-up 2 nd interview Development of BTP Action Plan with study investigators, set-up time for patient’s one week post- intervention self-assessment; initiate intervention 2 nd interview Development of BTP Action Plan with study investigators, set-up time for patient’s one week post- intervention self-assessment; initiate intervention 1 week 4 weeks 1 week 6 months post-study Table 1: Baseline demographics Descriptive analysis of nondrug measures used -Use of each intervention varied depending on type of chronic pain -Patient 2 with neuropathic pain (including TMJ) preferred self-massage and meditation therapy -Patient 3 with mixed lower back pain (LBP) and sciatica preferred meditation, heat therapy and exercise therapy (short walks) -Patient 4 with perianal neuropathic pain did not find any nondrug measure to be particularly helpful -Patient 5 with chronic LBP preferred deep breathing and rest (BTP often caused by overexertion) 6-months post-study follow-up -Questionnaire to determine satisfaction/compliance with Action Plan -To be completed (TBC) Figure 3: Overall pain score (NRS) * Meditation and controlled breathing were often combined as a single item on the action plan Positive thinking 4.8% Ice therapy 9.5% * * Mobility ( /40) Patient 1No data Patient 20 Patient 3 Patient 40 Patient 5-4 Vitality ( /30) Patient 1No data Patient 2-5 Patient 3-3 Patient 45 Patient 5-4 Psychosocial ( /50) Patient 1No data Patient 2 Patient 3-2 Patient 410 Patient 50 Table 2: Changes in POQ *Negative number indicates an improvement in parameter Mobility: ability to walk, carry items, climb stairs and use of walking aid Vitality: perception of overall energy, physical activity and endurance Psychosocial: rating of feelings of depression, anxiety, self-esteem concentration and tension Figure 1: Recruitment flow chart N=4 Findings Limitations -Observational trial → definitive conclusions cannot be made regarding the efficacy of behavioural interventions in pain management -Small sample size → hypothesis generating at best; no formal statistical analysis performed -Patient reporting bias → no feasible objective measurements for pain, thus must rely on patient self-reporting which may favour intervention -Long-term benefits of using less breakthrough medication not assessed -Conclusive data cannot be drawn from this pilot study -In the few patients analyzed, there appears to a reduction in BTP medication use without adversely affecting pain and function -Meditation, controlled breathing and heat therapy were the preferred nondrug measures -Long-term sustainability of BTP Action Plan to be completed -Extension of recruitment and 6-months follow-up data is required to determine feasibility of conducting a larger, more robust trial in this area Did not complete Outcome MeasureResult Average daily BTP medication ↓ by 1.25 doses (38%) Average daily morphine equivalents ↓ by 10.3 mg (40%) Overall pain and functionNot adversely affected Preferred behavioural interventions Meditation, controlled breathing, heat therapy Long-term sustainability - 6-month post-study data TBC - Extension of recruitment to increase sample size Feasibility of conducting a larger, more robust study in this area Design -Prospective, observational pilot study -Single center: VIHA Pain Program Study population InclusionExclusion -18 years of age and older -Followed through VIHA Pain Program -Chronic noncancer pain (excluding headache) of at least 6 months duration -Using long-acting baseline PLUS 2 or more short-acting breakthrough analgesics per day -Completion of the Pain Education Series (or similar) -Unable to read or write English -Unable attend appointments in person -Change of pain medication regimen in the 1 month before or anytime during study phase -Unwilling or unable to provide informed written consent -Tertiary pain population → pain management remains a challenge despite multiple trials of various analgesic and adjunctive medications -Evaluating nondrug BTP management as part of an individualized action plan using breakthrough medication use as an endpoint -BTP Action Plan comprised of 5 nondrug measures chosen by the patient in conjunction with study investigators Uniqueness of Research