Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to develop and validate a new comprehensive patient-reported measure of treatment burden-the Patient Experience with Treatment and Self-management (PETS). METHODS: A conceptual framework was used to derive the PETS with items reviewed and cognitively tested with patients. A survey battery, including a pilot version of the PETS, was mailed to 838 multi-morbid patients from two healthcare institutions for validation. RESULTS: A total of 332 multi-morbid patients returned completed surveys. Diagnostics supported deletion and consolidation of some items and domains. Confirmatory factor analysis supported a domain model for scaling comprised of 9 factors: medical information, medications, medical appointments, monitoring health, interpersonal challenges, medical/healthcare expenses, difficulty with healthcare services, role/social activity limitations, and physical/mental exhaustion. Scales showed good internal consistency (α range 0.79-0.95). Higher PETS scores, indicative of greater treatment burden, were correlated with more distress, less satisfaction with medications, lower self-efficacy, worse physical and mental health, and lower convenience of healthcare (Ps < 0.001). Patients with lower health literacy, less adherence to medications, and more financial difficulties reported higher PETS scores (Ps < 0.01). CONCLUSION: A comprehensive patient-reported measure of treatment burden can help to better characterize the impact of treatment and self-management burden on patient well-being and guide care toward minimally disruptive medicine.

Developing a dashboard for benchmarking the productivity of a medication therapy management program.

OBJECTIVES: To describe a method for internal benchmarking of medication therapy management (MTM) pharmacist activities. SETTING: Multisite MTM pharmacist practices within an integrated health care system. PRACTICE DESCRIPTION: MTM pharmacists are located within primary care clinics and provide medication management through collaborative practice. MTM pharmacist activity is grouped into 3 categories: direct patient care, nonvisit patient care, and professional activities. PRACTICE INNOVATION: MTM pharmacist activities were tracked with the use of the computer-based application Pharmacist Ambulatory Resource Management System (PhARMS) over a 12-month period to measure growth during a time of expansion. RESULTS: A total of 81% of MTM pharmacist time was recorded. A total of 1655.1 hours (41%) was nonvisit patient care, 1185.2 hours (29%) was direct patient care, and 1190.4 hours (30%) was professional activities. The number of patient visits per month increased during the study period. There were 1496 direct patient care encounters documented. Of those, 1051 (70.2%) were face-to-face visits, 257 (17.2%) were by telephone, and 188 (12.6%) were chart reviews. Nonvisit patient care and professional activities also increased during the period. IMPACT: PhARMS reported MTM pharmacist activities and captured nonvisit patient care work not tracked elsewhere. Internal benchmarking data proved to be useful for justifying increases in MTM pharmacist personnel resources. Reviewing data helped to identify best practices from high-performing sites. Limitations include potential for self-reporting bias and lack of patient outcomes data. CONCLUSION: Implementing PhARMS facilitated internal benchmarking of patient care and nonpatient care activities in a regional MTM program.

Collaboration between allergists and pharmacists increases ß-lactam antibiotic prescriptions in patients with a history of penicillin allergy.

BACKGROUND: Over 90% of patients with a history of penicillin allergy have negative penicillin skin tests. Pharmacists are trained to identify and resolve medication-related problems. We hypothesized that collaboration between allergists and pharmacists to identify and evaluate patients with a history of penicillin allergy would increase ß-lactam antibiotic prescription. METHODS: We conducted a prospective observational study in which patients with a history of penicillin allergy were identified and educated at the pharmacy about penicillin allergy and offered an allergist consultation with a penicillin skin test. All patients were followed up to determine which antibiotics were subsequently prescribed. RESULTS: A total of 503 patients were enrolled, and 71 (14%) were evaluated by an allergist. Sixty-seven of these 71 patients (94%) had a negative penicillin skin test. Twenty-nine patients evaluated by an allergist and 205 patients not evaluated were prescribed antibiotics. Patients prescribed antibiotics and evaluated by an allergist were compared to those not evaluated by an allergist, with the following results: 19 of 29 patients (66%) were prescribed a ß-lactam antibiotic compared to 54 of 205 (26%; p < 0.0001); 8 of 29 patients (28%) were prescribed penicillin compared to 7 of 205 (3%; p < 0.0001); 15 of 29 patients (52%) were prescribed a cephalosporin compared to 48 of 205 (23%; p < 0.01), and 10 of 29 patients (34%) were prescribed a non-ß-lactam antibiotic compared with 177 of 205 (86%; p < 0.0001). CONCLUSION: A collaborative effort between allergists and pharmacists can increase ß-lactam antibiotic prescriptions and decrease non-ß-lactam prescriptions in patients with a history of penicillin allergy.

Time-driven activity-based cost analysis for outpatient anticoagulation therapy: direct costs in a primary care setting with optimal performance.

OBJECTIVES: To determine how overall cost of anticoagulation therapy for warfarin compares with that of Novel Oral Anticoagulants (NOACs). Also, to demonstrate a scientific, comprehensive, and an analytical approach to estimate direct costs involved in monitoring and management of anticoagulation therapy for outpatients in an academic primary care clinic setting, post-initiation of therapy. METHODS: A population-based cross-sectional study was conducted in conjunction with observations of patient care processes between August 2014 and January 2015. The study was conducted in an academic primary care outpatient setting at Mayo Clinic's warfarin anticoagulation clinic, Rochester, MN. The anticoagulation clinic serves patients 18 years of age or older in Warfarin therapy management, for any indication, after referral from the patient's primary care provider. The study included anticoagulation clinic enrollment data on a population of 5,526 patients. Time-Driven Activity-Based Costing (TDABC) technique was applied. Detailed process flow maps which showed process steps for all the anticoagulation program components and care continuum phases were created. Staff roles associated with each of the process steps were identified and displayed on the maps. Process times and costs were captured and analyzed. The main outcome was direct cost of monitoring and management of anticoagulation therapy, post-initiation of therapy. RESULTS: The cost of warfarin management for patients who display unstable International Normalized Ratio (INR) is more than three times those who display stable INR over time. (Comparator to distinguish stability: Frequency of point-of-care visits needed by patients.) For complex anticoagulation patients, total cost of medication and monitoring for warfarin anticoagulation therapy is similar to that for NOACs. CONCLUSION: Despite warfarin being significantly less expensive to purchase than NOACs, overall warfarin management incurs higher costs due to laboratory monitoring and provider time than NOACs. NOAC treatment, therefore, may not be more expensive than warfarin therapy management for complex anticoagulation patients.

Impact of Pharmacist-Provided Medication Therapy Management on Healthcare Quality and Utilization in Recently Discharged Elderly Patients.

BACKGROUND: The optimization of medication use during care transitions represents an opportunity to improve overall health-related outcomes. The utilization of clinical pharmacists during care transitions has demonstrated benefit, although the optimal method of integration during the care transition process remains unclear. OBJECTIVE: To evaluate the impact of pharmacist-provided telephonic medication therapy management (MTM) on care quality in a care transitions program (CTP) for high-risk older adults. METHODS: This prospective, randomized, controlled study was conducted from December 8, 2011, through October 25, 2012, in a primary care work group at a tertiary care academic medical center in the midwestern United States. High-risk elderly (aged ≥60 years) patients were randomized to a pharmacist-provided MTM program via telephone or to usual care within an existing outpatient CTP. The primary outcome was the quality of medication prescribing and utilization based on the Screening Tool to Alert Doctors to the Right Treatment (START) and the Screening Tool of Older Persons' Prescriptions (STOPP) scores. The secondary outcomes were medication utilization using a modified version of the Medication Appropriateness Index, hospital resource utilization within 30 days of discharge, and drug therapy problems. RESULTS: Of 222 eligible high-risk patients, 25 were included in the study and were randomized to the pharmacist MTM intervention (N = 13) or to usual care (N = 12). No significant differences were found between the 2 groups in medications meeting the STOPP or START criteria. At 30-day follow-up, no significant differences were found between the 2 cohorts in medication utilization quality indicators or in hospital utilization. At 30-day follow-up, 3 (13.6%) patients had an emergency department visit or a hospital readmission since discharge. In all, 22 patients completed the study. Medication underuse was common, with 20 START criteria absent medications evident for all 25 patients at baseline, representing 15 (60%) patients with ≥1 missing medications. Overall, 55 drug therapy problems were identified at baseline, 24 (43.6%) of which remained unresolved at 30-day follow-up. CONCLUSION: The use of a pharmacist-provided MTM program did not achieve a significant difference compared with usual care in an existing CTP; however, the findings demonstrated frequent utilization of inappropriate medications as well as medication underuse, and many drug therapy problems remained unresolved. The small size of the study may have limited the ability to detect a difference between the intervention and usual care groups.

Finalizing a measurement framework for the burden of treatment in complex patients with chronic conditions.

PURPOSE: The workload of health care and its impact on patient functioning and well-being is known as treatment burden. The purpose of this study was to finalize a conceptual framework of treatment burden that will be used to inform a new patient-reported measure of this construct. PATIENTS AND METHODS: Semi-structured interviews were conducted with 50 chronically ill patients from a large academic medical center (n=32) and an urban safety-net hospital (n=18). We coded themes identifying treatment burden, with the themes harmonized through discussion between multiple coders. Four focus groups, each with five to eight participants with chronic illness, were subsequently held to confirm the thematic structure that emerged from the interviews. RESULTS: Most interviewed patients (98%) were coping with multiple chronic conditions. A preliminary conceptual framework using data from the first 32 interviews was evaluated and was modified using narrative data from 18 additional interviews with a racially and socioeconomically diverse sample of patients. The final framework features three overarching themes with associated subthemes. These themes included: 1) work patients must do to care for their health (eg, taking medications, keeping medical appointments, monitoring health); 2) challenges/stressors that exacerbate perceived burden (eg, financial, interpersonal, provider obstacles); and 3) impacts of burden (eg, role limitations, mental exhaustion). All themes and subthemes were subsequently confirmed in focus groups. CONCLUSION: The final conceptual framework can be used as a foundation for building a patient self-report measure to systematically study treatment burden for research and analytical purposes, as well as to promote meaningful clinic-based dialogue between patients and providers about the challenges inherent in maintaining complex self-management of health.

Factors that lessen the burden of treatment in complex patients with chronic conditions: a qualitative study.

PURPOSE: Patients with multiple chronic conditions (multimorbidity) often require ongoing treatment and complex self-care. This workload and its impact on patient functioning and well-being are, together, known as treatment burden. This study reports on factors that patients with multimorbidity draw on to lessen perceptions of treatment burden. PATIENTS AND METHODS: Interviews (n=50) and focus groups (n=4 groups, five to eight participants per group) were conducted with patients receiving care in a large academic medical center or an urban safety-net hospital. Interview data were analyzed using qualitative framework analysis methods, and themes and subthemes were used to identify factors that mitigate burden. Focus groups were held to confirm these findings and clarify any new issues. This study was part of a larger program to develop a patient-reported measure of treatment burden. RESULTS: Five major themes emerged from the interview data. These included: 1) problem-focused strategies, like routinizing self-care, enlisting support of others, planning for the future, and using technology; 2) emotion-focused coping strategies, like maintaining a positive attitude, focusing on other life priorities, and spirituality/faith; 3) questioning the notion of treatment burden as a function of adapting to self-care and comparing oneself to others; 4) social support (informational, tangible, and emotional assistance); and 5) positive aspects of health care, like coordination of care and beneficial relationships with providers. Additional subthemes arising from focus groups included preserving autonomy/independence and being proactive with providers. CONCLUSION: Patients attempt to lessen the experience of treatment burden using a variety of personal, social, and health care resources. Assessing these factors in tandem with patient perceptions of treatment burden can provide a more complete picture of how patients fit complex self-care into their daily lives.

Building a measurement framework of burden of treatment in complex patients with chronic conditions: a qualitative study.

BACKGROUND: Burden of treatment refers to the workload of health care as well as its impact on patient functioning and well-being. We set out to build a conceptual framework of issues descriptive of burden of treatment from the perspective of the complex patient, as a first step in the development of a new patient-reported measure. METHODS: We conducted semistructured interviews with patients seeking medication therapy management services at a large, academic medical center. All patients had a complex regimen of self-care (including polypharmacy), and were coping with one or more chronic health conditions. We used framework analysis to identify and code themes and subthemes. A conceptual framework of burden of treatment was outlined from emergent themes and subthemes. RESULTS: Thirty-two patients (20 female, 12 male, age 26-85 years) were interviewed. Three broad themes of burden of treatment emerged including: the work patients must do to care for their health; problem-focused strategies and tools to facilitate the work of self-care; and factors that exacerbate the burden felt. The latter theme encompasses six subthemes including challenges with taking medication, emotional problems with others, role and activity limitations, financial challenges, confusion about medical information, and health care delivery obstacles. CONCLUSION: We identified several key domains and issues of burden of treatment amenable to future measurement and organized them into a conceptual framework. Further development work on this conceptual framework will inform the derivation of a patient-reported measure of burden of treatment.