Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.

BACKGROUND: Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence. METHODS: The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined. CONCLUSION: The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.

Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using?

OBJECTIVES: Recent guidelines advise limiting opioid prescriptions for acute pain to a three-day supply; however, scant literature quantifies opioid use patterns after an emergency department (ED) visit. We sought to describe opioid consumption patterns after an ED visit for acute pain. DESIGN: Descriptive study with data derived from a larger interventional study promoting safe opioid use after ED discharge. SETTING: Urban academic emergency department (>88,000 annual visits). SUBJECTS: Patients were eligible if age >17 years, not chronically using opioids, and newly prescribed hydrocodone-acetaminophen and were included in the analysis if they returned the completed 10-day medication diary. METHODS: Patient demographics and opioid consumption are reported. Opioid use is described in daily number of pills and daily morphine milligram equivalents (MME) both for the sample overall and by diagnosis. RESULTS: Two hundred sixty patients returned completed medication diaries (45 [17%] back pain, 52 [20%] renal colic, 54 [21%] fracture/dislocation, 40 [15%] musculoskeletal injury [nonfracture], and 69 [27%] "other"). The mean age (SD) was 45 (15) years, and 59% of the sample was female. A median of 12 pills were prescribed. Patients with renal colic used the least opioids (total pills: median [interquartile range {IQR}] = 3 [1-7]; total MME: median [IQR] = 20 [10-50]); patients with back pain used the most (total pills: median [IQR] = 12 [7-16]; total MME: median [IQR] = 65 [47.5-100]); 92.5% of patients had leftover pills. CONCLUSIONS: In this sample, pill consumption varied by illness category; however, overall, patients were consuming low quantities of pills, and the majority had unused pills 10 days after their ED visit.

Barriers and solutions to implementing a pragmatic diabetes education trial in rural primary care clinics.

INTRODUCTION: The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics. METHODS: The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention. RESULTS: Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches. CONCLUSIONS: Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.

Who Is Keeping Their Unused Opioids and Why?

OBJECTIVE: To better understand patients' reasoning for keeping unused opioid pills. METHODS: As part of a larger study, patients were asked their plans for their unused opioids. Responses were categorized as "dispose," "keep," and "don't know." Baseline characteristics were compared between the "keep" and "dispose" groups. Verbatim responses categorized as "keep" were analyzed qualitatively using a team-based inductive approach with constant comparison across cases. RESULTS: One hundred patients planned to dispose of their pills; 117 planned to keep them. There were no differences in demographics between the groups. Among patients who planned to keep their pills, the mean age was 43 years and 47% were male. Analysis revealed four categories of patient responses: 1) plans to keep their pills "just in case," with reference to a medical condition (e.g., kidney stone); 2) plans to keep pills "just in case" without reference to any medical condition; 3) plans to dispose in delayed fashion (e.g., after pill expiration) or unsure of how to dispose; and 4) no identified plans, yet intended to keep pills. In this sample, there were no differences in characteristics of those reporting planning to keep vs dispose of pills; however, there were diverse reasons for keeping opioids. CONCLUSIONS: This manuscript describes a sample of patients who kept their unused opioids and presents qualitative data detailing their personal reasoning for keeping the unused pills. Awareness of the range of motivations underpinning this behavior may inform the development of tailored education and risk communication messages to improve opioid disposal.

A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial.

OBJECTIVES: Despite increased focus on opioid prescribing, little is known about the influence of prescription opioid medication information given to patients in the emergency department (ED). The study objective was to evaluate the effect of an Electronic Medication Complete Communication (EMC2 ) Opioid Strategy on patients' safe use of opioids and knowledge about opioids. METHODS: This was a three-arm prospective, randomized controlled pragmatic trial with randomization occurring at the physician level. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new hydrocodone-acetaminophen prescriptions received one of three care pathways: 1) usual care, 2) EMC2 intervention, or 3) EMC2  + short message service (SMS) text messaging. The ED EMC2 intervention triggered two patient-facing educational tools (MedSheet, literacy-appropriate prescription wording [Take-Wait-Stop]) and three provider-facing reminders to counsel (directed to ED physician, dispensing pharmacist, follow-up physician). Patients in the EMC2  + SMS arm additionally received one text message/day for 1 week. Follow-up at 1 to 2 weeks assessed "demonstrated safe use" (primary outcome). Secondary outcomes including patient knowledge and actual safe use (via medication diaries) were assessed 2 to 4 days and 1 month following enrollment. RESULTS: Among the 652 enrolled, 343 completed follow-up (57% women; mean ± SD age = 42 ± 14.0 years). Demonstrated safe opioid use occurred more often in the EMC2 group (adjusted odds ratio [aOR] = 2.46, 95% confidence interval [CI] = 1.19 to 5.06), but not the EMC2  + SMS group (aOR = 1.87, 95% CI = 0.90 to 3.90) compared with usual care. Neither intervention arm improved medication safe use as measured by medication diary data. Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC2  + SMS group (ß = 0.57, 95% CI = 0.09 to 1.06) than usual care. CONCLUSIONS: The study found that the EMC2 tools improved demonstrated safe dosing, but these benefits did not translate into actual use based on medication dairies. The text-messaging intervention did result in improved patient knowledge.

Implementation fidelity of patient-centered prescription label to promote opioid safe use.

PURPOSE: Patient-centered labels may improve safe medication use, but implementation challenges limit use. We assessed implementation of a patient-centered "PRN" (as needed) label entitled "Take-Wait-Stop" (TWS) with three deconstructed steps replacing traditional wording. METHODS: As part of a larger investigation, patients received TWS prescriptions (eg, Take: 1 pill if you have pain; Wait: at least 4 h before taking again; Stop: do not take more than 6 pills in 24 h). Prescriptions labels recorded at follow-up were classified into three categories: (1) one-step wording (Take 1 pill every 4 h [without daily limits]), (2) two-step wording (Take 1 pill every 4 h; do not exceed 6 pills/day), and (3) three-step wording. There were three subtypes of three-step wording: (3a) three-step, not TWS (three deconstructed steps, not necessarily TWS wording), (3b) TWS format, employing three steps with leading verbs, but "with additions or replacements" (eg, replaced "do not take" with "do not exceed"), and (3c) verbatim TWS. RESULTS: Two hundred eleven participants completed follow-up. Mean age was 44.3 years (SD 14.3); 44% were male. One-step bottles represented 12% (n = 25) of the sample, whereas 26% (n = 55) had two-step wording. The majority (44%, n = 93) had three-deconstructed steps, not TWS (3a); 16% (n = 34) retained TWS structure, but not verbatim (3b). Only 2% (n = 4) displayed verbatim TWS wording (3c). All category three labels (utilizing deconstructed instructions) were considered adequate implementation (62%). CONCLUSIONS: Exact intervention adherence was not achieved in the majority of cases, limiting impact. Nonetheless, community pharmacies were responsive to new instructions, but higher implementation reliability requires additional supports.

Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients.

Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.