Published Online: July 12, 2012
Rowena J. Dolor, MD, MHS; Andrew L. Masica, MD, MSCI; Daniel R. Touchette, PharmD, MA; Scott R. Smith, PhD; and Glen T. Schumock, PharmD, PhD, MBA
Objectives/Background: Lessons learned from the implementation of a pharmacist-delivered medication therapy management (MTM) intervention in primary care (PC) can inform future MTM studies and be adopted into real-world clinical settings. We sought to describe the variations and challenges of patient recruitment, enrollment, MTM pharmacist visits, and telephone follow-up in a 3-arm randomized trial of MTM interventions conducted at 3 health centers.
Study Design/Methods: Using a post-study structured interview, we interviewed study personnel, clinical pharmacists, and investigators about 5 study domains: recruitment, enrollment visits, MTM pharmacist visits, telephone follow-up, and data collection.
Results: All centers screened clinic schedules and conducted queries of administrative databases to identify eligible participants. Patients were recruited either during existing primary care visits or by mailing letters with telephone follow-up. Patients with many medical problems, with transportation difficulties, or who were unaccompanied by a family member were less likely to enroll. MTM visits scheduled separately from other clinic appointments had higher cancellation or no-show rates. Provider response to pharmacist recommendations was low overall but better when the provider was acquainted with the pharmacist who was making contact.
Conclusions: Off-site implementation of MTM services results in lower participation by patients and providers. Future MTM studies should consider integrating MTM services within the clinic during existing appointments by a pharmacist familiar to the primary care provider.
(Am J Manag Care. 2012;18(7):e238-e244)
This paper describes the lessons learned from implementing a pharmacist-delivered medication therapy management (MTM) intervention.
Patients with many medical problems, transportation difficulties, or who were unaccompanied by a family member were less likely to enroll. MTM visits scheduled separately from other clinic appointments had higher cancellation or no-show rates. Provider response to pharmacist recommendations was better when the provider was acquainted with the pharmacist who was making contact.
Off-site implementation of MTM services resulted in lower participation by patients and providers. Usual care implementation can be improved by integrating these services within the clinic during existing appointments by a pharmacist familiar to the primary care provider.
The Medication Evaluation and Drug Use Problem Identification to Improve Safety in High Risk Medicare Beneficiaries (MEDIS-MB) study was a randomized, multisite trial of different medication therapy management (MTM) strategies conducted at the University of Illinois at Chicago (UIC), the Baylor Health Care System in Dallas, Texas, and the Duke Primary Care Research Consortium (PCRC) in Durham, North Carolina. Patients 65 years or older with 3 or more chronic illnesses, 6 or more medications, and 1 or more risk factors for development of a drug-related problem (DRP) (eg, recent hospitalization or multiple providers) were randomly assigned to 1 of 3 treatment arms: usual care; basic MTM by patient interview only; or enhanced MTM with access to a clinical synopsis of medical history, laboratory data, and medications from the patient’s medical record.1 The overall results showed that MTM reduced DRPs and increased patient satisfaction. Access to the clinical synopsis in the enhanced MTM arm resulted in fewer medication list discrepancies.1 Touchette and colleagues discussed the potential benefits of expanding MTM services to include platforms for clinical record data sharing for community pharmacist access, thus potentially improving patient outcomes by reducing adverse drug events (ADEs).2
Communicating the study implementation issues that we experienced can inform clinicians, administrators, researchers, and payers who may be interested in 1) clinical adoption of the intervention, or 2) conducting future MTM studies. In this paper, we intend to describe the variations and challenges of patient recruitment, enrollment, MTM pharmacist visits, and telephone follow-up within this comparative effectiveness trial.
The detailed MEDIS-MB study design has been previously described.1 Institutional review boards at participating health systems approved the study; written informed consent was obtained from all patients. During the enrollment phase, weekly screening and enrollment reports, including reasons for ineligibility and patient refusal, were sent from Duke and Baylor to the UIC coordinating center and reported to the study sponsor. At the end of study, the investigators developed a questionnaire of 5 study domains—recruitment, enrollment visits, MTM pharmacist visits, telephone follow-up, and data collection issues—to understand the challenges of study implementation and gather feedback on how to improve future studies.
Under the recruitment domain we asked questions about the recruitment method (mail, phone, or in person), time spent on recruitment, previous MTM program enrollment, differences in patient participation, whether incentives were adequate, consent form problems, and how the various study team members approached the clinics and providers. Under the enrollment visit domain we asked questions about the length of visit and space available. Under the MTM pharmacist visit domain we asked about scheduling the visit and the number of visits needed/required, work flow issues, contacting or faxing the provider with recommendations, access to pill bottles, and completing the clinical synopsis, medication lists, and drug-related problem surveys. Under the telephone follow-up domain we asked about the length of the phone call and issues with filling out the symptom survey scale, resource utilization survey, and pharmacist satisfaction form. Finally, under the data collection domain, we asked questions about the methods of data collection (ie, filling out, making copies of, and mailing paper forms to the coordinating center), monthly study calls, and overall clinic participation. An initial conference call with the study personnel, clinical pharmacists, and investigators was held to gather initial responses to the questionnaire items; a second call confirmed their responses and gathered additional feedback. Personnel who were unable to attend the calls submitted written responses to the questionnaire.
The MEDIS-MB study was conducted at 3 institutions to reach the enrollment goal of 600 participants (approximately 200 participants per site). UIC worked with 1 family medicine (FM) and 1 internal medicine (IM) clinic, Baylor enrolled patients from 2 senior health centers, and Duke recruited participants from 6 primary care clinics (1 FM, 5 IM) within its practice-based research network (PBRN). Enrolling at 3 institutions resulted in ethnic diversity among participants (51% black, 48% white, 1% Asian/American Indian).2 Table 1 outlines the number of patients that were screened, contacted, and enrolled. Of the 3084 patients who were screened, we enrolled 637 (21%) participants. Patients were most often deemed ineligible for participation because they did not meet the inclusion criteria of taking at least 6 chronic medications (42%); patients most commonly refused to participate due to lack of interest (69.5%). Enrollnment lasted 9 months at Duke, 12 months at Baylor, and 13 months at UIC. Both Duke and Baylor enrolled more than 200 participants to help reach the total enrollment goal. Additional subjects (more than 600) were enrolled to replace patients who were lost to follow-up.
Feedback about the 5 study domains from investigators, coordinators, and pharmacists is shown in Table 2. Under the recruitment domain, study staff reported that administrative and pharmacy databases were useful for identifying eligible patients. All 3 sites initially used recruitment letters and phone calls to mimic real-world pharmacy implementation; however, Baylor and UIC switched to in-person clinic recruitment because response rates were low with the mail approach. Duke was able to continue the letter/telephone recruitment strategy given the larger patient population from 6 participating clinics. The differences in recruitment approach translated into the differences in the proportion of participants enrolled to the patients screened for this study (35.3% at UIC, 30.7% at Baylor, and 13.3% at Duke). Patients who were approached at the clinic visit and accompanied by a caregiver were more likely to participate. These caregivers viewed the MTM intervention as a benefit. The presence of a provider champion and a motivated clinic staff was felt to be useful for enhancing recruitment.
For the enrollment visit domain, patients with more chronic illnesses and multiple clinic appointments were more likely to decline participation due to perceived study visit burden. Patients who were concerned about the consent form language, cost of gas, or transportation difficulties were also less likely to participate. The free MTM intervention was perceived as a benefit; however, the study payment ($10 per completed visit, or $30 total) was perceived as too low by the patients. In addition, some patients in the control group inquired whether the MTM intervention could be offered to them after all study follow-up was completed. The amount of space available to conduct the enrollment and MTM visits varied at the 3 sites. UIC had ample space in the academic clinics, but limited space in the outpatient pharmacy. Baylor
used the clinic room space prior to the provider entering the room to see the patient, so timing was essential to limit interference with clinic work flow. Duke held all study visits at a central location that had available rooms depending on the day of the week.
PDF is available on the last page.