SummaryA licensed pharmacist or registered nurse periodically consults via telephone over a 7-month period with adult patients suffering from rheumatoid arthritis. The consultations focus on educating the patient about his or her medical condition and treatment options and assisting in overcoming specific barriers to medication adherence to maximize therapeutic benefit. The program improved medication adherence and physical functioning, generated high levels of patient satisfaction, and had an unclear impact on overall costs.Strong: The evidence consists primarily of an observational cohort study comparing medication adherence and drug costs in patients who enrolled in the program and a subset who completed it with the same metrics in two control groups—patients obtaining medications from a community pharmacy (who received little or no adherence support) and patients obtaining medications from a specialty pharmacy program (who received some support that was also given to program participants).
Developing OrganizationsPrescription Solutions
Date First Implemented2007
Patient PopulationThe program serves adults with rheumatoid arthritis who have been prescribed long-term treatment with injectable antirheumatic drugs.
Problem AddressedRheumatoid arthritis, a chronic, systemic inflammatory disease, often leads to disability and poor quality of life, and in some cases to death. Those with moderate to severe rheumatoid arthritis can benefit significantly from injectable antirheumatic drugs, but consistent adherence to prescribed regimens may not occur for a variety of reasons.
- A common, costly, and debilitating disease: Approximately 1.3 million adults suffer from rheumatoid arthritis,1 a chronic inflammatory disease that affects the joints and in some cases other organs, leading to pain, swelling, and stiffness. Over time, the disease can lead to significant disability, which, in turn, can substantially diminish quality of life, increase health care costs, and in some cases cause death.2,3
- Not fully realized potential of antirheumatic drugs: Many individuals with moderate to severe rheumatoid arthritis benefit from taking any of a number of injectable antirheumatic drugs, which have been shown to lower disease activity, retard disease progression, and improve physical functioning and quality of life.4 To achieve the maximum benefit from these drugs, patients must adhere to the prescribed regimen consistently over time.5 However, several factors can have a negative impact on adherence, including injection site issues, serious side effects, initial and/or ongoing discomfort with the idea of injecting oneself with a medication, seeing the treatment as too much of a burden, failure to see rapid results, and/or high out-of-pocket costs.6,7 Internal analysis at Prescription Solutions found that roughly 60 percent of rheumatoid arthritis patents getting antirheumatic drugs from community-based pharmacies consistently took their medication as prescribed,8 suggesting substantial opportunity for improvement.
Description of the Innovative ActivityA licensed pharmacist or registered nurse periodically consults via telephone over a 7-month period with adult patients suffering from rheumatoid arthritis. The consultations focus on educating the patient about his or her medical condition and treatment options and assisting the patient in overcoming specific barriers to medication adherence so as to maximize therapeutic benefit. This program supplements routine specialty pharmacy services, which include refill reminder calls, 24-hour access to a pharmacist, and mail service delivery. Key elements of the program include the following:
- Assignment to one clinician for program duration: Each participating patient is assigned to one clinician (a licensed pharmacist or registered nurse) throughout the 7-month program, thus allowing the patient to develop a strong, trusting relationship with the clinician.
- Initial consultation and risk stratification: Using a validated instrument for assessing case complexity and health care needs based on a biopsychosocial model, the clinician assesses the patient via telephone to determine which of two levels of program intensity should be provided. After this 40- to 60-minute session, the clinician recommends either the regular intensity program, which includes three additional sessions (held 1, 4, and 6 months after this assessment) or the high-intensity program, which calls for monthly sessions over the following 6 months. In a trial of the program, approximately 90 percent of patients received the regular-intensity program.8
- Periodic telephone conversations/consultations: The clinician engages in 20- to 30-minute telephone consultations with the patient at the appropriate intervals; patients receive reminder cards in advance of each session. Using a friendly, conversational approach, the clinician assesses patient knowledge and health concerns and provides relevant education and support related to the following core topics: pathophysiology of rheumatoid arthritis; laboratory values pertaining to rheumatoid arthritis or medication therapy; optimization of medication therapy, including the importance of adherence; symptom, pain, and stress management; the importance of maintaining a balanced diet and getting adequate exercise; the importance of patient–provider communication; appropriate use of assistive devices; home safety; and additional resources that may be required (e.g., financial assistance). The consultations have been modeled to mirror the five major factors that influence medication adherence identified by the World Health Organization (WHO),9 as outlined below:
- Health system and health care team factors: To overcome barriers related to provider–patient relationship and communication, clinicians encourage patients to find a regular care provider with whom they can speak openly about their issues during office visits. Clinicians also advise patients to keep a journal or otherwise write down questions that might arise between medical appointments.
- Therapy-related factors: To overcome therapy-related barriers, the clinician educates the patient on potential adverse drug reactions (e.g., injection site issues), including how to manage them, and on the potential consequences of missing a dose.
- Condition-related factors: To overcome condition-specific barriers, the clinician educates the patient about the damaging effects of rheumatoid arthritis and of nonadherence to the prescribed regimen.
- Patient-related factors: To overcome patient-related barriers such as forgetting to take a dose, the clinician provides a medication chart or calendar, which serves the dual purpose of reminding the patient to take each dose and of reducing the risk of double dosing.
- Socioeconomic factors: To address any socioeconomic barriers to adherence, the clinician helps the patient secure financial support from national foundations and drug manufacturers offering assistance programs.
- Postconsultation care plan: After each session, the clinician develops a personalized care plan that summarizes the phone consultation using a program-specific database (see last bullet for more details). Both the patient and the prescribing physician receive a copy of this care plan in the mail. The plan includes information tailored to the patient's situation, such as relevant information about rheumatoid arthritis and its symptoms, adverse drug reactions and how to manage them, healthy living, resources that could assist the patient, and the ongoing importance of patient–provider communication and home safety. Although the plan is customized to each patient, the clinician can, as appropriate, draw from standardized verbiage embedded in the system that has been developed by the pharmacist/nurse and reviewed and approved by the program supervisor.
- Educational mailings: Patients receive standardized educational mailings on a monthly basis throughout the program. These materials include general information on rheumatoid arthritis, such as living with the disease, available medications, tips on useful exercises and nutrition, dealing with psychological issues, and pain management.
- Program database to support clinicians: Clinicians use an internally developed database designed to facilitate workflow, data collection and documentation, care plan development and approval, and automatic scoring and reporting.
Context of the InnovationPrescription Solutions manages prescription drug benefits for employers, unions, and commercial, Medicare, and other governmental health plans. A part of UnitedHealth Group, the company serves customers through a national network of 64,000 community pharmacies, along with mail service pharmacies located in California and Kansas. The telephone consultation program grew out of a desire by clinical service leaders within Prescription Solutions to better understand how to influence medication adherence for high-cost biological, injectable drugs that treat rheumatoid arthritis. As noted earlier, patients prescribed these high-cost medications often face challenges in consistently adhering to the recommended regimen, thus jeopardizing the ability to achieve good health outcomes. Yet, little information existed in the literature on how to improve adherence. Program leaders felt that a health coaching program supplemented by regular mailings might have an impact by empowering patients with enhanced knowledge. Similar approaches had been successfully used in England with elderly patients prescribed new medications to treat chronic conditions.
ResultsThe program improved medication adherence and physical functioning, generated high levels of patient satisfaction, and had an unclear impact on overall costs.
Strong: The evidence consists primarily of an observational cohort study comparing medication adherence and drug costs in patients who enrolled in the program and a subset who completed it with the same metrics in two control groups—patients obtaining medications from a community pharmacy (who received little or no adherence support) and patients obtaining medications from a specialty pharmacy program (who received some support that was also given to program participants).
- Better adherence: Eighty-nine percent of 244 patients completing the program adhered to their prescribed medication regimen, well above the 60-percent adherence rate in a comparable-sized group of similar patients who received their medications from a community pharmacy, and also above the 81-percent adherence rate in a similar group receiving some adherence support (reminder cards, educational materials, mail service delivery, and 24-hour access to a pharmacist) from a specialty pharmacy.8 As noted earlier, program participants also received these specialty pharmacy services.
- Enhanced physical (but not psychological) functioning: In a group of 371 patients who enrolled in the program and completed the initial and final (month 6) consultation session, physical functioning improved, with the mean score on the Short Form 12 (more commonly known as SF-12) physical component showing a statistically significant increase from 34.9 at program enrollment to 36 at the end of the program. Statistically significant improvements also occurred in the overall Health Assessment Questionnaire Alternative Disability Index (HAQ-DI) score and in several specific HAQ-DI components, including dressing and grooming, arising (waking and getting out of bed), grip, and reach. Average scores on the SF-12 mental health component did not change.8
- High patient satisfaction: In a survey of the 371 patients referenced above, 72.2 percent found the program to be "very helpful" and another 25.9 percent found it "somewhat helpful." Overall, 58.5 percent rated the program as "excellent" and another 32.6 percent rated it as "very good."8
- Unclear impact on overall costs: As would be expected, higher adherence rates translated into higher drug costs for those participating, with average injectable rheumatoid arthritis drug costs during an 8-month follow up period being $12,679 for those completing the program, compared with $11,518 for those in the specialty pharmacy group, and $8,470 for those in the community pharmacy group. Total costs for all medications exhibited a similar pattern, with program participants having higher average costs than those in the other groups.8 To gain a better understanding of the impact of the program on overall medical costs, researchers conducted a post hoc analysis of a subset of patients with medical claims data (including 67 who started the program, 46 who competed it, 55 specialty pharmacy patients, and 32 community pharmacy patients). Preliminary results suggest that the increased pharmacy costs for program participants were partially offset by lower medical costs. However, these data on total costs may not accurately reflect those of the entire population. In addition, the sample sizes of patients with medical claims data were too small to detect differences across the groups. Consequently, further research is needed on the program's impact on total health care costs.
- Unexplainable, negative impact on work productivity: Scores on the Work Productivity and Activity Impairment (WPAI) Questionnaire showed a decline in productivity among participants, with average level of impairment rising from 12.9 to 28.3 percent during the 6-month program. Although program developers do not understand why this decline occurred, it may represent the natural progression of rheumatoid arthritis over time. In addition, the 28.3-percent impairment rate observed at month 6 still suggests a fairly low level of disease activity. Finally, the small sample size makes it difficult to interpret the productivity data because less than one in five participants (18.6 percent) worked and hence filled out the WPAI questionnaire.
Planning and Development ProcessKey steps included the following:
- Determining program focus: Using a broad definition of disease management developed by the Care Continuum Alliance (formerly the Disease Management Association of America), a small team of clinical service leaders at Prescription Solutions (including the director of outcomes research, vice president and director of clinical programs, and vice president of clinical analytics and outcomes research) determined which components of disease management the program should target. (The company was not in a position to offer full-fledged disease management services). The team decided to focus on enhancing self-management skills and promoting medication adherence.
- Developing core curriculum and program structure: Through literature searches and other research, the team identified the core topics to be addressed during consultation sessions (described earlier) and determined which topics should ideally be covered during which touchpoints with the patient. During this phase, the team decided to organize sessions around the five WHO-identified factors driving adherence and to promote use of a conversational approach where clinicians maintain the flexibility to address issues as they see fit based on individual needs. The literature search also shed light on the optimal duration of the program, with the team concluding that at least 6 months would be required to have a meaningful, sustained impact.
- Choosing stratification tool: The team conducted indepth research on available, validated tools to assess and stratify patients according to risk, thus allowing the clinician to determine the appropriate intensity of intervention. The team decided to work with the Intermed Foundation, a Netherlands-based organization that developed a methodology and action-oriented decision support tool to facilitate patient-oriented care for complex patients by stimulating interdisciplinary communication. Program leaders consulted the developer of the INTERMED method for validation of their interpretation of the tool and its application to the program model. They also sought feedback on samples cases to minimize the potential for misinterpretation or inaccurate scoring when using the tool.
- Hiring and training pharmacists and nurses: One team member interviewed candidates, carefully screening them to determine if they had the knowledge, skills, and empathy to perform the job well, including the ability to create a trusting relationship with patients. Those hired went through roughly 1 week of training, which consisted of self-paced learning through educational manuals and modules supplemented by inperson sessions. The focus of the training varied for nurses and pharmacists because each group had different needs. For nurses, training emphasized substantive knowledge related to rheumatoid arthritis, self-management, and medication adherence. For pharmacists, it focused on motivational interviewing techniques and other strategies/skills for engaging effectively with patients.
Resources Used and Skills Needed
- Staffing: Prescription Solutions typically has four full-time pharmacists and/or registered nurses dedicated to this program. Each individual can handle between 100 and 120 patients at a time. Program leaders recommend having at least one pharmacist in this role, as nurses sometimes need support with complex medication issues, including patients taking many different drugs.
- Costs: Data on program costs are not available. Major upfront expenses include building the aforementioned database, while ongoing expenses consist primarily of pharmacist and nurse compensation and printing and mailing costs for the care plans and educational materials.
Funding SourcesPrescription Solutions
The program is funded internally by Prescription Solutions.
Tools and Other ResourcesThe following Web sites offer more information on the various organizations mentioned earlier, including Prescription Solutions (http://www.prescriptionsolutions.com), Intermed (http://www.intermedfoundation.org), and the Care Continuum Alliance (http://www.carecontinuumalliance.org/).
Getting Started with This Innovation
- Sell benefits to providers and patients: Physicians and patients will not accept the program until they understand how it works and can help them. To that end, Prescription Solutions put together a short summary explaining program services and operations and outlining the benefits to both patients and physicians.
- Leverage existing resources: Prescription Solutions' leaders spent significant time researching issues related to rheumatoid arthritis medication adherence and developing the core curriculum, training manuals, etc., related to this program. Although these materials are not publicly available at this point, organizations interested in adopting this approach can consult with the program developer for advice and guidance.
- Screen candidates carefully: As noted, those providing consultation services must have the skills, motivation, and empathy to work effectively with patients over a period of time. To that end, carefully screen candidates through rigorous interviewing to ensure a good fit. Prescription Solutions' screening process has generally worked well, as the same core group of nurses and pharmacists have staffed the program since 2007.
- Include a pharmacist: As noted earlier, consider having at least one pharmacist available to assist nurses with complex medication issues.
Sustaining This Innovation
- Allow for and encourage customization: Although the program is based on a standardized set of core topics organized around the WHO factors, nurses and pharmacists remain free to determine the appropriate sequencing and timing of topics, and to determine the right tone and mix for the conversation. This ability to customize the program to patient needs and characteristics has allowed Prescription Solutions to keep patients interested over time, leading to a low dropout rate. (During the initial trial, 266 of 340 enrollees—approximately 78 percent—completed the program.8)
- Send out reminders, contact no-shows: As noted, Prescription Solutions mails out reminder cards about upcoming appointments, while program staff call to reschedule missed appointments.
Contact the InnovatorJennifer Shin, PharmD
Clinical Care Management
2300 Main St.
Irvine, CA 92614
Phone: (949) 252-5514
Innovator DisclosuresDr. Shin has not indicated whether she has financial interests or business/professional affiliations relevant to the work described in this profile; however, information on funders is available in the Funding Sources section.
References/Related ArticlesStockl KM, Shin JS, Lew HC, et al. Outcomes of a rheumatoid arthritis disease therapy management program focusing on medication adherence. J Manag Care Pharm. 2010;16(8):593-604. [PubMed]
Gabriel SE. Heart disease and rheumatoid arthritis: understanding the risks. Ann Rheum Dis. 2010;69(Suppl 1):i61-4. [PubMed]
Wong JB, Ramey DR, Singh G. Long-term morbidity, mortality, and economics of rheumatoid arthritis. Arthritis Rheum. 2001;44(12):2746-49. [PubMed]
Grijalva CG, Chung CP, Arbogast PG, et al. Assessment of adherence to and persistence on disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis. Med Care. 2007;45(10 Suppl 2):S66-76. [PubMed]
Stockl KM, Shin JS, Lew HC, et al. Outcomes of a rheumatoid arthritis disease therapy management program focusing on medication adherence. J Manag Care Pharm. 2010;16(8):593-604. [PubMed]
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Original publication: January 19, 2011.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: February 12, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: January 23, 2014.
Date verified by innovator indicates the most recent date the innovator provided feedback during the annual review process. The innovator is invited to review, update, and verify the profile annually.