The American Journal of Managed Care August 2009
A Telephone-Based Intervention for Increasing the Use of Osteoporosis Medication: A Randomized Controlled Trial
In this randomized controlled trial, women receiving monthly telephone calls had significantly higher use of osteoporosis medication at 1 year versus women receiving usual care.
Objective: To evaluate the effectiveness of a telephone-based “virtual” osteoporosis clinic in increasing the use of osteoporosis medication assessed at 1 year after receipt of a prescription.
Study Design: Randomized controlled trial.
Methods: Women 60 years and older with previously undiagnosed osteoporosis were randomized to evaluation and treatment by a dedicated telephone-based osteoporosis clinic with monthly telephone follow-up until medication was successfully started (intervention) or to usual care provided by their primary care physician (control). A successful outcome was defined as having filled a prescription for a 3-month supply of medication within 130 days, marking 1 year and 30 days since enrollment.
Results: A total of 235 women underwent randomization, and 211 received the allocation. Of 109 women in the telephone-based osteoporosis clinic group, 75 (68.8%) were using osteoporosis medication at 1 year compared with 46 of 102 women (45.1%) in the usual care group (P <.001). A poststudy questionnaire showed no significant differences between the groups in regard to knowledge about osteoporosis or attitude toward their osteoporosis care provider. The significant increase in osteoporosis medication use with the telephone intervention occurred at the same time that an independent health maintenance organization–wide program promoting osteoporosis treatment seemed to improve overall rates of use.
Conclusions: The use of osteoporosis medication among women with newly diagnosed osteoporosis may be significantly improved by a simple intervention based on monthly telephone followup. Overall use of osteoporosis medication in this trial may have been increased by a systemwide initiative to improve osteoporosis care conducted concurrently with the trial. (ClinicalTrials.gov Identifier: NCT00145067.)
(Am J Manag Care. 2009;15(8):e60-e70)
Adherence to osteoporosis medication use is suboptimal, with most observational studies reporting persistence rates of 30% to 50% after 1 year. In this randomized controlled trial, we found that simple monthly telephone calls until the use of osteoporosis medication was confirmed significantly increased the use of medication 1 year after trial entry compared with usual care by a primary care physician.
- The use at 1 year among women randomized to receive monthly telephone calls was 68.8% compared with 45.1% among women randomized to usual care.
- The simple protocol in this study has been readily adopted into a disease management “virtual” clinic serving approximately 6000 patients with osteoporosis.
Further adding to low treatment rates, adherence to medication use is poor among patients who are prescribed osteoporosis therapy. Observational studies5,6 report persistence with treatment at 12 months (defined as continuing to fill prescriptions) to be in the range of 30% to 50% as determined by pharmacy records.
Adherence to medication use is generally defined as having 2 components, namely, compliance (taking medication as prescribed) and persistence (period over which prescriptions continue to be filled).7 Both components have been associated with improved outcomes in chronic diseases in general8 and specifically in regard to osteoporosis medication use, for which studies9-11 have shown that increased adherence is directly associated with decreased risk of fractures. Despite this, few interventions designed to increase adherence to osteoporosis medication use have been studied. The use of weekly rather than daily dosing of osteoporosis medication has been associated with better adherence to bisphosphonate use in some studies12-15 but not in others,16,17 although overall adherence remained suboptimal regardless of dosing frequency. In other studies,18,19 increased direct contact with osteoporosis care providers through additional clinic visits has improved adherence.
Telephone-based interventions have also shown promise in increasing adherence to osteoporosis medication use in combination with increased clinic visits20 or decreased medication dosing frequency21 in randomized trials. Monthly telephone counseling alone achieved adherence rates that were significantly higher than historical rates in a recent nonrandomized trial.22
The use of a telephone consultation protocol to encourage the use of medication among women diagnosed as having uncomplicated osteoporosis has been previously described.23 The protocol involved telephone follow-up of patients until initiation of prescribed osteoporosis medication was confirmed. Given the promising results of the protocol, we conducted a study to compare the use of medication 1 year after prescription among women randomized to this “virtual” osteoporosis clinic with the use among women randomized to usual care for osteoporosis delivered in a staff-model not-for-profit health maintenance organization (HMO). We hypothesized that women receiving telephone follow-up would have a higher rate of medication use at 1 year than women receiving usual care.
The study was conducted at Kaiser Permanente San Diego Department of Preventive Medicine from January 2004 to March 2007 and was approved by the Kaiser Permanente Southern California Institutional Review Board. Women were eligible for the study who were 60 years and older, met the National Osteoporosis Foundation guidelines for uncomplicated osteoporosis (by having a T score of −2.5 or lower or by having sustained an osteoporotic fracture), and were not previously identified as having osteoporosis. Most patients were referred to the study through the Health Appraisal Center of the Department of Preventive Medicine or from the Orthopedics Department. Baseline laboratory values for creatinine, thyroid-stimulating hormone, calcium, parathyroid hormone, and 25-hydroxyvitamin D levels were obtained. Patients were excluded from participating if they had secondary osteoporosis other than vitamin D deficiency, were unable to provide informed consent, or spoke a language that precluded a conversation by telephone with the study staff. Recruitment occurred over the first 2 years of the 3-year study. Patients meeting entry criteria who gave informed consent were randomized by sequential enrollment according to a computer-generated list to usual care or to care provided by the osteoporosis clinic. The random assignment was performed by the physician assistant (ALB) who staffed the osteoporosis clinic.
Patients randomized to usual care received a referral to their usual primary care physician. Standard paper or electronic referrals were issued by the Health Appraisal Center, and the primary care physician was not informed of the patient’s participation in the study. The patient was advised that she would be contacted by her primary care physician for follow-up. All subsequent evaluation and treatment were performed by the primary care physician, and no further contact with the patient was initiated by the osteoporosis clinic until the end of the study. Baseline laboratory values were available to the primary care physician through electronic laboratory records.
Patients randomized to the osteoporosis clinic received care from the physician assistant under the supervision of a preventive medicine physician (EMB). The clinic was staffed by a provider (ALB) working full-time for the first 2½ years of the 3-year study and part-time thereafter. Patients with 25-hydroxyvitamin D levels below 30 ng/mL (to convert 25-hydroxyvitamin D level to nanomoles per liter, multiply by 2.496) were given a prescription for vitamin D (50,000 IU orally weekly). All other patients were advised to take vitamin D (800-1200 IU) and calcium (1000-1500 mg) daily. Patients received educational handouts in a one-time mailing and were contacted by telephone for an open-ended discussion with the osteoporosis clinic provider about osteoporosis treatment. Patients were then given a prescription for osteoporosis treatment with a second-generation bisphosphonate to be taken weekly. All prescriptions were for a 3-month supply of medication.
Four to 6 weeks after osteoporosis medication was prescribed, the patient received a standardized follow-up telephone call from the clinic provider. Each call lasted approximately 5 minutes. The patient was asked the following 3 basic questions: (1) if they had filled the prescription for the osteoporosis medication; (2) if they had started taking the medication; and (3) if they answered no to the second question, why they were not taking the medication. Patients were also invited to ask questions, which typically involved concerns about the cost of medication and the potential adverse effects detailed in the medication insert. Strategies for remembering to take the medication such as designating 1 day of the week as “bone day” were discussed. Patients who indicated they would have trouble paying for the medication were assisted in obtaining the drug at no cost from the study sponsor (Merck & Co, Inc, Whitehouse Station, NJ). If a patient had problems with the medication or had not begun therapy, a second telephone call was planned for the following month. Two to 3 telephone calls per patient per month were required on average to make contact with the patient. Monthly telephone calls were continued only until the patient reported that she had filled a prescription for the medication, was taking the medication, and was not having any problems with the medication. No further contact was initiated by the osteoporosis clinic provider.
During the time of the study, an independent HMO–wide program to improve osteoporosis treatment was launched. Endocrinologists identified as thought leaders met with primary care physicians, obstetrician/gynecologists, and orthopedists to emphasize the importance of osteoporosis treatment. Screening and treatment guidelines were promulgated, with brochures and Web sites targeted toward the same physician groups.
The use of medication was measured at 1 year and 30 days from entry into the study by querying the Kaiser pharmacy database. A successful outcome was defined as having filled a prescription for a 3-month supply of osteoporosis medication within 130 days preceding the query. Assessment of prescriptions filled was facilitated by the fact that most Kaiser enrollees fill all prescriptions through a Kaiser pharmacy. Patients who did not seem to be filling prescriptions at Kaiser were contacted by telephone to ascertain if they were filling medication at an outside pharmacy.
After 1 year and 30 days from enrollment, all patients in the study were sent a validated questionnaire to assess their understanding of osteoporosis and their satisfaction with their osteoporosis care (McHorney et al24; and T. W. Weiss, DrPH, personal written communication). The questionnaire was designed to evaluate osteoporosis treatment in the osteoporosis clinic group or the usual care group and not fracture care in the Orthopedics Department.
A sample size was not calculated a priori. The decision to stop the trial was based on results of a preplanned 2-year interim analysis demonstrating highly significant differences in the use of medication at 1 year between the study groups.
X2 Test and t test were used to test for differences in categorical variables and continuous variables, respectively. All statistical tests were 2-sided and had an a level of .05. Baseline variables and the use of medication at 1 year were compared between the treatment groups in the intent-to-treat analysis, as well as among the subset of subjects who filled at least 1 osteoporosis medication prescription during the trial. Comparisons of knowledge and attitudes between the treatment groups were limited to questionnaire respondents. All analyses were performed using SAS 9.1 (SAS Institute, Inc, Cary, NC).
A total of 442 women were referred to the study and identified as eligible over the 2-year enrollment period. Of these, 207 patients (46.8%) declined to participate, most frequently because of a preference to be treated by their primary care physician (61 patients), followed by having other medical conditions (18 patients), already starting treatment for osteoporosis (13 patients), having insufficient time (12 patients), and moving out of the Kaiser San Diego system (11 patients).
Of 235 patients undergoing randomization, 110 were assigned to usual care and 125 to the osteoporosis clinic. The 2 randomized groups were similar in age, provider-recorded race/ethnicity, percentage with incident fracture, and percentage with a documented T score of −2.5 or lower at baseline (Table 1). Of the randomized subjects, 24 did not complete the study, primarily because of moving out of the Kaiser system or death (Figure 1). The outcome was measured in 211 patients (102 patients in the usual care group and 109 patients in the osteoporosis clinic group). Of 109 patients randomized to the osteoporosis clinic who did not move out of the Kaiser system, 10 requested to be dropped from the study at the first telephone call but were included in the intent-to-treat analysis.