Perceptions of the Value of Clinical Pharmacy Medication Review for Women During Early Pregnancy.

BACKGROUND: The benefit of continuing medications to prevent or treat illness is often overlooked, since pregnant women tend to overestimate the teratogenic risk of medications. Pharmacists can serve as a resource to prescribers and pregnant women with their knowledge of the appropriate use and management of medications during pregnancy. Little information exists on the value women place on pharmacists' medication management during pregnancy. OBJECTIVE: To assess pregnant women's perceptions of an ambulatory care clinical pharmacist (CP) medication review service during early pregnancy that provided education regarding the risks and benefits of medication use during pregnancy. METHODS: This was a qualitative study of pregnant women using semistructured telephone interviews performed between December 12, 2018, and January 18, 2019, and conducted in an integrated health care delivery system. Potential participants were identified from CP encounter records. Consented English-speaking women aged ≥ 18 years participated in an up to 30-minute interview within 1 week of the CP encounter. Interviews were professionally transcribed and coded line by line using the constant comparison method with grounded theory used to gain insight into participants' perspectives. RESULTS: 62 women were invited to participate in semistructured telephone interviews of whom 24 (39%) completed the interview. Three main themes emerged from the qualitative analysis: satisfaction with the service, comfort with medication use during pregnancy, and connectedness to the health care team. Overall, the CP medication review and education service was perceived positively by the participants. Participants reported satisfaction in the quality, timeliness, and convenience of the service and found it beneficial to have their medications reviewed early during pregnancy to assist in medication use decisions before their first obstetric visit. CONCLUSIONS: CP medication review provided a comforting, valuable service for women during early pregnancy when medication-taking decisions can feel exigent. DISCLOSURES: This study was funded by Kaiser Permanente. The authors have nothing to disclose. Preliminary results were presented at the Mountain States Conference for Residents and Preceptors, May 2019, in Salt Lake City, UT.

Thyroid Stimulating Hormone Stability in Patients Prescribed Synthetic or Desiccated Thyroid Products: A Retrospective Study.

The purpose of this retrospective matched-cohort study was to evaluate the stability of thyroid stimulating hormone (TSH) in patients using synthetic compared with desiccated thyroid products. Patients using a thyroid product for the treatment of hypothyroidism were matched 1:1 on age, sex, race/ethnicity, and had a follow-up period of 3 years after the index date. The primary outcome was percent of in-range TSH values. Over 3 years, TSH values in both groups were in-range 79% of the time (P = 0.905). Our results showed no difference in longitudinal TSH stability between desiccated thyroid products and synthetic levothyroxine.

Value of Pharmacy Students Performing Population Management Activity Interventions as an Advanced Pharmacy Practice Experience.

Objective. To assess the value of an advanced pharmacy practice experience in which students engaged in population health management (PHM) activities for a managed care setting. Methods. Students were provided with a list of patients, trained on the requirements for each PHM activity and completed them independently. The students reviewed the electronic record for each patient on their list to identify those who were non-adherent to dual antiplatelet therapy (DAPT) within one year of coronary stent placement, non-adherent to beta blockers (BB) within six months post-acute myocardial infarction, or with renal dysfunction and requiring dose adjustment of lipid-lowering therapy. Students coded each intervention based on predefined categories such as patient education, medication discontinuation, or medication reconciliation, and then if necessary were reviewed with the pharmacy preceptor. The primary investigator determined the intervention to be either actionable or non-actionable. The primary outcome was the proportion and type of interventions made by each student. The secondary outcome was clinical pharmacist time offset. A retrospective, data-only pilot study was conducted to determine the outcomes from the program over four years. Results. Forty-six students made 3,774 interventions over the study period, 37% of which were categorized as actionable. The most common actionable interventions were providing patient education (52%), verifying prescription adherence (23%), and medication therapy adjustment (10.5%). Over the study period, an estimated 765.6 hours of clinical pharmacist time was offset, or approximately 191.4 hours per academic year. Conclusion. This study demonstrated that a population health management approach can be used successfully within an APPE. This approach can result in offset pharmacist time for precepting organizations, while offering meaningful clinical interventions for patients and learning opportunities for students.

Perceived value of leadership experiences in a postgraduate year 2 ambulatory care pharmacy residency.

PURPOSE: Leadership experiences taught within the Kaiser Permanente Colorado (KPCO) postgraduate year 2 (PGY2) ambulatory care pharmacy residency program were evaluated. METHODS: KPCO leadership training incorporated 6 mandatory leadership sessions and offered a 6-week elective rotation. In this qualitative study, an 18-item semistructured interview guide was developed, tested, and administered telephonically to former KPCO PGY2 residents who had been in clinical practice for a minimum of 1 year. The primary outcome was the perceived value of the leadership experiences, and perceived gaps was the secondary outcome. Qualitative analysis was performed for open-ended questions. Responses were coded and key phrases were highlighted to illustrate major concepts and themes. RESULTS: Of 34 former residents, 29 (85%) completed the interview. Ninety-seven percent of participants reported that the leadership experiences provided value in their professional career; 89% reported value in their personal development. The 3 most common themes of perceived value that emerged from the interviews were exposure to leadership, managing and leading self and others, and clinical service development. Identified gaps included further exposure to senior leadership within the organization and a better understanding of the national pharmacy landscape. CONCLUSION: Leadership experiences during the PGY2 ambulatory care pharmacy residency at KPCO were perceived positively by former residents on a professional and a personal level.

Feasibility of clinical pharmacist-led CYP2C19 genotyping for patients receiving non-emergent cardiac catheterization in an integrated health system.

OBJECTIVE: To assess the feasibility of clinical pharmacist-led CYP2C19 genotype-guided P2Y12 inhibitor antiplatelet drug therapy recommendations to cardiologists in an outpatient cardiology practice. METHODS: This was a prospective, open-labeled, single-arm study conducted in an integrated healthcare delivery system between March 1, 2013 and January 23, 2014. Patients requiring non-emergent cardiac catheterization were included. A clinical pharmacist provided interpretation and recommendations from genotyping results. The feasibility of implementing CYP2C19 genotype-guided antiplatelet therapy was assessed by the: 1) percentage of patients approached who consented to CYP2C19 genotyping, 2) percentage of patients with CYP2C19 genotyping results available prior to cardiac catheterization, and 3) percentage of clinical pharmacist CYP2C19 genotype-based antiplatelet recommendations accepted by cardiologists. RESULTS: Of the 43 patients identified for potential recruitment, 22 of these were eligible for study enrollment and 6 (27%) patients consented and received CYP2C19 genotyping. All patients had genotyping results available prior to catheterization and all clinical pharmacists' antiplatelet therapy recommendations were accepted by the patients' cardiologists. Three patients had the CYP2C19 wild-type (*1/*1) genotype and the clinical pharmacist recommended clopidogrel therapy. CYP2C19 variant genotypes (i.e., *1/*2, *1/*17, and *2/*17) were found in the other three patients; alternative antiplatelet therapy was recommended for the patient with the *1/*2 genotype, while clopidogrel was recommended for those with *1/*17 and *2/*17 genotypes. CONCLUSION: A relatively small proportion of patients undergoing non-emergent cardiac catheterization consented to pharmacogenetic testing; however, their cardiologists were receptive to clinical pharmacists conducting such testing and providing corresponding pharmacotherapy recommendations. Future studies should identify patient barriers to pharmacogenetic testing.

Feasibility of clinical pharmacist-led CYP2C19 genotyping for patients receiving non-emergent cardiac catheterization in an integrated health system

Objective: To assess the feasibility of clinical pharmacist-led CYP2C19 genotype-guided P2Y12 inhibitor antiplatelet drug therapy recommendations to cardiologists in an outpatient cardiology practice. Methods: This was a prospective, open-labeled, single-arm study conducted in an integrated healthcare delivery system between March 1, 2013 and January 23, 2014. Patients requiring non-emergent cardiac catheterization were included. A clinical pharmacist provided interpretation and recommendations from genotyping results. The feasibility of implementing CYP2C19 genotype-guided antiplatelet therapy was assessed by the: 1) percentage of patients approached who consented to CYP2C19 genotyping, 2) percentage of patients with CYP2C19 genotyping results available prior to cardiac catheterization, and 3) percentage of clinical pharmacist CYP2C19 genotype-based antiplatelet recommendations accepted by cardiologists. Results: Of the 43 patients identified for potential recruitment, 22 of these were eligible for study enrollment and 6 (27%) patients consented and received CYP2C19 genotyping. All patients had genotyping results available prior to catheterization and all clinical pharmacists’ antiplatelet therapy recommendations were accepted by the patients’ cardiologists. Three patients had the CYP2C19 wild-type (*1/*1) genotype and the clinical pharmacist recommended clopidogrel therapy. CYP2C19 variant genotypes (i.e., *1/*2, *1/*17, and *2/*17) were found in the other three patients; alternative antiplatelet therapy was recommended for the patient with the *1/*2 genotype, while clopidogrel was recommended for those with *1/*17 and *2/*17 genotypes. Conclusion: A relatively small proportion of patients undergoing non-emergent cardiac catheterization consented to pharmacogenetic testing; however, their cardiologists were receptive to clinical pharmacists conducting such testing and providing corresponding pharmacotherapy recommendations. Future studies should identify patient barriers to pharmacogenetic testing (AU)

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Evaluation of the Effect of A Structured Program to Guide Residents' Experience in Research (ASPIRE) on Pharmacy Residents' Knowledge, Confidence, and Attitude toward Research.

STUDY OBJECTIVE: To evaluate the effect of A Structured Program to guide Resident Experience in Research (ASPIRE) on pharmacy residents' knowledge, confidence, and attitude toward research. DESIGN: Nonrandomized controlled study using data from a validated questionnaire administered through an online survey. PARTICIPANTS: Of 60 pharmacy residents (residency year 2013-2014) who completed the baseline assessment, the 41 residents who also completed the follow-up assessment were included in the final analysis; of those, 26 Colorado pharmacy postgraduate year 1 (PGY1) and year 2 (PGY2) residents were enrolled in ASPIRE between July 2013 and June 2014 (intervention group) and 16 PGY1 and PGY2 pharmacy residents outside of Colorado did not participate in ASPIRE (control group). MEASUREMENTS AND MAIN RESULTS: Both the intervention and control groups completed a pre- and post-assessment at the beginning (July 2013 [baseline]) and end (May/June 2014 [follow-up]), respectively, of their residency year that measured knowledge (with a tool measuring biostatistics and research methodology knowledge), confidence, and attitude toward research. Research knowledge scores improved similarly from baseline to follow-up in the intervention and control groups: 11.8% and 11.3%, respectively (adjusted p=0.8). Research confidence improved significantly more in the intervention group, with a 48% increase in confidence score from before to after residency completion, compared with a 15% increase in the control group (adjusted p=0.002). Residents in both the intervention and control groups expressed positive attitudes toward pharmacist-conducted research, with 100% and 87% of intervention and control residents, respectively (adjusted p=0.970), agreeing that pharmacist-conducted research is essential to driving pharmacy practice and expanding the roles of pharmacists. CONCLUSION: ASPIRE was not associated with greater research methodology knowledge but did significantly increase confidence in performing research.

An Education Program for Patient Self-Management of Warfarin.

INTRODUCTION: Although improved anticoagulation therapy outcomes have been demonstrated in clinical trials evaluating warfarin patient self-management (PSM) programs, these studies did not provide detailed information regarding PSM program development and patient training. OBJECTIVE: To evaluate the feasibility of and methods for developing and administering an education program to support a novel pilot warfarin PSM program. METHODS: Patients receiving warfarin for atrial fibrillation were recruited to participate in a prospective, intervention-only, open-label pilot PSM program that released venipuncture international normalized ratio results to patients via a secure, online Web site. To support the pilot, a warfarin PSM education program with a dosing algorithm was developed and delivered to patients during a two-hour classroom session. MAIN OUTCOME MEASURE: A comparison of participants' PSM competency test scores before and after attending the PSM program. RESULTS: Forty-four patients attended the education program. The mean age of participants was 71 years and 50% were women. Patients declining study participation were older (p = 0.003) and had a greater burden of chronic disease (p = 0.005) than participants. Following PSM training, the mean competency score improved from 55.8% to 88.8% (p < 0.001), and the proportion achieving a passing score increased from 34.9% to 95.3% (p < 0.001). In the poststudy survey, 100% of responders perceived that PSM training prepared them to self-manage warfarin, and 92.9% of responders were comfortable changing warfarin doses on their own. CONCLUSION: Developing and administering a warfarin PSM education program for patients with atrial fibrillation was feasible. Improvement in PSM competency and high levels of self-reported comfort with warfarin PSM were identified.

Cluster-Randomized Trial of Clinical Pharmacist Tobacco Cessation Counseling Among Patients with Cardiovascular Disease.

Optimal management of patients with cardiovascular disease (CVD) includes evaluation of risk factors using a team-based approach. Tobacco use often receives less attention than other CVD risk factors; therefore, utilization of nonphysician health care providers may be valuable in addressing tobacco use. The purpose of this trial was to assess the impact of brief, structured, telephone tobacco cessation counseling (BST) delivered by clinical pharmacists on tobacco cessation attempts compared to usual care. The BST consisted of 1 to 5 minutes discussing 3 key counseling points, including a recommendation to quit and education about cessation aids. This was a cluster-randomized trial of tobacco-using patients with CVD who were enrolled in a clinical pharmacist-managed, physician-directed, CVD disease state management service. Clinical pharmacists were randomized to provide usual care (control) or BST (intervention) to their tobacco-using patients during a 4-month period. Patients were surveyed 3 months later to assess their tobacco cessation attempts, use of tobacco cessation aids, and self-reported cessation. One hundred twenty patients were enrolled. Subjects were predominately white males, aged ≥65 years, with a history of myocardial infarction. One hundred and four subjects completed the follow-up survey. No differences were detected between the 36.2% and 38.6% of control and intervention subjects, respectively, reporting a tobacco cessation attempt (P=0.804) or in the other outcomes (all P>0.05). A BST delivered by clinical pharmacists may not adequately affect patient motivation enough to increase tobacco cessation attempts in tobacco-dependent patients with CVD. Future research is needed to evaluate other team-based strategies that can decrease tobacco use in patients with CVD.

Impact of a clinical pharmacy research team on pharmacy resident research.

PURPOSE: A successful initiative by Kaiser Permanente Colorado (KPCO) to support pharmacy resident research projects and the publication of project results in peer-reviewed journals is described. METHODS: An observational study was conducted to evaluate the publication rates for resident research projects before and after the KPCO pharmacy department established a Clinical Pharmacy Research Team (CPRT) to encourage and enable resident research. All projects presented by KPCO residents at the annual Western States Conference (WSC) for Pharmacy Residents, Fellows, and Preceptors in the 10 years before the CPRT was established (1994-2004, the pre-CPRT group) and the 7 years after CPRT implementation (2005-11, the CPRT group) were included in the analysis. The proportions of presented projects in the two groups that were subsequently published in peer-reviewed journals were compared, with further analysis of project characteristics and publication outcomes. RESULTS: A total of 66 resident research projects were presented at the WSC during the study period: 30 (45.5%) and 36 (54.5%) in the pre-CPRT and CPRT groups, respectively. Overall, 45 projects (68.2%) were published in peer-reviewed journals. Projects in the CPRT group were significantly more likely than those in the pre-CPRT group to result in peer-reviewed publications (publication rate, 86.1% versus 46.7%; p = 0.001). The median times from residency completion to publication in the pre-CPRT and CPRT groups were 30 and 23 months, respectively (p = 0.08). CONCLUSION: An increase in the proportion of pharmacy resident research projects published in peer-reviewed journals was observed after the CPRT was established.

Out-of-plan pharmacy use: insights into patient behavior.

OBJECTIVES: The purpose of this study was to identify and describe patient rationales for filling prescriptions at an out-of-plan pharmacy (OOPP). STUDY DESIGN: A cross-sectional survey conducted in February 2013 among a random sample of 1000 patients. METHODS: Adult Kaiser Permanente Colorado (KPCO) patients who had a prescription electronically issued to an OOPP in November 2012 were surveyed. The study questionnaire was developed using items obtained from the literature and prepared de novo, as needed. The questionnaire included items regarding whether the electronic prescription issued to an OOPP was filled; if filled, which OOPP was used; factors that may have influenced the use of an OOPP; and the patient's ability to afford medications. Responses to the survey were tabulated and reported as percentages. RESULTS: The survey response rate was 38%. Respondents (N=382) had a mean age of 61 years, 35% were males, and anti-hypertensives were their most common OOPP prescription. Overall, 330 (86%) respondents reported that they had their prescription filled at an OOPP. The most commonly reported OOPPs utilized were supermarket pharmacies (42%). Factors that influenced the decision to use an OOPP included the prescription being less expensive (58%), the OOPP had a discount generic prescription program (57%), and the OOPP's location was convenient (44%). Thirty-nine percent of respondents reported that using an OOPP helped them afford their prescriptions. CONCLUSIONS: Prescription cost and pharmacy convenience were identified as the most significant drivers of OOPP use. Future research should be conducted to assess the health-related consequences of OOPP use.

Methadone for pain and the risk of adverse cardiac outcomes.

CONTEXT: There are few studies that describe cardiac adverse events in patients prescribed methadone for pain management. OBJECTIVES: To describe incident cardiac adverse events and risk factors for cardiac adverse events in primary care patients prescribed methadone for pain. METHODS: This was a retrospective, descriptive, cohort study in patients 18 years or older receiving methadone for pain management during 2010. Patients were followed for 12 months and were categorized as "chronic" or "non-chronic" methadone users. The primary outcomes were a cardiac event, at risk for an event, or neither. Patients were grouped on their outcome and were compared on risk factors and methadone monitoring. RESULTS: A total of 1246 patients were included. Thirty (2.4%), 628 (50.4%), and 588 (47.2%) patients had a cardiac event, were at risk for an event, or had neither an event nor a risk factor, respectively. Overall, the rate of QTc prolongation was 49.4% and the rate of adherence to recommended cardiac monitoring was 39.0%. Similar percentages of chronic and non-chronic users had a cardiac event (P > 0.05). Among the patients who had a cardiac event and were at risk for an event, factors independently associated with having had an event included age (odds ratio = 1.06; 95% CI = 1.03-1.09) and a dose 100 mg/day or higher (odds ratio = 6.18; 95% CI = 1.08-35.45). CONCLUSION: Few cardiac adverse events resulting from methadone use for pain were detected. However, a large proportion of patients were at risk for an adverse event, especially patients who were older and had received ≥ 100 mg/day of methadone.

Pilot study of a novel patient self-management program for warfarin therapy using venipuncture-acquired international normalized ratio monitoring.

STUDY OBJECTIVE: To compare clinical and safety outcomes of warfarin therapy before and after implementation of a novel patient self-management (PSM) program in which patients received their venipuncture-derived international normalized ratio (INR) results through a secure online messaging system and adjusted their warfarin dosages and follow-up visits according to provided support tools. DESIGN: Prospective, open-label, 3-month, pilot study. SETTING: Centralized clinical pharmacy anticoagulation service. PATIENTS: Forty-four patients with atrial fibrillation who were receiving warfarin for more than 6 months were enrolled in the trial between January 1, 2011, and February 28, 2011; 39 patients completed the trial. Patients acted as their own controls. INTERVENTION: Patients received dosing decision support tools during a 2-hour live PSM training class. Those who then demonstrated proficiency in PSM assumed responsibility for their warfarin therapy management. MEASUREMENTS AND MAIN RESULTS: Outcomes of warfarin therapy were measured in each patient before and after implementation of the PSM program. Study variables included time in the therapeutic INR range (TTR), numbers of INR tests performed, and episodes of major bleeding or thrombosis. No significant difference in TTR occurred between the 90 days before PSM program participation and the 90 days of PSM (82.9% vs 81.2%, p=0.65). The mean number of INR tests performed for each patient increased from 2.97 before PSM program participation to 4.38 during PSM (p<0.01). No bleeding or thrombotic events occurred during the PSM phase. CONCLUSION: Patients were trained to engage in PSM using support tools and venipuncture-derived INR results received by an online messaging system to adjust warfarin dosage and frequency of INR testing. No significant difference in TTR occurred in these patients before and during the PSM. This novel PSM model appears to be a feasible method of managing warfarin therapy in carefully selected patients; however, a larger, randomized controlled trial is needed to evaluate the safety and efficacy of the model and its effect on anticoagulation service workload.

Twelve-month outcomes of an Internet-based diabetes self-management support program.

OBJECTIVE: Internet-based programs offer potential for practical, cost-effective chronic illness self-management programs. METHODS: We report 12-month results of an Internet-based diabetes self-management program, with and without additional support, compared to enhanced usual care in a 3-arm practical randomized trial. Patients (n=463) were randomized: 77.3% completed 12-month follow-up. Primary outcomes were changes in health behaviors of healthy eating, physical activity, and medication taking. Secondary outcomes were hemoglobin A1c, body mass index, lipids, blood pressure, and psychosocial factors. RESULTS: Internet conditions improved health behaviors significantly vs. usual care over the 12-month period (d for effect size=.09-.16). All conditions improved moderately on biological and psychosocial outcomes. Latinos, lower literacy, and higher cardiovascular disease risk patients improved as much as other participants. CONCLUSIONS: The Internet intervention meets the reach and feasibility criteria for a potentially broad public health impact. However, 12-month magnitude of effects was small, suggesting that different or more intensive approaches are necessary to support long-term outcomes. Research is needed to understand the linkages between intervention and maintenance processes and downstream outcomes. PRACTICE IMPLICATIONS: Automated self-management interventions should be tailored and integrated into primary care; maintenance of patient self-management can be enhanced through links to community resources.

Linking internet-based diabetes self-management to primary care: lessons learned and implications for research translation and practice implementation.

There has been little discussion of or research on the key translational issue of how to integrate patient self-management programs across multiple primary care clinics within an HMO. The purpose of this study was to summarize our experiences and lessons learned in trying to integrate information from a web-based diabetes self-management program into primary care and the electronic health record (EHR). We describe plans, implementation, adaptations made, and data on patient and physician reactions to the My Path diabetes self-management program provided to 331 adult primary care patients. Mixed methods results revealed that, despite the availability of a state-of-the-art EHR, the intervention was not well integrated into primary care. Information from health-promotion and disease management programs, even within the same organization and with advanced EHR systems, is challenging to integrate into busy primary care.

Engagement in a diabetes self-management website: usage patterns and generalizability of program use.

BACKGROUND: Increased access to the Internet and the availability of efficacious eHealth interventions offer great promise for assisting adults with diabetes to change and maintain health behaviors. A key concern is whether levels of engagement in Internet programs are sufficient to promote and sustain behavior change. OBJECTIVE: This paper used automated data from an ongoing Internet-based diabetes self-management intervention study to calculate various indices of website engagement. The multimedia website involved goal setting, action planning, and self-monitoring as well as offering features such as "Ask an Expert" to enhance healthy eating, physical activity, and medication adherence. We also investigated participant characteristics associated with website engagement and the relationship between website use and 4-month behavioral and health outcomes. METHODS: We report on participants in a randomized controlled trial (RCT) who were randomized to receive (1) the website alone (n = 137) or (2) the website plus human support (n = 133) that included additional phone calls and group meetings. The website was available in English and Spanish and included features to enhance engagement and user experience. A number of engagement variables were calculated for each participant including number of log-ins, number of website components visited at least twice, number of days entering self-monitoring data, number of visits to the "Action Plan" section, and time on the website. Key outcomes included exercise, healthy eating, and medication adherence as well as body mass index (BMI) and biological variables related to cardiovascular disease risk. RESULTS: Of the 270 intervention participants, the average age was 60, the average BMI was 34.9 kg/m², 130 (48%) were female, and 62 (23%) self-reported Latino ethnicity. The number of participant visits to the website over 4 months ranged from 1 to 119 (mean 28 visits, median 18). Usage decreased from 70% of participants visiting at least weekly during the first 6 weeks to 47% during weeks 7 to 16. There were no significant differences between website only and website plus support conditions on most of the engagement variables. In total, 75% of participants entered self-monitoring data at least once per week. Exercise action plan pages were visited more often than medication taking and healthy eating pages (mean of 4.3 visits vs 2.8 and 2.0 respectively, P < .001). Spearman nonparametric correlations indicated few significant associations between patient characteristics and summary website engagement variables, and key factors such as ethnicity, baseline computer use, age, health literacy, and education were not related to use. Partial correlations indicated that engagement, especially in self-monitoring, was most consistently related to improvement in healthy eating (r = .20, P = .04) and reduction of dietary fat (r = -.31, P = .001). There was also a significant correlation between self-monitoring and improvement in exercise (r = .20, P = .033) but not with medication taking. CONCLUSIONS: Participants visited the website fairly often and used all of the theoretically important sections, but engagement decreased over 4 months. Usage rates and patterns were similar for a wide range of participants, which has encouraging implications for the potential reach of online interventions. TRIAL REGISTRATION: NCT00987285; http://clinicaltrials.gov/show/NCT00987285 (Archived by WebCite at http://www.webcitation.org/5vpe4RHTV).

Outcomes of minimal and moderate support versions of an internet-based diabetes self-management support program.

OBJECTIVE: Internet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition. RESEARCH DESIGN AND METHODS: A three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure. RESULTS: The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention. CONCLUSIONS: The Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes.

Recruitment for an internet-based diabetes self-management program: scientific and ethical implications.

BACKGROUND: Little is known about the reach of Internet self-management interventions. PURPOSE: The aim of this study was to evaluate different definitions of participation rate and compare characteristics among subcategories of participants and nonparticipants on demographic and clinical factors using de-identified electronic medical record data. METHODS: Data are presented on recruitment results and characteristics of 2,603 health maintenance organization members having type 2 diabetes invited to participate in an Internet self-management program. RESULTS: There was a 37% participation rate among all members attempted to contact and presumed eligible. There were several significant differences between participants and nonparticipants and among subgroups of participants (e.g., proactive volunteers vs. telephone respondents) on factors including age, income, ethnicity, smoking rate, education, blood pressure, and hemoglobin A1c. CONCLUSION: These results have important implications for the impact of different recruitment methods on health disparities and generalization of results. We provide recommendations for reporting of eligibility rate, participation rate, and representativeness analyses.