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Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial.

ABSTRACT: Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633.

SUBMITTER: Graumlich JF

PROVIDER: S-EPMC5028848 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial.

Graumlich James F JF Wang Huaping H Madison Anna A Wolf Michael S MS Kaiser Darren D Dahal Kumud K Morrow Daniel G DG

Journal of diabetes research 20160906

Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multice ...[more]

PMID: 27699179

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Project description:BACKGROUND:Survivorship care plans (SCPs) are intended to facilitate communication and coordination between patients, oncologists, and primary care providers. Most SCP initiatives have focused on oncology providers initiating the SCP process, but time and resource barriers have limited uptake. OBJECTIVE:This trial compares the feasibility and value of 2 Web-based SCP tools: provider-initiated versus patient-initiated. METHODS:This mixed-methods study recruited clinicians from 2 academically-affiliated community oncology practices. Eligible patients were treated by a participating oncologist, had nonmetastatic cancer, completed acute treatment ? 2 months before enrollment, and had no evidence of disease. Patients were randomized 1:1 to either provider-initiated or patient-initiated SCPs-both are Web-based tools. We conducted qualitative interviews with providers at baseline and follow-up and with patients 2 months after enrollment. In addition, patients were administered the Preparing for Life as a (New) Survivor (PLANS) and Cancer Survivors' Unmet Needs (CaSUN) surveys at baseline and 2 months. RESULTS:A total of 40 providers were approached for the study, of whom 13 (33%) enrolled. Providers or clinic staff required researcher assistance to identify eligible patients; 41 patients were randomized, of whom 25 completed follow-up (61%; 13 provider-initiated, 12 patient-initiated). Of the 25, 11 (44%) had initiated the SCP; 5 (20%) provided the SCP to their primary care provider. On the Preparing for Life as a (New) Survivor and Cancer Survivors' Unmet Needs, patients in both arms tended to report high knowledge and confidence and few unmet needs. In qualitative interviews, providers and patients discussed SCPs' value. CONCLUSIONS:Regardless of patient- versus provider-initiated templates and the Web-based design of these tools, barriers to survivorship care planning persist. Further efforts should emphasize workflow functions for identifying and completing SCPs-regardless of the SCP form used. TRIAL REGISTRATION:ClinicalTrials.gov NCT02405819; https://clinicaltrials.gov/ct2/show/NCT02405819 (Archived by WebCite at http://www.webcitation.org/6jWqcWOvK).

Project description:BackgroundEnhanced patient-provider engagement can improve patient health outcomes in chronic conditions, including major depressive disorder (MDD).ObjectiveWe evaluated the impact of a digitally enabled care mobile app, Pathway, designed to improve MDD patient-provider engagement. Patients used a mobile interface to assess treatment progress and share this information with primary care providers (PCPs).MethodsIn this 52-week, real-world effectiveness and feasibility study conducted in primary care clinics, 40 patients with MDD who were recently prescribed antidepressant monotherapy were randomized to use a mobile app with usual care (20/40, 50%) or usual care alone (20/40, 50%). Patients in the app arm engaged with the app daily for 18 weeks; a report was generated at 6-week intervals and shared with the PCPs to facilitate shared treatment decision-making discussions. The patients discontinued the app at week 18 and were followed through year 1. Coprimary outcome measures, assessed via research visits, included change from baseline in the 13-item Patient Activation Measure (PAM-13) and 7-item Patient-Provider Engagement Scale scores at week 18. Additional outcome measures included depression severity (9-item Patient Health Questionnaire [PHQ-9]) and cognitive symptoms (5-item Perceived Deficits Questionnaire-Depression).ResultsAll 37 patients (app arm: n=18, 49%; usual care arm: n=19, 51%) who completed the 18-week follow-up period (n=31, 84% female, mean age 36, SD 11.3 years) had moderate to moderately severe depression. Improvements in PAM-13 and PHQ-9 scores were observed in both arms. Increases in PAM-13 scores from baseline to 18 weeks were numerically greater in the app arm than in the usual care arm (mean 10.5, SD 13.2 vs mean 8.8, SD 9.4; P=.65). At 52 weeks, differences in PAM-13 scores from baseline demonstrated significantly greater improvements in the app arm than in the usual care arm (mean 20.2, SD 17.7 vs mean 1.6, SD 14.2; P=.04). Compared with baseline, PHQ-9 scores decreased in both the app arm and the usual care arm at 18 weeks (mean 7.8, SD 7.2 vs mean 7.0, SD 6.5; P=.73) and 52 weeks (mean 9.5, SD 4.0 vs mean 4.7, SD 6.0; P=.07). Improvements in 7-item Patient-Provider Engagement Scale and WHO-5 scores were observed in both arms at 18 weeks and were sustained through 52 weeks in the app arm. Improvements in WHO-5 scores at 52 weeks were significantly greater in the app arm than in the usual care arm (41.5 vs 20.0; P=.02).ConclusionsPatients with MDD will engage with a mobile app designed to track treatment and disease progression. PCPs will use the data generated as part of their assessment to inform clinical care. The study results suggest that an app-enabled clinical care pathway may enhance patient activation and benefit MDD management.Trial registrationClinicalTrials.gov NCT03242213; https://clinicaltrials.gov/ct2/show/NCT03242213.

Project description:BackgroundGrowing numbers of people use medication for chronic conditions; nonadherence is common, leading to poor disease control. A web-based tool to identify an increased risk for nonadherence with related potential individual barriers might facilitate tailored interventions and improve adherence.ObjectiveThis study aims to assess the effectiveness of a newly developed tool aimed at improving medication adherence.MethodsWe performed a cluster randomized controlled trial in patients initiating cardiovascular or oral blood glucose-lowering medication. Participants were recruited from community pharmacies. They completed an online questionnaire comprising assessments of their risk for medication nonadherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients with high nonadherence risk in face-to-face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by pharmacists. Barriers of control patients were not presented nor discussed and these patients received usual care. The primary outcome was the effectiveness of the intervention on medication adherence at 8 months' follow-up between patients with an increased nonadherence risk from the intervention and control groups, calculated from dispensing data.ResultsData from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (B=-0.01; 95% CI -0.59 to 0.57; P=.96), nor in the post hoc per-protocol analysis (B=0.19; 95% CI -0.50 to 0.89; P=.58).ConclusionsThis study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effectiveness were identified. These explanations relate, for instance, to high medication adherence in the control group, study power, and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation.Trial registrationThe Netherlands National Trial Register NTR5186; https://tinyurl.com/5d8w99hk.

Project description:Significant underutilization of breast cancer chemoprevention remains, despite guidelines stating that physicians should recommend chemoprevention with antiestrogen therapy to high-risk women. We randomized women, ages 35 to 75 years, who met high-risk criteria for breast cancer, without a personal history of breast cancer or prior chemoprevention use, to standard educational materials alone or combined with a web-based decision aid. All healthcare providers, including primary care providers and breast specialists, were given access to a web-based decision support tool. The primary endpoint was chemoprevention uptake at 6 months. Secondary outcomes included decision antecedents (perceived breast cancer risk/worry, chemoprevention knowledge, self-efficacy) and decision quality (decision conflict, chemoprevention informed choice) based upon patient surveys administered at baseline, 1 and 6 months after randomization. Among 282 evaluable high-risk women enrolled from November 2016 to March 2020, mean age was 57 years (SD, 9.9) and mean 5-year invasive breast cancer risk was 2.98% (SD, 1.42). There was no significant difference in chemoprevention uptake at 6 months between the intervention and control groups (2.1% vs. 3.5%). Comparing the intervention and control arms at 1 month, there were significant differences among high-risk women in accurate breast cancer risk perceptions (56% vs. 39%, P = 0.017), adequate chemoprevention knowledge (49% vs. 27%, P < 0.001), mean decision conflict (34.0 vs. 47.0, P < 0.001), and informed choice (41% vs. 23%, P = 0.003). These differences were no longer significant at 6 months. Although our decision support tools did not result in a significant increase in chemoprevention uptake, we did observe improvements in decision antecedents and decision quality measures.Prevention relevanceIn this randomized controlled trial of decision support for 300 high-risk women and 50 healthcare providers, we did not observe a significant increase in chemoprevention uptake, which remained low at under 5%. However, these decision support tools may increase knowledge and informed choice about breast cancer chemoprevention.

Project description:BackgroundMost adolescents do not meet the recommendations for physical activity (PA) of at least 1 h per day. Individual planning (IP) interventions, including forming plans for when, where and how (action planning) to engage in a behavior, as well as the planning for how to deal with arising barriers (coping planning), are effective to enhance PA in adults. Collaborative planning (CP) is conjoint planning of two individuals regarding a behavior which is performed together. It is assumed that CP stimulates social exchange processes between the planning partners. However, it remains unclear whether planning interventions of PA in adolescents are successful and which planning intervention is more effective. Thus, this cluster randomized controlled trial (RCT) examines changes in daily moderate-to-vigorous PA in adolescents' friendship dyads resulting from planning. Individual self-regulating mechanism and social exchange processes are proposed as mediating mechanisms of the effects of planning for health behavior change.MethodsA single-blind four-arm parallel-group cluster-RCT is used. The sample consists of 400 friendship dyads between 14 and 18 years of age. As the recruitment takes place in schools, a cluster randomization of the schools is used to enroll dyads to (a) an IP intervention, (b) a CP intervention or (c) one of the two no-planning control conditions. Devise-measured and self-reported PA as the primary outcomes, self-regulatory strategies, and social exchange processes as secondary outcomes are assessed at three or four time points. After baseline measurement, the baseline ecological momentary assessment of the main variables takes place for 8 days followed by the intervention and a 7-days diary phase. Follow-ups are 1 month and 6 months later. Subsequent to the six-month follow-up, another 7-days diary phase takes place.DiscussionThis is the first study examining IP in comparison to CP in adolescents applying a single-blind cluster RCT. Consequently, the study allows for understanding the efficacy of individual and collaborative planning and the underlying mechanisms in adolescent dyads.Trial registrationThis RCT was funded by the Swiss National Science Foundation (100019_169781/1) and was registered on 18/06/2018 at ClinicalTrials.gov : NCT03575559 .

Dataset Information

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial.

Publications

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial.

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