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Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

ABSTRACT: BACKGROUND:Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation. OBJECTIVE:To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults. METHODS:Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated. CONCLUSIONS:This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations. CLINICAL TRIAL REGISTRATION:This trial is registered on clinicaltrials.govNCT02820753.

SUBMITTER: Bailey SC

PROVIDER: S-EPMC5641260 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

Bailey Stacy Cooper SC Wismer Guisselle A GA Parker Ruth M RM Walton Surrey M SM Wood Alastair J J AJJ Wallia Amisha A Brokenshire Samantha A SA Infanzon Alexandra C AC Curtis Laura M LM Kwasny Mary J MJ Wolf Michael S MS

Contemporary clinical trials 20170818

<h4>Background</h4>Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation.<h4>Objective</h4>To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medicati ...[more]

PMID: 28823927

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Project description:BackgroundOne-third of the community-dwelling older persons fall annually. Guidelines recommend the use of multifactorial falls prevention interventions. However, these interventions are difficult to implement into the community. This systematic review aimed to explore strategies used to implement multifactorial falls prevention interventions into the community.MethodsA systematic search in PubMed (including MEDLINE), CINAHL (EBSCO), Embase, Web of Science (core collection), and Cochrane Library was performed and updated on the 25th of August, 2022. Studies reporting on the evaluation of implementation strategies for multifactorial falls prevention interventions in the community setting were included. Two reviewers independently performed the search, screening, data extraction, and synthesis process (PRISMA flow diagram). The quality of the included reports was appraised by means of a sensitivity analysis, assessing the relevance to the research question and the methodological quality (Mixed Method Appraisal Tool). Implementation strategies were reported according to Proctor et al.'s (2013) guideline for specifying and reporting implementation strategies and the Taxonomy of Behavioral Change Methods of Kok et al. (2016).ResultsTwenty-three reports (eighteen studies) met the inclusion criteria, of which fourteen reports scored high and nine moderate on the sensitivity analysis. All studies combined implementation strategies, addressing different determinants. The most frequently used implementation strategies at individual level were "tailoring," "active learning," "personalize risk," "individualization," "consciousness raising," and "participation." At environmental level, the most often described strategies were "technical assistance," "use of lay health workers, peer education," "increasing stakeholder influence," and "forming coalitions." The included studies did not describe the implementation strategies in detail, and a variety of labels for implementation strategies were used. Twelve studies used implementation theories, models, and frameworks; no studies described neither the use of a determinant framework nor how the implementation strategy targeted influencing factors.ConclusionsThis review highlights gaps in the detailed description of implementation strategies and the effective use of implementation frameworks, models, and theories. The review found that studies mainly focused on implementation strategies at the level of the older person and healthcare professional, emphasizing the importance of "tailoring," "consciousness raising," and "participation" in the implementation process. Studies describing implementation strategies at the level of the organization, community, and policy/society show that "technical assistance," "actively involving stakeholders," and "forming coalitions" are important strategies.Trial registrationPROSPERO CRD42020187450.

Project description:IntroductionCardiovascular diseases (CVDs) are a leading cause of morbidity and mortality in low-income countries including India. There is a need for effective, low-cost methods to prevent CVDs in rural India. One strategy is to identify and implement interventions at high-risk individuals using community health workers (CHWs). There is a paucity of CHW-based CVD intervention trials from low-income countries.MethodsWe designed a multicenter, household-level, cluster-randomized trial with 1:1 allocation to intervention and control arms. The CHWs undertook a door-to-door survey and screened 5,699 households in 28 villages from 3 rural regions in India to identify at-risk households. The households were defined as those with ?1 individual aged ?35 years and at moderate or high risk for CVD based on the non-laboratory-based National Health and Nutrition Examination Survey score. All at-risk individuals were invited to attend a physician-led village clinic that provided a CVD risk reduction prescription and education about target risk factor levels for CVD control. All households in which at least 1 member at moderate to high risk for CVD had received a risk reduction prescription were eligible for randomization. Households randomized to the CHW-based intervention will receive 1 household visit by a CHW every 2 months, for 12 months. During these visits, CHWs will measure blood pressure, ascertain and reinforce adherence to prescribed therapies, and modify therapy to meet targets. Households randomized to the control arm do not receive CHW visits. At 12 months after randomization, we will evaluate 2 primary outcomes of systolic blood pressure and adherence to antihypertensive drugs and secondary outcomes of INTERHEART risk score, body mass index, and waist-to-hip ratios. At 18 to 24 months after randomization and 6 to 12 months after the last intervention, we will record these outcomes to evaluate sustainability of intervention.ResultsCommunity health workers screened a total of 5,033 households that included 9,248 individuals and identified 2,571 households with 3,784 at-risk individuals. We randomized 2,438 households (1,219 to intervention and 1,219 to control groups).ConclusionOur large trial of CHWs in rural India will provide important information regarding a promising approach to primary prevention of CVDs.

Project description:BackgroundHome medication management has been insufficiently studied, including the factors that impact the development and effectiveness of adherence strategies under both routine and anomalous circumstances. Older adults are a particularly important population to study due to the greater likelihood of taking medication in combination with the desire to "age in place."ObjectiveThis interview study aims to understand how older adults develop medication management strategies, identify when and why such strategies succeed or fail, learn more about how older adults think about their medication, and explore interventions that increase medication adherence.MethodsThis study used a qualitative, semistructured interview design to elicit older adults' experiences with home medication management. Overall, 22 participants aged ≥50 years taking 1 to 3 prescription medications were recruited and interviewed. Interview responses were recorded, and thematic, qualitative analysis was performed by reviewing recordings and identifying recurring patterns and themes. Responses were systematically coded, which not only facilitated the identification of these themes but also allowed us to quantify the prevalence of behaviors and perceptions, providing a robust understanding of medication management and medication adherence.ResultsParticipants reported developing home medication management strategies on their own, with none of the participants receiving guidance from health care providers and 59% (13/22) of the participants using trial and error. The strategies developed by study participants were all unique and generally encompassed prescription medication and vitamins or supplements, with no demarcation between what was prescribed or recommended by a physician and what they selected independently. Participants thought about their medications by their chemical name (10/22, 45%), by the appearance of the pill (8/22, 36%), by the medication's purpose (2/22, 9%), or by the medication's generic name (2/22, 9%). Pill cases (17/22, 77%) were more popular than prescription bottles (5/22, 23%) for storage of daily medication. Most participants (19/22, 86%) stored their pill cases or prescription bottles in visible locations in the home, and those using pill cases varied in their refill routines. Participants used ≥2 routines or objects as triggers to take their medication. Nonadherence was associated with a disruption to their routine. Finally, only 14% (3/22) of the participants used a time-based reminder or alarm, and none of the participants used a medication adherence device or app.ConclusionsParticipants in our study varied considerably in their home medication management strategies and developed unique routines to remember to take their medication as well as to refill their pill cases. To reduce trial and error in establishing a strategy, there are opportunities for physicians and pharmacists to provide adherence guidance to older adults. To minimize the impact of disruptions on adherence, there are opportunities to develop more durable strategies and to design aids to medication adherence that leverage established daily routines.

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Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

Publications

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

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