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1.
J Gen Intern Med ; 2022 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-35581452

RESUMO

OBJECTIVE: The aim of this study was to evaluate the effectiveness of a digital health intervention plus community health worker (CHW) support on self-monitoring of blood glucose and glycosylated hemoglobin (HbA1c) among adult Medicaid beneficiaries with diabetes. DESIGN: Randomized controlled trial. SETTING: Urban outpatient clinic. PARTICIPANTS: Adult Medicaid beneficiaries living with diabetes and treated with insulin and who had a HbA1c ≥ 9%. INTERVENTION: Participants were randomly assigned to one of three arms. Participants in the usual-care arm received a wireless glucometer if needed. Those in the digital arm received a lottery incentive for daily glucose monitoring. Those in the hybrid arm received the lottery plus support from a CHW if they had low adherence or high blood glucose levels. MAIN MEASURES: The primary outcome was the difference in adherence to daily glucose self-monitoring at 3 months between the hybrid and usual-care arms. The secondary outcome was difference in HbA1c from baseline at 6 months. KEY RESULTS: A total of 150 participants were enrolled in the study. A total of 102 participants (68%) completed the study. At 3 months, glucose self-monitoring rates in the hybrid versus usual-care arms were 0.72 vs 0.65, p = 0.23. At 6 months, change in HbA1c in the hybrid versus usual-care arms was - 0.74% vs - 0.49%, p = 0.69. CONCLUSION: There were no statistically significant differences between the hybrid and usual care in glucose self-monitoring adherence or improvements in HbA1C. TRIAL REGISTRATION: This trial is registered with clinicaltrials.gov identifier: NCT03939793.

2.
JAMA Intern Med ; 182(6): 643-649, 2022 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-35532915

RESUMO

Importance: Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death. Objective: To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF. Design, Setting, and Participants: The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat. Interventions: Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact. Main Outcomes and Measures: Time to death or readmission for any cause within 12 months. Results: Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital. Conclusions and Relevance: In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.


Assuntos
Insuficiência Cardíaca , Alta do Paciente , Adulto , Diuréticos , Economia Comportamental , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade
3.
PLoS One ; 17(3): e0263425, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35353815

RESUMO

To promote COVID-19 vaccination, many states in the US introduced financial incentives ranging from small, guaranteed rewards to lotteries that give vaccinated individuals a chance to win large prizes. There is limited evidence on the effectiveness of these programs and conflicting evidence from survey experiments and studies of individual states' lotteries. To assess the effectiveness of COVID-19 vaccination incentive programs, we combined information on statewide incentive programs in the US with data on daily vaccine doses administered in each state. Leveraging variation across states in the daily availability of incentives, our difference-in-differences analyses showed that statewide programs were not associated with a significant change in vaccination rates. Furthermore, there was no significant difference in vaccination trends between states with and without incentives in any of the 14 days before or after incentives were introduced. Heterogeneity analyses indicated that neither lotteries nor guaranteed rewards were associated with significant change in vaccination rates.


Assuntos
COVID-19 , Motivação , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Humanos , Vacinação
4.
Proc Natl Acad Sci U S A ; 119(6)2022 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-35105809

RESUMO

Encouraging vaccination is a pressing policy problem. To assess whether text-based reminders can encourage pharmacy vaccination and what kinds of messages work best, we conducted a megastudy. We randomly assigned 689,693 Walmart pharmacy patients to receive one of 22 different text reminders using a variety of different behavioral science principles to nudge flu vaccination or to a business-as-usual control condition that received no messages. We found that the reminder texts that we tested increased pharmacy vaccination rates by an average of 2.0 percentage points, or 6.8%, over a 3-mo follow-up period. The most-effective messages reminded patients that a flu shot was waiting for them and delivered reminders on multiple days. The top-performing intervention included two texts delivered 3 d apart and communicated to patients that a vaccine was "waiting for you." Neither experts nor lay people anticipated that this would be the best-performing treatment, underscoring the value of simultaneously testing many different nudges in a highly powered megastudy.


Assuntos
Programas de Imunização , Vacinas contra Influenza/administração & dosagem , Farmácias , Vacinação/métodos , Idoso , COVID-19 , Feminino , Humanos , Influenza Humana/prevenção & controle , Masculino , Pessoa de Meia-Idade , Farmácias/estatística & dados numéricos , Sistemas de Alerta , Envio de Mensagens de Texto , Vacinação/estatística & dados numéricos
5.
Med Decis Making ; : 272989X211069980, 2022 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-35018863

RESUMO

HIGHLIGHTS: Electronic health records are not a single system but a series of overlapping and legacy systems that require time and expertise to use efficiently.Commonly measured patient characteristics such as weight and body mass index are relatively easy to locate for most trial enrollees but less common characteristics, like ejection fraction, are not.Acquiring essential supplementary data-in this trial, state data on hospital admission-can be a lengthy and difficult process.

6.
Contemp Clin Trials Commun ; 25: 100878, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34977421

RESUMO

BACKGROUND: Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. METHODS: The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. CONCLUSION: The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.

7.
Ann Am Thorac Soc ; 19(2): 303-314, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34384042

RESUMO

Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. By using an additive study design, all four arms provide standard "ask-advise-refer" care. Arm 2 adds free or subsidized pharmacologic cessation aids, arm 3 adds financial incentives up to $600 for cessation, and arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared with arm 1. We will enroll 3,200 adults with LCS orders at four U.S. health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., is Black or Latinx, is a rural resident, completed a high school education or less, and/or has a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic randomized clinical trial will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with clinicaltrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.


Assuntos
Neoplasias Pulmonares , Abandono do Hábito de Fumar , Adulto , Detecção Precoce de Câncer/métodos , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Fumar , Abandono do Hábito de Fumar/métodos , Populações Vulneráveis
8.
Health Aff (Millwood) ; 41(3): 424-433, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35254932

RESUMO

An initial opioid prescription with a greater number of pills is associated with a greater risk for future long-term opioid use, yet few interventions have reliably influenced individual clinicians' prescribing. Our objective was to evaluate the effect of feedback interventions for clinicians in reducing opioid prescribing. The interventions included feedback on a clinician's outlier prescribing (individual audit feedback), peer comparison, and both interventions combined. We conducted a four-arm factorial pragmatic cluster randomized trial at forty-eight emergency department (ED) and urgent care (UC) sites in the western US, including 263 ED and 175 UC clinicians with 294,962 patient encounters. Relative to usual care, there was a significant decrease in pills per prescription both for peer comparison feedback (-0.8) and for the combination of peer comparison and individual audit feedback (-1.2). This decrease was sustained during follow-up. There were no significant changes for individual audit feedback alone, and no interventions changed the proportion of encounters with an opioid prescription.


Assuntos
Analgésicos Opioides , Padrões de Prática Médica , Analgésicos Opioides/uso terapêutico , Serviço Hospitalar de Emergência , Retroalimentação , Humanos , Prescrição Inadequada , Grupo Associado
9.
Behav Med ; : 1-9, 2021 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-34847825

RESUMO

Incentives are a useful tool in encouraging healthy behavior as part of public health initiatives. However, there remains concern about motivation crowd out-a decline in levels of motivation to undertake a behavior to below baseline levels after incentives have been removed-and few public health studies have assessed for motivation crowd out. Here, we assess the feasibility of identifying motivation crowd out following a lottery to promote participation in a Chagas disease vector control campaign. We look for evidence of crowd out in subsequent participation in the same behavior, a related behavior, and an unrelated behavior. We identified potential motivation crowd out for the same behavior, but not for related behavior or unrelated behaviors after lottery incentives are removed. Despite some limitations, we conclude that motivation crowd out is feasible to assess in large-scale trials of incentives.

10.
Nature ; 600(7889): 478-483, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34880497

RESUMO

Policy-makers are increasingly turning to behavioural science for insights about how to improve citizens' decisions and outcomes1. Typically, different scientists test different intervention ideas in different samples using different outcomes over different time intervals2. The lack of comparability of such individual investigations limits their potential to inform policy. Here, to address this limitation and accelerate the pace of discovery, we introduce the megastudy-a massive field experiment in which the effects of many different interventions are compared in the same population on the same objectively measured outcome for the same duration. In a megastudy targeting physical exercise among 61,293 members of an American fitness chain, 30 scientists from 15 different US universities worked in small independent teams to design a total of 54 different four-week digital programmes (or interventions) encouraging exercise. We show that 45% of these interventions significantly increased weekly gym visits by 9% to 27%; the top-performing intervention offered microrewards for returning to the gym after a missed workout. Only 8% of interventions induced behaviour change that was significant and measurable after the four-week intervention. Conditioning on the 45% of interventions that increased exercise during the intervention, we detected carry-over effects that were proportionally similar to those measured in previous research3-6. Forecasts by impartial judges failed to predict which interventions would be most effective, underscoring the value of testing many ideas at once and, therefore, the potential for megastudies to improve the evidentiary value of behavioural science.


Assuntos
Ciências do Comportamento/métodos , Ensaios Clínicos como Assunto/métodos , Exercício Físico/psicologia , Promoção da Saúde/métodos , Projetos de Pesquisa , Adulto , Feminino , Humanos , Masculino , Motivação , Análise de Regressão , Recompensa , Fatores de Tempo , Estados Unidos , Universidades
11.
NPJ Digit Med ; 4(1): 172, 2021 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-34934140

RESUMO

The use of wearables is increasing and data from these devices could improve the prediction of changes in glycemic control. We conducted a randomized trial with adults with prediabetes who were given either a waist-worn or wrist-worn wearable to track activity patterns. We collected baseline information on demographics, medical history, and laboratory testing. We tested three models that predicted changes in hemoglobin A1c that were continuous, improved glycemic control by 5% or worsened glycemic control by 5%. Consistently in all three models, prediction improved when (a) machine learning was used vs. traditional regression, with ensemble methods performing the best; (b) baseline information with wearable data was used vs. baseline information alone; and (c) wrist-worn wearables were used vs. waist-worn wearables. These findings indicate that models can accurately identify changes in glycemic control among prediabetic adults, and this could be used to better allocate resources and target interventions to prevent progression to diabetes.

12.
J Grad Med Educ ; 13(5): 717-721, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34721802

RESUMO

BACKGROUND: Medical interns are at risk for sleep deprivation from long and often rotating work schedules. However, the effects of specific rotations on sleep are less clear. OBJECTIVE: To examine differences in sleep duration and alertness among internal medicine interns during inpatient intensive care unit (ICU) compared to general medicine (GM) rotations. METHODS: This secondary analysis compared interns during a GM or ICU rotation from a randomized trial (2015-2016) of 12 internal medicine residency programs assigned to different work hour limit policies (standard 16-hour shifts or no shift-length limits). The primary outcome was sleep duration/24-hour using continuous wrist actigraphy over a 13-day period. Secondary outcomes assessed each morning during the concomitant actigraphy period were sleepiness (Karolinska Sleepiness Scale [KSS]), alertness (number of Brief Psychomotor Vigilance Test [PVT-B] lapses), and self-report of excessive sleepiness over past 24 hours. Linear mixed-effect models with random program intercept determined associations between each outcome by rotation, controlling for age, sex, and work hour policy followed. RESULTS: Of 398 interns, 386 were included (n = 261 GM, n = 125 ICU). Average sleep duration was 7.00±0.08h and 6.84±0.10h, and number of PVT lapses were 5.5±0.5 and 5.7±0.7 for GM and ICU, respectively (all P > .05). KSS was 4.8±0.1 for both rotations. Compared to GM, ICU interns reported more days of excessive sleepiness from 12am-6am (2.6 vs 1.7, P < .001) and 6am-12pm (2.6 vs 1.9, P = .013) and had higher percent of days with sleep duration < 6 hours (27.6% vs 23.4%, P < .001). GM interns reported more days with no excessive sleepiness (5.3 vs 3.7, P < .001). CONCLUSIONS: Despite ICU interns reporting more excessive sleepiness in morning hours and more days of insufficient sleep (<6 hours), overall sleep duration and alertness did not significantly differ between rotations.


Assuntos
Internato e Residência , Tolerância ao Trabalho Programado , Cuidados Críticos , Humanos , Sono , Vigília
13.
Appl Clin Inform ; 12(5): 1021-1028, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34734403

RESUMO

OBJECTIVE: We describe the design, implementation, and validation of an online, publicly available tool to algorithmically triage patients experiencing severe acute respiratory syndrome coronavirus (SARS-CoV-2)-like symptoms. METHODS: We conducted a chart review of patients who completed the triage tool and subsequently contacted our institution's phone triage hotline to assess tool- and clinician-assigned triage codes, patient demographics, SARS-CoV-2 (COVID-19) test data, and health care utilization in the 30 days post-encounter. We calculated the percentage of concordance between tool- and clinician-assigned triage categories, down-triage (clinician assigning a less severe category than the triage tool), and up-triage (clinician assigning a more severe category than the triage tool) instances. RESULTS: From May 4, 2020 through January 31, 2021, the triage tool was completed 30,321 times by 20,930 unique patients. Of those 30,321 triage tool completions, 51.7% were assessed by the triage tool to be asymptomatic, 15.6% low severity, 21.7% moderate severity, and 11.0% high severity. The concordance rate, where the triage tool and clinician assigned the same clinical severity, was 29.2%. The down-triage rate was 70.1%. Only six patients were up-triaged by the clinician. 72.1% received a COVID-19 test administered by our health care system within 14 days of their encounter, with a positivity rate of 14.7%. CONCLUSION: The design, pilot, and validation analysis in this study show that this COVID-19 triage tool can safely triage patients when compared with clinician triage personnel. This work may signal opportunities for automated triage of patients for conditions beyond COVID-19 to improve patient experience by enabling self-service, on-demand, 24/7 triage access.


Assuntos
COVID-19 , Triagem , Humanos , SARS-CoV-2
14.
JAMA Netw Open ; 4(10): e2121908, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34605920

RESUMO

Importance: Financial incentives may improve health behaviors. It is unknown whether incentives are more effective if they target a key process (eg, medication adherence), an outcome (eg, low-density lipoprotein cholesterol [LDL-C] levels), or both. Objective: To determine whether financial incentives awarded daily for process (adherence to statins), awarded quarterly for outcomes (personalized LDL-C level targets), or awarded for process plus outcomes induce reductions in LDL-C levels compared with control. Design, Setting, and Participants: A randomized clinical trial was conducted from February 12, 2015, to October 3, 2018; data analysis was performed from October 4, 2018, to May 27, 2021, at the University of Pennsylvania Health System, Philadelphia. Participants included 764 adults with an active statin prescription, elevated risk of atherosclerotic cardiovascular disease, suboptimal LDL-C level, and evidence of imperfect adherence to statin medication. Interventions: Interventions lasted 12 months. All participants received a smart pill bottle to measure adherence and underwent LDL-C measurement every 3 months. In the process group, daily financial incentives were awarded for statin adherence. In the outcomes group, participants received incentives for achieving or sustaining at least a quarterly 10-mg/dL LDL-C level reduction. The process plus outcomes group participants were eligible for incentives split between statin adherence and quarterly LDL-C level targets. Main Outcomes and Measures: Change in LDL-C level from baseline to 12 months, determined using intention-to-treat analysis. Results: Of the 764 participants, 390 were women (51.2%); mean (SD) age was 62.4 (10.0) years, 310 (40.6%) had diabetes, 298 (39.0%) had hypertension, and mean (SD) baseline LDL-C level was 138.8 (37.6) mg/dL. Mean LDL-C level reductions from baseline to 12 months were -36.9 mg/dL (95% CI, -42.0 to -31.9 mg/dL) among control participants, -40.0 mg/dL (95% CI, -44.7 to -35.4 mg/dL) among process participants, -41.6 mg/dL (95% CI, -46.3 to -37.0 mg/dL) among outcomes participants, and -42.8 mg/dL (95% CI, -47.4 to -38.1 mg/dL) among process plus outcomes participants. In exploratory analysis among participants with diabetes and hypertension, no spillover effects of incentives were detected compared with the control group on hemoglobin A1c level and blood pressure over 12 months. Conclusions and Relevance: In this randomized clinical trial, process-, outcomes-, or process plus outcomes-based financial incentives did not improve LDL-C levels vs control. Trial Registration: ClinicalTrials.gov Identifier: NCT02246959.


Assuntos
Anticolesterolemiantes/economia , Colesterol/análise , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Reembolso de Incentivo/normas , Idoso , Anticolesterolemiantes/uso terapêutico , Colesterol/sangue , Correlação de Dados , Feminino , Humanos , Masculino , Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodos , Philadelphia , Reembolso de Incentivo/estatística & dados numéricos
15.
JAMA Cardiol ; 6(12): 1387-1396, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34468691

RESUMO

Importance: Health promotion efforts commonly communicate goals for healthy behavior, but the best way to design goal setting among high-risk patients has not been well examined. Objective: To test the effectiveness of different ways to set and implement goals within a behaviorally designed gamification intervention to increase physical activity. Design, Setting, and Participants: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences was conducted from January 15, 2019, to June 1, 2020. The 24-week randomized clinical trial included a remotely monitored 8-week introductory intervention period, 8-week maintenance intervention period, and 8-week follow-up period. A total of 500 adults from lower-income neighborhoods in and around Philadelphia, Pennsylvania, who had either an atherosclerotic cardiovascular disease (ASCVD) condition or a 10-year ASCVD risk score greater than or equal to 7.5% were enrolled. Participants were paid for enrolling in and completing the trial. Interventions: All participants used a wearable device to track daily steps, established a baseline level, and were then randomly assigned to an attention control or 1 of 4 gamification interventions that varied only on how daily step goals were set (self-chosen or assigned) and implemented (immediately or gradually). Main Outcome Measures: The primary outcome was change in mean daily steps from baseline to the 8-week maintenance intervention period. Other outcomes included changes in minutes of moderate to vigorous physical activity. All randomly assigned participants were included in the intention-to-treat analysis. Results: Of the 500 participants, 331 individuals (66.2%) were Black, 114 were White (22.8%), and 348 were women (69.6%). Mean (SD) age was 58.5 (10.8) years and body mass index was 33.2 (7.8). A total of 215 participants (43.0%) had an ASCVD condition. Compared with the control arm, participants with self-chosen and immediate goals had significant increases in the number of daily steps during the maintenance intervention period (1384; 95% CI, 805-1963; P < .001) that were sustained during the 8-week follow-up (1391; 95% CI, 785-1998; P < .001). This group also had significant increases in daily minutes of moderate to vigorous physical activity during the maintenance intervention (4.1; 95% CI, 1.8-6.4; P < .001) that were sustained during follow-up (3.5; 95% CI, 1.1-5.8; P = .004). No other gamification arms had consistent increases in physical activity compared with the control arm. No major adverse events were reported. Conclusions and Relevance: In this trial among economically disadvantaged adults at elevated risk for major adverse cardiovascular events, a gamification intervention led to increases in physical activity that were sustained during 8 weeks of follow-up when goals were self-chosen and implemented immediately. Trial Registration: ClinicalTrials.gov Identifier: NCT03749473.


Assuntos
Doenças Cardiovasculares/terapia , Exercício Físico/fisiologia , Objetivos , Comportamentos Relacionados com a Saúde , Participação Social , Populações Vulneráveis , Índice de Massa Corporal , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/fisiopatologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos/epidemiologia
16.
JAMA Intern Med ; 181(11): 1479-1488, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34542553

RESUMO

Importance: Incentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals. Objective: To determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements. Design, Setting, and Participants: Two RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020. Interventions: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial. Main Outcomes and Measures: The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes. Results: There were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions. Conclusions and Relevance: In these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial. Trial Registration: ClinicalTrials.gov Identifier: NCT02697799.


Assuntos
Motivação , Seleção de Pacientes , Sujeitos da Pesquisa/psicologia , Abandono do Hábito de Fumar , Caminhada/psicologia , Grupos Controle , Transtorno Depressivo Maior/psicologia , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Motivação/classificação , Motivação/ética , Avaliação de Processos e Resultados em Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , Recompensa , Abandono do Hábito de Fumar/métodos , Abandono do Hábito de Fumar/psicologia
17.
JAMA Netw Open ; 4(9): e2124132, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34491350

RESUMO

Importance: Modest weight loss can lead to meaningful risk reduction in adults with obesity. Although both behavioral economic incentives and environmental change strategies have shown promise for initial weight loss, to date they have not been combined, or compared, in a randomized clinical trial. Objective: To test the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in adults with obesity. Design, Setting, and Participants: This randomized clinical trial was conducted from 2015 to 2019 at 3 large employers in Philadelphia, Pennsylvania. A 2-by-2 factorial design was used to compare the effects of lottery-based financial incentives, environmental strategies, and their combination vs usual care on weight loss and maintenance. Interventions were delivered via website, text messages, and social media. Participants included adult employees with a body mass index (BMI; weight in kilograms divided by height in meters squared) of 30 to 55 and at least 1 other cardiovascular risk factor. Data analysis was performed from June to July 2021. Interventions: Interventions included lottery-based financial incentives based on meeting weight loss goals, environmental change strategies tailored for individuals and delivered by text messages and social media, and combined incentives and environmental strategies. Main Outcome and Measures: The primary outcome was weight change from baseline to 18 months, measured in person. Results: A total of 344 participants were enrolled, with 86 participants each randomized to the financial incentives group, environmental strategies group, combined financial incentives and environmental strategies group, and usual care (control) group. Participants had a mean (SD) age of 45.6 (10.5) years and a mean (SD) BMI of 36.5 (7.1); 247 participants (71.8%) were women, 172 (50.0%) were Black, and 138 (40.1%) were White. At the primary end point of 18 months, participants in the incentives group lost a mean of 5.4 lb (95% CI, -11.3 to 0.5 lb [mean, 2.45 kg; 95% CI, -5.09 to 0.23 kg]), those in the environmental strategies group lost a mean of a 2.2 lb (95% CI, -7.7 to 3.3 lb [mean, 1.00 kg; 95% CI, -3.47 to 1.49 kg]), and the combination group lost a mean of 2.4 lb (95% CI, -8.2 to 3.3 lb [mean, 1.09 kg; 95% CI, -3.69 to 1.49 kg]) more than participants in the usual care group. Financial incentives, environmental change strategies, and their combination were not significantly more effective than usual care. At 24 months, after 6 months without an intervention, the difference in the change from baseline was similar to the 18-month results, with no significant differences among groups. Conclusions and Relevance: In this randomized clinical trial, across all study groups, participants lost a modest amount of weight but those who received financial incentives, environmental change, or the combined intervention did not lose significantly more weight than those in the usual care group. Employees with obesity may benefit from more intensive individualized weight loss strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02878343.


Assuntos
Obesidade/prevenção & controle , Reembolso de Incentivo , Perda de Peso , Programas de Redução de Peso , Local de Trabalho , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
18.
J Am Dent Assoc ; 152(9): 747-755, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34454649

RESUMO

BACKGROUND: Oral health care use remains low among adult Medicaid recipients, despite the Patient Protection and Affordable Care Act's expansion increasing access to care in many states. It remains unclear the extent to which low use reflects either low demand for care or barriers to accessing care. The authors aimed to examine factors associated with low oral health care use among adults enrolled in Medicaid. METHODS: The authors conducted a survey from May through September 2018 among able-bodied (n = 9,363) Medicaid recipients who were aged 19 through 65 years and nondisabled childless adults in Kentucky. The survey included questions on perceived oral health care use. Semistructured interviews were also conducted from May through November 2018 among a subset of participants (n = 127). RESULTS: More than one-third (37.8%) of respondents reported fair or poor oral health, compared with 26.2% who reported fair or poor physical health. Although 47.6% of respondents indicated needing oral health care in the past 6 months, only one-half of this group reported receiving all of the care they needed. Self-reported barriers included lack of coverage for needed services and lack of access to care (for example, low provider availability and transportation difficulties). CONCLUSIONS: Low rates of oral health care use can be attributed to a subset of the study population having low demand and another subset facing barriers to accessing care. Although Medicaid-covered services might be adequate for beneficiaries with good oral health, those with advanced dental diseases and a history of irregular care might benefit from coverage for more extensive restorative services. PRACTICAL IMPLICATIONS: These results can inform dentists and policy makers about how to design effective interventions and policies to improve oral health care use and oral health outcomes.


Assuntos
Medicaid , Patient Protection and Affordable Care Act , Adulto , Acesso aos Serviços de Saúde , Humanos , Kentucky , Saúde Bucal , Estados Unidos
19.
JAMA Netw Open ; 4(5): e2110255, 2021 05 03.
Artigo em Inglês | MEDLINE | ID: mdl-34028550

RESUMO

Importance: Gamification is increasingly being used to promote healthy behaviors. However, it has not been well tested among patients with chronic conditions and over longer durations. Objective: To test the effectiveness of behaviorally designed gamification interventions to enhance support, collaboration, or competition to promote physical activity and weight loss among adults with uncontrolled type 2 diabetes. Design, Setting, and Participants: A 4-arm randomized clinical trial with a 1-year intervention was conducted from January 23, 2017, to January 27, 2020, with remotely monitored intervention. Analyses were conducted between February 10 and October 6, 2020. Participants included 361 adults with type 2 diabetes with hemoglobin A1c levels greater than or equal to 8% and body mass index greater than or equal to 25. Interventions: All participants received a wearable device, smart weight scale, and laboratory testing. Participants in the control group received feedback from their devices but no other interventions. Participants in the gamification arms conducted goal setting and were entered into a 1-year game designed using insights from behavioral economics with points and levels for achieving step goals and weight loss targets. The game varied by trial arm to promote either support, collaboration, or competition. Main Outcomes and Measures: Co-primary outcomes included daily step count, weight, and hemoglobin A1c level. Secondary outcome was low-density lipoprotein cholesterol level. Intention-to-treat analysis was used. Results: Participants had a mean (SD) age of 52.5 (10.1) years; hemoglobin A1c level, 9.6% (1.6%); daily steps, 4632 (2523); weight, 107.4 kg (20.8 kg); and body mass index, 37.1 (6.6). Of the 361 participants, 202 (56.0%) were women, 143 (39.6%) were White, and 185 (51.2%) were Black; with 87 (24.1%) randomized to control; 92 (25.4%) randomized to gamification with support and intervention; 95 (26.3%) randomized to gamification with collaboration; and 87 (24.1%) randomized to gamification with competition. Compared with the control group over 1 year, there was a significant increase in mean daily steps from baseline among participants receiving gamification with support (adjusted difference relative to control group, 503 steps; 95% CI, 103 to 903 steps; P = .01) and competition (606 steps; 95% CI, 201 to 1011 steps; P = .003) but not collaboration (280 steps; 95% CI, -115 to 674 steps; P = .16). All trial arms had significant reductions in weight and hemoglobin A1c levels from baseline, but there were no significant differences between any of the intervention arms and the control arm. There was only 1 adverse event reported that may have been related to the trial (arthritic knee pain). Conclusions and Relevance: Among adults with uncontrolled type 2 diabetes, a behaviorally designed gamification intervention in this randomized clinical trial significantly increased physical activity over a 1-year period when designed to enhance either support or competition but not collaboration. No differences between intervention and control groups were found for other outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02961192.


Assuntos
Terapia Comportamental/métodos , Doença Crônica/terapia , Diabetes Mellitus Tipo 2/psicologia , Diabetes Mellitus Tipo 2/terapia , Promoção da Saúde/métodos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pennsylvania
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