Dataset Information

Financial incentives for hypertension control: rationale and study design.

ABSTRACT:

Background

Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled trials, the benefits of adhering to these treatments have not been popularized among the general public. Studies suggest that incentive approaches based on behavioral economic concepts can improve patients' adherence to treatment. Therefore, we aimed to test whether financial incentives will reduce the blood pressure (BP) of hypertensive patients in China.

Methods/design

This is a multicenter, randomized controlled trial with two parallel arms. A total of 400 participants from six cities in the Liaoning and Shanxi provinces of China are block-randomized into intervention and control group with a 1:1 ratio. Patients in the control group will receive interactive management of mobile devices, including patient education and communication. Patients in the intervention group will receive financial incentives in addition to interactive management of mobile devices, conditional on them achieving their antihypertensive goals or hypertension control. Masking the arm allocation will be precluded by the behavioral nature of the intervention and investigators of BP measurement and statistics are masked to clinic assignment. The primary outcome is net change in systolic BP (SBP) from baseline to month 12 between the intervention and control groups. The secondary outcomes are net change in diastolic BP (DBP), BP control, change in medication adherence and lifestyle, and cost-effectiveness.

Discussion

This trial will determine whether financial incentives will improve hypertension control and generate necessary data for controlling hypertension and concomitant cardiovascular diseases among hypertensive patients in China.

Trial registration

ISRCTN13467677. Registered on 16 May 2019.

SUBMITTER: Zheng L

PROVIDER: S-EPMC6998348 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Financial incentives for hypertension control: rationale and study design.

Zheng Liqiang L Wang Yali Y Liu Sitong S Zheng Rui R Pei Dongmei D Sun Yingxian Y Sun Zhaoqing Z

Trials 20200203 1

<h4>Background</h4>Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled trials, the benefits of adhering to these treatments have not been popularized among the general public. Studies suggest that incentive approaches based on behavioral economic concepts can improve patients' adherence to treatment. Therefore, we aimed to test whether financ ...[more]

PMID: 32014046

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Project description:IntroductionObesity is a major public health challenge and exacerbates economic disparities through employment discrimination and increased personal health expenditures. Financial incentives for weight management may intensify individuals' utilisation of evidence-based behavioural strategies while addressing obesity-related economic disparities in low-income populations. Trials have focused on testing incentives contingent on achieving weight loss outcomes. However, based on social cognitive and self-determination theories, providing incentives for achieving intermediate behavioural goals may be more sustainable than incentivising outcomes if they enhance an individual's skills and self-efficacy for maintaining long-term weight loss. The objective of this paper is to describe the rationale and design of the Financial Incentives foR Weight Reduction study, a randomised controlled trial to test the comparative effectiveness and cost-effectiveness of two financial incentive strategies for weight loss (goal directed vs outcome based) among low-income adults with obesity, as well as compared with the provision of health behaviour change resources alone.Methods and analysisWe are recruiting 795 adults, aged 18-70 years with a body mass index ≥30 kg/m2, from three primary care clinics serving residents of socioeconomically disadvantaged neighbourhoods in New York City and Los Angeles. All participants receive a 1-year commercial weight loss programme membership, self-monitoring tools (bathroom scale, food journal and Fitbit Alta HR), health education and monthly check-in visits. In addition to these resources, those in the two intervention groups can earn up to $750 over 6 months for: (1) participating in an intensive weight management programme, self-monitoring weight and diet and meeting physical activity guidelines (goal-directed arm); or (2) a ≥1.5% to ≥5% reduction in baseline weight (outcome-based arm). To maximise incentive efficacy, we incorporate concepts from behavioural economics, including immediacy of payments and framing feedback to elicit regret aversion. We will use generalised mixed effect models for repeated measures to examine intervention effects on weight at 6, 9 and 12 months.Ethics and disseminationHuman research protection committees at New York University School of Medicine, University of California Los Angeles (UCLA) David Geffen School of Medicine and Olive-View-UCLA Medical Center granted ethics approval. We will disseminate the results of this research via peer-reviewed publications, conference presentations and meetings with stakeholders.Trial registration numberNCT03157713.

Project description:IntroductionSmoking remains the leading preventable cause of death in the USA. Low utilisation of treatments for smoking cessation remains a major barrier for reducing smoking rates. Financial incentives represent an innovative approach to increasing use of therapies for smoking cessation. This paper will describe the rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) study, a randomised controlled trial to evaluate the effectiveness and feasibility of goal-directed and outcome-based financial incentives to promote smoking cessation among hospitalised smokers.Methods and analysisWe are recruiting adult participants who smoked tobacco in the 30 days prior to initial interview and are contemplating quitting smoking. These participants will come from two hospitals in underserved communities in New York City and Los Angeles. They will be randomised into one of three arms. The first arm consists of goal-directed financial incentives plus enhanced usual care, which includes hospital-directed information about quitting smoking, nicotine replacement therapy and referral to a Quitline. The second arm involves outcome-based financial incentives plus enhanced usual care. The third arm consists of enhanced usual care alone. Multiple phone interviews with the participants will be completed after randomisation to assess smoking cessation. Participants will earn $20 for each follow-up interview completed and $30 for each smoking cessation test completed. Those who are randomised to the financial incentive groups can earn an additional $700. The participants in the outcome-based group will receive payments solely for exhibiting cessation, whereas the participants in the goal-based group are also eligible for receiving payments after meeting milestones such as speaking with a helpline coach.EthicsHuman research protection committees at New York University School of Medicine and the University of California Los Angeles (UCLA) David Geffen School of Medicine granted ethics approval.Protocol number: IRB#19-000 084.Trial registration numberNCT03979885.

Project description:Background: Given the increase in financial-incentive programs nationwide, many physicians and physician groups are concerned about potential unintended consequences of providing financial incentives to improve quality of care. However, few studies examine whether actual unintended consequences result from providing financial incentives to physicians. We sought to document the extent to which the unintended consequences discussed in the literature were observable in a randomized clinical trial (RCT) of financial incentives.Methods: We conducted a qualitative observational study nested within a larger RCT of financial incentives to improve hypertension care. We conducted 30-minute telephone interviews with primary care personnel at facilities participating in the RCT housed at12 geographically dispersed Veterans Affairs Medical Centers nationwide. Participants answered questions about unintended effects, clinic team dynamics, organizational impact on care delivery, study participation. We employed a blend of inductive and deductive qualitative techniques for analysis.Participants: Sixty-five participants were recruited from RCT enrollees and personnel not enrolled in the larger RCT, plus one primary care leader per site.Results: Emergent themes included possible patient harm, emphasis on documentation over improving care, reduced professional morale, and positive spillover. All discussions of unintended consequences involving patient harm were only concerns, not actual events. Several unintended consequences concerned ancillary initiatives for quality improvement (e.g., practice guidelines and performance measurement systems) rather than financial incentives.Conclusions: Many unintended consequences of financial incentives noted were either only concerns or attributable to ancillary quality-improvement initiatives. Actual unintended consequences included improved documentation of care without necessarily improving actual care, and positive unintended consequences.Trial registration: Clinicaltrials.gov Identifier: NCT00302718.

Project description:BACKGROUND:Many employers offer worksite wellness programs, including financial incentives to achieve goals. Evidence supporting such programs is sparse. OBJECTIVE:To assess whether diabetes and cardiovascular risk factor control in employees improved with financial incentives for participation in disease management and for attaining goals. DESIGN:Retrospective cohort study using insurance claims linked with electronic medical record data from January 2008-December 2012. PARTICIPANTS:Employee patients with diabetes covered by the organization's self-funded insurance and propensity-matched non-employee patient comparison group with diabetes and commercial insurance. INTERVENTION:Financial incentives for employer-sponsored disease management program participation and achieving goals. MAIN MEASURES:Change in glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL), systolic blood pressure (SBP), and weight. RESULTS:A total of 1092 employees with diabetes were matched to non-employee patients. With increasing incentives, employee program participation increased (7 % in 2009 to 50 % in 2012, p?<?0.001). Longitudinal mixed modeling demonstrated improved diabetes and cardiovascular risk factor control in employees vs. non-employees [HbA1c yearly change -0.05 employees vs. 0.00 non-employees, difference in change (DIC) p <0.001]. In their first participation year, employees had larger declines in HbA1c and weight vs. non-employees (0.33 vs. 0.14, DIC p?=?0.04) and (2.3 kg vs. 0.1 kg, DIC p?<?0.001), respectively. Analysis of employee cohorts corresponding with incentive offerings showed that fixed incentives (years 1 and 2) or incentives tied to goals (years 3 and 4) were not significantly associated with HbA1c reductions compared to non-employees. For each employee cohort offered incentives, SBP and LDL also did not significantly differ in employees compared with non-employees (DIC p?>?0.05). CONCLUSIONS:Financial incentives were associated with employee participation in disease management and improved cardiovascular risk factors over 5 years. Improvements occurred primarily in the first year of participation. The relative impact of specific incentives could not be discerned.

Project description:IntroductionInternet-delivered behavioral weight control is promising for expanding the reach and availability of weight management, but online programs produce lower weight losses than typically achieved in person. Financial incentives have been shown to increase weight losses. This study examined whether adding financial incentives for self-monitoring and achieving target weight losses increases weight losses attained in a fully online, group-based behavioral weight management program compared with the same program alone.Study designThis study was an RCT.Setting/participantsAdults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers.InterventionThe intervention was a 24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet + incentives).Main outcome measuresThis study measured weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity). Data were collected between February 2016 and August 2018, and analyses were completed in 2019.ResultsParticipants randomized to the Internet + incentives group lost more weight (-6.4 [SD=5.5] kg) than those in the Internet-only group (-4.7 [SD=6.6] kg; p<0.01). Further, a higher proportion of the Internet + incentives group achieved ≥5% weight loss (55%) than those in the Internet-only group (40%; p<0.05). Treatment engagement was higher in the Internet + incentives condition, with greater self-monitoring of behaviors targeted by incentives, as well as higher rates of behaviors not targeted and higher self-reported physical activity. Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).ConclusionsAdding financial incentives to a program delivered fully online increases weight losses compared with the program alone and can achieve weight losses comparable to in-person programs, offering potential for substantial geographic reach.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02688621.

Project description:ImportanceEvidence-based guidelines recommend thiazide diuretics as a first-line therapy for uncomplicated hypertension; however, thiazides are underused, and hypertension remains inadequately managed.ObjectiveTo test the efficacy of a patient activation intervention with financial incentives to promote thiazide prescribing.Design, setting, and participantsThe Veterans Affairs Project to Implement Diuretics, a randomized clinical trial, was conducted at 13 Veterans Affairs primary care clinics from August 1, 2006, to July 31, 2008, with 12 months of follow-up. A total of 61 019 patients were screened to identify 2853 eligible patients who were not taking a thiazide and not at their blood pressure (BP) goal; 598 consented to participate. Statistical analysis was conducted from December 1, 2017, to September 12, 2018.InterventionsPatients were randomized to a control group (n = 196) or 1 of 3 intervention groups designed to activate patients to talk with their primary care clinicians about thiazides and hypertension: group A (n = 143) received an activation letter, group B (n = 128) received a letter plus a financial incentive, and group C (n = 131) received a letter, financial incentive, and a telephone call encouraging patients to speak with their primary care clinicians.Main outcomes and measuresPrimary outcomes were thiazide prescribing and BP control. A secondary process measure was discussion between patient and primary care clinician about thiazides.ResultsAmong 598 participants (588 men and 10 women), the mean (SD) age for the combined intervention groups (n = 402) was 62.9 (8.8) years, and the mean baseline BP was 148.1/83.8 mm Hg; the mean (SD) age for the control group (n = 196) was 64.1 (9.2) years, and the mean baseline BP was 151.0/83.4 mm Hg. At index visits, the unadjusted rate of thiazide prescribing was 9.7% for the control group (19 of 196) and 24.5% (35 of 143) for group A, 25.8% (33 of 128) for group B, and 32.8% (43 of 131) for group C (P < .001). Adjusted analyses demonstrated an intervention effect on thiazide prescribing at the index visit and 6-month visit, which diminished at the 12-month visit. For BP control, there was a significant intervention effect at the 12-month follow-up for group C (adjusted odds ratio, 1.73; 95% CI, 1.06-2.83; P = .04). Intervention groups exhibited improved thiazide discussion rates in a dose-response fashion: group A, 44.1% (63 of 143); group B, 56.3% (72 of 128); and group C, 68.7% (90 of 131) (P = .004).Conclusions and relevanceThis patient activation intervention about thiazides for hypertension resulted in two-thirds of patients having discussions and nearly one-third initiating a prescription of thiazide. Adding a financial incentive and telephone call to the letter resulted in incremental improvements in both outcomes. By 12 months, improved BP control was also evident. This low-cost, low-intensity intervention resulted in high rates of discussions between patients and clinicians and subsequent thiazide treatment and may be used to promote evidence-based guidelines and overcome clinical inertia.Trial registrationClinicalTrials.gov Identifier: NCT00265538.

Project description:Pay for performance is intended to align incentives to promote high-quality care, but results have been contradictory.To test the effect of explicit financial incentives to reward guideline-recommended hypertension care.Cluster randomized trial of 12 Veterans Affairs outpatient clinics with 5 performance periods and a 12-month washout that enrolled 83 primary care physicians and 42 nonphysician personnel (eg, nurses, pharmacists).Physician-level (individual) incentives, practice-level incentives, both, or none. Intervention participants received up to 5 payments every 4 months; all participants could access feedback reports.Among a random sample, number of patients achieving guideline-recommended blood pressure thresholds or receiving an appropriate response to uncontrolled blood pressure, number of patients prescribed guideline-recommended medications, and number who developed hypotension.Mean (SD) total payments over the study were $4270 ($459), $2672 ($153), and $1648 ($248) for the combined, individual, and practice-level interventions, respectively. The unadjusted baseline and final percentages and the adjusted absolute change over the study in patients meeting the combined blood pressure/appropriate response measure were 75% to 84% and 8.84% (95% CI, 4.20% to 11.80%) for the individual group, 80% to 85% and 3.70% (95% CI, 0.24% to 7.68%) for the practice-level group, 79% to 88% and 5.54% (95% CI, 1.92% to 9.52%) for the combined group, and 86% to 86% and 0.47% (95% CI, -3.12% to 4.04%) for the control group. The adjusted absolute estimated difference in the change between the proportion of patients with blood pressure control/appropriate response for individual incentive and control groups was 8.36% (95% CI, 2.40% to 13.00%; P=.005). The other incentive groups did not show a significant change compared with controls for this outcome. For medications, the unadjusted baseline and final percentages and the adjusted absolute change were 61% to 73% and 9.07% (95% CI, 4.52% to 13.44%), 56% to 65% and 4.98% (95% CI, 0.64% to 10.08%), 65% to 80% and 7.26% (95% CI, 2.92% to 12.48%), and 63% to 72% and 4.35% (95% CI, -0.28% to 9.28%), respectively. These changes in the use of guideline-recommended medications were not significant in any of the incentive groups compared with controls, nor was the incidence of hypotension. The effect of the incentive was not sustained after a washout.Individual financial incentives, but not practice-level or combined incentives, resulted in greater blood pressure control or appropriate response to uncontrolled blood pressure; none of the incentives resulted in greater use of guideline-recommended medications or increased incidence of hypotension compared with controls. Further research is needed on the factors that contributed to these findings.clinicaltrials.gov Identifier: NCT00302718.

Dataset Information

Financial incentives for hypertension control: rationale and study design.

Background

Methods/design

Discussion

Trial registration

Publications

Financial incentives for hypertension control: rationale and study design.

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