Efficacy of Patient Activation Interventions With or Without Financial Incentives to Promote Prescribing of Thiazides and Hypertension Control: A Randomized Clinical Trial.
ABSTRACT: Importance:Evidence-based guidelines recommend thiazide diuretics as a first-line therapy for uncomplicated hypertension; however, thiazides are underused, and hypertension remains inadequately managed. Objective:To test the efficacy of a patient activation intervention with financial incentives to promote thiazide prescribing. Design, Setting, and Participants:The 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. Interventions:Patients 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 Measures:Primary outcomes were thiazide prescribing and BP control. A secondary process measure was discussion between patient and primary care clinician about thiazides. Results:Among 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?
Project description:The SPRINT (Systolic Blood Pressure Intervention Trial) study reported that intensive blood pressure (BP) treatment with a systolic BP target of <120 mm Hg decreased the risks of cardiovascular events. However, it remains unknown whether specific medications can further improve cardiovascular outcome in patients receiving intensive BP treatment. This study examined whether thiazide use improves cardiovascular outcome in patients receiving intensive BP treatment. We used data of nondiabetic patients receiving intensive BP treatment in the SPRINT study. The primary outcome was a composite end point of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death. We analyzed hazard ratios for outcomes with 95% CIs in patients taking thiazides compared with those not taking thiazides using Cox proportional hazard models. This study included 2847 patients and the mean follow-up period was 3.3 years. The risk of primary outcome events was significantly lower in patients taking thiazides than in those not taking thiazides in both entire and propensity score-matched cohorts. Particularly, heart failure risk was significantly lower in those taking thiazides. These associations were also observed in various subgroups. In addition, thiazide use was associated with decreased risk of all-cause mortality. Hypokalemia occurred more frequently in patients taking thiazides than in those not taking thiazides. Thiazide use decreased risk of cardiovascular events, particularly heart failure, in nondiabetic high-risk patients receiving intensive BP treatment.
Project description:This qualitative evaluation follows a randomized-control trial of a patient activation intervention in which hypertensive patients received a letter in the mail asking them to discuss thiazide diuretics with their provider. Results of the parent study indicated that the intervention was effective at facilitating discussions between patients and providers and enhancing thiazide prescribing rates. In the research presented here, our objective was to interview patients to determine their receptivity to patient activation, a potential leverage point for implementing interventions.Semi-structured phone interviews were conducted with 54 patients, purposefully sampled from a randomized controlled trial of a patient activation intervention. All subjects had a history of hypertension and received primary care from one of twelve Veterans Affairs primary care clinics. All interviews were transcribed verbatim and reviewed by the interviewer. Interviews were independently coded by three qualitative researchers until consensus was attained, and relevant themes and responses were identified, grouped, and compared. NVivo 8.0 was used for data management and analysis.Data from this qualitative study revealed that most participants held favorable opinions toward the patient activation intervention used in the clinical trial. Most (82%) stated they had a positive reaction. Patients emphasized they liked the intervention because it was straightforward and encouraged them to initiate discussions with their provider. Also, by being active participants in their healthcare, patients felt more invested. Of the few patients offering negative feedback (11%), their main concern was discomfort with possibly challenging their providers' healthcare practices. Another outcome of interest was the patients' perceptions of why they were or were not prescribed a thiazide diuretic, for which several clinically relevant reasons were provided.Patients' perceptions of the intervention indicated it was effective via the encouragement of dialogue between themselves and their provider regarding evidence-based treatment options for hypertension. Additionally, patients' experiences with thiazide prescribing discussions shed light on the facilitators and barriers to implementing clinical practice guidelines regarding thiazides as first-line therapy for hypertension.National Clinical Trial Registry number NCT00265538.
Project description:BACKGROUND: All clinical practice guidelines recommend thiazides as a first-choice drug for the management of uncomplicated hypertension. Thiazides are also the lowest priced antihypertensive drugs. Despite this, the use of thiazides is much lower than that of other drug-classes. We wanted to estimate the potential for savings if thiazides were used as the first choice drug for the management of uncomplicated hypertension. METHODS: For six countries (Canada, France, Germany, Norway, the UK and the US) we estimated the number of people that are being treated for hypertension, and the proportion of them that are suitable candidates for thiazide-therapy. By comparing this estimate with thiazide prescribing, we calculated the number of people that could switch from more expensive medication to thiazides. This enabled us to estimate the potential drug-cost savings. The analysis was based on findings from epidemiological studies and drug trials, and data on sales and prescribing provided by IMS for the year 2000. RESULTS: For Canada, France, Germany, Norway, the UK and the US the estimated potential annual savings were US13.8 million dollars, US37.4 million dollars, US72.2 million dollars, US10.7 million dollars, US119.7 million dollars and US433.6 million dollars, respectively.
Project description:Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes. This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system.The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group).The setting involves all Ontario general/family practice physicians. Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an "insert" (two-page evidence-based article) and/or one of two different versions of an "outsert" (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides). The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices.Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54.The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension.ISRCTN72772651.
Project description:BACKGROUND: The purpose of our study was to evaluate the effects of a new reimbursement rule for antihypertensive medication that made thiazides mandatory first-line drugs for newly treated, uncomplicated hypertension. The objective of the new regulation was to reduce drug expenditures. METHODS AND FINDINGS: We conducted an interrupted time-series analysis on prescribing data before and after the new reimbursement rule for antihypertensive medication was put into effect. All patients started on antihypertensive medication in 61 general practices in Norway were included in the analysis. The new rule was put forward by the Ministry of Health and was approved by parliament. Adherence to the rule was monitored only minimally, and there were no penalties for non-adherence. Our primary outcome was the proportion of thiazide prescriptions among all prescriptions made for persons started on antihypertensive medication. Secondary outcomes included the proportion of patients who, within 4 mo, reached recommended blood-pressure goals and the proportion of patients who, within 4 mo, were not started on a second antihypertensive drug. We also compared drug costs before and after the intervention. During the baseline period, 10% of patients started on antihypertensive medication were given a thiazide prescription. This proportion rose steadily during the transition period, after which it remained stable at 25%. For other outcomes, no statistically significant differences were demonstrated. Achievement of treatment goals was slightly higher (56.6% versus 58.4%) after the new rule was introduced, and the prescribing of a second drug was slightly lower (24.0% versus 21.8%). Drug costs were reduced by an estimated Norwegian kroner 4.8 million (0.58 million Euros, US$0.72 million) in the first year, which is equivalent to Norwegian kroner 1.06 per inhabitant (0.13 Euros, US$0.16). CONCLUSIONS: Prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a reimbursement rule requiring the use of thiazides as the first-choice therapy was put into effect. However, the resulting savings on drug expenditures were modest. There were no significant changes in the achievement of treatment goals or in the prescribing of a second antihypertensive drug.
Project description:Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians' guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT.We developed and sent TPB postal questionnaires to a random sub-sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs. We used analysis of covariance to test for group differences using a 2 × 3 factorial design. We content-analysed an open-ended question about perceived barriers to thiazide prescription. Using control group data, we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up.Four hundred twenty-six physicians completed pre- and post-intervention questionnaires. Baseline scores on measures of TPB constructs were high: intention mean = 5.9 out of 7 (SD = 1.4), attitude mean = 5.8 (SD = 1.1), subjective norm mean = 5.8 (SD = 1.1) and PBC mean = 6.2 (SD = 1.0). The arms did not significantly differ post-intervention on any of the theory-based constructs, suggesting a possible ceiling effect. Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient clinical characteristics and potential side effects. Baseline intention (β = 0.63, p < 0.01) but not PBC (β = 0.04, p = 0.78) predicted 42.6 % of the variance in self-reported behaviour at follow-up in the control group.Congruent with the Ontario Printed Educational Messages trial results and aligned with the TPB, we saw no impact of the intervention on any TPB constructs. The theoretical basis of this evaluation suggests possible explanations for the failure of the PEM intervention to change professional behaviour, which can directly inform the design and content of future theory-based PEM interventions to change professional behaviour.ISRCTN, Canada ISRCTN72772651.
Project description:To analyze patient perspectives of the use of financial incentives in a hypertension intervention. Study Setting. Twelve Veterans Affairs primary care clinics over a 9-month period.Qualitative semistructured interviews conducted with 54 hypertensive veterans participating in an intervention to promote guideline-consistent therapy. Intervention components included an intervention letter requesting patients talk with their providers, an offer of U.S.$20 to bring in the letter to their provider, and a health educator phone call.Semistructured interviews were conducted. Transcripts were coded for thematic content. The financial incentive theme was then subcoded for more detailed analysis.Most participants (n=48; 88.9 percent) stated the incentive had (or would have) no effect on their decision to initiate a discussion with their provider. Some participants articulated reservations about the effectiveness and/or appropriateness of financial incentives in health care decisions; however, a few expressed the opinion that there may be some potential benefits to the use of financial incentives if they encourage patients to be active in their health care.The findings of this study raise questions about the appropriateness and unintended consequences of employing patient-directed financial incentives in health care settings.
Project description:BACKGROUND:Hypertension guidelines recommend the use of thiazide diuretics as first-line therapy for uncomplicated hypertension, yet diuretics are under-prescribed, and hypertension is frequently inadequately treated. This qualitative evaluation of provider attitudes follows a randomized controlled trial of a patient activation strategy in which hypertensive patients received letters and incentives to discuss thiazides with their provider. The strategy prompted high discussion rates and enhanced thiazide-prescribing rates. Our objective was to interview providers to understand the effectiveness and acceptability of the intervention from their perspective, as well as the suitability of patient activation for more widespread guideline implementation. METHODS:Semi-structured phone interviews were conducted with 21 primary care providers. Interviews were transcribed verbatim and reviewed by the interviewer before being analyzed for content. Interviews were coded, and relevant themes and specific responses were identified, grouped, and compared. RESULTS:Of the 21 providers interviewed, 20 (95%) had a positive opinion of the intervention, and 18 of 20 (90%) thought the strategy was suitable for wider use. In explaining their opinions of the intervention, many providers discussed a positive effect on treatment, but they more often focused on the process of patient activation itself, describing how the intervention facilitated discussions by informing patients and making them more pro-active. Regarding effectiveness, providers suggested the intervention worked like a reminder, highlighted oversights, or changed their approach to hypertension management. Many providers also explained that the intervention 'aligned' patients' objectives with theirs, or made patients more likely to accept a change in medications. Negative aspects were mentioned infrequently, but concerns about the use of financial incentives were most common. Relevant barriers to initiating thiazide treatment included a hesitancy to switch medications if the patient was at or near goal blood pressure on a different anti-hypertensive. CONCLUSIONS:Patient activation was acceptable to providers as a guideline implementation strategy, with considerable value placed on the activation process itself. By 'aligning' patients' objectives with those of their providers, this process also facilitated part of the effectiveness of the intervention. Patient activation shows promise for wider use as an implementation strategy, and should be tested in other areas of evidence-based medicine. TRIAL REGISTRATION:National Clinical Trial Registry number NCT00265538.
Project description:Thiazide and thiazide-like diuretics are widely used in the management of hypertension, but recently the equivalence of hydrochlorothiazide and chlorthalidone for blood pressure (BP) lowering and prevention of cardiovascular disease has been questioned. We performed a meta-analysis to characterize the dose-response relationships for 3 commonly prescribed thiazide diuretics, hydrochlorothiazide, chlorthalidone, and bendroflumethiazide, on BP, serum potassium, and urate. Randomized, double-blind, parallel placebo-controlled trials meeting the following criteria, ? 2 different monotherapy dose arms, follow-up duration ? 4 weeks, and baseline washout of medication ? 2 weeks, were identified using Embase (1980-2010 week 50), Medline (1950-2010 November week 3), metaRegister of Controlled Trials, and Cochrane Central. A total of 26 trials examined hydrochlorothiazide, 3 examined chlorthalidone, and 1 examined bendroflumethiazide. Studies included a total of 4683 subjects in >53 comparison arms. Meta-regression of the effect of thiazides on systolic BP showed a log-linear relationship with a potency series: bendroflumethiazide>chlorthalidone>hydrochlorothiazide. The estimated dose of each drug predicted to reduce systolic BP by 10 mm Hg was 1.4, 8.6, and 26.4 mg, respectively, and there was no evidence of a difference in maximum reduction of systolic BP by high doses of different thiazides. Potency series for diastolic BP, serum potassium, and urate were similar to those seen for systolic BP. Hydrochlorothiazide, chlorthalidone, and bendroflumethiazide have markedly different potency. This may account for differences in the antihypertensive effect between hydrochlorothiazide and chlorthalidone using standard dose ranges.
Project description:Population-level strategies to improve healthy food choices are needed for obesity prevention. We conducted a randomized controlled trial of 2672 employees at the Massachusetts General Hospital who were regular customers of the hospital cafeteria with all items labeled green (healthy), yellow (less healthy), or red (unhealthy) to determine if social norm (peer-comparison) feedback with or without financial incentives increased employees' healthy food choices.Participants were randomized in 2012 to three arms: 1) monthly letter with social norm feedback about healthy food purchases, comparing employee to "all" and to "healthiest" customers (feedback-only); 2) monthly letter with social norm feedback plus small financial incentive for increasing green purchases (feedback-incentive); or 3) no contact (control). The main outcome was change in proportion of green-labeled purchases at the end of 3-month intervention. Post-hoc analyses examined linear trends.At baseline, the proportion of green-labeled purchases (50%) did not differ between arms. At the end of the 3-month intervention, the percentage increase in green-labeled purchases was larger in the feedback-incentive arm compared to control (2.2% vs. 0.1%, P=0.03), but the two intervention arms were not different. The rate of increase in green-labeled purchases was higher in both feedback-only (P=0.04) and feedback-incentive arms (P=0.004) compared to control. At the end of a 3-month wash-out, there were no differences between control and intervention arms.Social norms plus small financial incentives increased employees' healthy food choices over the short-term. Future research will be needed to assess the impact of this relatively low-cost intervention on employees' food choices and weight over the long-term.Clinical Trials.gov: NCT01604499.