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A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial.

ABSTRACT: Primary care providers do not routinely follow guidelines for the care of patients with chronic kidney disease (CKD). Multidisciplinary efforts may improve care for patients with chronic disease. Pharmacist based interventions have effectively improved management of hypertension. We performed a pragmatic, randomized, controlled trial to evaluate the effect of a pharmacist based quality improvement program on 1) outcomes for patients with CKD and 2) adherence to CKD guidelines in the primary care setting.Patients with moderate to severe CKD receiving primary care services at one of thirteen community-based Veterans Affairs outpatient clinics were randomized to a multifactorial intervention that included a phone-based pharmacist intervention, pharmacist-physician collaboration, patient education, and a CKD registry (n?=?1070) or usual care (n?=?1129). The primary process outcome was measurement of parathyroid hormone (PTH) during the one year study period. The primary clinical outcome was blood pressure (BP) control in subjects with poorly controlled hypertension at baseline.Among those with poorly controlled baseline BP, there was no difference in the last recorded BP or the percent at goal BP during the study period (42.0% vs. 41.2% in the control arm). Subjects in the intervention arm were more likely to have a PTH measured during the study period (46.9% vs. 16.1% in the control arm, P <0.001) and were on more classes of antihypertensive medications at the end of the study (P?=?0.02).A one-time pharmacist based intervention proved feasible in patients with CKD. While the intervention did not improve BP control, it did improve guideline adherence and increased the number of antihypertensive medications prescribed to subjects with poorly controlled BP. These findings can inform the design of quality improvement programs and future studies which are needed to improve care of patients with CKD.ClinicalTrials.gov: NCT01290614.

SUBMITTER: Cooney D

PROVIDER: S-EPMC4405859 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial.

Cooney Danielle D Moon Helen H Liu Yang Y Miller Richard Tyler RT Perzynski Adam A Watts Brook B Drawz Paul E PE

BMC nephrology 20150416

<h4>Background</h4>Primary care providers do not routinely follow guidelines for the care of patients with chronic kidney disease (CKD). Multidisciplinary efforts may improve care for patients with chronic disease. Pharmacist based interventions have effectively improved management of hypertension. We performed a pragmatic, randomized, controlled trial to evaluate the effect of a pharmacist based quality improvement program on 1) outcomes for patients with CKD and 2) adherence to CKD guidelines ...[more]

PMID: 25881226

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Project description:BackgroundLay health workers (LHWs) play a pivotal role in addressing the high TB burden in Malawi. LHWs report lack of training to be a key barrier to their role as TB care providers. Given the cost of traditional off-site training, an alternative approach is needed. Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs.MethodsThe study design is a pragmatic cluster randomized trial. The study was embedded within a larger trial, PALMPLUS, and compared three arms which included 28 health centers in Zomba district, Malawi. The control arm included 14 health centers randomized as controls in the larger trial and maintained as control sites. Seven of 14 PALMPLUS intervention sites were randomized to the LHW intervention (PALM/LHW intervention arm), and the remaining 7 PALMPLUS sites maintained as a PALM only arm. PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers. LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs. Control sites received no intervention. The main outcome measure is the proportion of treatment successes.ResultsAmong the 28 sites, there were 178 incident TB cases with 46/80 (0.58) successes in the control group, 44/68 (0.65) successes in the PALMPLUS group, and 21/30 (0.70) successes in the PALM/LHW intervention group. There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster randomization (p = 0.578) or multivariate analysis controlling for covariates with significant model effects (p = 0.760). The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance (p = 0.056), with the interaction significant only in the control arm [RR of treatment success for pulmonary TB relative to non-pulmonary TB, 1.18, 95% CI 1.05-1.31].ConclusionsWe found no significant treatment effect of our intervention. Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training, further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted.Trial registrationClinicalTrials.gov NCT01356095 .

Project description:OBJECTIVE: Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics. STUDY DESIGN: A 12-month prospective, single-blind, randomized, controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure. METHODS: As compared to usual primary care, intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocols. At baseline, there was no significant difference in blood pressure between groups. Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end. Secondary measures included blood pressure goal attainment (<140/90 mmHg), hypertension-related knowledge, medication adherence, home blood pressure monitoring, resource utilization, quality of life, and satisfaction. RESULTS: A total of 463 subjects were enrolled (n = 233 control, n = 230 intervention). Subjects receiving the intervention achieved significantly lower systolic (p = 0.007) and diastolic (p = 0.002) blood pressures compared to control (137/75 mmHg vs. 143/78 mmHg). In addition, 62% of intervention subjects achieved target blood pressure compared to 44% of control subjects (p = 0.003). The intervention group received more total office visits (7.2 vs. 4.9, p < 0.0001), however had fewer physician visits (3.2 vs. 4.7, p < 0.0001) compared to control. Intervention subjects were prescribed more antihypertensive medications (2.7 vs. 2.4, p = 0.02), but did not take more antihypertensive pills per day (2.4 vs. 2.5, p = 0.87). There were minimal differences between groups in hypertension-related knowledge, medication adherence, quality of life, or satisfaction. CONCLUSIONS: Patients randomized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction.

Project description:Background and objectivesWe conducted a pilot, pragmatic, cluster-randomized trial to evaluate feasibility and preliminary effectiveness of screening for CKD using a triple-marker approach (creatinine, cystatin C, and albumin/creatinine ratio), followed by education and guidance, to improve care of hypertensive veterans in primary care. We used the electronic health record for identification, enrollment, intervention delivery, and outcome ascertainment.Design, setting, participants, & measurementsWe randomized 1819 veterans without diabetes but with hypertension (41 clusters) into three arms: (1) CKD screening followed by patient and provider education; (2) screening, education, plus pharmacist comanagement; or (3) usual care. The primary clinical outcome was BP change over 1 year. Implementation and process measures included proportion screened; CKD detection rate; and total and new use of renin-angiotensin system inhibitors, nonsteroidal anti-inflammatory drugs, and diuretics.ResultsMedian age was 68 years, 55% were white, 1658 (91%) had a prior creatinine measure, but only 172 (9%) had prior urine albumin/creatinine ratio, and 83 (5%) had a prior cystatin C measure. Among those in the intervention, 527 of 1215 (43%) were identified with upcoming appointments to have CKD screening. Of these, 367 (69%) completed testing. Among those tested, 77 (21%) persons had newly diagnosed CKD. After 1 year, change in systolic BP was -1 mm Hg (interquartile range, -11 to 11) in usual care, -2 mm Hg (-11 to 11) in the screen-educate arm, and -2 mm Hg (-13 to 10) in the screen-educate plus pharmacist arm; P=0.49. There were no significant differences in secondary outcomes in intention-to-treat analyses. In as-treated analyses, higher proportions of participants in the intervention arms initiated a renin-angiotensin system inhibitor (15% and 12% versus 7% in usual care, P=0.01) or diuretic (9% and 12% versus 4%, P=0.03).ConclusionsThe pragmatic design made identification, enrollment, and intervention delivery highly efficient. The limited ability to identify appointments resulted in inadequate between-arm differences in CKD testing rates to determine whether screening improves clinical outcomes.

Project description:Background/objectiveGuatemala's indigenous Maya population has one of the highest perinatal and maternal mortality rates in Latin America. In this population most births are delivered at home by traditional birth attendants (TBAs), who have limited support and linkages to public hospitals. The goal of this study was to characterize the detection of maternal and perinatal complications and rates of facility-level referral by TBAs, and to evaluate the impact of a mHealth decision support system on these rates.MethodsA pragmatic one-year feasibility trial of an mHealth decisions support system was conducted in rural Maya communities in collaboration with TBAs. TBAs were individually randomized in an unblinded fashion to either early-access or later-access to the mHealth system. TBAs in the early-access arm used the mHealth system throughout the study. TBAs in the later-access arm provided usual care until crossing over uni-directionally to the mHealth system at the study midpoint. The primary study outcome was the monthly rate of referral to facility-level care, adjusted for birth volume.ResultsForty-four TBAs were randomized, 23 to the early-access arm and 21 to the later-access arm. Outcomes were analyzed for 799 pregnancies (early-access 425, later-access 374). Monthly referral rates to facility-level care were significantly higher among the early-access arm (median 33 referrals per 100 births, IQR 22-58) compared to the later-access arm (median 20 per 100, IQR 0-30) (p = 0.03). At the study midpoint, the later-access arm began using the mHealth platform and its referral rates increased (median 34 referrals per 100 births, IQR 5-50) with no significant difference from the early-access arm (p = 0.58). Rates of complications were similar in both arms, except for hypertensive disorders of pregnancy, which were significantly higher among TBAs in the early-access arm (RR 3.3, 95% CI 1.10-9.86).ConclusionsReferral rates were higher when TBAs had access to the mHealth platform. The introduction of mHealth supportive technologies for TBAs is feasible and can improve detection of complications and timely referral to facility-care within challenging healthcare delivery contexts.Trial registrationClinicaltrials.gov NCT02348840 .

Project description:BackgroundDuring the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit.ObjectivesThe primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention.MethodsWe used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception.ResultsThe median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06).ConclusionsWe have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system.Trial registrationClinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk).

Project description:Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.

Project description:Rationale & objectiveMost adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care.Study designPragmatic cluster-randomized trial.Setting & participants524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m2 cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment.InterventionsEach PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS).OutcomesThe primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy.ResultsAll 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m2. Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002).LimitationsRecruitment of smaller than intended sample size and limited uptake of the testing component of the intervention.ConclusionsAlthough we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD.FundingGrants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities.Trial registrationRegistered at ClinicalTrials.gov with study number NCT02925962.

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A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial.

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A pharmacist based intervention to improve the care of patients with CKD: a pragmatic, randomized, controlled trial.

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