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Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

ABSTRACT: Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear.We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy.Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power.DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices.NCT01029288.

SUBMITTER: Branda ME

PROVIDER: S-EPMC3751736 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

Branda Megan E ME LeBlanc Annie A Shah Nilay D ND Tiedje Kristina K Ruud Kari K Van Houten Holly H Pencille Laurie L Kurland Marge M Yawn Barbara B Montori Victor M VM

BMC health services research 20130808

<h4>Background</h4>Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear.<h4>Methods</h4>We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 201 ...[more]

PMID: 23927490

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Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated?haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:IMPORTANCE:For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE:Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS:We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION:Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES:Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS:We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P =?.03), satisfaction (risk ratio [RR], from 1.25 [P =?.81] to RR, 2.4 [P =?.002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P <?.001) and satisfaction (RR, 1.64; P =?.02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE:The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01502891.

Project description:BackgroundMyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams.ObjectiveAssess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics.MethodsWe conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups.ResultsOne thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors.ConclusionAn interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

Project description:BackgroundProstate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it.PurposeThe purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer.MethodsTwo hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers.DiscussionShared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general.Innovation and overall impactGiven the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term.

Project description:BackgroundInnovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion.MethodsIn this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later.ResultsFrom August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance.ConclusionThe CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

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Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

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Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

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