Table 1. Summary of Study Characteristics.
Study | Location | Target and main topic | Purpose and population | Design and setting | Sample size | |
---|---|---|---|---|---|---|
No. of patients | No. of clinicians | |||||
Adarkwah et al,72 2016 | Germany | Patients and clinicians; multiple CVD risk factors | To compare the new TTE illustration with the established emoticons looking at the degree of SDM in the consultation process and various secondary outcomes of decisional conflict and accessibility | Cluster RCT: practice, clinic, or office | 304 | 32 |
Applegate et al,73 2021 | US | Patients only; multiple CVD risk factors | To determine whether Project ACTIVE improved utilization of preventive care, estimated life expectancy compared with usual care, or both | RCT: practice, clinic, or office; hospital | 132 | NR |
Bailey et al,71 2016 | US | Patients only; diabetes | To test the effectiveness of the intervention in clinical practice and assess whether an EHR-linked clinical decision support system slowed increases in modifiable cardiovascular risk among adults with serious mental illness | Pragmatic RCT: practice, clinic, or office | 225 | NR |
Bailey et al,70 2018 | US | Patients only; diabetes | To assess the effectiveness of different interventions on knowledge transfer and behavior modification to improve PROMs for T2D | Pragmatic RCT: practice, clinic, or office | 225 | NR |
Boulware et al,68 2020 | US | Patients only; hypertension | To assess whether an intervention to help patients prioritize goals for their visit would improve patient-clinician communication and clinical outcomes | Pragmatic, comparative effectiveness RCT: practice, clinic, or office; home | 159 | NR |
Branda et al,69 2013 | US | Patients and clinicians; diabetes | To evaluate the effect of PDAs vs usual care on decision-making measures, metabolic control, and medication adherence among patients with T2D | Cluster RCT: practice, clinic, or office; other (nonacademic and rural primary care practice) | 103 | 41 |
Buhse et al,66 2015 | Germany | Patients and clinicians; diabetes | To investigate the cardiovascular risk factor profile among young men (aged 18-50 y) with hypertension in family practices and analyze the effectiveness of a computer-based decision aid promoting SDM in modifying cardiovascular risk factors | RCT: practice, clinic, or office | 154 | NR |
Buhse et al,67 2018 | Germany | Patients and clinicians; diabetes | To determine whether communicating personalized statin therapy effects obtained by a prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable CVD compared with standard (nonpersonalized) therapy effects | Cluster RCT: practice, clinic, or office | 279 | NR |
Cheng et al,65 2021 | China | Patients only; diabetes | To compare the new TTE illustration with the established emoticons looking at the degree of SDM in the consultation process and various secondary outcomes such as decisional conflict and accessibility | RCT: practice, clinic, or office; hospital | 242 | NR |
Cooper et al,64 2011 | US | Patients and clinicians; hypertension | To compare the effectiveness of patient and physician interventions (separately and in combination with one another) with the effectiveness of minimal interventions, by evaluating the effect of the intervention on (1) patient and physician communication behaviors, (2) patient ratings of the interpersonal process of care, (3) patient adherence to medications, and (4) BP levels and control over 12 mo | RCT: practice, clinic, or office | 279 | 41 |
Coronado-Vázquez et al,62 2019 | Spain | Patients and clinicians; multiple CVD risk factors and medication | To determine the effectiveness of an SDM intervention for medication appropriateness in patients with chronic diseases and polypharmacy | Randomized, multicenter quasi-experimental study: practice, clinic, or office | 122 | 22 |
Den Ouden et al,63 2017 | Netherlands | Patients and clinicians; multiple CVD risk factors | To evaluate in a cluster-randomized practical trial the effect of PDAs vs usual care on decision-making measures, metabolic control, and medication adherence in nonacademic and rural primary care practices and their patients with T2D | Cluster RCT: practice, clinic, or office | 153 | NR |
Denig et al,61 2014 | Netherlands | Patients only; diabetes | To evaluate an informed SDM program for individuals with T2D under high-fidelity conditions | Pragmatic RCT: practice, clinic, or office | 344 | NR |
Dwinger et al,60 2020 | Germany | Patients only; multiple CVD risk factors | To determine the effectiveness of a PDA for patients with T2D receiving metformin who require treatment intensification | Prospective, pragmatic RCT: community | 10 815 | NR |
Eaton et al,59 2011 | US | Patients and clinicians; multiple CVD risk factors | To determine whether an intervention based on patient activation and a physician decision support tool is more effective than usual care for improving adherence to National Cholesterol Education Program guidelines | Cluster RCT: practice, clinic, or office | 4105 | 55 |
Eckman et al,58 2012 | US | Patients only; multiple CVD risk factors | To evaluate the effectiveness of an empowerment self-management intervention on psychological distress and quality of life among patients with poorly controlled T2D | RCT: ambulatory setting | 170 | NR |
Edwards et al,57 2006 | UK | Patients only; diabetes | To compare the effectiveness of patient and physician interventions (separately and in combination with one another) on (1) patient and physician communication behaviors, (2) patient ratings of the interpersonal process of care, (3) patient adherence to medications, and (4) BP levels and control over 12 mo | RCT: online | 508 | NR |
Farmer et al,56 2005 | UK | Patients only; diabetes | To determine whether real-time telemedicine support can improve glycemic control in T1D | RCT: practice, clinic, or office | 93 | NR |
Grant et al,55 2008 | US | Patients only; diabetes | To examine whether the use of diabetes-specific personal health records improves diabetes care management by increasing patient knowledge and engagement in their own care and by facilitating patient-physician communication | RCT: practice, clinic, or office; hospital; community | 244 | 230 |
Greenfield et al,54 1988 | US | Patients only; diabetes | To examine the effects of an intervention designed to increase the involvement of patients with diabetes in medical decision-making on blood glucose control and quality of life | RCT: practice, clinic, or office | 59 | NR |
Heisler et al,53 2014 | US | Patients only; diabetes | To evaluate the effectiveness of iDecide in improving key diabetes outcomes compared to delivery by CHWs of the same evidence-based information without tailoring using print consumer booklets developed by the AHRQ | RCT: practice, clinic, or office; home; or other agreed-upon place | 188 | NR |
Hsu et al,52 2016 | US | Patients only; diabetes | To test the efficacy of a cloud-based diabetes management program in helping individuals starting basal insulin achieve better glycemic control | RCT: practice, clinic, or office | 40 | NR |
Hu et al,51 2021 | China | Patients only; diabetes and medication | To evaluate a combined fasting blood glucose–based dosage self-titration and decision-supported telephone coaching intervention on glycemic control and diabetes self-management skills | RCT: practice, clinic, or office; via telephone calls | 869 | NR |
Jaspers et al,50 2021 | Netherlands | Patients only; CVD risk | To determine whether communicating personalized statin therapy effects obtained by a prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable CVD | RCT: practice, clinic, or office | 303 | NR |
Jouni et al,49 2017 | US | Patients only; multiple CVD risk factors | To assess the effect of disclosing CHD genetic risk on LDL-C levels | RCT: practice, clinic, or office | 207 | NR |
Karagiannis et al,48 2016 | Greece | Patients only; diabetes | To assess the efficacy of the Diabetes Medication Choice decision aid among patients with T2D in Greece in primary and secondary care practice | Cluster RCT: practice, clinic, or office | 204 | NR |
Kask-Flight et al,47 2021 | Estonia | Patients and clinicians; multiple CVD risk factors | To analyze the effectiveness of a computer-based decision aid promoting SDM in changing cardiovascular risk factors among young men (aged 18-50 y) with hypertension in family practices | Cluster RCT: practice, clinic, or office | 130 | NR |
Keyserling et al,46 2014 | US | Patients only; smoking | To assess the effectiveness, acceptability, and cost-effectiveness of a combined lifestyle and medication intervention to reduce CHD risk offered in counselor-delivered and web-based formats | RCT: practice, clinic, or office | 385 | NR |
Koelewijn-van Loon et al,44 2009 | Netherlands | Patients and clinicians; multiple CVD risk factors | To investigate whether a nurse-led intervention in primary care had a positive effect on lifestyle and 10-y cardiovascular risk | Cluster RCT: practice, clinic, or office | 615 | 24 |
Koelewijn-van Loon et al,45 2010 | Netherlands | Patients and clinicians; multiple CVD risk factors | To determine whether lifestyle and risk perception improved with an intervention to involve patients in cardiovascular risk management by the practice nurse | Cluster RCT: practice, clinic, or office | 615 | 24 |
Krones et al,43 2008 | Germany | Patients and clinicians; CVD risk | To determine the effect of promoting the effective communication of absolute CVD risk and SDM through dissemination of a simple decision aid for use in family practice consultations | Pragmatic, cluster RCT: practice, clinic, or office | 1132 | 91 |
Kulzer et al,17 2018 | Germany | Patients and clinicians; diabetes and medication | To investigate whether taking care of patients with insulin-treated T2D using integrated personalized diabetes management improves glycemic control, PROs, and physician treatment satisfaction and intensifies therapy adjustments | Cluster RCT: practice, clinic, or office | 907 | NR |
Kunneman et al,42 2022 | US | Patients and clinicians; diabetes and medication | To determine the effectiveness of an SDM tool vs guideline-informed usual care in translating evidence into primary care, and to explore how the tool changed patient perspectives about diabetes medication decision-making | Mixed methods cluster RCT: practice, clinic, or office | 350 | 99 |
Lauffenburger et al,41 2019 | US | Patients only; diabetes and medication | To evaluate the effect of a telephone-based patient-centered intervention on glycated HbA1c control for individuals with poorly controlled diabetes | Pragmatic RCT: insurance community | 1400 | NR |
Lee et al,40 2016 | South Korea | Patients only; smoking | To develop a culturally tailored decision aid for smoking cessation and evaluate its effect on the use of smoking cessation medication | Pragmatic cluster RCT: practice, clinic, or office | 414 | NR |
Maindal et al,39 2014 | Denmark | Patients and clinicians; diabetes | To assess whether a 12-wk participant-driven health education program offered to individuals with screening-detected hyperglycemia in Danish primary care would lead to improvements in cardiovascular risk factors, health behavior, and PROs after 3 y | RCT: practice, clinic, or office | 509 | NR |
Mathers et al,38 2012 | UK | Patients and clinicians; diabetes | To determine the effectiveness of a PDA on improving decision quality and glycemic control in individuals with diabetes making treatment decisions | Pragmatic cluster RCT: practice, clinic, or office | 175 | NR |
Moin et al,37 2019 | US | Patients only; diabetes and medication | To test the effectiveness of a prediabetes SDM intervention | Cluster RCT: practice, clinic, or office | 1379 | NR |
Montgomery et al,16 2003 | UK | Patients only; hypertension and medication | To evaluate 2 interventions for assisting patients with newly diagnosed hypertension in the decision whether to start drug therapy for reducing BP | Factorial RCT: practice, clinic, or office; community | 217 | NR |
Mullan et al,36 2009 | US | Patients only; diabetes and medication | To determine the ability of a decision aid to promote patient involvement in choosing antihyperglycemic agents and to evaluate the effects of this strategy on medication adherence and patient outcomes | Cluster RCT: practice, clinic, or office | 85 | 40 |
Naik et al,35 2011 | US | Patients only; diabetes | To evaluate the comparative effectiveness of 2 diabetes group clinic interventions on glycated HbA1c levels in primary care | RCT: practice, clinic, or office | 87 | NR |
O’Malley et al,34 2022 | US | Patients and clinicians; multiple CVD risk factors and medication | To assess whether an intervention to help patients prioritize goals for their visit would improve patient-clinician communication and clinical outcomes | RCT: practice, clinic, or office | 120 | 11 |
Peiris et al,33 2015 | Australia | Patients and clinicians; CVD risk | To test whether a multifaceted quality improvement intervention comprising computerized decision support, audit/feedback tools, and staff training improved (1) guideline-indicated risk factor measurements and (2) guideline-indicated medications for those at high CVD risk | Cluster RCT: practice, clinic, or office | 38 725 | NR |
Perestelo-Pérez et al,32 2016 | Spain | Patients and clinicians; CVD risk and medication | To test whether a multifaceted quality improvement intervention comprising computerized decision support, audit/feedback tools, and staff training improved (1) guideline-indicated risk factor measurements and (2) guideline-indicated medications for those at high CVD risk | Cluster RCT: practice, clinic, or office | 168 | 29 |
Prabhakaran et al,74 2019 | India | Patients and clinicians; multiple CVD risk factors | To evaluate the effectiveness of a nurse-facilitated, mHealth-based EDS for the integrated management of 5 chronic conditions in primary care settings in India as part of the mWellcare trial | Pragmatic RCT: community health centers | 3324 | NR |
Ramallo-Fariña et al,30 2021 | Spain | Patients and clinicians; diabetes | To assess the effectiveness of different interventions of knowledge transfer and behavior modification to improve PROMs in patients with T2D | Open, community-based pragmatic, multicenter, controlled trial with random allocation by cluster: practice, clinic, or office | 2334 | 211 |
Rost et al,31 1991 | US | Patients only; diabetes | To determine whether a short intervention that enhanced patient information seeking and decision-making during hospitalization improved metabolic control and functional status in patients with diabetes | RCT: clinical research center | 61 | NR |
Smith et al,29 2008 | US | Patients and clinicians; diabetes | To assess the effect of a specialist telemedicine intervention for improving diabetes care using the CCM | RCT: primary care clinic | 639 | 97 |
Sperl-Hillen et al,28 2018 | US | Patients and clinicians; cardiovascular risk | To evaluate whether a clinical decision support intervention can improve 10-y CVD risk trajectory in patients in primary care settings | RCT: primary care clinics | 7914 | 102 |
Swoboda et al,27 2017 | US | Patients; diabetes | To evaluate a telephone-based goal setting and decision support coaching intervention among adults with T2D and to evaluate the effect of these approaches for diet and physical activity behavior changes in relation to an attention control group | RCT: community setting | 54 | NR |
Tinsel et al,26 2013 | Germany | Clinicians; hypertension | To implement an evaluated SDM training program for GPs within the context of hypertension treatment, and to examine whether the SDM training enhanced patients’ perceived participation and lowered BP | Cluster RCT: general practices | 1120 | NR |
Tinsel et al,25 2018 | Germany | Patients; CVD risk | To investigate the applicability of the DECADE intervention and the potential effects of the intervention on patients with cardiovascular risk factors | RCT: primary care | 78 | NR |
Tusa et al,24 2021 | Finland | Patients; CVD risk | To examine the influence of a participatory patient care plan on health-related quality of life and disease-specific outcomes related to diabetes, ischemic heart disease, and hypertension | RCT: primary care | 605 | NR |
Tutino et al,22 2017 | China | Patients; diabetes | To test whether the delivery of integrated care augmented by a web-based disease management program and nurse coordinator could improve treatment target attainment and health-related behavior | RCT: hospital | 3586 | NR |
van Steenkiste et al,23 2007 | Netherlands | Clinicians and patients; multiple CVD risk factors | To test whether a decision support tool can improve primary prevention of CVD in primary care | Cluster RCT: hospital | 490 | 34 |
Warner et al,21 2015 | US | Clinicians and patients; smoking | To develop and pilot test a decision aid to increase patient involvement in decisions regarding smoking behavior of cigarette smokers scheduled for elective surgery | RCT: academic medical center | 130 | NR |
Weymiller et al,20 2007 | US | Clinicians and patients; diabetes | To examine a decision aid tool’s acceptability to patients and its effect on patient knowledge of the information about the potential merits and demerits of the options and decisional conflict | Cluster RCT: metabolic clinic | 98 | 21 |
Wollny et al,19 2019 | Germany | Clinicians and patients; diabetes | To investigate whether an educational intervention facilitated by GPs increased patient-centeredness and perceived SDM in the treatment of patients with poorly controlled T2D | Cluster RCT: primary care | 833 | 108 |
Yu et al,18 2020 | Canada | Clinicians and patients; diabetes | To assess the effect of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level | Cluster RCT: primary care | 213 | 53 |
Abbreviations: AHRQ, Agency for Healthcare Research and Quality; BP, blood pressure; CCM, chronic care model; CHD, coronary heart disease; CHW, community health worker; CVD, cardiovascular disease; DECADE, decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases; EDS, electronic decision support; EHR, electronic health record; GP, general practitioner; HbA1c, hemoglobin A1c; LDL-C, low-density lipoprotein cholesterol; NR, not reported; PDA, patient decision aid; PRO, patient-reported outcome; PROM, patient-reported outcome measure; RCT, randomized clinical trial; SDM, shared decision-making; T1D, type 1 diabetes; T2D, type 2 diabetes; TTE, time-to-event.