key: cord-1037144-xbf2tkn3 authors: Taksler, Glen B.; Hu, Bo; DeGrandis, Frederic; Montori, Victor M.; Fagerlin, Angela; Nagykaldi, Zsolt; Rothberg, Michael B. title: Effect of Individualized Preventive Care Recommendations vs Usual Care on Patient Interest and Use of Recommendations: A Pilot Randomized Clinical Trial date: 2021-11-02 journal: JAMA Netw Open DOI: 10.1001/jamanetworkopen.2021.31455 sha: 5f13220738ca836b78d95df6e9684545798564c1 doc_id: 1037144 cord_uid: xbf2tkn3 IMPORTANCE: This randomized clinical trial examines the feasibility and acceptability of a decision-making tool for increasing patient interest in individualized recommendations for preventive care services. OBJECTIVE: To pilot a tool to help patients compare life expectancy gains from evidence-based preventive services. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial examined patient and physician responses to a pilot decision tool incorporating personalized risk factors at 3 US primary care clinics between 2017 and 2020. Eligible patients were between ages 45 to 70 years with 2 or more high-risk factors. Patients were followed-up after 1 year. INTERVENTIONS: The gain in life expectancy associated with guideline adherence to each recommended preventive service was estimated. Personalized estimates incorporating risk factors in electronic health records were displayed in a physician-distributed visual aid. During development, physicians discussed individualized results with patients using shared decision-making (SDM). During the trial, patients were randomized to receive individualized recommendations or usual care (nonmasked, parallel, 1:1 ratio). MAIN OUTCOMES AND MEASURES: Primary outcome was patient interest in individualized recommendations, assessed by survey. Secondary outcomes were use of SDM, decisional comfort, readiness to change, and preventive services received within 1 year. RESULTS: The study enrolled 104 patients (31 development, 39 intervention, 34 control), of whom 101 were included in analysis (mean [SD] age, 56.5 [5.3] years; 73 [72.3%] women; 80 [79.2%] Black patients) and 20 physicians. Intervention patients found the tool helpful and wanted to use it again, rating it a median 9 of 10 (IQR, 8-10) and 10 of 10 (8-10), respectively. Compared with the control group, intervention patients more often correctly identified the service least likely (18 [46%] vs 0; P = .03) to improve their life expectancy. A greater number of patients also identified the service most likely to improve their life expectancy (26 [69%] vs 10 [30%]; P = .07), although this result was not statistically significant. Intervention patients reported greater mean [SD] improvement in SDM (4.7 [6.9] points) and near-term readiness to change (13.8 points for top-3-ranked recommendations). Point estimates indicated that patients in the intervention group experienced greater, although non–statistically significant, reductions in percentage of body weight (−2.96%; 95% CI, −8.18% to 2.28%), systolic blood pressure (−6.42 mm Hg; 95% CI, −16.12 to 3.27 mm Hg), hemoglobin A(1c) (−0.68%; 95% CI, −1.82% to 0.45%), 10-year atherosclerotic cardiovascular disease risk score (−1.20%; 95% CI, −3.65% to 1.26%), and low-density lipoprotein cholesterol (−8.46 mg/dL; 95% CI, −26.63 to 9.70 mg/dL) than the control group. Nineteen of 20 physicians wanted to continue using the decision tool in the future. CONCLUSIONS AND RELEVANCE: In this clinical trial, an individualized preventive care decision support tool improved patient understanding of primary prevention and demonstrated promise for improved shared decision-making and preventive care utilization. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03023813 Quitting smoking would lower your risk of a heart attack, heart disease, stroke, and various cancers. You may also cough less and have fewer sore throats. It is hard to quit smoking. Most people try to quit smoking 7 times before they succeed. Edwards and distribute a printed copy of the tailored decision aid to each patient's physician. Additional 254 copies will be provided on the day of appointment. Providers will be asked to show each patient 255 his/her individualized recommendations and engage in shared decision making about preventive 256 care goals. At the end of the visit, a medical assistant or study staff will hand the patient a 257 printed copy of the decision aid to take home, along with an after-visit summary that s/he already 258 provides 259 Eligibility questionnaire: In addition to our above inclusion/exclusion criteria, in order to be 260 eligible, the participant must: -Complete an eligibility questionnaire (see attachment) -Select "Yes" for at least 2 items on the question, "In your opinion, which of the following 263 things are important for YOUR health?" -NOT select 7 (on a 7-point scale) for ALL items in the question, "In your opinion, which of the 265 following things are you likely to do in the next 1 month?" or the following 2 questions. The eligibility questionnaire is needed to ensure that enrolled patients are aware that they have Feedback: We will seek feedback from intervention patients and participating physicians. promote longevity than before receipt of the intervention. We also hypothesize that patients who 290 receive the intervention will report use of shared decision making. We also will interview 291 physicians ( Figure 6 ). week pilot, leaving adequate sample size even if the decision aid is not always utilized. Assuming that controls do not systematically differ from intervention patients (the only 296 difference is the week of an appointment), we expect to minimize potential bias. In total, we shadowing, but use of the decision aid meets criteria for waiver of informed consent. The 302 intervention is minimal risk because physicians can ignore individualized recommendations, and 303 physicians retain discretion in ordering. Rapid Improvement: Following each burst, the study team will review feedback and identify 305 next steps. We will spend approx. 1-4 weeks improving use of the decision aid, the quality of 306 shared decision making (from both patient and provider perspectives), 102 and workflow before 307 implementing the next round. Testing will stop after approx. 4 rounds or when feedback 308 suggests that the process cannot be further improved in an exploratory study. The finished 309 product will represent a tailored decision aid ready for wide-scale testing. Videotaping: At some appointments (particularly early in the study), patients will be asked to 311 allow a member of the research team to shadow (observe) or videotape their appointment with 312 their physician. This will allow the researchers to better understand how the decision aid is 313 being discussed during appointments, and variation across patients/physicians. The informed 314 consent document will allow patients to indicate whether they consent to shadowing, 315 videotaping, both, or neither, and patients will be told that they do not have to allow study staff 316 to observe or videotape their appointments. his/her physician. Study staff will approach eligible patients in the waiting room to obtain 324 consent. Survey mechanics: The surveys, and eligibility questionnaire, will be administered in RedCAP. Patients will be asked for their email address upon expressing interest in the survey, and will be receive the intervention will report use of shared decision making. We also will interview 413 physicians ( Figure 6 ). sheet will be used for physicians, and an additional information sheet will also be provided to 422 patients stating that their doctor is participating in a research study. For patients who are 423 interested in providing feedback, the information sheet will also describe the survey. The 424 intervention is minimal risk because physicians can ignore individualized recommendations, and 425 physicians retain discretion in ordering. Rapid Improvement: Following each burst, the study team will review feedback and identify 427 next steps. We will spend approx. 1-4 weeks improving use of the decision aid, the quality of suggests that the process cannot be further improved in an exploratory study. The finished 431 product will represent a tailored decision aid ready for wide-scale testing. to participate in training. We also will discuss ways to probe patient values in the exam room 480 (e.g., "Are you willing to change your lifestyle to prevent a serious health problem in the future? What kinds of things would you consider? How do you feel about blood tests and X-rays that 482 may be less impactful on your health, but are easier to do?"). Best practices for decision aids require a values clarification (e.g., helping patients to think about 484 which aspects matter most to them) and explanation that a patient is free to choose nontreatment. (obtained by data feed from our EMR group; our institution routinely uses this process.) Study 502 staff will contact eligible patients by mail, telephone or in waiting rooms (see attachment). Study staff then will review the chart, manually enter model inputs, and distribute a printed copy 504 of the tailored decision aid to each patient's providers. Additional copies will be provided on the 505 day of appointment. Providers will be the research subjects. Providers will be asked to show 506 each patient his/her individualized recommendations and engage in shared decision making 507 about preventive care goals. At the end of the visit, a medical assistant or study staff will hand 508 the patient a printed copy of the decision aid to take home, along with an after-visit summary that 509 s/he already provides Feedback: We will seek feedback from participating providers. Feedback 510 may be in whatever form is most convenient for each provider (oral, written, email, etc.). Additionally, we will inform patients that their doctor is participating in a research study, and ask 512 patients if they would be interested in providing feedback in the form of a 10-15 minute survey. The patient will not be required to complete the survey. If the patient chooses to complete the 514 survey, then s/he will receive $25. We do not require any pre-specified number of patients to 515 agree. We chose this method as a variant of prior work that has cluster randomized clinical 516 practices to early vs. delayed intervention (where controls were patients in the delayed group 517 before implementation), 1,28 recognizing the non-randomized, exploratory nature of our study. For providers, our goal from feedback will be to create a tool that is easily understood, that 519 providers are interested in using, and that providers believe improves the patient visit and 3. Shortly before each appointment at which the decision aid may be discussed, the visit 537 will be randomized to "intervention" or "control." During intervention appointments, 538 the individualized recommendations will be made available to providers as per Aim 539 1. During control appointments, the research team may still generate individualized 540 recommendations but will not make them available to providers. Regardless of 541 whether the appointment was intervention or control, the patient will still be informed 542 that their doctor is participating in a research study, and we will ask patients if they 543 would be interested in providing feedback in the form of a 10-15 minute survey, as 544 per Aim 1. As with Aim 1, the patient will not be required to complete the survey. 4. Patients who choose to complete the survey will be notified that after their 547 appointment, we may review their medical record to see which health care services 548 they receive during the next 1 year. Providers will be similarly notified that we may 6. Employees who participated in Phase I pilot testing will be eligible for participation 566 in Phase II and will provide an updated information sheet if they are asked to 567 participate. We attach a script for this discussion. Patients who participated in Phase 568 I pilot testing will not be eligible for participation in Phase II. Information sheets, a patient information letter and scripts for Phase II pilot testing are attached. they intend to do in the next 1 month or 6 months). We also hypothesize that patients who 582 receive the intervention will report use of shared decision making. We also will interview 583 providers ( Figure 6 ). Sample Size: On average, a 1.0 FTE provider sees 8 eligible patients/week; our median FTE is 585 0.5 (range: 0.2-1.0). As pilot testing, we do not require a pre-specified number of surveys to be 586 completed. (We assume a baseline SDM-Q-9 mean and standard error of 31 and 9, respectively, 587 on a 45 point scale. 69,101 ) An information sheet will be used for providers, and an additional 588 information sheet will also be provided to patients stating that their doctor is participating in a 589 research study. For patients who are interested in providing feedback, the information sheet will 590 also describe the survey. The intervention is minimal risk because providers can ignore 591 individualized recommendations, and providers retain discretion in ordering. Rapid Improvement: Following each burst, the study team will review feedback and identify 593 next steps. As needed, we will spend approx. 1-4 weeks improving use of the decision aid, the 594 quality of shared decision making (from both patient and provider perspectives), 102 and 595 workflow before implementing the next round. Testing will stop after approx. 4 rounds or when 596 feedback suggests that the process cannot be further improved in an exploratory study. The 597 finished product will represent a tailored decision aid ready for wide-scale testing. (in a secure REDCap database) and access will be controlled in accordance to Cleveland Clinic 616 and HIPAA standards. Protected Health Information (PHI) will not be shared outside of Additionally, we will inform patients that their doctor is participating in a research study, and ask 682 patients if they would be interested in providing feedback in the form of a 10-15 minute survey. The patient will not be required to complete the survey. If the patient chooses to complete the 684 survey, then s/he will receive $25. We do not require any pre-specified number of patients to 685 agree. We chose this method as a variant of prior work that has cluster randomized clinical 686 practices to early vs. delayed intervention (where controls were patients in the delayed group 687 before implementation), 1,28 recognizing the non-randomized, exploratory nature of our study. For providers, our goal from feedback will be to create a tool that is easily understood, that 689 providers are interested in using, and that providers believe improves the patient visit and information sheet will also be provided to patients stating that their doctor is participating in a 760 research study. For patients who are interested in providing feedback, the information sheet will 761 also describe the survey. The intervention is minimal risk because providers can ignore 762 individualized recommendations, and providers retain discretion in ordering. Rapid Improvement: Following each burst, the study team will review feedback and identify 764 next steps. As needed, we will spend approx. 1-4 weeks improving use of the decision aid, the 765 quality of shared decision making (from both patient and provider perspectives), 102 and 766 workflow before implementing the next round. Testing will stop after approx. 4 rounds or when 767 feedback suggests that the process cannot be further improved in an exploratory study. The 768 finished product will represent a tailored decision aid ready for wide-scale testing. Survey mechanics: The surveys will be administered in RedCAP. Patients will be offered the 775 opportunity to complete the survey immediately after their appointment, on a Cleveland Clinic 776 computer. Alternatively, patients who prefer may complete the survey on their own computer, 777 using the internet. In this case, we will provide patients with the web address and a code 778 required by RedCap. This printout will come directly from RedCap, and an example is enclosed. Finally, if patients prefer, we can ask them the survey questions over the phone. Patients will 780 have 3 business days after their appointment to complete the survey. Survey responses will be 781 confidential, not anonymous, in order to allow researchers to know which patients completed the 782 survey for mailing of gift cards. Answers to the survey questions will not be shared with 783 patient's doctors; participants will be informed of confidentiality. Thinking back to your office visit what else was particularly helpful during the visit, how was 837 that more or less useful than the individualized recommendations, etc. Is there anything else you would like to share with us? Thank you for your time. We appreciate your continued participation in the research study. During intervention appointments, 708 the individualized recommendations will be made available to providers as per Aim 709 1. During control appointments, the research team may still generate individualized 710 recommendations but will not make them available to providers. Regardless of 711 whether the appointment was intervention or control, the patient will still be informed 712 that their doctor is participating in a research study, and we will ask patients if they 713 would be interested in providing feedback in the form of a 10-15 minute survey, as 714 per Aim 1. As with Aim 1, the patient will not be required to complete the survey. 715 716 4. Patients who choose to complete the survey will be notified that after their 717 appointment, we may review their medical record to see which health care services 718 they receive during the next 1 year. Providers will be similarly notified that we may 719 review the medical records of their study patients. The purpose of this review is to 720 see whether provider conversations had an impact on which preventive services were 721 ultimately provided to patients While Phase I pilot testing 728 is primarily intended for general feedback on the design of individualized preventive 729 care recommendations The Phase II survey may be conducted electronically, in writing, or 732 by telephone. The written Phase II pilot testing survey uses a different version for 733 males and females because some preventive services only apply to one sex Employees who participated in Phase I pilot testing will be eligible for participation 737 in Phase II and will provide an updated information sheet if they are asked to 738 participate. We attach a script for this discussion. Patients who participated in Phase 739 I pilot testing will not be eligible for participation in Phase II Information sheets, a patient information letter and scripts for Phase II pilot testing are attached We hypothesize that providers who utilized individualized, tailored recommendations will find 745 that they facilitate discussions of preventive care and shared decision-making. We hypothesize 746 that patients who received individualized, tailored recommendations will change their intentions 747 around preventive care 621 622 We will conduct pilot testing of the decision aid. Pilot 623 testing will be conducted in multiple phases, an initial 624 phase for basic feedback and a subsequent phase for 625 more advanced pilot testing. Phase I pilot testing 627 This initial pilot testing will be conducted with preference to decide on a course of action. 50,67,68 Providers will be encouraged, but not required, 646 to participate in training. We also will discuss ways to probe patient values in the exam room 647 (e.g., "Are you willing to change your lifestyle to prevent a serious health problem in the future? What kinds of things would you consider? How do you feel about blood tests and X-rays that 649 may be less impactful on your health, but are easier to do?"). Best practices for decision aids require a values clarification (e.g., helping patients to think about 651 which aspects matter most to them) and explanation that a patient is free to choose nontreatment.