Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial.
ABSTRACT: Importance:Poor preoperative communication can have serious consequences, including unwanted treatment and postoperative conflict. Objective:To compare the effectiveness of a question prompt list (QPL) intervention vs usual care on patient engagement and well-being among older patients considering major surgery. Design, Setting, and Participants:This randomized clinical trial used a stepped-wedge design to randomly assign patients to a QPL intervention (n?=?223) or usual care (n?=?223) based on the timing of their visit with 1 of 40 surgeons at 5 US study sites. Patients were 60 years or older with at least 1 comorbidity and an oncologic or vascular (cardiac, neurosurgical, or peripheral vascular) problem that could be treated with major surgery. Family members were also enrolled (n?=?263). The study dates were June 2016 to November 2018. Data analysis was by intent-to-treat. Interventions:A brochure of 11 questions to ask a surgeon developed by patient and family stakeholders plus an endorsement letter from the surgeon were sent to patients before their outpatient visit. Main Outcomes and Measures:Primary patient engagement outcomes included the number and type of questions asked during the surgical visit and patient-reported Perceived Efficacy in Patient-Physician Interactions scale assessed after the surgical visit. Primary well-being outcomes included (1) the difference between patient's Measure Yourself Concerns and Well-being (MYCaW) scores reported after surgery and scores reported after the surgical visit and (2) treatment-associated regret at 6 to 8 weeks after surgery. Results:Of 1319 patients eligible for participation, 223 were randomized to the QPL intervention and 223 to usual care. Among 446 patients, the mean (SD) age was 71.8 (7.1) years, and 249 (55.8%) were male. On intent-to-treat analysis, there was no significant difference between the QPL intervention and usual care for all patient-reported primary outcomes. The difference in MYCaW scores for family members was greater in usual care (effect estimate, 1.51; 95% CI, 0.28-2.74; P?=?.008). When the QPL intervention group was restricted to patients with clear evidence they reviewed the QPL, a nonsignificant increase in the effect size was observed for questions about options (odds ratio, 1.88; 95% CI, 0.81-4.35; P?=?.16), expectations (odds ratio, 1.59; 95% CI, 0.67-3.80; P?=?.29), and risks (odds ratio, 2.41; 95% CI, 1.04-5.59; P?=?.04) (nominal ??=?.01). Conclusions and Relevance:The results of this study were null related to primary patient engagement and well-being outcomes. Changing patient-physician communication may be difficult without addressing clinician communication directly. Trial Registration:ClinicalTrials.gov identifier: NCT02623335.
Project description:INTRODUCTION:Older patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected outcomes, conflict between surgeons and patients, and treatment inconsistent with patient preferences. This article describes the protocol for a multisite, cluster-randomised trial that uses a stepped wedge design to test a patient-driven question prompt list (QPL) intervention aimed to improve preoperative decision making and inform postoperative expectations. METHODS AND ANALYSIS:This Patient-Centered Outcomes Research Institute-funded trial will be conducted at five academic medical centres in the USA. Study participants include surgeons who routinely perform vascular or oncological surgery, their patients and families. We aim to enrol 40 surgeons and 480 patients over 24 months. Patients age 65 or older who see a study-enrolled surgeon to discuss a vascular or oncological problem that could be treated with high-risk surgery will be enrolled at their clinic visit. Together with stakeholders, we developed a QPL intervention addressing preoperative communication needs of patients considering major surgery. Guided by the theories of self-determination and relational autonomy, this intervention is designed to increase patient activation. Patients will receive the QPL brochure and a letter from their surgeon encouraging its use. Using audio recordings of the outpatient surgical consultation, patient and family member questionnaires administered at three time points and retrospective chart review, we will compare the effectiveness of the QPL intervention to usual care with respect to the following primary outcomes: patient engagement in decision making, psychological well-being and post-treatment regret for patients and families, and interpersonal and intrapersonal conflict relating to treatment decisions and treatments received. ETHICS AND DISSEMINATION:Approvals have been granted by the Institutional Review Board at the University of Wisconsin and at each participating site, and a Certificate of Confidentiality has been obtained. Results will be reported in peer-reviewed publications and presented at national meetings. TRIAL REGISTRATION NUMBER:NCT02623335.
Project description:"The objective of this study was to" test the effectiveness of an enhanced genomic report on patient-centered outcome domains including communication, engagement and satisfaction. "Study design utilized" a prospective, randomized, mixed-methods desctiptive study of a whole genome sequencing results report, GenomeCOMPASS™, that was accessed by providers through the electronic health record and by patients through the associated patient portal. "The study was set in" an integrated healthcare delivery system in central Pennsylvania. "Eighty-four" parents of 46 children with undiagnosed Intellectual Disability, Autism Spectrum Disorder and/or multiple congenital anomalies who had participated in a previous study offering whole genome sequencing for their affected child were invited to enroll. Fifty-two parents enrolled. Following a traditional genetics results informing visit, the study coordinator stratified families by diagnostic result and uninformative result and then randomized families within each group to an intervention arm to receive the GenomeCOMPASS™ report or to the usual care arm to receive a summary letter from the medical geneticist. A letter inviting enrollment included a baseline survey, which once returned, constituted enrollment. Surveys were administered at 3 months post-genetics visit. At 6 months, the usual care arm crossed over to receive the intervention and were administered an additional survey at 3 months. Qualitative interviews were conducted following survey completion to augment the survey data regarding the patient centered outcomes of interest. Patient reported outcomes including communication, engagement, empowerment and satisfaction. In the intervention arm, GenomeCOMPASS™ reports were released to 14 families (N?=?28 parents) and of those 21 (75%) returned 3 month surveys. In the usual care arm, 12 families (N?=?24 parents) received usual care summary letters and of those 20 (83%) returned 3 month surveys. At crossover, GenomeCOMPASS™ reports were released to 20 individuals and 15 (75%) returned 3 month surveys. Qualitative interviews were conducted with 5 individuals. Use of the GenomeCOMPASS™ report was reported by this small group of parents to improve communication with providers and non-health professionals such as educators and therapists and led to increased engagement and high satisfaction. Providers and others involved in the children's care also endorsed the report's effectiveness. Reports that addressed negative findings, i.e. uninformative results, were not found to be useful. Although the number of users was small, this study supports that customizable template reports may provide a useful and durable source of information that can support and enhance the information provided by genetics professionals in traditional face-to-face encounters.Clinicaltrials.gov (Record 2013-0594).
Project description:Background:Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. Objective:To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening. Design:Randomized clinical trial. (ClinicalTrials.gov: NCT02088333). Setting:6 community-based primary care practices. Participants:450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. Intervention:An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. Measurements:The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Results:Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) "self-ordered" a test via the program. Limitation:Participants were English speakers in a single health care system. Conclusion:A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. Primary Funding Source:National Cancer Institute.
Project description:Older, chronically ill patients with limited health literacy are often under-engaged in managing their health and turn to the emergency department (ED) for healthcare needs. We tested the impact of an ED-initiated coaching intervention on patient engagement and follow-up doctor visits in this high-risk population. We also explored patients' care-seeking decisions.We conducted a mixed-methods study including a randomized controlled trial and in-depth interviews in two EDs in northern Florida. Participants were chronically ill older ED patients with limited health literacy and Medicare as a payer source. Patients were assigned to an evidence-based coaching intervention (n= 35) or usual post-ED care (n= 34). Qualitative interviews (n=9) explored patients' reasons for ED use. We assessed average between-group differences in patient engagement over time with the Patient Activation Measure (PAM) tool, using logistic regression and a difference-in-difference approach. Between-group differences in follow-up doctor visits were determined. We analyzed qualitative data using open coding and thematic analysis.PAM scores fell in both groups after the ED visit but fell significantly more in "usual care" (average decline -4.64) than "intervention" participants (average decline -2.77) (?=1.87, p=0.043). There were no between-group differences in doctor visits. Patients described well-informed reasons for ED visits including onset and severity of symptoms, lack of timely provider access, and immediate and comprehensive ED care.The coaching intervention significantly reduced declines in patient engagement observed after usual post-ED care. Patients reported well-informed reasons for ED use and will likely continue to make ED visits unless strategies, such as ED-initiated coaching, are implemented to help vulnerable patients better manage their health and healthcare.
Project description:Introduction: Post-operative delirium remains a significant problem, particularly in the older surgical patient. Previous evidence suggests that the provision of supplementary visual feedback about ones environment via the use of a mirror may positively impact on mental status and attention (core delirium diagnostic domains). We aimed to explore whether use of an evidence-based mirrors intervention could be effective in reducing delirium and improving post-operative outcomes such as factual memory encoding of the Intensive Care Unit (ICU) environment in older cardiac surgical patients. Methods: This was a pilot time-cluster randomized controlled trial at a 32-bed ICU, enrolling 223 patients aged 70 years and over, admitted to ICU after elective or urgent cardiac surgery from October 29, 2012 to June 23, 2013. The Mirrors Group received a structured mirrors intervention at set times (e.g., following change in mental status). The Usual Care Group received the standard care without mirrors. Primary outcome was ICU delirium incidence; secondary outcomes were ICU delirium days, ICU days with altered mental status or inattention, total length of ICU stay, physical mobilization (balance confidence) at ICU discharge, recall of factual and delusional ICU memories at 12 weeks, Health-Related Quality of Life at 12 weeks, and acceptability of the intervention. Results: The intervention was not associated with a significant reduction in ICU delirium incidence [Mirrors: 20/115 (17%); Usual Care: 17/108 (16%)] or duration [Mirrors: 1 (1-3); Usual Care: 2 (1-8)]. Use of the intervention on ICU was predictive of significantly higher recall of factual (but not delusional) items at 12 weeks after surgery (p = 0.003) and acceptability was high, with clinicians using mirrors at 86% of all recorded hourly observations. The intervention did not significantly impact on other secondary outcomes. Conclusion: Use of a structured mirrors intervention on the post-operative ICU does not reduce delirium, but may result in improved factual memory encoding in older cardiac surgical patients. This effect may occur via mechanisms unrelated to delirium, altered mental status, or inattention. The intervention may provide a new means of improving outcomes in patients at risk of post-ICU anxiety and/or Post-Traumatic Stress Disorder. Trial Registration: Clinicaltrials.gov identifier NCT01599689.
Project description:Human papillomavirus (HPV) infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics.Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408) and their mothers (N = 305) enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months.At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9%) but not significantly after adjusting for patient's age and mother's education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm.Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines.Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16.
Project description:BACKGROUND:Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits. OBJECTIVE:To test the hypothesis that a "Pre-Visit Prioritization" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes. DESIGN:We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system. PARTICIPANTS:Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c)?>?=?8.0%, and were registered users of the KPNC online patient portal. INTERVENTIONS:Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care. MAIN MEASURES:Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences. KEY RESULTS:During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n?=?457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p?=?0.048) and being given treatment choices to consider (81% vs 73%, p?=?0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56%?±?1.45%), with no significant differences between arms. CONCLUSIONS:A "light touch" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation. TRIAL REGISTRY:NCT02375932.
Project description:BACKGROUND:Patient empowerment represents a potent tool for addressing racial, ethnic and socioeconomic disparities in health care, particularly for chronic conditions such as HIV infection that require active patient engagement. This multimodal intervention, developed in concert with HIV patients and clinicians, aims to provide HIV patients with the knowledge, skills, attitudes and tools to become more activated patients. METHODS/DESIGN:Randomized controlled trial of a multimodal intervention designed to activate persons living with HIV. The intervention includes four components: 1) use of a web-enabled hand-held device (Apple iPod Touch) loaded with a Personal Health Record (ePHR) customized for HIV patients; 2) six 90-minute group-based training sessions in use of the device, internet and the ePHR; 3) a pre-visit coaching session; and 4) clinician education regarding how they can support activated patients. Outcome measures include pre- post changes in patient activation measure score (primary outcome), eHealth literacy, patient involvement in decision-making and care, medication adherence, preventive care, and HIV Viral Load. DISCUSSION:We hypothesize that participants receiving the intervention will show greater improvement in empowerment and the intervention will reduce disparities in study outcomes. Disparities in these measures will be smaller than those in the usual care group. Findings have implications for activating persons living with HIV and for other marginalized groups living with chronic illness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02165735, 6/13/2014.
Project description:Research has shown that higher activation and engagement with health care is associated with better self-management. To our knowledge, the linkage intervention (LINKAGE) is the first to engage patients receiving addiction treatment with health care using the electronic health record and a patient activation approach.To examine the effects of an intervention aiming to link patients receiving addiction treatment with health care.A nonrandomized clinical trial evaluating the LINKAGE intervention vs usual care by applying an alternating 3-month off-and-on design over 30 months. Participants were recruited from an outpatient addiction treatment clinic in a large health system between April 7, 2011, and October 2, 2013.Six group-based, manual-guided sessions on patient engagement in health care and the use of health information technology resources in the electronic health record, as well as facilitated communication with physicians, vs usual care.Primary outcomes, measured at 6 months after enrollment, were patient activation (by interview using the Patient Activation Measure), patient engagement in health care (by interview and electronic health record), and alcohol, drug, and depression outcomes (by interview using the Addiction Severity Index for alcohol and drug outcomes and Patient Health Questionnaire (PHQ) for depression).A total of 503 patients were recruited and assigned to the LINKAGE (n?=?252) or usual care (n?=?251) conditions, with no differences in baseline characteristics between conditions. The mean (SD) age of the patients was 42.5 (11.8) years, 31.0% (n?=?156) were female, and 455 (90.5%) completed the 6-month interview. Compared with usual care participants, LINKAGE participants showed an increase in the mean number of log-in days (incidence rate ratio, 1.53; 95% CI, 1.19-1.97; P?=?.001). Similar results were found across types of patient portal use (communicating by email, viewing laboratory test results and information, and obtaining medical advice). LINKAGE participants were more likely to talk with their physicians about addiction problems (odds ratio, 2.30; 95% CI, 1.52-3.49; P?<?.001). Although 6-month abstinence rates were high for both conditions (?70.0% for both) and depression symptoms improved (the proportion with scores ?15 on the 9-item PHQ dropped from 15.1% [38 of 252] to 8.0% [18 of 225] among LINKAGE participants), there were no differences between conditions. Those who received all intervention components had significantly better alcohol and other drug outcomes than those who received fewer intervention components.Findings support the feasibility and effectiveness of the LINKAGE intervention in helping patients receiving addiction treatment engage in health care and increase communication with their physicians. The intervention did not affect short-term abstinence or depression outcomes. Understanding if the LINKAGE intervention helps prevent relapse and manage long-term recovery will be important.clinicaltrials.gov Identifier: NCT01621711.
Project description:BACKGROUND:In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of early specialist palliative care interventions in surgical oncology settings is not well studied. METHODS:The Surgery for Cancer with Option for Palliative Care Expert (SCOPE) Trial is a single-center, prospective, single-blind, randomized controlled trial of a specialist palliative care intervention for cancer patients undergoing non-palliative surgery. It will enroll 236 patients scheduled for major abdominal operations for malignancy, who will be randomized 1:1 at enrollment to receive usual care (control arm) or specialist palliative care consultation (intervention arm). Intervention arm patients will receive consultations from a palliative care specialist (physician or nurse practitioner) preoperatively and postoperatively. The primary outcome is physical and functional wellbeing at 90?days postoperatively. Secondary outcomes are quality of life at 90?days postoperatively, posttraumatic stress disorder symptoms at 180?days postoperatively, days alive at home without an emergency room visit in the first 90 postoperative days, and overall survival at 1 year postoperatively. Participants will be followed for 3 years after surgery for exploratory analyses of their ongoing quality of life, healthcare utilization, and mortality. DISCUSSION:SCOPE is an ongoing randomized controlled trial evaluating specialist palliative care interventions for cancer patients undergoing non-palliative oncologic surgery. Findings from the study will inform ways to identify and improve care of surgical patients who will likely benefit from specialist palliative care services. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03436290 First Registered: 16 February 2018 Enrollment Began: 1 March 2018 Last Update: 20 December 2018.