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Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.

ABSTRACT: BACKGROUND:There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations. OBJECTIVE:Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge. DESIGN:Pragmatic, randomized comparative effectiveness trial. PATIENTS:Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care. INTERVENTIONS:TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred. MAIN MEASURES:The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days. KEY RESULTS:Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90). CONCLUSIONS:Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days. TRIAL REGISTRATION:clinicaltrials.gov identifier NCT03066492.

SUBMITTER: Liss DT

PROVIDER: S-EPMC6712181 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.

Liss David T DT Ackermann Ronald T RT Cooper Andrew A Finch Emily A EA Hurt Courtney C Lancki Nicola N Rogers Angela A Sheth Avani A Teter Caroline C Schaeffer Christine C

Journal of general internal medicine 20190529 9

<h4>Background</h4>There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations.<h4>Objective</h4>Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge.<h4>Design</h4>Pragmatic, randomized comparative effectiveness trial.<h4>Patients</h4>Adults discharged from an initial emergency, observation, or inpatient hospital encounte ...[more]

PMID: 31144279

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Project description:ImportanceOnly one-third of patients with complex psychiatric disorders engage in specialty mental health care, and only one-tenth receive adequate treatment in primary care. Scalable approaches are critically needed to improve access to effective mental health treatments in underserved primary care settings.ObjectiveTo compare 2 clinic-to-clinic interactive video approaches to delivering evidence-based mental health treatments to patients in primary care clinics.Design, setting, and participantsThis pragmatic comparative effectiveness trial used a sequential, multiple-assignment, randomized trial (SMART) design with patient-level randomization. Adult patients treated at 24 primary care clinics without on-site psychiatrists or psychologists from 12 federally qualified health centers in 3 states who screened positive for posttraumatic stress disorder and/or bipolar disorder and who were not already receiving pharmacotherapy from a mental health specialist were recruited from November 16, 2016, to June 30, 2019, and observed for 12 months.InterventionsTwo approaches were compared: (1) telepsychiatry/telepsychology-enhanced referral (TER), where telepsychiatrists and telepsychologists assumed responsibility for treatment, and (2) telepsychiatry collaborative care (TCC), where telepsychiatrists provided consultation to the primary care team. TER included an adaptive intervention (phone-enhanced referral [PER]) for patients not engaging in treatment, which involved telephone outreach and motivational interviewing.Main outcomes and measuresSurvey questions assessed patient-reported outcomes. The Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score was the primary outcome (range, 0-100). Secondary outcomes included posttraumatic stress disorder symptoms, manic symptoms, depressive symptoms, anxiety symptoms, recovery, and adverse effects.ResultsOf 1004 included participants, 701 of 1000 (70.1%) were female, 660 of 994 (66.4%) were White, and the mean (SD) age was 39.4 (12.9) years. Baseline MCS scores were 2 SDs below the US mean; the mean (SD) MCS scores were 39.7 (14.1) and 41.2 (14.2) in the TCC and TER groups, respectively. There was no significant difference in 12-month MCS score between those receiving TCC and TER (β = 1.0; 95% CI, -0.8 to 2.8; P = .28). Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (TCC: Cohen d = 0.81; 95% CI, 0.67 to 0.95; TER: Cohen d = 0.90; 95% CI, 0.76 to 1.04). For patients not engaging in TER at 6 months, there was no significant difference in 12-month MCS score between those receiving PER and TER (β = 2.0; 95% CI, -1.7 to 5.7; P = .29).Conclusions and relevanceIn this comparative effectiveness trial of patients with complex psychiatric disorders randomized to receive TCC or TER, significantly and substantially improved outcomes were observed in both groups. From a health care system perspective, clinical leadership should implement whichever approach is most sustainable.Trial registrationClinicalTrials.gov Identifier: NCT02738944.

Project description:ObjectiveTo evaluate the effectiveness of a nurse-led hospital-to-home transitional care intervention versus usual care on mental functioning (primary outcome), physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use costs in older adults with multimorbidity (≥ 2 comorbidities) and depressive symptoms.Design and settingPragmatic multi-site randomized controlled trial conducted in three communities in Ontario, Canada. Participants were allocated into two groups of intervention and usual care (control).Participants127 older adults (≥ 65 years) discharged from hospital to the community with multimorbidity and depressive symptoms.InterventionThis evidence-based, patient-centred intervention consisted of individually tailored care delivery by a Registered Nurse comprising in-home visits, telephone follow-up and system navigation support over 6-months.Outcome measuresThe primary outcome was the change in mental functioning, from baseline to 6-months. Secondary outcomes were the change in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use cost, from baseline to 6-months. Intention-to-treat analysis was performed using ANCOVA modeling.ResultsOf 127 enrolled participants (63-intervention, 64-control), 85% had six or more chronic conditions. 28 participants were lost to follow-up, leaving 99 (47 -intervention, 52-control) participants for the complete case analysis. No significant group differences were seen for the baseline to six-month change in mental functioning or other secondary outcomes. Older adults in the intervention group reported receiving more information about health and social services (p = 0.03) compared with the usual care group.ConclusionsAlthough no significant group differences were seen for the primary or secondary outcomes, the intervention resulted in improvements in one aspect of patient experience (information about health and social services). The study sample fell below the target sample (enrolled 127, targeted 216), which can account for the non-significant findings. Further research on the impact of the intervention and factors that contribute to the results is recommended.Trial registrationclinicaltrials.gov Identifier: NCT03157999.

Project description:BackgroundThis study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care on health outcomes, self-management, patient experience, and health and social service use costs in older adults (≥ 55 years) with stroke and multimorbidity (≥ 2 chronic conditions).MethodsThis pragmatic randomized controlled trial (RCT) included older adults discharged from hospital to community with stroke and multimorbidity using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional (IP) team, and included care coordination/system navigation support, phone/video visits, monthly IP team conferences, and an online resource to support system navigation. The primary outcome was risk of hospital readmission (all cause) after six-months. Secondary outcomes included physical and mental functioning, stroke self-management, patient experience, and health and social service use costs. The intention-to-treat principle was used to conduct the primary and secondary analyses.ResultsNinety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). No significant between-group differences were seen for baseline to six-month risk of hospital readmission. Differences favouring the intervention group were seen in the following secondary outcomes: physical functioning (SF-12 PCS mean difference: 5.10; 95% CI: 1.58-8.62, p = 0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51-11.50, p = 0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p = 0.005). No between-group differences were found in total healthcare costs or other secondary outcomes.ConclusionsAlthough participation in the TCSI did not impact hospital readmissions, there were improvements in physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs. Challenges associated with the COVID-19 pandemic, including the shift from in-person to virtual delivery, and re-deployment of interventionists could have influenced the results. A larger pragmatic RCT is needed to determine intervention effectiveness in diverse geographic settings and ethno-cultural populations and examine intervention scalability.Trial registrationClinicalTrials.gov Identifier: NCT04278794 . Registered May 2, 2020.

Project description:BackgroundEfforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes.ObjectiveTo examine practice contextual features that moderate intervention effectiveness.DesignSecondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care.ParticipantsForty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment.Main measuresThe primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos).Key resultsAcross the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm.ConclusionsThis study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

Project description:BackgroundFor patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.MethodsBalance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.DiscussionFor underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.Trials registrationNCT03003403 . Registered December 28, 2016.

Project description:BackgroundTranscutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive therapy delivering calibrated stimulation to the median and radial nerves. Previous randomized controlled studies have demonstrated the efficacy and safety of TAPS therapy in some patients with essential tremor (ET), but evidence supporting therapeutic benefits of TAPS versus standard of care (SOC) is lacking. This randomized prospective study evaluated the clinical benefit of adding TAPS treatment to SOC versus SOC alone.MethodsThis randomized pragmatic trial recruited patients from a large health plan's Commercially Insured and Medicare Advantage population. All 310 patients received a TAPS device and were randomized 1:1 to either one month adding TAPS therapy to usual care (TX arm) or usual care with tremor assessment only (SOC arm). The pre-specified endpoints were changes in tremor power measured by motion sensors on the device (primary) and improvement in Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores (secondary) between TX and SOC in all patients who completed the one-month study.Results276 patients completed the one-month study (N = 133 TX, N = 143 SOC). The study met the primary and secondary endpoints, with significantly reduced tremor power in TX compared with SOC (0.017 (0.003) versus 0.08 (0.014) (m/s2)2; geometric mean (SE); p < 0.0001) and greater improvement in the BF-ADL score in TX than SOC (1.6 (0.43) vs 0.2 (0.37) points; mean (SE); p < 0.05). No serious device-related adverse events were reported.DiscussionThis trial demonstrates that adding TAPS treatment to SOC significantly improves tremor power and BF-ADLs in patients with ET compared to SOC alone over one month of home use.HighlightsThis study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC alone over one month of home use. This real-world evidence study suggests that non-invasive TAPS therapy is a safe and valuable treatment option for patients with ET.

Dataset Information

Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.

Publications

Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial.

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