Dataset Information

Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design.

ABSTRACT: BACKGROUND:Integrating mental health providers into primary care clinics improves access to and outcomes of mental health care. In the Veterans Health Administration (VA) Primary Care Mental Health Integration (PCMHI) program, mental health providers are co-located in primary care clinics, but the implementation of this model is challenging outside large VA medical centers, especially for rural clinics without full mental health staffing. Long wait times for mental health care, little collaboration between mental health and primary care providers, and sub-optimal outcomes for rural veterans could result. Telehealth could be used to provide PCMHI to rural clinics; however, the clinical effectiveness of the tele-PCMHI model has not been tested. Based on evidence that implementation facilitation is an effective implementation strategy to increase uptake of PCMHI when delivered on-site at larger VA clinics, it is hypothesized that this strategy may also be effective with regard to ensuring adequate uptake of the tele-PCMHI model at rural VA clinics. METHODS:This study is a hybrid type 2 pragmatic effectiveness-implementation trial of tele-PCMHI in six sites over 24?months. Tele-PCMHI, which will be delivered by clinical staff available in routine care settings, will be compared to usual care. Fidelity to the care model will be monitored but not controlled. We will use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to evaluate the patient-level clinical effectiveness of tele-PCMHI in rural VA clinics and also to evaluate the fidelity to and outcomes of the implementation strategy, implementation facilitation. The proposed study will employ a stepped-wedge design in which study sites sequentially begin implementation in three steps at 6-month intervals. Each step will include (1) a 6-month period of implementation planning, followed by (2) a 6-month period of active implementation, and (3) a final period of stepped-down implementation facilitation. DISCUSSION:This study will evaluate the effectiveness of PCMHI in a novel setting and via a novel method (clinical video telehealth). We will test the feasibility of using implementation facilitation as an implementation strategy to deploy tele-PCMHI in rural VA clinics. TRIAL REGISTRATION:ClinicalTrials.gov registration number NCT02713217 . Registered on 18 March 2016.

SUBMITTER: Owen RR

PROVIDER: S-EPMC6429823 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design.

Owen Richard R RR Woodward Eva N EN Drummond Karen L KL Deen Tisha L TL Oliver Karen Anderson KA Petersen Nancy J NJ Meit Scott S SS Fortney John C JC Kirchner JoAnn E JE

Implementation science : IS 20190321 1

<h4>Background</h4>Integrating mental health providers into primary care clinics improves access to and outcomes of mental health care. In the Veterans Health Administration (VA) Primary Care Mental Health Integration (PCMHI) program, mental health providers are co-located in primary care clinics, but the implementation of this model is challenging outside large VA medical centers, especially for rural clinics without full mental health staffing. Long wait times for mental health care, little co ...[more]

PMID: 30898129

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Project description:BackgroundSuccessful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya.MethodsAs part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010.FindingsAfter the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation.InterpretationWe observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible.FundingNational Institute of Mental Health and Bill & Melinda Gates Foundation.

Project description:BackgroundFacilitation is a complex, relational implementation strategy that guides change processes. Facilitators engage in multiple activities and tailor efforts to local contexts. How this work is coordinated and shared among multiple, external actors and the contextual factors that prompt and moderate facilitators to tailor activities have not been well-described.MethodsWe conducted a mixed methods evaluation of a trial to improve the quality of transient ischemic attack care. Six sites in the Veterans Health Administration received external facilitation (EF) before and during a 1-year active implementation period. We examined how EF was employed and activated. Data analysis included prospective logs of facilitator correspondence with sites (160 site-directed episodes), stakeholder interviews (a total of 78 interviews, involving 42 unique individuals), and collaborative call debriefs (n=22) spanning implementation stages. Logs were descriptively analyzed across facilitators, sites, time periods, and activity types. Interview transcripts were coded for content related to EF and themes were identified. Debriefs were reviewed to identify instances of and utilization of EF during site critical junctures.ResultsMulti-tiered EF was supported by two groups (site-facing quality improvement [QI] facilitators and the implementation support team) that were connected by feedback loops. Each site received an average of 24 episodes of site-directed EF; most of the EF was delivered by the QI nurse. For each site, site-directed EF frequently involved networking (45%), preparation and planning (44%), process monitoring (44%), and/or education (36%). EF less commonly involved audit and feedback (20%), brainstorming solutions (16%), and/or stakeholder engagement (5%). However, site-directed EF varied widely across sites and time periods in terms of these facilitation types. Site participants recognized the responsiveness of the QI nurse and valued her problem-solving, feedback, and accountability support. External facilitators used monitoring and dialogue to intervene by facilitating redirection during challenging periods of uncertainty about project direction and feasibility for sites. External facilitators, in collaboration with the implementation support team, successfully used strategies tailored to diverse local contexts, including networking, providing data, and brainstorming solutions.ConclusionsMulti-tiered facilitation capitalizing on emergent feedback loops allowed for tailored, site-directed facilitation. Critical juncture cases illustrate the complexity of EF and the need to often try multiple strategies in combination to facilitate implementation progress.Trial registrationThe Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) is a registered trial ( NCT02769338 ), May 11, 2016-prospectively registered.

Project description:Practice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care. Using practice facilitation, the Improved Delivery of Cardiovascular Care (IDOCC) project aimed to improve the delivery of evidence-based cardiovascular care in primary care practices across a large health region. Our goal was to evaluate IDOCC's impact on adherence to processes of care delivery.A pragmatic stepped wedge cluster randomized trial recruiting primary care providers in practices located in Eastern Ontario, Canada (ClinicalTrials.gov: NCT00574808). Participants were randomly assigned by region to one of three steps. Practice facilitators were intended to visit practices every 3-4 (year 1-intensive) or 6-12 weeks (year 2-sustainability) to support changes in practice behavior. The primary outcome was mean adherence to indicators of evidence-based care measured at the patient level. Adherence was assessed by chart review of a randomly selected cohort of 66 patients per practice in each pre-intervention year, as well as in year 1 and year 2 post-intervention.Eighty-four practices (182 physicians) participated. On average, facilitators had 6.6 (min: 2, max: 11) face-to-face visits with practices in year 1 and 2.5 (min: 0 max: 10) visits in year 2. We collected chart data from 5292 patients. After adjustment for patient and provider characteristics, there was a 1.9 % (95 % confidence interval (CI): -2.9 to -0.9 %) and 4.2 % (95 % CI: -5.7 to -2.6 %) absolute decrease in mean adherence from baseline to intensive and sustainability years, respectively.IDOCC did not improve adherence to best-practice guidelines. Our results showed a small statistically significant decrease in mean adherence of questionable clinical significance. Potential reasons for this result include implementation challenges, competing priorities in practices, a broad focus on multiple chronic disease indicators, and use of an overall index of adherence. These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice.ClinicalTrials.gov NCT00574808.

Project description:ObjectiveTo evaluate the impact of Teach-Back on communication quality in a national telephone-based telehealth service, for callers varying in health literacy.DesignCross-sectional stepped wedge cluster randomised trial with continuous recruitment, short (fixed) exposure and blinded outcome assessors. Nurses were stratified by hours worked and randomised into training groups using a computer generated sequence.SettingAn Australian national pregnancy and parenting telephone helpline.InterventionComplex intervention involving a single 2-hour group Teach-Back training session, combined with ongoing nurse self-reflection on their communication following each call and each shift.ParticipantsParticipants were 637 callers to the telephone helpline aged 18-75 (87% female), of whom 127 (13%) had inadequate health literacy (measured with the Single Item Literacy Screener); and 15 maternal and child health nurses with 15 years' experience on average.MeasuresPrimary outcome was a modified subscale of the Health Literacy Questionnaire, 'having sufficient information to manage health'. Secondary caller outcomes included caller confidence, perceived actionability of information and nurse effort to listen and understand. Nurse outcomes were perceptions of their communication effectiveness.ResultsOver a 7 week period, 376 surveyed callers received usual care and 261 Teach-Back. Ratings on the primary outcome increased over time (OR 1.17, CI 1.01 to 1.32, p = 0.03) but no independent Teach-Back effect was observed. A consistent pattern suggests that, compared with usual care, Teach-Back helps callers with inadequate health literacy feel listened to (OR 2.3, CI 0.98 to 5.42, p = 0.06), confident to act (OR 2.44, CI 1.00 to 5.98, p = 0.06), and know what steps to take (OR 2.68, CI 1.00 to 7.17, p = 0.06). Nurse perceptions of both their own communication effectiveness (OR = 2.31; CI 1.38 to 3.86, p<0.0001), and caller understanding (OR = 2.56; CI 1.52 to 4.30, p<0.001) both increased with Teach-Back. No harms were reported.ConclusionsTeach-Back appears to benefit telephone health service users with inadequate health literacy, but the extent of this is unclear due to smaller numbers of lower literacy participants. Improving caller ratings over time are likely due to increasing nurse communication competence.

Project description:BACKGROUND:Controlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial. METHODS:The trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes. RESULTS:From 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99. CONCLUSIONS:Sequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding. TRIAL REGISTRATION:Registered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.

Project description:BACKGROUND:Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs. METHODS:Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals. RESULTS:Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3?months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled). CONCLUSIONS:Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out. TRIAL REGISTRATION:ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

Project description:BackgroundMany clinical trial designs are impractical for community-based clinical intervention trials. Stepped wedge trial designs provide practical advantages, but few descriptions exist of their clinical implementational features, statistical design efficiencies, and limitations.ObjectivesEnhance efficiency of stepped wedge trial designs by evaluating the impact of design characteristics on statistical power for the British Columbia Telehealth Trial.MethodsThe British Columbia Telehealth Trial is a community-based, cluster-randomized, controlled clinical trial in rural and urban British Columbia. To determine the effect of an Internet-based telehealth intervention on healthcare utilization, 1000 subjects with an existing diagnosis of congestive heart failure or type 2 diabetes will be enrolled from 50 clinical practices. Hospital utilization is measured using a composite of disease-specific hospital admissions and emergency visits. The intervention comprises online telehealth data collection and counseling provided to support a disease-specific action plan developed by the primary care provider. The planned intervention is sequentially introduced across all participating practices. We adopt a fully Bayesian, Markov chain Monte Carlo-driven statistical approach, wherein we use simulation to determine the effect of cluster size, sample size, and crossover interval choice on type I error and power to evaluate differences in hospital utilization.ResultsFor our Bayesian stepped wedge trial design, simulations suggest moderate decreases in power when crossover intervals from control to intervention are reduced from every 3 to 2 weeks, and dramatic decreases in power as the numbers of clusters decrease. Power and type I error performance were not notably affected by the addition of nonzero cluster effects or a temporal trend in hospitalization intensity.Conclusion/limitationsStepped wedge trial designs that intervene in small clusters across longer periods can provide enhanced power to evaluate comparative effectiveness, while offering practical implementation advantages in geographic stratification, temporal change, use of existing data, and resource distribution. Current population estimates were used; however, models may not reflect actual event rates during the trial. In addition, temporal or spatial heterogeneity can bias treatment effect estimates.

Dataset Information

Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design.

Publications

Using implementation facilitation to implement primary care mental health integration via clinical video telehealth in rural clinics: protocol for a hybrid type 2 cluster randomized stepped-wedge design.

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