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Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial.

ABSTRACT: BACKGROUND:Large-scale implementation of evidence-based psychotherapies (EBPs) such as cognitive processing therapy (CPT) for posttraumatic stress disorder can have a tremendous impact on mental and physical health, healthcare utilization, and quality of life. While many mental health systems (MHS) have invested heavily in programs to implement EBPs, few eligible patients receive EBPs in routine care settings, and clinicians do not appear to deliver the full treatment protocol to many of their patients. Emerging evidence suggests that when CPT and other EBPs are delivered at low levels of fidelity, clinical outcomes are negatively impacted. Thus, identifying strategies to improve and sustain the delivery of CPT and other EBPs is critical. Existing literature has suggested two competing strategies to promote sustainability. One emphasizes fidelity to the treatment protocol through ongoing consultation and fidelity monitoring. The other focuses on improving the fit and effectiveness of these treatments through appropriate adaptations to the treatment or the clinical setting through a process of data-driven, continuous quality improvement. Neither has been evaluated in terms of impact on sustained implementation. METHODS:To compare these approaches on the key sustainability outcomes and provide initial guidance on sustainability strategies, we propose a cluster randomized trial with mental health clinics (n?=?32) in three diverse MHSs that have implemented CPT. Cohorts of clinicians and clinical managers will participate in 1 year of a fidelity oriented learning collaborative or 1 year of a continuous quality improvement-oriented learning collaborative. Patient-level PTSD symptom change, CPT fidelity and adaptation, penetration, and clinics' capacity to deliver EBP will be examined. Survey and interview data will also be collected to investigate multilevel influences on the success of the two learning collaborative strategies. This research will be conducted by a team of investigators with expertise in CPT implementation, mixed method research strategies, quality improvement, and implementation science, with input from stakeholders in each participating MHS. DISCUSSION:It will have broad implications for supporting ongoing delivery of EBPs in mental health and healthcare systems and settings. The resulting products have the potential to significantly improve efforts to ensure ongoing high quality implementation and consumer access to EBPs. TRIAL REGISTRATION:NCT02449421 . Registered 02/09/2015.

SUBMITTER: Wiltsey Stirman S

PROVIDER: S-EPMC5339953 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial.

Wiltsey Stirman Shannon S Finley Erin P EP Shields Norman N Cook Joan J Haine-Schlagel Rachel R Burgess James F JF Dimeff Linda L Koerner Kelly K Suvak Michael M Gutner Cassidy A CA Gagnon David D Masina Tasoula T Beristianos Matthew M Mallard Kera K Ramirez Vanessa V Monson Candice C

Implementation science : IS 20170306 1

<h4>Background</h4>Large-scale implementation of evidence-based psychotherapies (EBPs) such as cognitive processing therapy (CPT) for posttraumatic stress disorder can have a tremendous impact on mental and physical health, healthcare utilization, and quality of life. While many mental health systems (MHS) have invested heavily in programs to implement EBPs, few eligible patients receive EBPs in routine care settings, and clinicians do not appear to deliver the full treatment protocol to many of ...[more]

PMID: 28264720

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Project description:BackgroundPeople who are diagnosed with both mental and chronic medical illness present unique challenges for the health care system. In resource-limited settings, such as rural India, people with depression and anxiety are often under-served, due to both stigma and lack of trained providers and resources. These challenges can lead to complications in the management of chronic disease as well as increased suffering for patients, families and communities. In this study, we evaluate the effects of integrating mental health and chronic disease treatment of patients in primary health care (PHC) settings using a collaborative care model to improve the screening, diagnosis and treatment of depression in rural India.MethodsThis study is a multi-level randomized controlled trial among patients with depression or anxiety and co-morbid diabetes, or cardiovascular disease. Aim 1 examines whether patients screened at community health-fairs are more likely to be diagnosed and treated for these co-morbid conditions than patients screened after presenting at PHCs. Aim 2 evaluates the impact of collaborative care compared to usual care in a cluster RCT, randomizing at the level of the PHCs. Intervention arm PHC staff are trained in mental health diagnoses, treatment, and the collaborative care model. The intervention also involves community-based "Healthy Living groups" co-led by Ashas, using cognitive-behavioral strategies to promote healthy behaviors. The primary outcome is severity of common mental disorders, with secondary outcomes being diabetes and cardiovascular risk, staff knowledge and patient perceptions.DiscussionIf effective, our results will contribute to the field in five ways: 1) expand on implementation research in low resource settings by examining how multiple chronic diseases can be treated using integrated low-cost, evidence-based strategies, 2) build the capacity of PHC staff to diagnose and treat mental illness within their existing clinic structure and strengthen referral linkages; 3) link community members to primary care through community-based health fairs and healthy living groups; 4) increase mental health awareness in the community and reduce mental health stigma; 5) demonstrate the potential for intervention scale-up and sustainability.Trial registrationhttp://Clinicaltrials.gov : NCT02310932 registered December 8, 2014 URL: https://clinicaltrials.gov/ct2/show/record/NCT02310932 ; Clinical Trials Registry India: CTRI/2018/04/013001 retrospectively registered on April 4, 2018.

Project description:BackgroundTo determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting.MethodsA prospective cluster randomized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto. Preventive Care Checklist Forms were created to be used by family physicians at adult health check-ups over a five-month period. The sex-specific forms incorporate evidence-based recommendations on preventive health services and documentation space for routine procedures such as physical examination. The forms were used in two intervention clinics and two control clinics. Rates and relative risks (RR) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups.ResultsRandomly-selected charts were reviewed at baseline (n = 509) and post-intervention (n = 608). Baseline rates for provision of preventive health services ranged from 3% (fecal occult blood testing) to 93% (blood pressure measurement), similar to other settings. The percentage of up-to-date preventive health services delivered per patient at the end of the intervention was 48.9% in the control group and 71.7% in the intervention group. This is an overall 22.8% absolute increase (p = 0.0001), and 46.6% relative increase in the delivery of preventive health services per patient in the intervention group compared to controls. Eight of thirteen preventive health services showed a statistically significant change (p < 0.05) in favor of the intervention (adjusted RR (95% C.I.)): counseling on brushing/flossing teeth (9.2 (4.3-19.6)), folic acid counseling (7.5 (2.7-20.8)), fecal occult blood testing (6.7 (1.9-24.1)), smoking cessation counseling (3.9 (2.2-7.2)), tetanus immunization (3.0 (1.7-5.2)), history of alcohol intake (1.33 (1.2-1.5)), history of smoking habits (1.28 (1.2-1.4)) and blood pressure measurement (1.05 (1.00-1.10)).ConclusionThis simple, low cost, clinically relevant intervention improves the delivery of preventive health services by prompting physicians of evidence-based recommendations in a checklist format that incorporates existing practice patterns. Periodic updates of the Preventive Care Checklist Forms will allow a feasible and easy-to-use tool for primary care physicians to provide evidence-based preventive health services to adults at routine health check-ups. The forms can also be incorporated into an electronic health record. The Preventive Care Checklist Forms are accessible in English and French at the College of Family Physicians of Canada web site.

Project description:BackgroundThe Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here.MethodsThe CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys.ResultsThere were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys.ConclusionsRandomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012.

Project description:Domestic Violence and Abuse (DVA) is associated with a range of psychosocial and mental health problems. Having a psychiatric illness increases likelihood of being a victim of DVA. Despite the evidence of a high risk for DVA and the serious effects of violent victimization in psychiatric patients, detection rates are low and responses are inadequate. The aim of the BRAVE (Better Reduction trough Assessment of Violence and Evaluation) study is to improve detection of and response to DVA in psychiatric patients. In this article, we present the protocol of the BRAVE study which follows the SPIRIT guidelines.The BRAVE study is a cluster randomized controlled trial. We will include 24 community mental health teams from Rotterdam and The Hague. Twelve teams will provide care as usual and 12 teams will receive the intervention. The intervention consists of 1) a knowledge and skills training for mental health professionals about DVA, 2) a knowledge and skills training of DVA professionals about mental illness, 3) provision and implementation of a referral pathway between community mental health and DVA services. The follow up period is 12 months. Our primary outcome is the rate of detected cases of recent or any history of DVA in patients per team in 12 months. Detection rates are obtained through a systematic search in electronic patient files. Our secondary aims are to obtain information about the gain and sustainability of knowledge on DVA in mental health professionals, and to obtain insight into the feasibility, sustainability and acceptability of the intervention. Data on our secondary aims will be obtained through structured in depth interviews and a questionnaire on knowledge and attitudes on DVA.This study is the first cluster randomized controlled trial to target both male and female psychiatric patients that experience DVA, using an intervention that involves training of professionals. We expect the rate of detected cases of DVA to increase in the intervention teams. With early detection of victimization of DVA in psychiatric patients we hope to improve the mental health of psychiatric patients in the short and long term.ISRCTN:14115257 . Date of registration: 15th January 2015.

Project description:BACKGROUND:Physically inactive and sedentary lifestyles are negatively related to both mental health and cognition. For office-workers, who spend two-thirds of their workday sitting, it is important to improve these lifestyles. The aim of this study is to assess the effectiveness of multi-component interventions, incorporating individual, environmental and organizational changes, to increase physical activity or reduce sedentary behavior among office-workers in order to improve mental health and cognition. METHODS:a 3-arm, clustered randomized controlled trial (RCT) with waiting list control group amongst adult office-workers of two large Swedish companies. Cluster teams will be randomized into 6-month interventions or to a passive waiting list control group which will receive the allocated intervention with a 6-month delay. Two multicomponent interventions will be studied of which one focuses on improving physical activity and the other on reducing sedentary behavior. Both interventions include 5 sessions of motivational counselling. In the physical activity intervention persons also get access to a gym and team leaders will organize lunch walks and encourage to exercise. In the sedentary behavior intervention standing- and walking meetings will be implemented and team leaders will encourage to reduce sitting. The recruitment target is 110 office-workers per arm (330 in total). Measurements will be repeated every 6?months for a total intended duration of 24?months. Proximal main outcomes are physical activity measured with accelerometers and sedentary behavior with inclinometers. Distal outcomes are self-reported mental health and a cognition test battery. Additional outcomes will include cardiovascular fitness, body composition, sleep, self-reported physical activity and sedentary behavior, other health habits, physical health, and working mechanisms from blood samples and questionnaires. DISCUSSION:This cluster RCT will contribute to the currently available evidence by comparing the effectiveness of multi-component interventions targeting physical activity or sedentary behavior with the end goal of improving mental health and cognition. This study is strong in its cluster randomized design, numerous objective outcome measures and long-term follow-up. The exact content of the interventions has been defined by combining theory with results from a larger research project as well as having a continuous dialogue with the involved companies. TRIAL REGISTRATION:ISRCTN92968402 .

Project description:BackgroundSignificant investments are being made to close the mental health (MH) treatment gap, which often exceeds 90% in many low- and middle-income countries (LMICs). However, limited attention has been paid to patient quality of care in nascent and evolving LMIC MH systems. In system assessments across sub-Saharan Africa, MH loss-to-follow-up often exceeds 50% and sub-optimal medication adherence often exceeds 60%. This study aims to fill a gap of evidence-based implementation strategies targeting the optimization of MH treatment cascades in LMICs by testing a low-cost multicomponent implementation strategy integrated into routine government MH care in Mozambique.MethodsUsing a cluster-randomized trial design, 16 clinics (8 intervention and 8 control) providing primary MH care will be randomized to the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) or an attentional placebo control. SAIA-MH is a multicomponent implementation strategy blending external facilitation, clinical consultation, and provider team meetings with system-engineering tools in an overall continuous quality improvement framework. Following a 6-month baseline period, intervention facilities will implement the SAIA-MH strategy for a 2-year intensive implementation period, followed by a 1-year sustainment phase. Primary outcomes will be the proportion of all patients diagnosed with a MH condition and receiving pharmaceutical-based treatment who achieve functional improvement, adherence to medication, and retention in MH care. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success. Specific Aim 1b will include the evaluation of mechanisms of the SAIA-MH strategy using longitudinal structural equation modeling as well as specific aim 2 estimating cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique to provincial and national levels.DiscussionThis study is innovative in being the first, to our knowledge, to test a multicomponent implementation strategy for MH care cascade optimization in LMICs. By design, SAIA-MH is a low-cost strategy to generate contextually relevant solutions to barriers to effective primary MH care, and thus focuses on system improvements that can be sustained over the long term. Since SAIA-MH is integrated into routine government MH service delivery, this pragmatic trial has the potential to inform potential SAIA-MH scale-up in Mozambique and other similar LMICs.Trial registrationClinicalTrials.gov; NCT05103033 ; 11/2/2021.

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Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial.

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Improving and sustaining delivery of CPT for PTSD in mental health systems: a cluster randomized trial.

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