From Randomized Controlled Trials to Real-Life: Models for Moving Dementia Caregiver Intervention Research to Community and Home : From Randomized Controlled Trials to Real-Life: Models for Moving Dementia Caregiver Intervention Research to Community and Home Laura N. Gitlin, Ph.D. Director, Center for Applied Research on Aging and Health Thomas Jefferson University, Philadelphia (Supported by funds from NIA/NINR #5 U01 AG13265 And AOA # 90CG257)


Overview of Presentation: Overview of Presentation What is the evidence? Moving from randomized trials to practice 3 types of randomized trials Implications for translation Translational steps Advancing Translational Work


WHAT IS THE EVIDENCE?: WHAT IS THE EVIDENCE?


Slide4: Key Developments in Dementia Caregiver Research 1985 to present 1990s to present 1985-1995 1997-1999 1997 to present 1999 2000 2001 to present Descriptive research– prevalence and characteristics of caregiving Measurement – burden scales; assessing problem behaviors among AD patients Stress Health Process Models applied to caregiving and refined Modest success achieved with individual based interventions Economic incentive programs have limited impact 1995 to present Psychiatric and physical morbidity effects identified Role conflict and other secondary stressors identified Economic value and costs of caregiving Multi-site randomized interventions trials (e.g. REACH) developed and tested Caregiver risks of poor health and mortality identified Multi-component interventions achieve clinically significant outcomes Proliferation of caregiver interventions tested using RCT and found to be effective Translation of intervention strategies to practice settings


Summary from Meta-analyses: Summary from Meta-analyses Small but significant benefits derived on a wide range of outcomes: Skill enhancement Burden/depression CR symptom reduction/NH placement Multi-component interventions more effective Tailoring to individual participants important Women benefit more than men Few tested studies with diverse caregivers


Research-Practice Gap : Research-Practice Gap Caregiver assessment not integrated within existing services Interventions with known efficacy have not been translated/integrated into: Aging network of services National Family Caregiver Programs Existing health services (e.g., home care, hospital discharge planning) Families continue to be underserved and do not receive proven interventions


From Randomized Trial to Practice : From Randomized Trial to Practice


Phases of RCTs: Phases of RCTs Phase I (safety, feasibility, acceptability) Phase II (preliminary effect size, side effects, dosing) Phase III (efficacy of new treatment compared to standard) Phase IV (application in clinical setting; long-term safety ,fidelity) Phase V (sustainability) Forward Translation Reverse Translation


Translational Efforts: Translational Efforts Forward Translation Hierarchical system converging toward clinical practice Research chain starting with experimental and theoretical models converging or leading to clinical practice Glasgow et al (RE-AIM model) – Need to expand assessment of interventions beyond efficacy


3 Models : 3 Models Pure top down Not service setting or profession specific Not all treatment elements may have translation potential Funding mechanism for sustainability unclear REACH II Multi-component (Annals of Internal Medicine, 2006) ________________________________________ Hybrid Service setting and profession specific Potential for reimbursement under current Medicare Part B guidelines REACH I Environmental Skill-building Program (ESP) (Gitlin et al., TG, 2001, 2003, 2005) _______________________________________ Embedded Tested within adoption setting by staff Cost absorbed by setting Adult Day Service Plus (ADS Plus) (Gitlin et al., TG, 2006)


Study Highlights: Study Highlights


Study Highlights: Study Highlights


Study Highlights: Study Highlights


Pure Form (REACH II) Pros/Cons: Pure Form (REACH II) Pros/Cons Strong research design possible Allows testing of new, innovative approaches without concern for setting or professional boundaries Multi-site design high in internal and external validity Treatment implementation data allows for component and dose-response analysis Tested intervention may be too complex for real-world conditions Entire intervention approach may not translate easily Cost-efficiency questionable Who, what, when and where to place intervention needs to be evaluated


Hybrid (Philadelphia Site REACH I) Pros/Cons: Hybrid (Philadelphia Site REACH I) Pros/Cons Strong research design possible Intervention components are service ready Some ecological validity Profession-based May limit generalizability to settings with limited access to interventionists Affordability of adoption can become issue Dependent in part on whims of funding mechanisms and service structures for which it was designed


Embedded (Adult Day Plus) Pros/Cons: Embedded (Adult Day Plus) Pros/Cons Intervention is service ready High ecological validity Able to evaluate provider adoption and CG acceptability within targeted setting Outcomes may be confounded by site/practice characteristics Best used if able to build on proven interventions


RE-AIM Model:Translational Capacity of 3 Models : RE-AIM Model: Translational Capacity of 3 Models


Phase I: Translational Steps: Phase I: Translational Steps


Slide20: Pure REACH II Hybrid ESP Embedded ADS Plus # of Translational steps High Low


Phase II: Translational Steps: Phase II: Translational Steps 1. Site Development Assess staff needs (e.g, hire of interventionists) Prepare site (e.g., importance of evidence-based programs, introduction to intervention) Establish referral mechanism, intake forms and billing/reimbursement procedures for intervention Develop marketing materials and plan for rollout


Phase II: Translational Steps: Phase II: Translational Steps 2. Refine Intervention/Service Program Refine eligibility criteria Identify core domains to evaluate outcomes Refine session by session protocols Refine treatment manuals and package for site usability Identify treatment fidelity approach


Phase II: Translational Steps: Phase II: Translational Steps 3. Training Establish certification criteria for training staff/interventionists Refine training manuals and materials Implement training and evaluate uptake 4. Implementation and Evaluation Ongoing monitoring of fidelity Evaluation of participant benefit Booster training if necessary On-going identification of lessons learned/costs etc.


Site Adoption Considerations: Site Adoption Considerations Required resources for adoption Integration in existing structures to reduce cost and enhance sustainability Buy-in by site personnel: Importance of using evidence-based programs Immutable and mutable aspects of intervention need to be identified (e.g., what can site change and what must be kept in tact when implementing a proven intervention) Treatment Fidelity – development of monitoring forms and quality assurance to assure integrity of implementation


Conclusions: Conclusions 3 models of existing caregiver interventions Each are theory based, attain scientific integrity, & proven effectiveness 3 models represent different translational needs and challenges Each model has different relationship to translational effort Each model presents pros/cons for science and translation


Conclusions: Conclusions Translational steps depend on type of RCT: E.g., Embedded model has fewer and different set of translational steps than Pure Model If primary goal is immediate translation – hybrid/embedded models may be preferred: Able to test simultaneously efficacy and translational issues Very high ecological validity in that end users are part of intervention development and testing More rapid transition to real-world settings May be more efficient Cost, adoption capacity are easily tested as part of efficacy model


Implications: Implications Identifying translational steps for RCTs may expedite research-practice integration No one successful translational strategy Each model has pros/cons Designing interventions based on current reimbursement mechanisms and service structures may serve immediate needs but can hinder science and long-term benefits for families Need to balance translational approaches with basic science needs


Implications: Implications Moving forward with caregiver intervention studies: Design of Phase III trials should identify upfront translational steps Need for more hybrid and embedded models Need for collaboration with potential adoption sites in developing study design/intervention Combine efficacy and effectiveness in one phase Funding mechanisms for translational research not well developed NIMH, NCI, NIH Roadmap Cost of translation needs to be considered