Article Figures & Data
Tables
- Table 1.
Purpose, Intent, and Elements of Traditional Efficacy Studies and Practical Effectiveness Trials
Issue Traditional Efficacy Study Practical Effectiveness Trial I. Purpose and intent Study goal Isolate treatment mechanism; unique approach Replicable treatment Key criteria Internal validity External validity Purpose/world view Isolate cause Understand program in context Decisions regarding Theory Practice and policy II. Study elements Participants Homogeneous, motivated Heterogeneous, representative Settings Homogeneous, single or few under control of investigator Heterogeneous, multiple to evaluate generalization across settings Intervention Intensive, highly structured, complex Less intensive, moderate structure, and flexible to permit options Intervention staff Research staff or highly trained experts Regular staff in representative settings Contextual factors Implementation consistency Generalization (reach, adoption, maintenance) Economic outcomes Behavior change (including clinical staff behavior, such as quality of care delivery, if applicable) Biologic change or clinical outcomes Quality of life Goal: To identify interventions that can: Example Smoking Study* Example Diabetes Study† Reach large numbers of people, especially those who can most benefit. 76% participation among low income, young female smokers. Participants appeared representative. 50% participation among primary care diabetes patients. Participants representative on key variables. Be effective in producing targeted outcomes at reasonable cost and produce minimal negative impacts, relative to alternatives. 11% vs. 7% cessation at 6 weeks, P < .05 Quality of life and/or adverse consequences were not measured. Intervention time reported but costs not calculated. Significant improvement on both preventive assessments and behavioral counseling aspects of care. Both conditions improved on quality of life. Intervention costs estimated at $222 per patient. Be widely adopted by many types of settings. 4 of 4 clinics with most diverse populations in the metro area. 6% of family medicine and internal medicine physicians throughout Colorado. Those participating were representative on variety of practice characteristics. Be consistently implemented by staff members with moderate levels of training and expertise. 85%–100% implementation by usual clinical staff for all treatment components except calls (43%). 97% completion of key intervention components. Produce replicable and long-lasting maintenance effects. Cessation differences (11.6% vs. 8.5%) no longer significant. Effectiveness measures were of equal magnitude and significance at 12-month follow-up as initial 6-month assessment. * Information from Glasgow et al.45
† Information from Glasgow et al.46
RE-AIM Dimension Questions to Ask Ways to Enhance Impact Reach (individual level) What percentage of the target population comes into contact? Does program reach those most in need? Will participants be representative of the patients in your practice? Formative evaluation with potential users with those declining Small-scale recruitment studies to test methods Identify and reduce barriers to participation Use multiple channels of recruitment Effectiveness (individual level) Does program achieve greater key targeted outcomes compared with other treatments? Does it produce unintended adverse consequences? How will or did it impact quality of life (QoL)? Incorporate more tailoring to individual Reinforce via repetition, multiple modalities, social support, and systems change Use stepped-care approach; less intensive intervention first Evaluate adverse outcomes and QoL for program revision Adoption (setting/organizational level) Will organizations having underserved or high-risk populations use it? Does program help the organization address its primary mission? Conduct formative evaluation with adoptees and settings that decline Recruit settings that have most contact with target audience Provide different cost options and customization of intervention Develop recruitment materials outlining program benefits and required resources Implementation (setting/organizational level) How many staff within a setting will try this? Can different levels of staff implement the program successfully? Are different components delivered as intended? Provide delivery staff with training and technical assistance Provide clear intervention protocols Consider automating all or part of the program Monitor and provide staff feedback and recognition for implementation Maintenance (individual and setting levels) Does the program produce lasting effects at individual level? Can organizations sustain the program over time? Are those persons and settings that show maintenance those most in need? Reduce level of resources required; make contacts extensive, not intensive Incorporate “natural environmental” and community supports Conduct follow-up assessments and interviews to characterize success at both levels Incorporate incentives and policy supports
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