Denise Orwig

Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium.

Treatment fidelity refers to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. This article describes a multisite effort by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium (BCC) to identify treatment fidelity concepts and strategies in health behavior intervention research. The work group reviewed treatment fidelity practices in the research literature, identified techniques used within the BCC, and developed recommendations for incorporating these practices more consistently. The recommendations cover study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Funding agencies, reviewers, and journal editors are encouraged to make treatment fidelity a standard part of the conduct and evaluation of health behavior intervention research.

A New Tool to Assess Treatment Fidelity and Evaluation of Treatment Fidelity across 10 Years of Health Behavior Research.

A. Bellg, B. Borrelli, et al. (2004) previously developed a framework that consisted of strategies to enhance treatment fidelity of health behavior interventions. The present study used this framework to (a) develop a measure of treatment fidelity and (b) use the measure to evaluate treatment fidelity in articles published in 5 journals over 10 years. Three hundred forty-two articles met inclusion criteria; 22% reported strategies to maintain provider skills, 27% reported checking adherence to protocol, 35% reported using a treatment manual, 54% reported using none of these strategies, and 12% reported using all 3 strategies. The mean proportion adherence to treatment fidelity strategies was .55; 15.5% of articles achieved greater than or equal to .80. This tool may be useful for researchers, grant reviewers, and editors planning and evaluating trials.

Gender differences in mortality after hip fracture: the role of infection.

Possible explanations for the observed gender difference in mortality after hip fracture were examined in a cohort of 804 men and women. Mortality during 2 years after fracture was identified from death certificates. Men were twice as likely as women to die, and deaths caused by pneumonia/influenza and septicemia showed the greatest increase.

The Effect of Social Support on Exercise Behavior in Older Adults

The purpose of this study was to test the relationship among social supports related to exercise (family, friends, and expert support), self-efficacy expectations, outcome expectations, and exercise behavior in a sample of older adults living in a continuing care retirement community. The sample included 74 older adults with a mean age of 85.6±5.5. Path analysis using Amos 4.0 was done. The model fit the data (chi-square = 4.6, df = 3, p = .21, normed fit index of .99, relative fit index of .98, and root mean square error of approximation of .08) and explained 53% of the variance in exercise behavior. Five of the seven hypothesized paths in the model were statistically significant. Friend support indirectly influenced exercise through self-efficacy and outcome expectations. This suggests interventions to improve exercise behavior in older adults should incorporate social supports to strengthen self-efficacy and outcome expectations related to exercise.

Treatment fidelity in behavior change research: a case example.

BackgroundTreatment fidelity refers to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. Assuring optimal treatment fidelity also may decrease the costs of a study and help the research team explain findings. ApproachThe Behavioral Change Consortium developed a comprehensive model of treatment fidelity that incorporates 5 areas: (a) study design, (b) training providers, (c) delivery of treatment, (d) receipt of treatment, and (e) enactment of treatment skills. The definitions of these areas and a case example (Testing the Effectiveness of the Exercise Plus Program) are provided. ResultsThere was evidence of treatment fidelity related to delivery based on careful monitoring of the study implementation. A comprehensive plan for training of the interventionists was provided, although evidence of treatment fidelity to training was not quantified. There were evidence based on observations of treatment sessions of delivery and receipt of the intervention and evidence of enactments based on evaluation of exercise calendars. DiscussionThe development and implementation of a treatment fidelity plan requires a careful conceptualization of what is relevant to treatment fidelity in any given study. Monitoring of treatment fidelity ideally requires direct or indirect observations of sessions, which can be built into the study design so that costs are minimal in terms of time and resources. Monitoring treatment fidelity allows research teams to truly test interventions and to develop and implement interventions that ultimately improve the overall health and well-being of individuals.

Inappropriate drug use and risk of transition to nursing homes among community-dwelling older adults.

Background:Adverse events from inappropriate medications are preventable risk factors for nursing home admissions. Objective:We sought to investigate the relationship between inappropriate medications in older adults and transitions to nursing home. Methods:A retrospective cohort of Medicare beneficiaries with employer-sponsored supplemental health insurance was analyzed using a longitudinal data set of Medicare supplemental insurance claims. After a baseline year with no nursing home admissions, subjects were followed until the first month of transition to nursing home, loss to follow-up, or the end of the 24-month follow-up period. Survival analysis was used to compare the risk of nursing home transition among those with and without inappropriate drug use in the previous 3 months. Results:Of the 487,383 subjects in the cohort, 22,042 (4.5%) had a nursing home admission. Use of inappropriate drugs was associated with a 31% increase in risk of nursing home admission, compared with no use of inappropriate drugs (adjusted relative risk 1.31, 99% confidence interval [CI] 1.26–1.36). Analyses of individual drug classes showed the risk of nursing home admission was similar, or lower, for inappropriate drugs versus other drugs of the same class. For example, the relative risk of nursing home admission was 2.34 (99% CI 2.20–2.47) for inappropriate narcotics and 2.68 (99% CI 2.55–2.82) for other narcotics, compared with no narcotic use. Conclusion:Inappropriate drug use was associated with increased risk of nursing home transition, but the increased risk may be explained by underlying patient conditions for which the drugs were prescribed rather than the inappropriate drug.

Testing the effectiveness of the exercise plus program in older women post-hip fracture

Background: Exercise is an important strategy with potential to improve recovery in older adults following a hip fracture.Purpose: The purpose of this study was to test the impact of a self-efficacy based intervention, the Exercise Plus Program, and the different components of the intervention, on self-efficacy, outcome expectations, and exercise behavior among older women post-hip fracture.Methods: Participants were randomized to one of four groups: exercise plus, exercise only, plus only (i.e., motivation), or routine care. Data collection was done at baseline (within 22 days of fracture), 2, 6, and 12 months post-hip fracture.Results: A total of 209 women were recruited with an average age of 81.0 years (SD=6.9). The majority was White (97.1%), was widowed (57.2%), and had a high school education (66.7%). Generalized Estimating Equations were used to perform repeated measures analyses. No differences in trajectories of recovery were observed for self-efficacy or outcome expectations. A statistically significant difference in the overall trajectory of time in exercise was seen (p<.001), with more time spent exercising in all three treatment groups.Conclusions: The study demonstrated that it was possible to engage these women in a home-based exercise program and that the plus only, exercise only, and the exercise plus groups all increased exercise.

Delivery and Outcomes of a Yearlong Home Exercise Program After Hip Fracture: A Randomized Controlled Trial

BACKGROUND Hip fracture affects more than 1.6 million persons worldwide and causes substantial changes in body composition, function, and strength. Usual care (UC) has not successfully restored function to most patients, and prior research has not identified an effective restorative program. Our objective was to determine whether a yearlong home-based exercise program initiated following UC could be administered to older patients with hip fracture and improve outcomes. METHODS A randomized controlled trial of 180 community dwelling female patients with hip fracture, 65 years and older, randomly assigned to intervention (n = 91) or UC (n = 89). Patients were recruited within 15 days of fracture from 3 Baltimore-area hospitals from November 1998 through September 2004. Follow-up assessments were conducted at 2, 6, and 12 months after fracture. The Exercise Plus Program was administered by exercise trainers that included supervised and independently performed aerobic and resistive exercises with increasing intensity. Main outcome measures included bone mineral density of the contralateral femoral neck. Other outcomes included time spent and kilocalories expended in physical activity using the Yale Physical Activity Scale, muscle mass and strength, fat mass, activities of daily living, and physical and psychosocial functioning. The effect of intervention for each outcome was estimated by the difference in outcome trajectories 2 to 12 months after fracture. RESULTS More than 80% of participants received trainer visits, with the majority receiving more than 3 quarters (79%) of protocol visits. The intervention group reported more time spent in exercise activity during follow-up (P < .05). Overall, small effect sizes of 0 to 0.2 standard deviations were seen for bone mineral density measures, and no significant patterns of time-specific between-group differences were observed for the remaining outcome measures. CONCLUSION Patients with hip fracture who participate in a yearlong, in-home exercise program will increase activity level compared with those in UC; however, no significant changes in other targeted outcomes were detected. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00390741.

Model testing for reliability and validity of the Outcome Expectations for Exercise Scale.

BackgroundDevelopment of a reliable and valid measure of outcome expectations for exercise appropriate for older adults will help establish the relationship between outcome expectations and exercise. Once established, this measure can be used to facilitate the development of interventions to strengthen outcome expectations and improve adherence to regular exercise in older adults. ObjectivesBuilding on initial psychometrics of the Outcome Expectation for Exercise (OEE) Scale, the purpose of the current study was to use structural equation modeling to provide additional support for the reliability and validity of this measure. MethodsThe OEE scale is a 9-item measure specifically focusing on the perceived consequences of exercise for older adults. The OEE scale was given to 191 residents in a continuing care retirement community. The mean age of the participants was 85 ± 6.1 and the majority were female (76%), White (99%), and unmarried (76%). Using structural equation modeling, reliability was based on R 2 values, and validity was based on a confirmatory factor analysis and path coefficients. ResultsThere was continued evidence for reliability of the OEE based on R 2 values ranging from .42 to .77, and validity with path coefficients ranging from .69 to .87, and evidence of model fit (X 2 of 69, df = 27, p < .05, NFI = .98, RMSEA = .07). ConclusionThe evidence of reliability and validity of this measure has important implications for clinical work and research. The OEE scale can be used to identify older adults who have low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and thereby improve exercise behavior.

Pressure Ulcers in Elderly Patients with Hip Fracture Across the Continuum of Care

OBJECTIVES: To identify care settings associated with greater pressure ulcer risk in elderly patients with hip fracture in the postfracture period.