Virtual Learning Collaborative Compared to Technical Assistance as a Strategy for Implementing Health Promotion in Routine Mental Health Settings: A Hybrid Type 3 Cluster Randomized Trial.

BACKGROUND: Despite widespread use of learning collaboratives, few randomized trials have evaluated their effectiveness as a strategy for implementing evidence based practices. This randomized trial evaluated the effectiveness of a virtual learning collaborative (VLC) in the implementation of a health promotion program for persons with serious mental illness (SMI) aimed at reducing cardiovascular risk reduction in routine mental health settings, compared to routine technical assistance (TA). METHODS: Fifty-five mental health provider organizations were recruited to participate in a Hybrid Type 3 cluster randomized implementation-effectiveness trial of the InSHAPE health promotion program for persons with SMI. Sites were stratified by size and randomized prior to implementation to an 18-month group-based VLC with monthly learning sessions or individual site TA with four scheduled conference calls over 18 months. Primary implementation and service outcomes were InSHAPE program fidelity, participation, and reach. Primary clinical outcomes were weight loss, cardiorespiratory fitness, and cardiovascular risk reduction (≥ 5% weight loss or > 50 m increase on the 6-Minute Walk Test). Program fidelity was assessed at 6, 12, and 24 months; program participation and participant-level outcomes were assessed at 3, 6, 9, and 12 months. RESULTS: VLC (N = 27) and TA (N = 28) sites were similar in organizational characteristics (all p > 0.05). At 12-month follow-up mean program fidelity score was higher in VLC compared to TA (90.5 vs. 79.1; p = 0.002), with over double the proportion with good fidelity (VLC = 73.9% vs. TA = 34.8%; p = 0.009). Over half of individuals in both VLC and TA achieved cardiovascular risk-reduction at 6-month follow-up (VLC: 51.0%; TA: 53.5%; p = 0.517) and at 12-month follow-up (62% VLC and TA; p = 0.912). At 12-month follow-up VLC compared to TA was associated with greater participation (VLC 69.5% vs. TA 56.4% attending at least 50% of sessions, p = 0.002); larger caseloads (VLC = 16 vs. TA = 11; p = 0.024); greater reach consisting of 45% greater number of participants receiving InSHAPE (VLC = 368 vs. TA = 253), and 58% greater number of participants achieving cardiovascular risk reduction (VLC = 150 vs. TA = 95). CONCLUSION: Virtual learning collaboratives compared to routine technical assistance as an implementation strategy for evidence-based health promotion promote greater intervention fidelity, greater levels of intervention participation, greater reach, and a greater number of participants achieving clinically significant risk reduction outcomes, while achieving similarly high levels of intervention effectiveness for participants who completed at least 6 months of the program.

A pilot evaluation of the In SHAPE individualized health promotion intervention for adults with mental illness.

This pilot study examined whether participation in the individualized, community-integrated In SHAPE health promotion program would result in improved physical activity and dietary behaviors, health indicators, and psychological functioning or symptoms in 76 adults with schizophrenia, bipolar disorder, major depression, or other mental disorders. Over a 9-month period, participation was associated with increased exercise, vigorous activity, and leisurely walking (P < .01), and a trend toward improved readiness to reduce caloric intake (P = .053). Participants demonstrated a reduction in waist circumference (P < .05), but no change in BMI. Satisfaction with fitness (P < .001) and mental health functioning (P < .05) improved, and severity of negative symptoms decreased (P < .01). This study demonstrated the feasibility and potential effectiveness of the In SHAPE program, which consisted of exercise and dietary modification. Based on these promising results, randomized controlled trials of the In SHAPE program are necessary to establish its effectiveness compared with usual care and alternative approaches to enhancing fitness.

Evaluating agency-led adaptions to an evidence-based lifestyle intervention for adults with serious mental illness.

Background: Limited empirical evidence exists on the impact of adaptations that occur in implementing evidence-based practices (EBPs) in real-world practice settings. The purpose of this study was to measure and evaluate adaptations to an EBP (InSHAPE) for obesity in persons with serious mental illness in a national implementation in mental health care settings. Methods: We conducted telephone interviews with InSHAPE provider teams at 37 (95%) of 39 study sites during 24-month follow-up of a cluster randomized trial of implementation strategies for InSHAPE at behavioral health organizations. Our team rated adaptations as fidelity-consistent or fidelity-inconsistent. Multilevel regression models were used to estimate the relationship between adaptations and implementation and participant outcomes. Results: Of 37 sites interviewed, 28 sites (76%) made adaptations to InSHAPE (M = 2.1, SD = 1.3). Sixteen sites (43%) made fidelity-consistent adaptations, while 22 (60%) made fidelity-inconsistent adaptations. The number of fidelity-inconsistent adaptations was negatively associated with InSHAPE fidelity scores (ß = -4.29; p < .05). A greater number of adaptations were associated with significantly higher odds of participant-level cardiovascular risk reduction (odds ratio [OR] = 1.40; confidence interval [CI] = [1.08, 1.80]; p < .05). With respect to the type of adaptation, we found a significant positive association between the number of fidelity-inconsistent adaptations and cardiovascular risk reduction (OR = 1.59; CI = [1.01, 2.51]; p < .05). This was largely explained by the fidelity-inconsistent adaptation of holding exercise sessions at the mental health agency versus a fitness facility in the community (a core form of InSHAPE) (OR = 2.52; 95% CI = [1.11, 5.70]; p < .05). Conclusions: This research suggests that adaptations to an evidence-based lifestyle program were common during implementation in real-world mental health practice settings even when fidelity was monitored and reinforced through implementation interventions. Results suggest that adaptations, including those that are fidelity-inconsistent, can be positively associated with improved participant outcomes when they provide a potential practical advantage while maintaining the core function of the intervention. Plain language abstract: Treatments that have been proven to work in research studies are not always one-size-fits-all. In real-world clinical settings where people receive mental health care, sometimes there are good reasons to change certain things about a treatment. For example, a particular treatment might not fit well in a specific clinic or cultural context, or it might not meet the needs of specific patient groups. We studied adaptations to an evidence-based practice (InSHAPE) targeting obesity in persons with serious mental illness made by teams implementing the program in routine mental health care settings. We learned that adaptations to InSHAPE were common, and that an adaptation that model experts initially viewed as inconsistent with fidelity to the model turned out to have a positive impact on participant health outcomes. The results of this study may encourage researchers and model experts to work collaboratively with mental health agencies and clinicians implementing evidence-based practices to consider allowing for and guiding adaptations that provide a potential practical advantage while maintaining the core purpose of the intervention.

A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial.

BACKGROUND: Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance. METHODS: Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study. DISCUSSION: This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1.

Implementation of a Lifestyle Intervention for People With Serious Mental Illness in State-Funded Mental Health Centers.

OBJECTIVE: The purpose of this study was to evaluate health outcomes of a state-supported implementation in community mental health settings of an evidence-based lifestyle intervention for overweight and obese adults with serious mental illness. METHODS: Weight and fitness outcomes were evaluated for 122 overweight or obese adults with serious mental illness in four community mental health centers (CMHCs) that were participating in a phased statewide implementation of the In SHAPE lifestyle intervention. Six- and 12-month outcomes were compared between two CMHCs that implemented In SHAPE in the first 12 months and two CMHCs with similar characteristics that implemented In SHAPE in a subsequent phase in the statewide implementation 12 months later. RESULTS: Participants in the two In SHAPE sites (N=63 participants) lost significantly more weight (p=.003) and showed greater improvement in fitness (p=.011) compared with participants at the two usual care control sites (N=59 participants). At six months, nearly half (49%) of In SHAPE participants and at 12 months more than half (60%) of In SHAPE participants showed clinically significant cardiovascular risk reduction defined as ≥5% weight loss or improved fitness (>50 m [164 feet] increase on the six-minute walk test). The difference between the In SHAPE and control groups was not statistically significant. CONCLUSIONS: This natural experiment demonstrated promising public health benefits of a practical implementation of health promotion programming for overweight and obese adults with serious mental illness and offers a potential model for reducing risk of early mortality among individuals served by state-funded mental health centers nationwide.

Clinically significant improved fitness and weight loss among overweight persons with serious mental illness.

OBJECTIVE: The objective of this study was to evaluate the effectiveness of a fitness health mentor program (In SHAPE) in improving physical fitness and weight loss among overweight and obese adults with serious mental illness. METHODS: A randomized controlled trial was conducted with 133 persons with serious mental illness and a body mass index (BMI) >25 who were assigned either to the In SHAPE program (one year of weekly sessions with a fitness trainer plus a fitness club membership) or to one year of fitness club membership and education. Assessments were conducted at baseline and three, six, nine, and 12 months later. RESULTS: Participants had a mean baseline weight of 231.8±54.8 pounds and a mean BMI of 37.6±8.2. At 12-month follow-up, In SHAPE (N=67) compared with fitness club membership and education (N=66) was associated with three times greater fitness club attendance, twice as much participation in physical exercise, greater engagement in vigorous physical activity, and improvement in diet. Twice the proportion of participants (40% versus 20%) achieved clinically significant improvement in cardiorespiratory fitness (>50 m on the six-minute walk test). Weight loss and BMI did not differ between groups. Among In SHAPE participants, 49% achieved either clinically significant increased fitness or weight loss (5% or greater), and 24% achieved both clinically significant improved fitness and weight loss. CONCLUSIONS: The In SHAPE program achieved clinically significant reduction in cardiovascular risk for almost one-half of participants at 12 months. Although the intervention showed promise in improving fitness, optimizing weight loss may require additional intensive, multicomponent dietary interventions.