A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial

Oddone, Eugene Z.; Damschroder, Laura J.; Gierisch, Jennifer M.; Olsen, Maren K.; Fagerlin, Angela; Sanders, Linda; Sparks, Jordan B; Turner, Marsha J.; May, Carrie L.; McCant, Felicia; Curry, David G.; White-Clark, Courtney; Juntilla, Karen A.

doi:10.1016/j.cct.2017.01.007

Cited by 5 publications

(9 citation statements)

References 28 publications

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“…These eight trials started recruitment between 2011 and 2014. Of these trials, one included dyads of patients and caregivers (Van Houtven et al, 2014), four targeted cardiovascular disease risk factors including obesity and hypertension (Jackson et al, 2016;Oddone et al, 2017;Voils et al, 2014;Voils et al, 2016;Zullig et al, 2014;Zullig et al, 2015), one addressed smoking cessation (Wilson et al, 2016), one addressed emergency department follow-up (Hastings et al, 2014), and one addressed osteoarthritis of the knee and hip (Allen et al, 2012; Table 1). The mean participant age was 57.7 years for women and 65.9 years for men.…”

Section: Resultsmentioning

confidence: 99%

“…In doing so, we found that the proportion of women ranged from 5.1% to 13.3% at the initial data pull, 4.4%-11.7% for mailed recruitment letters, 4.4%-19.2% during attempted to contact for screening, 3.3%-22.0% of those consented, and 3.3%-22.2% of those participants who completed the final outcome assessment. Five studies consented more than 10% women (Hastings et al, 2014;Oddone et al, 2017;Voils et al, 2014;Wilson et al, 2016;Zullig et al, 2014), and all but one of those targeted conditions that are not inherently tied to the patient's age (e.g., smoking, obesity, inactivity, or emergency department use). The one study that did target age-related conditions, specifically hypertension and hyperlipidemia, also aimed to increase recruitment of women (Zullig et al, 2014).…”

Section: Resultsmentioning

confidence: 99%

“…The one study that did target age-related conditions, specifically hypertension and hyperlipidemia, also aimed to increase recruitment of women (Zullig et al, 2014). Of the five studies with available numbers for participants completing screening and refusals, the proportion of women who refused participation was lower in three studies (Hastings et al, 2014;Oddone et al, 2017;Wilson et al, 2016), similar in one (Allen et al, 2012), and greater in one (Van Houtven et al, 2014). Of those who consented to study participation, 63.2%-100% of women completed the primary outcome assessment compared with 61.4%-99.6% of men; these proportions were generally similar within specific studies (data not shown).…”

Section: Resultsmentioning

confidence: 99%

“…Six of the eight studies required an in-person visit to complete the informed consent process. Two studies had all recruitment processes handled by women study team members (Hastings et al, 2014;Oddone et al, 2017). One study stratified randomization by sex and used a midcourse plan to increase the recruitment of women (Zullig et al, 2014).…”

Section: Resultsmentioning

confidence: 99%

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Enrollment and Retention of Men and Women in Health Services Research and Development Trials

Goldstein

Duan-Porter

Alkon

et al. 2019

Women's Health Issues

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Introduction: Sex-and gender-specific science is essential to inform patient-centered, evidence-based care. Developing such evidence requires adequate inclusion of both women and men in trials. We sought to describe study participation of women and men in Department of Veterans Affairs Health Services Research and Development trials. Methods: We identified recent health services research trials from one Health Services Research and Development Center of Innovation and compared the participation of women and men from trial recruitment to study completion. We also calculated the participation to prevalence ratio (PPR) by sex for each trial. Results: We included eight trials that started recruitment between 2011 and 2014. Only one study purposefully attempted to boost the recruitment of women. Overall, the PPR for women ranged from 0.2 to 4.5, with seven studies having a PPR of greater than 1, indicating that women participated in these trials at proportions greater than their prevalence in the disease population within the Department of Veterans Affairs. The PPR for men ranged from 0.8 to 1.1. Retention was best with those studies that used administrative data for final outcomes assessment. No studies provided results stratified by sex or conducted analyses to explore treatment effect by sex. Conclusions: At a single site, women participated in Health Services Research and Development trials at similar or greater rates to men without cross-study efforts to enrich the recruitment or retention of women. Adding strategic recruitment approaches could further boost the proportion of women in Department of Veterans Affairs trials and enable adequately powered sex-based analyses. Published by Elsevier Inc. on behalf of Jacobs Institute of Women's Health. Sex-and gender-based differences in the pathophysiology, quality of care, and patient experiences of disease require sexand gender-specific science to inform the provision of patientcentered, evidence-based care. For example, when compared with men, women with coronary artery disease are less likely to take statins and antiplatelet medications (Johansen, Hefner, & Foraker, 2015), and respond differently to pharmacologic interventions for pain (Bartley & Fillingim, 2013). Acquiring the evidence needed to optimize patient-centered care for women Supported by the Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) (CIN 13-410

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Enrollment and Retention of Men and Women in Health Services Research and Development Trials

Goldstein

Duan-Porter

Alkon

et al. 2019

Women's Health Issues

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“…The ACTIVATE trial was a randomized controlled trial evaluating enrollment in prevention programs and changes in behavioral activation in Veterans receiving a comprehensive health risk assessment and telephone coaching intervention compared to Veterans receiving health risk assessment and usual care. 32 The study was conducted in three Veterans Health Administration (VHA) primary care clinics in Ann Arbor, Michigan, Durham, North Carolina, and Greenville, North Carolina; the Ann Arbor and Durham VA Medical Centers are academically-affiliated, and the Greenville VA is affiliated with the Durham VA. Eligible Veterans included those who were enrolled in primary care and had at least one modifiable risk factor: BMI ≥ 30, current smoker, and/or less than 150 min of moderate/vigorous physical activity per week.…”

Section: The Activate Trialmentioning

confidence: 99%

Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE

et al. 2019

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BACKGROUND: Health coaching is an effective behavior change strategy. Understanding if there is a differential impact of health coaching on patients with low health literacy has not been well investigated. OBJECTIVE: To determine whether a telephone coaching intervention would result in similar improvements in enrollment in prevention programs and patient activation among Veterans with low versus high health literacy (specifically, reading literacy and numeracy). DESIGN: Secondary analysis of a randomized controlled trial. PARTICIPANTS: Four hundred seventeen Veterans with at least one modifiable risk factor: current smoker, BMI ≥ 30, or < 150 min of moderate physical activity weekly. METHODS: A single-item assessment of health literacy and a subjective numeracy scale were assessed at baseline. A logistic regression and general linear longitudinal models were used to examine the differential impact of the intervention compared to control on enrollment in prevention programs and changes in patient activation measures (PAM) scores among patients with low versus high health literacy. RESULTS: The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy. The coaching intervention had a greater effect on the probability of enrollment in prevention programs for patients with low numeracy (intervention vs control difference of 0.31, 95% CI 0.18, 0.45) as compared to those with high numeracy (0.13, 95% CI − 0.01, 0.27); the low compared to high differential effect was clinically, but not statistically significant (0.18, 95% CI − 0.01, 0.38; p = 0.07). Among patients with high numeracy, the intervention group had greater increases in PAM as compared to the control group at 6 months (mean difference in improvement 4.8; 95% CI 1.7, 7.9; p = 0.003). This led to a clinically and statistically significant differential intervention effect for low vs high numeracy (− 4.6; 95% CI − 9.1, − 0.15; p = 0.04). CONCLUSIONS:We suggest that health coaching may be particularly beneficial in behavior change strategies in populations with low numeracy when interpretation of health risk information is part of the intervention. CLINICALTRIALS.GOV IDENTIFIER: NCT01828567KEY WORDS: telephone coaching; health risk assessment; health literacy; health numeracy.

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Telephone counselling for smoking cessation

Matkin

Ordóñez‐Mena

Hartmann‐Boyce

2019

Cochrane Database of Systematic Reviews

179

155

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Background Telephone services can provide information and support for smokers. Counselling may be provided proactively or o ered reactively to callers to smoking cessation helplines. Objectives To evaluate the e ect of telephone support to help smokers quit, including proactive or reactive counselling, or the provision of other information to smokers calling a helpline. Search methods We searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the ICTRP for studies of telephone counselling, using search terms including 'hotlines' or 'quitline' or 'helpline'. Date of the most recent search: May 2018. Selection criteria Randomised or quasi-randomised controlled trials which o ered proactive or reactive telephone counselling to smokers to assist smoking cessation. Data collection and analysis We used standard methodological procedures expected by Cochrane. We pooled studies using a random-e ects model and assessed statistical heterogeneity amongst subgroups of clinically comparable studies using the I 2 statistic. In trials including smokers who did not call a quitline, we used meta-regression to investigate moderation of the e ect of telephone counselling by the planned number of calls in the intervention, trial selection of participants that were motivated to quit, and the baseline support provided together with telephone counselling (either self-help only, brief face-to-face intervention, pharmacotherapy, or financial incentives). Main results We identified 104 trials including 111,653 participants that met the inclusion criteria. Participants were mostly adult smokers from the general population, but some studies included teenagers, pregnant women, and people with long-term or mental health conditions. Most trials (58.7%) were at high risk of bias, while 30.8% were at unclear risk, and only 11.5% were at low risk of bias for all domains assessed. Most studies (100/104) assessed proactive telephone counselling, as opposed to reactive forms. Among trials including smokers who contacted helplines (32,484 participants), quit rates were higher for smokers receiving multiple sessions of proactive counselling (risk ratio (RR) 1.38, 95% confidence interval (CI) 1.19 to 1.61; 14 trials, 32,484 participants; I 2 = 72%) Telephone counselling for smoking cessation (Review)

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A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial

Cited by 5 publications

References 28 publications

Enrollment and Retention of Men and Women in Health Services Research and Development Trials

Enrollment and Retention of Men and Women in Health Services Research and Development Trials

Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE

Telephone counselling for smoking cessation

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