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Challenges in assessing population reach in a pragmatic trial.

ABSTRACT: Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) was a pragmatic cluster-randomized trial conducted at federally qualified health centers and designed to "Reach" as many unscreened patients as possible by directly mailing them fecal screening tests. STOP CRC used an electronic health record registry to identify individuals' needing CRC screening and mail interventions to them. The registry was updated daily removing individuals completing CRC screening or those who no longer were clinic patients. Reach, a component RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance), is defined as the absolute number, percent, and representativeness of individuals "willing to participate in" or "exposed to" an initiative. We describe the complexities of measuring Reach in a pragmatic trial. Overall 21,134 patients were on the registry list for at least one day, with 18,226 remaining after removing patients completing screening before any mailings. Observed Reached (the percent of individuals exposed to the intervention) using each denominator was 30.7% and 35.6% respectively. Reach improved only modestly after accounting for factors that made it impossible for clinics to send mailings. Few differences were observed in demographic and health care utilization factors among individuals Reached versus not Reached, suggesting that health center Implementation was more influential than patients' willingness or ability to participate. A pragmatic definition of Reach that accounted for dynamic changes the absolute number eligible and the proportion exposed was more useful than traditional definitions of Reach. Actual Reach was dependent on Implementation and not patient level characteristics. Clinical Trials Registration Number: ClincalTrials.gov (NCT01742065).

SUBMITTER: Green BB

PROVIDER: S-EPMC6558213 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Challenges in assessing population reach in a pragmatic trial.

Green Beverly B BB Vollmer William M WM Keast Erin E Petrik Amanda F AF Coronado Gloria D GD

Preventive medicine reports 20190529

Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) was a pragmatic cluster-randomized trial conducted at federally qualified health centers and designed to "Reach" as many unscreened patients as possible by directly mailing them fecal screening tests. STOP CRC used an electronic health record registry to identify individuals' needing CRC screening and mail interventions to them. The registry was updated daily removing individuals completing CRC screening or thos ...[more]

PMID: 31198661

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Project description:In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population.To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain.A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day period at the offices of 28 Vermont licensed acupuncturists. PROMIS® questionnaires were administered prior to and at the end of the treatment period to assess changes in pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation. Questionnaires also captured patients' overall impressions of treatments as well as self-reported changes in medication use and work function.One hundred eleven women (71%) and 45 men (29%) with a wide range of pain complaints received a mean of 8.2 treatments during the intervention period. Measurements captured prior to and at the end of the treatment period showed significant improvements in group mean pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) measures (paired t tests, P < .01). Fifty-seven percent of patients using analgesic (nonopioid) medication reported reductions in use. Thirty-two percent of patients using opioid medication reported reductions in use of opioid medication following the intervention. Seventy-four percent of employed patients reported improved capacity to work. Ninety-six percent of patients said that they would recommend acupuncture to others with chronic pain, and 91% reported qualitative improvements, including physical (31%), functional/behavioral (29%), and psycho-emotional (24%) improvements.Our findings demonstrate that acupuncture treatment for chronic pain is feasible and well received by patients in the Vermont Medicaid population. Receiving care from Licensed Acupuncturists was associated with significant improvements in physical, functional, psycho-emotional, and occupational outcomes compared with before receiving acupuncture treatments.

Project description:BACKGROUND:Mixed urinary incontinence (MUI) is a common, bothersome condition in women. In MUI, the two subtypes of urinary incontinence that coexist are treated differently; stress urinary incontinence (SUI) is primarily treated surgically while urge urinary incontinence (UUI) is primarily treated medically. There is no evidence to guide the treatment for women with significant bother from both incontinence subtypes. Therefore, investigators of the Urinary Incontinence Treatment Network (UITN) designed and initiated a randomized clinical trial comparing outcomes for two distinct initial treatment approaches for women with mixed urinary incontinence (MUI): therapy initiated with surgery versus therapy initiated with nonsurgical treatment. PURPOSE:The aim of this manuscript is to describe the challenges in planning and implementing this randomized clinical trial. METHODS:The mixed incontinence: medical or surgical approach (MIMOSA) trial was designed as a practical or pragmatic clinical trial to establish the relative efficacy of two specific treatment approaches. The design presented many challenging decisions including: (1) selection of practical paradigm; (2) refining inclusion/ exclusion criteria to offer equipoise; (3) selection of feasibility sample size; (4) recruitment challenges for two divergent treatment approaches (medical vs. surgical), and (5) resolution of ethical and methodological issues. RESULTS:MIMOSA recruitment was planned in two phases, starting with a 5-month pilot and feasibility phase followed by a full trial contingent on the outcome of the first phase. The feasibility portion of the MIMOSA trial started in November 2008. 1198 subjects were screened and approached for study enrollment, but only 27 consented to randomization. The feasibility study was halted due to lack of enrollment in March 2009. LIMITATIONS:The challenges of this trial included a lack of information from subjects who did not enroll, increasing the difficulty of interpreting the feasibility phase. CONCLUSIONS:Successful recruitment to a randomized trial that compares significantly different treatment approaches poses a challenge.

Project description:BACKGROUND:Obesity is a major risk factor behind some of the most common problems encountered in primary care. Although effective models for obesity treatment have been developed, the 'reach' of these interventions is poor and only a small fraction of primary care patients receive evidence-based treatment. The purpose of this study is to identify factors that impact the uptake (reach) of an evidence-based obesity treatment program within the context of a pragmatic cluster randomized controlled trial comparing three models of care delivery. METHODS:Recruitment and reach were evaluated by the following measures: 1) mailing response rates, 2) referral sources among participants contacting the study team, 3) eligibility rates, 4) participation rates, and 5) representativeness based on demographics, co-morbid conditions, and healthcare utilization of 1432 enrolled participants compared to >?17,000 non-participants from the clinic-based patient populations. Referral sources and participation rates were compared across study arms and level of clinic engagement. RESULTS:The response rate to clinic-based mailings was 13.2% and accounted for 66% of overall program recruitment. An additional 22% of recruitment came from direct clinic referrals and 11% from media, family, or friends. Of those screened, 87% were eligible; among those eligible, 86% enrolled in the trial. Participation rates did not vary across the three care delivery arms, but were higher at clinics with high compared to low provider involvement. In addition, clinics with high provider involvement had a higher rate of in clinic referrals (33% versus 16%) and a more representative sample with regards to BMI, rurality, and months since last clinic visit. However, across clinics, enrolled participants compared to non-participants were older, more likely to be female, more likely to have had a joint replacement but less likely to have CVD or smoke, and had fewer hospitalizations. CONCLUSIONS:A combination of direct patient mailings and in-clinic referrals may enhance the reach of primary care behavioral weight loss interventions, although more proactive outreach is likely necessary for men, younger patients, and those at greater medial risk. Strategies are needed to enhance provider engagement in referring patients to behavioral weight loss programs. TRIAL REGISTRATION:clnicialtrials.gov NCT02456636. Registered May 28, 2015, https://www.clinicaltrials.gov/ct2/results?cond=&term=RE-POWER&cntry=&state=&city=&dist=.

Project description:BackgroundHigh attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.PurposeTo describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.MethodsThis study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.DiscussionThis study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.

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Challenges in assessing population reach in a pragmatic trial.

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Challenges in assessing population reach in a pragmatic trial.

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