A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics

Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.     

HealthLinks randomized controlled trial: Design and baseline results

Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; and 3302 employees across the worksites participated in the baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness.     

Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial

Prostate cancer patients receiving androgen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment. Because physical activity improves physical and psychological well-being, a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life (QOL). No studies have evaluated an intervention to improve multiple QOL domains in patients receiving androgen ablation therapy. Active for Life After Cancer is a three-group randomized controlled trial designed to evaluate the effectiveness of a lifestyle physical activity intervention (Lifestyle Program) in improving QOL. The Lifestyle Program, a 6-month behavioral skills training group, is compared to an Educational Support Program and Standard Care. The purpose of this paper is to describe the design of the randomized trial and present baseline data that will characterize the QOL of the sample. Challenges to recruitment for the trial also will be presented and discussed.     

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial

BACKGROUND: Smoking cessation of patients with cancer can improve treatment efficacy and survival. OBJECTIVE: To determine whether a motivational interviewing intervention increased successful smoking cessation attempts of patients with cancer attending a South Australian public hospital, as compared with usual care. METHODS: A randomized controlled trial was used to study 137 patients with mixed cancer sites, including 74 intervention patients and 63 control patients. The motivational interviewing intervention was delivered over a 3-month period. The intervention included a visit with a smoking cessation counselor, provision of smoking cessation booklets, nicotine replacement therapy, family advice to quit, and an in-person or telephone follow-up conversation. RESULTS: At the 6-month follow-up visit, an intention-to-treat analysis found no difference in biochemically confirmed 3-month prevalence quit rates between the intervention (5%) and control (6%) groups. A sensitivity analysis using more lenient criteria indicated quit rates of 29% for the intervention group and 18% for the control group (p = .32). The predictors of smoking cessation at 6 months for all the patients included a smoking-related cancer site, more cessation attempts in the year before enrollment in the study, and no radiation therapy. CONCLUSIONS: Future efforts to improve smoking cessation in this patient group might focus on the delivery of more direct methods for encouraging spouse cessation and support to the patient in quitting, and the use of bupropion (Zyban) as an adjunct to cessation for this heavy smoking patient group.     

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥ 140 mm Hg for non-diabetic or ≥ 130 mm Hg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12 months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5 years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6 mm Hg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.     

An anti-inflammatory dietary intervention to reduce breast cancer recurrence risk: Study design and baseline data

U.S. breast cancer survivors (BCSs) are expected to increase to 4 million in the next 5–10 years. Cancer recurrence risk is highest among obese survivors. Inflammatory (Pro-I) biomarkers including C-reactive protein (CRP), Interleukins -3, -6, and -8 (IL-3, IL-6, IL-8), and Tumor Necrosis Factor (TNF)–α have been associated with cancer recurrence risk. Nutritional interventions aimed at reducing inflammation (INF) may contribute to reduced cancer recurrence risk, but studies have been limited to animal models. The goals of this one-year, culinary-based, pilot intervention were to: 1) decrease Pro-I biomarkers and increase anti-inflammatory (AI) cytokine, IL-10, by promoting AI food incorporation into BCS diets; and 2) examine intervention effects on cancer risk factors including body mass index (BMI) and circulating adipose stromal cells (ASCs). A total of 153 BCSs were recruited. Overweight and obese women aged 18 or older were randomized into Intervention (IG; n = 76) and Control (CG; n = 77) groups. CG received monthly nutritional brochures from the American Institute for Cancer Research. IG attended 6 monthly workshops (lectures on AI topics and chef-prepared food demonstrations), and received monthly newsletters and telephone calls incorporating Motivational Interviewing. At baseline, 6- and 12-month assessments, fasting serum was assayed for Pro-I/AI marker and ASC levels. Using R and Stata version 14 (Stata Corp, 2015), no significant differences were found between groups on baseline demographic variables. Correlations between serum cytokine levels, BMI, % body fat, ASCs, and self-reported variables are discussed.     

Supportive intervention for fatigue in patients undergoing chemotherapy: a randomized controlled trial

This study evaluated a supportive intervention for fatigue in patients undergoing chemotherapy. One hundred three chemotherapy-naïve patients were recruited, stratified by treatment regimen, and randomly allocated to intervention or usual care. The intervention was conducted over three months. Recipients were provided with an investigator-designed information pack and Fatigue Diary that they completed during the week following each treatment. Additionally, support nurses visited them monthly at home. They assessed fatigue, provided psychological support, and coached participants in self-care. The intervention group reported significantly less fatigue (P < 0.05), lower associated distress (P < 0.05), and less impact of fatigue on valued pastimes (P < 0.05) than the control group. Further, they reported significantly less anxiety (P < 0.05) and depression (P < 0.05) and displayed more adaptive coping (P < 0.05). The intervention enabled patients to adapt to living with fatigue and contributed to their psychological/emotional well-being and ability to cope with their illness and treatment.     

Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources

This article describes the methodology, recruitment, participant characteristics, and sustained, intensive stakeholder engagement for Project ACE (Achieving control, Connecting resources, Empowering families). Project ACE is a randomized controlled trial of children and youth ages 8–16 with type 1 diabetes evaluating the impact of tailored self-management resources on hemoglobin A1c (A1c) and quality of life (QOL). Despite strong evidence that controlling A1c reduces long-term complications, < 25% of US youth with type 1 diabetes meet A1c targets. Many interventions are efficacious in improving A1c and QOL for these youth, whose families often struggle with the substantial demands of the treatment regimen. However, most such interventions are ineffective in the real world due to lack of uptake by families and limited healthcare system resources. Project ACE is a multi-site trial designed to improve diabetes outcomes by tailoring existing, evidence-based interventions to meet families' needs and preferences. We hypothesize that this family-centered approach will result in better A1c and QOL than usual care. Project ACE has recruited and randomized 214 eligible 8–16 year old youth and their parents. The 9-month intervention consisted of 4 group sessions tailored to families' self-management barriers as identified by a validated instrument. Outcomes including A1c and QOL for parents and youth will be assessed for 1 year after the intervention. Stakeholder engagement was used to enhance this trial's recruitment, retention and integration into routine clinical care. Findings will inform implementation and dissemination of family-centered approaches to address self-management barriers.Trial Registration Number: NCT02024750Trial Registrar: Clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT02024750     

Design and baseline data from the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized controlled trial

BackgroundDepression and anxiety in cardiac patients are independently associated with adverse cardiovascular outcomes, including mortality. Collaborative care (CC) programs, which use care managers to assess patients, coordinate care, and perform therapeutic interventions, have proven effective in managing depression in this population. However, no prior CC intervention has simultaneously managed depression and anxiety disorders, and there has been minimal study of CC in high-risk cardiac inpatients.Materials and methodsThe Management of Sadness and Anxiety in Cardiology (MOSAIC) study was a prospective randomized trial of a low-intensity CC intervention, compared to enhanced usual care, for patients hospitalized for acute coronary syndrome, heart failure, or arrhythmia, and diagnosed with depression, generalized anxiety disorder (GAD), or panic disorder (PD). The primary outcome measure for MOSAIC was mental health-related quality of life (HRQoL), measured using the Medical Outcomes Study Short Form-12. Additional outcomes included psychological, functional, and medical outcomes, including rehospitalizations.ResultsA total of 183 eligible participants were enrolled (92 collaborative care, 91 enhanced usual care); 94% of depressed patients reported being depressed for > 1 month, and 53% of those with GAD reported clinically significant anxiety for > 1 year. One hundred thirty-three patients had depression, 118 had GAD, and 19 had PD; 74 participants (40%) had two or more of the disorders.ConclusionThe MOSAIC trial will provide data regarding whether an intervention that concurrently manages these common psychiatric disorders results in meaningful improvements in HRQoL, psychiatric symptoms, and medical outcomes in cardiac patients at high risk for adverse outcomes.     

A randomized clinical trial of the effects of parent mentors on early childhood obesity: Study design and baseline data

BackgroundFew effective community-based interventions exist for early childhood obesity. Parent mentors have been successful as an intervention for other conditions, but have not been used in childhood obesity. We designed an intervention for early childhood obesity using parent mentors and a positive outlier approach to assess potential efficacy, feasibility, and acceptability.MethodsThis trial enrolled obese (≥ 95th BMI percentile for age and gender) 2–5-year-old children in a Head Start program and their parents, with allocation to either parent mentors trained in positively deviant behaviors regarding childhood obesity, or community health workers delivering health education on obesity-related behaviors. The primary outcome is body mass index z-score change at the six-month follow-up assessment. Secondary outcomes include feeding behaviors and practices, health-related quality of life, dietary intake, and participation levels.ResultsWe enrolled three parent mentors and 60 parent–child dyads. The population is 100% Hispanic; 44% of parents speak Spanish as their primary language and 45% were not high-school graduates. Children had a reported median vegetable and fruit intake of 0.3 and 1.1 cups per day, respectively, at baseline, and a median daily screen time of three hours. There was no intergroup difference in quality-of-life scores at baseline. Retention has been high, at 90% in three months.ConclusionsIn this randomized trial of the effects of parent mentors on early childhood obesity, parent–child dyads from an underserved, Hispanic population were successfully enrolled through a partnership with a Head Start organization, with a high retention rate.     

A Web-based self-management exercise and diet intervention for breast cancer survivors: Pilot randomized controlled trial

BackgroundRegular exercise and dietary practices have been shown to affect the health-related quality of life (HRQOL) and survival of breast cancer patients.ObjectiveThe current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients.DesignA 12-week randomized, controlled trial.SettingOncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea.ParticipantsFifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0–III cancers within 2 years prior to the study were recruited.MethodsParticipants were randomly assigned to either the intervention group, which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model (TTM)-based strategies (n = 29), or to the control group, which used a 50-page educational booklet on exercise and diet (n = 28). The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables (F&V) per day, dietary quality, HRQOL, anxiety, depression, fatigue, motivational readiness, and self-efficacy.ResultsThe proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week; ate 5 servings of F&V per day; and had overall improvements in dietary quality, physical functioning and appetite loss (HRQOL), fatigue, and motivational readiness was greater in the intervention group than in the control group. The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group. A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy, although further research with a larger sample size is required to enable definitive conclusions.     

Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention

BackgroundSuccessful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.MethodsA randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.ResultsThe state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.ConclusionsDigital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.Trial registration: The ClinicalTrials.gov registration number is NCT03278340.     

Rationale,design, and baseline findings from HIPP: A randomized controlled trial testing a home-based,individually-tailored physical activity print intervention for African American women in the Deep South

African American women report high rates of physical inactivity and related health disparities. In our previous formative research, we conducted a series of qualitative assessments to examine physical activity barriers and intervention preferences among African American women in the Deep South. These data were used to inform a 12-month Home-based, Individually-tailored Physical activity Print (HIPP) intervention, which is currently being evaluated against a wellness contact control condition among 84 post-menopausal African American women residing in the metropolitan area of Birmingham, Alabama. This paper reports the rationale, design and baseline findings of the HIPP trial. The accrued participants had an average age of 57 (SD = 4.7), a BMI of 32.1 kg/m² (SD = 5.16) with more than half (55%) having a college education and an annual household income under $50,000 (53.6%). At baseline, participants reported an average of 41.5 min/week (SD = 49.7) of moderate intensity physical activity, and 94.1% were in the contemplation or preparation stages of readiness for physical activity. While social support for exercise from friends and family was low, baseline levels of self-efficacy, cognitive and behavioral processes of change, decisional balance, outcome expectations, and enjoyment appeared promising. Baseline data indicated high rates of obesity and low levels of physical activity, providing strong evidence of need for intervention. Moreover, scores on psychosocial measures suggested that such efforts may be well received. This line of research in technology-based approaches for promoting physical activity in African American women in the Deep South has great potential to address health disparities and impact public health.     

Rationale,design, and baseline findings from Seamos Saludables: A randomized controlled trial testing the efficacy of a culturally and linguistically adapted,computer- tailored physical activity intervention for Latinas

BackgroundLatinos are now the largest (and fastest growing) ethnic minority group in the United States. Latinas report high rates of physical inactivity and suffer disproportionately from obesity, diabetes, and other conditions that are associated with sedentary lifestyles. Effective physical activity interventions are urgently needed to address these health disparities.Method/designAn ongoing randomized controlled trial will test the efficacy of a home-based, individually tailored physical activity print intervention for Latinas (1R01NR011295). This program was culturally and linguistically adapted for the target population through extensive formative research (6 focus groups, 25 cognitive interviews, iterative translation process). This participant feedback was used to inform intervention development. Then, 268 sedentary Latinas were randomly assigned to receive either the Tailored Intervention or the Wellness Contact Control arm. The intervention, based on Social Cognitive Theory and the Transtheoretical Model, consists of six months of regular mailings of motivation-matched physical activity manuals and tip sheets and individually tailored feedback reports generated by a computer expert system, followed by a tapered dose of mailings during the second six months (maintenance phase). The main outcome is change in minutes/week of physical activity at six months and one year as measured by the 7-Day Physical Activity Recall (7-Day PAR). To validate these findings, accelerometer data will be collected at the same time points.DiscussionHigh reach, low cost, culturally relevant interventions to encourage physical activity among Latinas could help reduce health disparities and thus have a substantial positive impact on public health.     

Rationale,design, and baseline findings from Seamos Saludables: A randomized controlled trial testing the efficacy of a culturally and linguistically adapted,computer- tailored physical activity intervention for Latinas

BackgroundLatinos are now the largest (and fastest growing) ethnic minority group in the United States. Latinas report high rates of physical inactivity and suffer disproportionately from obesity, diabetes, and other conditions that are associated with sedentary lifestyles. Effective physical activity interventions are urgently needed to address these health disparities.Method/designAn ongoing randomized controlled trial will test the efficacy of a home-based, individually tailored physical activity print intervention for Latinas (1R01NR011295). This program was culturally and linguistically adapted for the target population through extensive formative research (6 focus groups, 25 cognitive interviews, iterative translation process). This participant feedback was used to inform intervention development. Then, 268 sedentary Latinas were randomly assigned to receive either the Tailored Intervention or the Wellness Contact Control arm. The intervention, based on Social Cognitive Theory and the Transtheoretical Model, consists of six months of regular mailings of motivation-matched physical activity manuals and tip sheets and individually tailored feedback reports generated by a computer expert system, followed by a tapered dose of mailings during the second six months (maintenance phase). The main outcome is change in minutes/week of physical activity at six months and one year as measured by the 7-Day Physical Activity Recall (7-Day PAR). To validate these findings, accelerometer data will be collected at the same time points.DiscussionHigh reach, low cost, culturally relevant interventions to encourage physical activity among Latinas could help reduce health disparities and thus have a substantial positive impact on public health.     

Pragmatic lifestyle intervention in patients recovering from colon cancer: a randomized controlled pilot study

Bourke L, Thompson G, Gibson DJ, Daley A, Crank H, Adam I, Shorthouse A, Saxton J. Pragmatic lifestyle intervention in patients recovering from colon cancer: a randomized controlled pilot study.

Objective

To investigate the feasibility of a pragmatic lifestyle intervention in patients who had recently completed surgery and chemotherapy for colon cancer and to obtain preliminary data of its impact on important health outcomes.

Design

A prospective, randomized, controlled pilot trial.

Setting

University rehabilitation facility.

Participants

Eighteen (N=18) colon cancer survivors (mean age=69y; range, 52–80y), Dukes stage A to C.

Interventions

Participants were randomized 6 to 24 months postoperatively to either a 12-week program of combined exercise and dietary advice or standard treatment.

Main Outcome Measures

Exercise and dietary behavior, fatigue, health-related quality of life (QOL), aerobic exercise tolerance, functional capacity, muscle strength, and anthropometery were assessed at baseline and immediately after the intervention.

Results

Adherences to supervised and independent exercise during the intervention were 90% and 94%, respectively, and there was low attrition (6%). The lifestyle intervention elicited improvements in exercise behavior (P=.068), fatigue (P=.005), aerobic exercise tolerance (P=.010), chair sit-to-stand performance (P=.003), and waist-to-hip ratio (P=.002). A positive change in dietary fiber intake (P=.044) was also observed in the intervention group. No change in QOL was observed (P=.795).

Conclusions

These preliminary results suggest that a pragmatic lifestyle intervention implemented 6 to 24 months after primary treatment for colon cancer was feasible. We observed a significant impact on dietary behavior, fatigue, aerobic exercise tolerance, functional capacity, and waist-to-hip ratio. These findings need to be confirmed with a larger-scale definitive randomized controlled trial.     

A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial

This study describes an evaluation of a psycho-educational intervention for family caregivers of patients dying of cancer at home. In a randomized controlled trial, participants (n = 106) received standard home-based palliative care services (n = 52) or these services plus the new intervention (n = 54). Data were collected at three time points: upon commencement of home-based palliative care (Time 1), five weeks later (Time 2), and then eight weeks following patient death (Time 3). No intervention effects were identified with respect to preparedness to care, self-efficacy, competence, and anxiety. However, participants who received the intervention reported a significantly more positive caregiver experience than those who received standard care at both Times 2 and 3. The findings indicate that it is possible to increase caregiver rewards despite being immersed in challenging circumstances that often yield considerable negative psychosocial sequelae. Furthermore, it is feasible for health professionals to discuss emotive topics, such as impending death, with caregivers without adverse effects.     

Peer-led alcohol intervention for college students: A pilot randomized controlled trial

This study aims to assess the preliminary efficacy and feasibility of a brief, peer-led alcohol intervention to reduce alcohol consumption in binge-drinking Spanish nursing students. A pilot randomized controlled trial was conducted with 50 first-year nursing students who were randomly assigned either a 50-min peer-led motivational intervention with individual feedback or a control condition. Primary outcomes for testing the preliminary efficacy were alcohol use and alcohol-related consequences. Quantitative and content analyses of open-ended survey questions were performed. Participants in the intervention condition significantly reduced binge-drinking episodes, peak blood alcohol content, and consequences compared to the control group. Principal facilitators were completing the questionnaire during the academic schedule and providing tailored feedback through a graphic report. The main barrier was the unreliability of students' initial commitment. The findings suggest that a brief motivational intervention could be effective for reducing alcohol consumption and alcohol-related consequences in Spanish college students. Peer counselors and participants reported high satisfaction, indicating that the intervention is feasible. However, a full trial should be conducted taking into account the identified barriers and facilitators.     

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol

Upstream interventions – e.g. housing programs and community health worker interventions– address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence.At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients' selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases.Clinical trials registration: ClinicalTrials.gov Identifier: NCT01900470.