Dataset Information

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

ABSTRACT: Background:Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. Objective:To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening. Design:Randomized clinical trial. (ClinicalTrials.gov: NCT02088333). Setting:6 community-based primary care practices. Participants:450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. Intervention:An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. Measurements:The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Results:Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) "self-ordered" a test via the program. Limitation:Participants were English speakers in a single health care system. Conclusion:A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. Primary Funding Source:National Cancer Institute.

SUBMITTER: Miller DP

PROVIDER: S-EPMC6033519 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

Miller David P DP Denizard-Thompson Nancy N Weaver Kathryn E KE Case L Doug LD Troyer Jennifer L JL Spangler John G JG Lawler Donna D Pignone Michael P MP

Annals of internal medicine 20180313 8

<h4>Background</h4>Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened.<h4>Objective</h4>To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening.<h4>Design</h4>Randomized clinical trial. (ClinicalTrials.gov: NCT02088333).<h4>Setting</h4>6 community-based primary care practices.<h4>Participants</h4>450 patients (223 in the mPATH-CRC group and 227 in ...[more]

PMID: 29532054

Similar Datasets

Project description:BackgroundThe prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care.ObjectiveThis study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers.MethodsBalance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point.ResultsWe randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points).ConclusionsIn adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention.Trial registrationClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403.International registered report identifier (irrid)RR2-10.1186/s12889-019-6926-7.

Project description:Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients.We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening.This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities.ClinicalTrials.gov NCT02054598.

Project description:BackgroundThere is certain evidence on the efficacy of smartphone-based mental health interventions. However, the mechanisms of action remain unclear. Placebo effects contribute to the efficacy of face-to-face mental health interventions and may also be a potential mechanism of action in smartphone-based interventions.ObjectiveThis study aimed to investigate whether different types of efficacy expectancies as potential factors underlying placebo effects could be successfully induced in a smartphone-based digital placebo mental health intervention, ostensibly targeting mood and stress.MethodsWe conducted a randomized, controlled, single-blinded, superiority trial with a multi-arm parallel design. Participants underwent an Android smartphone-based digital placebo mental health intervention for 20 days. We induced prospective efficacy expectancies via initial instructions on the purpose of the intervention and retrospective efficacy expectancies via feedback on the success of the intervention at days 1, 4, 7, 10, and 13. A total of 132 healthy participants were randomized to a prospective expectancy-only condition (n=33), a retrospective expectancy-only condition (n=33), a combined expectancy condition (n=34), or a control condition (n=32). As the endpoint, we assessed changes in efficacy expectancies with the Credibility Expectancy Questionnaire, before the intervention and on days 1, 7, 14, and 20. For statistical analyses, we used a random effects model for the intention-to-treat sample, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs no) and retrospective expectancy (yes vs no), allowed to vary over participant and intervention day.ResultsCredibility (β=-1.63; 95% CI -2.37 to -0.89; P<.001) and expectancy (β=-0.77; 95% CI -1.49 to -0.05; P=.04) decreased across the intervention days. For credibility and expectancy, we found significant three-way interactions: intervention day×prospective expectancy×retrospective expectancy (credibility: β=2.05; 95% CI 0.60-3.50; P=.006; expectancy: β=1.55; 95% CI 0.14-2.95; P=.03), suggesting that efficacy expectancies decreased least in the combined expectancy condition and the control condition.ConclusionsTo our knowledge, this is the first empirical study investigating whether efficacy expectancies can be successfully induced in a specifically designed placebo smartphone-based mental health intervention. Our findings may pave the way to diminish or exploit digital placebo effects and help to improve the efficacy of digital mental health interventions.Trial registrationClinicaltrials.gov NCT02365220; https://clinicaltrials.gov/ct2/show/NCT02365220.

Dataset Information

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

Publications

Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets