Implementing Digital Technology to Transitioning a Clinical Trial to a Registry – TAILOR-PCI Digital Study: Methods/Study Design (Preprint)

2021 ◽  
Author(s):  
Robert Avram ◽  
Derek So ◽  
Erin Iturriaga ◽  
Julia Byrne ◽  
Ryan Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Completion Rate ◽  
Phone Call ◽  
Consent Rate ◽  
Digital Platform ◽  
Phone Calls ◽  
Patient Reported ◽  
Research Platform

BACKGROUND TAILOR-PCI was the largest cardiovascular genotype-based randomized clinical trial (RCT) investigating whether CYP2C19 genotype-guided selection of oral P2Y12 inhibitor therapy improved ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Registry was a novel proof-of-concept study that evaluated the feasibility of extending the main RCT follow-up period using a remote digital platform. OBJECTIVE To describe patients onboarding, engagement and results of a digital registry after enrollment in a RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letters containing a URL to the TAILOR-PCI Digital Registry website (http://tailorpci.eurekaplatform.org), instructing them to download the study app. Patients previously enrolled in the TAILOR-PCI study, with a smartphone, were eligible to join the Digital Registry. Those who did not respond to the letter were contacted by phone to survey reasons for non-participation and were invited again to join the study. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard, consent and enrol patients in the Digital Registry. Patients were asked to complete health-related surveys and provide follow-up data digitally. Consent rate to the Digital Registry, duration of participation in the Digital Registry and monthly activity completion rate. The hypothesis being tested was formulated before data collection began. RESULTS After the parent trial was completed, letters were mailed to 907 eligible patients (representing 19% of total enrolled in the RCT) across 24 sites, who were within 15.6 ± 5.2 months after randomization leading to 290 unique individuals visits to the Digital Registry website. Among those invited, 110 patients (12%) consented: 45 (41%) after the letter, 37 (34%) after the 1st phone call and 28 (25%) after a 2nd call. Of the 862 who didn’t consent after the letter, 453 patients (53%) did not respond to repeated phone calls and among the 409 patients who responded, 171 (41%) declined participation stating lack of time, 128 (31%), due to lack of smartphone and 47 (11%) due to difficulty understanding what was expected of them in the study. Patients who consented were older, had less diabetes or tobacco use; a greater proportion had bachelor's degrees or higher and were more computer literate than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9±7.6% without a decrease in this rate throughout the study duration. There were no differences between randomization arms in any patient reported outcomes using the digital platform. CONCLUSIONS Extended follow-up after enrollment in a RCT using a digital registry is technically feasible but was limited due to inability to contact most eligible patients, lack of time or access to a smartphone. Among those enrolled, most patients completed required electronic visits. Enhanced recruitment methods, such as introduction of the digital study at the time of RCT consent, provision of smartphone and robust study support for onboarding, should be explored further. CLINICALTRIAL TAILOR-PCI (Clinicaltrials.gov: NCT01742117)

Transitioning a randomized controlled trial to a digital registry – experience from the TAILOR-PCI digital follow-up study on onboarding, engagement and geofencing consent rate

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Avram ◽  
D So ◽  
E Iturriaga ◽  
J Byrne ◽  
R.J Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Mobile App ◽  
Funding Source ◽  
Location Tracking ◽  
Main Trial ◽  
Phone Calls ◽  
Effective Manner ◽  
Research Platform

Abstract Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if no response to the letter, to determine reason for non-participation. A NIH-funded direct-to-participant digital research platform (the Eureka Research Platform) was used to onboard, consent and enroll participants for the digital follow-up. Participants were asked to answer health-related surveys at fixed intervals using the Eureka mobile app and desktop platform. To capture hospitalizations, participants could enable geofencing to allow background location tracking, which triggered surveys if a hospitalization was detected. Result(s) Letters were mailed to 893 of 929 eligible participants across 22 sites in the United States and Canada leading to 226 homepage visits and 118 registrations. There were 107 consents (12.0% of invited; mean age: 66.4±9.0; 19 females [18%]): 47 (44%) participants consented after the letter, 36 (34%) consented after the 1st call and 24 (22%) consented after a 2nd call. Among those who consented, 100 were eligible (7 did not have a smartphone) 81 downloaded the study mobile app and 73 agreed for geofencing (Figure 1). Among the 722 invited participants who were surveyed, 354 declined participation: due to lack of time (146; 20.2%), lack of smartphone (125; 17.3%), difficulty understanding (41; 5.7%), concern about using smartphone (34; 4.7%), concern of data privacy (14; 1.9%), concerns of location tracking (6; 0.8%) and other reasons (57; 7.9%). Conclusion Extended follow-up of a clinical trial using a digital platform is feasible but uptake in this study population was limited largely due to lack of time or a smartphone among participants. Based on data from other digital studies, uptake may also have been limited since digital follow-up consent was not incorporated at the time of consent for the main trial. Figure 1. Onboarding of the digital substudy Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

Abstract T MP103: Effect of Follow-up Phone Calls on 30-day Readmission Rates for Stroke Patients

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Kelly Anderson
Keyword(s):  
Intervention Group ◽  
Signs And Symptoms ◽  
Lifestyle Changes ◽  
Phone Call ◽  
Control Group ◽  
Readmission Rates ◽  
Convenience Sample ◽  
Phone Calls ◽  
Number Of Patients

Background and Purpose: Patients who are hospitalized for a stroke or TIA go home with a great deal of information about risk factors, medications, diet and exercise, signs and symptoms of stroke and follow-up care. This information may be difficult for the patient or caregiver to understand and can be overwhelming in the face of a new life-changing event. In addition, The Centers for Medicare and Medicaid Services will start publicly reporting 30-day readmission rates beginning in 2016. The purpose of this study is to determine if follow-up phone calls with a nurse help to reduce 30 day readmission rates for patients with stroke and TIA. Methods: This study utilized a convenience sample of adult patients who were admitted for ischemic stroke, ICH, SAH or TIA from March 2013 to February 2014. Patients in the intervention group participated in a phone call seven days after discharge to assess their compliance with medications, physician appointments and lifestyle changes. The proportion of readmissions between the groups was compared with Fisher’s exact test. Results: The total number of patients enrolled in the study was 586 and there were no significant differences in demographics between the control and intervention groups. Of the 533 patients in the control group, 54 (10%) of them were readmitted, including 11 patients readmitted for elective surgical procedures. Of the 52 patients in the intervention group, 3 (5.7%) of them were readmitted before the 7-day phone call. Of the 49 patients who participated in the 7-day phone call, none of them were readmitted ( p =0.0098). Conclusions: Patients who participate in a 7-day phone call appear to benefit and are less likely to be readmitted to the hospital. Other strategies may need to be considered for patients who are at higher risk, and thus more likely to be readmitted within seven days of discharge. In addition, some providers may wish to reconsider how they schedule elective procedures for secondary stroke prevention.

Automated text messaging follow-up for patients who receive peripheral nerve blocks

2021 ◽  
pp. rapm-2021-102472
Author(s):  
Daniel Gessner ◽  
Oluwatobi O Hunter ◽  
Alex Kou ◽  
Edward R Mariano
Keyword(s):  
Regional Anesthesia ◽  
Nerve Block ◽  
Text Messaging ◽  
Low Cost ◽  
Automated System ◽  
Phone Call ◽  
Nerve Blocks ◽  
Patient Response ◽  
Patient Reported

BackgroundRoutine follow-up of patients who receive a nerve block for ambulatory surgery typically consists of a phone call from a regional anesthesia clinician. This process can be burdensome for both patients and clinicians but is necessary to assess the efficacy and complication rate of nerve blocks.MethodsWe present our experience developing an automated system for completing follow-up via short message service text messaging and our preliminary results using it at three clinical sites. The system is built on REDCap, a secure online research data capture platform developed by Vanderbilt University and currently available worldwide.ResultsOur automated system queried patients who received a variety of nerve block techniques, assessed patient-reported nerve block duration, and surveyed patients for potential complications. Patient response rate to text messaging averaged 91% (higher than our rates of daily phone contact reported previously) for patients aged 18 to 90 years.ConclusionsGiven the wide availability of REDCap, we believe this automated text messaging system can be implemented in a variety of health systems at low cost with minimal technical expertise and will improve both the consistency of patient follow-up and the service efficiency of regional anesthesia practices.

Abstract TP288: Overcoming Obstacles Making People Healthy (OOMPH): A Patient Centered Post Discharge Follow-up Program for Stroke Patients

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jonathan Muller ◽  
Barbara Gatton ◽  
Linda Fox ◽  
Joseph A Bove ◽  
Johanna Donovan Turner ◽  
...  
Keyword(s):  
Support Groups ◽  
Medical Information ◽  
Patient Adherence ◽  
Hospital Readmissions ◽  
Phone Call ◽  
Stroke Patients ◽  
Post Discharge ◽  
Phone Calls ◽  
Stroke Support Groups

Background and Purpose: At least 12% of stroke patients are readmitted to a hospital within 30 days of discharge. We know that patients hospitalized for other conditions are less likely to be readmitted within 30 days if they are seen by their PCP shortly after discharge. However, less than a third of patients in the New York metropolitan area admitted for heart failure, heart attacks, and pneumonia see their PCP within 14 days after discharge and nearly 40% of patients do not adhere to their prescribed regimen. In the case of cerebrovascular diseases, outpatient follow-up may prevent the majority of avoidable readmissions. The purpose of this project is to identify and reduce unnecessary, unplanned hospital readmissions after stroke. Our goal is to encourage patient adherence to prescribed medication and other therapies, as well as to ensure timely follow-up with their PCP. Methods: Stroke and transient ischemic attack (TIA) patients with a disposition of either home or short-term rehabilitation are visited and offered enrollment. Participants are given a kit which includes a personalized binder (to manage essential medical information) and a 28-slot pill box. Each patient then receives 3 phone call interviews at 7, 21 and 32 days after discharge. The aim of the phone calls is to identify obstacles to compliance with treatment regimen and follow-up care. Results: From January 2015 to June 2016, 247 patients were enrolled and followed up. Within 30 days of discharge, 10% were readmitted and 50% of all readmissions occurred within the first 7 days. Of those readmitted, 19% were due to an injury from physical therapy. Data from follow-up phone calls revealed that 83% were taking all prescribed medications, 89% had completed a follow-up with any physician, 69% were using the binder, and 61% had done all three. Conclusions: While we have not enrolled enough patients to see a statistically significant reduction in readmissions, our interviews showed that weather, depression, as well as a lack of insurance, family support, and a home health aide are all determinants on how patients will follow their prescribed regimen. The results of this study have allowed us to begin implementing stroke support groups and pre-discharge follow-up appointment scheduling.

Swallowing Function in Survivors of Oropharyngeal Cancer Is Associated With Advanced T Classification

2019 ◽  
Vol 128 (8) ◽  
pp. 696-703 ◽  
Author(s):  
Aaron Harms ◽  
Sagar Kansara ◽  
Carol Stach ◽  
Peter A. Richardson ◽  
George Chen ◽  
...  
Keyword(s):  
Functional Status ◽  
Medical Center ◽  
The United States ◽  
Barium Swallow ◽  
Tobacco Exposure ◽  
Level Of Evidence ◽  
Swallowing Dysfunction ◽  
Patient Reported ◽  
T Classification

Objectives: The incidence of oropharyngeal squamous cell carcinoma (OPSCC) is rapidly increasing in the United States. The aim of this study was to characterize the functional status of OPSCC survivors to identify predictors of swallowing dysfunction in this patient population. Methods: OPSCC survivors (n = 81) treated at the Michael E. DeBakey Veterans Affairs Medical Center between 2005 and 2015 with at least 2 years of clinical follow-up were reviewed. Functional status was ascertained using (1) gastrostomy and tracheostomy placement and retention, (2) gastrostomy use at last follow-up, (3) patient-reported diet, and (4) modified barium swallow. Results: Median follow-up duration was 5.6 years; 67% of patients had ≥10-pack-year tobacco exposure; 96% of tumors for which p16 data were available were p16 positive. At last follow-up, 82% of patients reported a regular diet, and only 9 patients required gastrostomy use. Gastrostomy use at last follow-up was higher in patients with T3 and T4 tumors compared with those with T1 and T2 tumors ( P = .01). The relationship between T classification and gastrostomy use persisted even when the analysis was limited to p16+ tumors and p16+ tumors with ≥10-pack-year history of tobacco exposure. Conclusions: Advanced T classification at presentation is a critical predictor of gastrostomy use in long-term OPSCC survivors irrespective of p16 status or tobacco exposure history. Level of Evidence: 2b

Plasma citrulline levels as a biomarker for bowel toxicity in prostate stereotactic radiotherapy with or without pelvic nodal radiation.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 73-73
Author(s):  
Ciaran Fairmichael ◽  
Kelly M. Redmond ◽  
Ciara Lyons ◽  
Sarah R. Stevenson ◽  
Sarah O. Osman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Small Bowel ◽  
Stereotactic Radiotherapy ◽  
Summary Score ◽  
Pelvic Radiotherapy ◽  
Exact Test ◽  
Plasma Citrulline ◽  
Patient Reported ◽  
To Receive

73 Background: Plasma levels of citrulline, an amino acid, are derived mainly from small bowel enterocytes. Decreased levels occur in a range of bowel conditions and citrulline has been proposed as a biomarker of bowel toxicity in pelvic radiotherapy. In a prospective study, we identify no correlation between plasma citrulline and toxicity in men receiving prostate stereotactic radiotherapy randomized to receive either pelvic nodal irradiation or not. Furthermore, citrulline levels were not significantly different between these two groups. Methods: As part of an approved clinical trial, men with intermediate to high risk prostate cancer were randomised 1:1 to prostate only or prostate + pelvic nodal radiotherapy, delivered with a rectal spacer gel in situ. The prostate and proximal seminal vesicles received 40 Gy in 5 fractions. Those randomised to the pelvic nodal arm also received 25 Gy in 5 fractions to pelvic nodes. Citrulline was measured at 10 points during treatment – consent, before fraction 1, 1 and 24 hours following fraction 1, prior to each fraction 2 – 5 and at 6 weeks’ and 3 months’ follow up. Bowel toxicity was measured by EPIC patient reported scores. Results: 16 men with follow up of at least 3 months (median 9, maximum 18 months) were analysed. Reported toxicity was significantly higher in the prostate and pelvis arm: 5 of 9 men showed a decrease in EPIC bowel domain summary score of 10 points or more compared to 0 of 7 in the prostate-only arm (p = 0.0337, two tailed Fisher’s exact test). No significant correlation between toxicity and citrulline levels was seen, nor did citrulline vary significantly between arms or fall as treatment progressed. Data analysis for a further 8 men already recruited to the study is ongoing. Conclusions: Toxicity was more commonly reported by men randomised to receive pelvic radiotherapy, suggesting that the small bowel irradiated in pelvic fields plays a role in bowel toxicity experienced during stereotactic radiotherapy. Citrulline levels showed no significant correlation with toxicity or radiation dose to small bowel. We propose that citrulline is not a useful biomarker of small bowel toxicity in this setting. Clinical trial information: NCT03253978.

Same setting, different norms: Phone call beginnings in France and the United States

1977 ◽  
Vol 6 (2) ◽  
pp. 209-219 ◽  
Author(s):  
Daniele Godard
Keyword(s):  
United States ◽  
Native Speakers ◽  
The United States ◽  
Phone Call ◽  
Physical Conditions ◽  
Speech Event ◽  
Phone Calls ◽  
Telephone Calls

AbstractFrench native speakers' reactions to phone calls in the United States are an indication of a difference in the norms of interaction between the two countries. This difference, in turn, is understood when one realizes that the phone call, constituting a speech event, is open to different cultural interpretations, in spite of a similarity in the physical conditions of the interaction between the caller and the answerer. (Sequencing conventional opening; cultural variability; telephone calls; France and United States.)

scholarly journals Effect of Balloon Eustachian Tuboplasty in Adults That Only Have Symptoms of Chronic Eustachian Tube Dysfunction, With a 1-Year Follow-Up: Prospective Clinical Trial

2020 ◽  
pp. 014556132098019
Author(s):  
Martin Formánek ◽  
Debora Formánková ◽  
Lukáš Školoudík ◽  
Karol Zeleník ◽  
Viktor Chrobok ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Eustachian Tube ◽  
Pure Tone Audiometry ◽  
Adult Patients ◽  
Eustachian Tube Dysfunction ◽  
Prospective Clinical Trial ◽  
Patient Reported ◽  
Tube Dysfunction ◽  
Balloon Eustachian Tuboplasty

Objectives: Balloon eustachian tuboplasty (BET) is a promising therapeutic option for eustachian tube (ET) dysfunction. However, data are lacking on the effect of BET in adults with symptoms of chronic ET dysfunction but without a contributing pathology. This study investigated the effect of BET in adult patients with only symptoms of chronic ET dysfunction. Methods: This prospective clinical trial included adult patients with aerated physiological middle ears and symptoms of ET dysfunction for more than 6 months. Compliance with follow-up was 93.3%. We evaluated the effects of BET with tympanometry, assessment of the Valsalva or Toynbee maneuver with tympanometry verification, a Eustachian Tube Dysfunction Questionnaire (ETDQ-7), and pure-tone audiometry. Data were recorded 1 day before surgery and 2, 6, and 12 months after BET. Therapy was considered successful when the patient exhibited a newly acquired ability to perform the Valsalva or Toynbee maneuver or when the ETDQ-7 score improved by 20% or more. Results: We included 14 ears in the analysis. After 2, 6, and 12 months, therapy was successful, according to the ETDQ-7, in 11/14 (78.6%; 95% CI: 48.8-94.3), 13/14 (92.9%; 95% CI: 64.2-99.6), and 12/14 (85.7%; 95% CI: 56.2-97.5) ears, respectively. These results were statistically significant. The ETDQ-7 scores also significantly decreased at 2, 6, and 12 months after the BET, when any change was observed. All patients experienced improvement. Only 1 patient reported temporary deterioration after 2 months. Treatment was more frequently successful in patients without nasal polyps or pollinosis. Conclusions: Adults with only symptoms of chronic ET dysfunction benefitted more and had longer lasting results from BET, compared to patients with pathologies caused by ET dysfunction. Balloon eustachian tuboplasty could be recommended for these patients.

scholarly journals Efficiency and acceptability of an automated electronic system (DayCOR) compared with a telephone call system, for follow-up of day surgery patients

2019 ◽  
Vol 47 (3) ◽  
pp. 242-250 ◽  
Author(s):  
Nicole LT Tan ◽  
John R Sestan
Keyword(s):  
Demographic Data ◽  
Electronic System ◽  
Day Surgery ◽  
Telephone Call ◽  
Healthcare Organisation ◽  
Post Discharge ◽  
Phone Calls ◽  
Patient Reported ◽  
Call System

Post-discharge phone calls are a widely used yet suboptimal method of ascertaining recovery of day surgery patients. We compared the efficiency of an automated electronic system of follow-up, the Day Care Anaesthesia Outcomes Recording Registry (DayCOR), and a telephone call system that was standard practice in our non-profit private healthcare organisation in Victoria, Australia. We also surveyed a group of clinicians to assess their acceptance of DayCOR compared with the telephone call system. DayCOR is a web-based system which collects, alerts, manages and analyses patient-reported outcomes. Patients may opt in to respond to a 15-question survey via a link sent by text message or email. DayCOR’s patient response rate was 77.5%, compared with 66.0% for the telephone call system. Both systems collected data on clinical, process, and experience outcomes. Completeness of data collection was 100% using DayCOR compared with 51%–61.4% of data items using the telephone call system. We estimated that replacing our telephone call system with DayCOR to follow up 60,000 day surgery patients a year would represent an annual cost reduction of AUD$101,345 (53%) using manual demographic data entry, and AUD$142,745 (74%) if DayCOR was integrated with the institution’s existing administrative software. Seventy-eight percent of day surgery nurses and 94% of anaesthetists preferred DayCOR to the telephone call system. All anaesthetists surveyed stated that DayCOR provided more valuable feedback, and almost one-fifth had changed their clinical practice as a result. DayCOR’s efficiency and acceptability will allow more effective collection of post-discharge patient outcomes than is currently possible in our institution, and will support interventional studies aimed at improving quality of recovery of day surgery patients.

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