Tele-Health Electronic Monitoring to Reduce Post Discharge Complications &

Status Completed

Clinical Trial Summary

Abstract:

It is intuitive that post discharge surgical complications are associated with increased patient dissatisfaction, and directly associated with an increase in medical expenditures. It is also easy to make the connection that many post hospital discharge surgical complications including surgical site infections could be influenced or exacerbated by patient co-morbidities. The authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors of surgical site infections after vascular reconstruction was performed. The main concern for optimal patient care especially in geographically isolated areas of West Virginia is to have early, expeditious, and prompt diagnosis of early surgical site infection with subsequent indicated interventions. This theme will lead to patient satisfaction, minimizing third party interventions and decrease the total cost associated with these complications. Nevertheless, it seems reasonable to believe that monitoring using telehealth technology and managing the general health care patients receive after a hospital vascular intervention will improve overall health and reduce post-operative complications.

Aims/Objectives:

1. The primary objective of the current project is to compare early and late outcomes for patients who receive post discharge health care monitoring (which includes using Telehealth electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine discharge instructions and no monitoring.

Methods:

1. Randomize patients who are scheduled to have revascularization interventions with groin incisions to receive either telehealth electronic health care monitoring or normal standard of follow-up care.

2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications. In addition, have participants complete the follow-up survey questionnaires.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02767011
Study type	Interventional
Source	CAMC Health System
Contact
Status	Completed
Phase	N/A
Start date	July 2016
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05335525` - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Active, not recruiting	`NCT01903044` - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating	Phase 1/Phase 2
Completed	`NCT02228564` - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease	N/A
Completed	`NCT02271529` - Zilver PTX Delivery System	N/A
Recruiting	`NCT02054871` - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty	N/A
Completed	`NCT00822172` - Evaluation of Cilostazol in Combination With L-Carnitine	Phase 4
Completed	`NCT00574782` - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)	N/A
Completed	`NCT00029991` - Extract of Ginkgo Biloba (EGB 761) and Vascular Function	Phase 1/Phase 2
Completed	`NCT01355406` - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System	N/A
Recruiting	`NCT05804097` - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?	Phase 4
Recruiting	`NCT03638115` - The VaSecure BTK Study	N/A
Active, not recruiting	`NCT03241459` - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon	N/A
Active, not recruiting	`NCT01661231` - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe	N/A
Completed	`NCT01722877` - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions	N/A
Completed	`NCT01444378` - Absolute Pro® MOMENTUM™	N/A
Completed	`NCT00753337` - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study	N/A
Completed	`NCT00538226` - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg	Phase 1
Completed	`NCT00593385` - Atrium iCAST Iliac Stent Pivotal Study	N/A
Recruiting	`NCT00385385` - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease	Phase 2
Completed	`NCT00392509` - ALD-301 for Critical Limb Ischemia, Randomized Trial	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections — THEM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms