Readmissions to Hospital Among Patients With COPD After Telemedicine Video Consultation - a Pilot Project

NCT ID: NCT02006082

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study was to evaluate the effects of telemedicine video-consultation (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess the impact of TVC on the length of recurrent hospital stays and time to re-admission within 12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to TVC.

Detailed Description

The study is conducted as a retrospective uni-center observation study of a population of COPD patients who after discharge from hospital for acute COPD exacerbation, or during outpatient treatment for acute COPD exacerbation, was monitored for 2 weeks by TVC during a pilot project period from 16 April 2010 to 31 December 2011. To study a possible change in amount of hospital admissions we have compared the frequencies and durations of such events before and after TVC in comparable time periods.

A detailed patient history comprising demographic data, social status, smoking habits, body mass index (BMI), use of medication, co-morbidity and the habitual lung function were registered. Dates of admittance and discharge were noted. Retrospectively, medical records were scrutinized for re-admissions due to COPD exacerbations at 12 months follow-up. Frequency of and date of re-admissions, length of hospital stay, and clinical data were recorded. Also frequency of admission due to COPD exacerbation and length of hospital stay(s) during the last 12 months prior to the TVC were recorded, and date of last discharge was noted. Finally, all patients were encouraged to complete a questionnaire concerning patient satisfaction and impact on patient's quality of life. All answers were registered anonymously.

Data were entered to a database by one trained nurse and monitored by another person, who compared data entered into the registry against predefined rules for range or consistency with other data fields in the registry. All patients who had been monitored by TVC during the pilot project period, gave informed consent to participate in the observational study, and no patient was lost to follow-up.

Continuously distributed variables of baseline characteristics were given as mean + SEM, while variables with more skewed distributions were given as median and upper and lower quartiles.

The Shapiro-Wilk test for normality was performed to study the distribution of parameters. A chi-square test was applied to compare the frequency of re-admissions during 12 months following TVC to the frequency of hospital admissions during the last 12 months prior to TVC. The total number of days in hospital during the last 12 months prior to TVC was compared to number of days in hospital during 12 months following TVC by a paired t-test. Differences in baseline characteristics between patients who were re-admitted and those who were not, were analyzed by a Two-sample Student's T-test, or in case of non-normality, by the Mann-Whitney Rank Sum test.

The number of days to re-admission following TVC as compared to number of days from last discharge to date of index admittance was displayed in a Kaplan Meier plot, with a hazard ratio (HR) calculation by a by a Cox regression analysis.

A statistically significant level of p < 0.05 was applied for all tests. All statistical analyses were performed using the statistical package of SigmaPlot Version 12.

Power calculations have not been performed for the purpose of this pilot study, because of too many unknown factors. The results of this study will form the basis of power calculations for a future prospective randomized study.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Telemedicine video-consultation (TVC); Re-admission to hospital; Time to re-admission; Length if hospital stay; Patient satisfaction; Chronic obstructive pulmonary disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COPD patients followed after TVC

All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 \< 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period (16th April 2010 - 31st December 2011). The telemedicine equipment consisted of a computer with a web camera with a microphone, through which the patient at home and the specially trained nurse in hospital were able to communicate, and also comprised requisites to measure the patient's oxygen saturation and heart rate, and to perform a spirometry.

Telemedicine video-consultation (TVC)

Intervention Type: DEVICE

All patients enrolled in the study, were previously monitored by TVC, and the number and length of hospital stays within 6 and 12 months following TVC were compared to similar numbers before TVC in comparable time periods. Thus, TVC is actually not to be considered as an intervention.

Interventions

Telemedicine video-consultation (TVC)

All patients enrolled in the study, were previously monitored by TVC, and the number and length of hospital stays within 6 and 12 months following TVC were compared to similar numbers before TVC in comparable time periods. Thus, TVC is actually not to be considered as an intervention.

Intervention Type: DEVICE

Other Intervention Names

Video-conferencing in Telemedicine

Eligibility Criteria

Inclusion Criteria

• All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 < 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital or DMC in Egersund, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period
• Written informed consent was obtained

Exclusion critera:

• Previously inclusion in the study
• Unwillingness to participate
• Residence in service housing with care or in nursing homes
• Inability to communicate

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Grundt, MD PhD

Role: STUDY_CHAIR

Helse Stavanger HF

Locations

Stavanger University Hospital

Stavanger, Rogaland, Norway

Countries

Norway

Other Identifiers

SUS-IDPVO2011/50COPD

Identifier Type: OTHER

Identifier Source: secondary_id

SUS-IDPVO2011/50

Identifier Type: -

Identifier Source: org_study_id