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Completed

NCT Number: NCT02006082

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine video-consultation (TVC)

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.

Other names: Video-conferencing in Telemedicine

Primary outcomes

  1. Frequency of hospital re-admissions due to COPD exacerbations during 12 months follow-up after TVC, as compared to admissions due to COPD exacerbations during 12 months pre-TVC

    Time frame: 12 months from inclusion period 16th April 2010 to 31st December 2011

    Number of re-admissions in hospital due to COPD exacerbations during 12 months follow-up after TVC, as compared to number of hospital admissions caused by COPD exacerbations the 12 months preceding TVC

Secondary outcomes

  1. Length of hospital stays (days in hospital) when re-admitted during 12 months follow-up after TVC, as compered to length of hospital stays due to COPD the year preceding TVC

    Time frame: 12 months after inclusion period from 16th April 2010 to 31st December 2011

Other outcomes

  1. self-perception of safety (n, %)

    Time frame: 4 weeks after TVC at inclusion, inclusion period from 16th April 2010 to 31st December 2011

    Patient's self-perception of safety when discharged from hospital without TVC, as compared to discharged to TVC at home

  2. Time to first re-admission for COPD exacerbation

    Time frame: Days to re-admission from end of TVC, 14 days after included during inclusion period from 16th April 2010 to 31st December 2011

    Days to first re-admission for COPD exacerbation during 12 months follow-up after TVC, as compared to days from last discharge from hospital during the last 12 months preceding TVC to the index stay followed by TVC

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

Readmissions to Hospital and Patient Satisfaction Among Patients With Chronic Obstructive Pulmonary Disease After Telemedicine Video Consultation - a Pilot Project

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2013
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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