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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006082
• Other study ID #: SUS-IDPVO2011/50
• Secondary ID: SUS-IDPVO2011/50
• Status: Completed
• Phase: N/A
• First received: September 13, 2013
• Last updated: December 4, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 88 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	self-perception of safety (n, %)	Patient's self-perception of safety when discharged from hospital without TVC, as compared to discharged to TVC at home	4 weeks after TVC at inclusion, inclusion period from 16th April 2010 to 31st December 2011	No
Other	Time to first re-admission for COPD exacerbation	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	Days to re-admission from end of TVC, 14 days after included during inclusion period from 16th April 2010 to 31st December 2011	No
Primary	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	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	12 months from inclusion period 16th April 2010 to 31st December 2011	No
Secondary	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		12 months after inclusion period from 16th April 2010 to 31st December 2011	No