Interactive Videoconferencing in the Provision of Remote Peritoneal Dialysis
Condition: ESRD
Study type: Observational

Summary: 
      Home dialysis patients must be seen in a face to face visit on a monthly basis. For patients
      who live remotely these visits may impact their quality of life due to the amount of time
      needed to attend these visits. The central hypothesis is that implementation of telemedicine
      visits as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period
      will improve quality of life as judged by the quality of life (QoL) indices Kidney Disease
      Quality of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to QoL
      scales taken during a time period when the patient is on standard of care.
    

Detailed description: 
      Background:

      Peritoneal Dialysis is used by over 100,000 patients worldwide but only about 7% of patients
      in the United States. 1 As it is much less expensive than its in-center hemodialysis
      counterpart and provides improved quality of life, strategies are needed to increase its
      utilization. One potential barrier to peritoneal dialysis is the geographic barriers to care
      which exist in geographically diverse and large countries such as Canada, India, Australia,
      and the United States. 2,3 Access to an experienced home dialysis unit is limited in many
      parts of the United States and can contribute to low utilization rates by physician
      discomfort with the therapy as well as increased technique failure rates with inexperienced
      centers. 4-7 Prakash et al recently have shown that only 55% of dialysis units are certified
      to provide home dialysis. 8 In more rural networks such as network 8 (Alabama, Mississippi,
      and Tennessee), this number drops to 38% thus increasing the geographic barriers to the
      provision of home dialysis care. Patients currently living in rural areas and on a home
      therapy are faced with long commutes and time commitments adding up to significant financial
      hardships for the patients. Furthermore, these commutes impact quality of life. Telemedicine
      and telemonitoring may provide a means to bridge these geographic barrier thus improving
      access to home dialysis care and improving patient quality of life on the therapy and thus
      increasing its utilization.

      The use of telemedicine in the provision of home dialysis care has received very limited
      attention worldwide and even less in the United States. Early studies using telemedicine in
      remote care suffered from high costs of implementing secure T1 lines and limited technology.9
      Gallar et al in Spain published 2 years of experience using alternating videoconferencing
      visits and standard hospitalized visits, showing cost savings, ability to evaluate the
      patient for edema and exit site evaluation, as well as decreased time associated with each
      visit. 10 Nakamoto et al. in Japan published on their tool to transmit blood pressures,
      glucose readings remotely etc. 11 Since these initial studies and conceptualization of
      telemedicine, technology has increased at a very fast pace. Videoconferencing technology has
      become much smaller, more sophisticated, easier to use, and more inexpensive making it a
      mainstay in daily life including applications such as face time and skype. Technology
      literacy as well has continued to increase since early 2000. A recent survey among peritoneal
      dialysis patients showed that 88% owned a computer and 94% knew how to use a computer. 12
      Furthermore, 83% of patients wished to participate in telemedicine. 12 It is within this
      environment that telemedicine and the application to home dialysis may begin to transform the
      delivery of care in home dialysis thus increasing peritoneal dialysis utilization by
      improving convenience of the therapy and improving the quality of life. Such interventions
      are already gaining popularity in countries such as India. 3 Studies are needed to determine
      the feasibility of telemedicine in the provision of home dialysis care in the United States
      and if quality of life of patients using this mechanism are improved. Furthermore, studies
      showing outcomes are similar if not improved using telemedicine are needed.

      The long-term goal of this project is to improve access to peritoneal dialysis care and the
      quality of lives of patients on dialysis by evaluating ways to eliminate the geographic
      barrier. The objective here is to determine if specifically telemedicine has this capacity.
      By evaluating and establishing a framework by which home dialysis care could be provided via
      telemedicine and determining the impact on quality of life for these patients, policy could
      be informed as to coverage of telemedicine as a substitute for the current face-to-face
      requirement by Medicare. Furthermore, this intervention has the possibility of improving
      quality of life and if effective possibly increasing the utilization of peritoneal dialysis
      both by patients rural and urban due to increased convenience of the therapy with respect to
      in-center hemodialysis. The central hypothesis is that implementation of telemedicine visits
      as a substitute for the 2 out of 3 monthly face-to-face visits over a 6 month period will
      improve quality of life as judged by the quality of life (QoL) indices Kidney Disease Quality
      of Life - Short Form and the Illness Intrusiveness Ratings Scale when compared to QoL scales
      taken during a time period when the patient is on standard of care.

      Specific Aims

        1. Determine the impact of telemedicine on quality of life as indicated two quality of life
           surveys: 1) The KDQOL- SF and the Illness Intrusiveness Ratings Scale .

           The investigators postulate that patients, during the telemedicine intervention will
           improve the quality of life scores on the KDQOL-SF form by the minimum clinically
           significant change of 3 points, as compared to themselves during a time period of
           standard of care visits (Not telemedicine).

        2. Determine the feasibility of the use of telemedicine and remote monitoring in the
           provision of care for peritoneal dialysis patients as a substitute for two out of 3
           monthly face-to-face visits over a 6 month period.

           Based on the work by Nayak et al. in India, the investigators feel that telemedicine
           visits as a substitute for the face-to-face visit will be both feasible and
           advantageous.

        3. Obtain preliminary data on efficacy of the intervention with regards to outcomes with a
           composite endpoint of episodes of peritonitis and hospitalizations.

      The investigators postulate that there will be either no difference in outcomes or an
      improvement in outcomes in the telemedicine intervention arm.

      Study Design:

      Patients will be recruited from the University of Alabama at Birmingham Peritoneal Dialysis
      Unit. All patient's addresses are known and will be screened in order to determine inclusion
      criteria. Upon enrollment, patients will be administered the KDQOL-SF and the IIRS. Patient
      will all start in the standard of care arm. During this time period the patients will receive
      6 months of visits as per the usual standard of care. Data will be collected during this time
      regarding hospitalizations, peritonitis, technique failures, and access procedures. Monthly
      labwork including hemoglobin, phosphorus, parathyroid level, iron, total iron binding
      capacity, and ferritin will also be collected. At the end of 6 months the KDQOL-SF and IIRS
      will again be administered.

      The patient will then transition to the telemedicine arm of the study for the duration of 6
      months. During this time, the patient will come to the dialysis unit on a quarterly basis for
      a standard visit with labs being drawn in-center and for an in-center Kt/V. For the 2 months
      following the visit ,however, the patient will not be required to come to the dialysis unit.
      The monthly face to face and labs will be achieved remotely.

      In order to do this, the investigators have partnered with the Alabama Department of Public
      Health. During the telemedicine visits, the patient will present to their county health
      department which are now outfitted with the capability to provide interactive telemedicine
      visits.

      Exam: The patient will be examined during this telemedicine encounter using blue-tooth
      stethoscopes, placed on the patients chest by personnel in the county health department. The
      exit site will be examined using the remote camera. Fluid status will be monitored by both
      lung exam, weights which the patient does on a routine basis, and the examination of pitting
      edema as done over a telemedicine interface.

      Labs- On the quarterly "standard" visit during the telemedicine intervention, the patient
      will be given 2 preaddressed and prestamped containers with all vials needed to collect their
      monthly labs. The patient during their telemedicine visits will bring this container with
      blood collection tubes to the county health department. There, personnel a the health
      department will perform phlebotomy, using the predetermined blood collection tubes. Once
      filled, these tubes will be sent in the prestamped container to the Davita Central Lab for
      further processing. In this way, no additional cost for labs will be incurred, and lab
      results will be standardized in one central lab.

      Flow sheets: Patients records of therapy will be obtained using the Baxter ProCard. The
      patient will be trained on these cards prior to going to the telemedicine arm of the study.
      The patients will then be given 2 cards. Patients will use 1 procard for the month, and prior
      to their telemedicine visit will send this card in for download. Patients will then begin to
      use thesecond card, the previous card will be sent back to the patient via mail prior to
      their second visit such that it is had for their 3rd month.

      Remote QoL Surveys: Patients will be administered either over the phone or on a paper form
      depending on literacy the KDQOL-SF and the IIRS survey on Visit 3, and Visit 6.

      After completion of telemedicine arm, patients will return to Standard of Care and after 2
      months of being back on standard of care, KDQOL-SF and IIRS again will be administered.
    

Intervention name(s): Telemedicine
Intervention type(s): Other
Intervention description(s): Patients will be administered the KDQOL-SF and the IIRS and will all start in the standard of care arm. During this time period the patients will receive 6 months of visits as per the usual standard of care. At the end of 6 months the KDQOL-SF and IIRS will again be administered. The patient will then transition to the telemedicine arm of the study for the duration of 6 months. During this time, the patient will come to the dialysis unit on a quarterly basis for a standard visit with labs being drawn in-center and for an in-center Kt/V. For the 2 months following the visit ,however, the patient will not be required to come to the dialysis unit. The monthly face to face and labs will be achieved remotely
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        UAB patients on peritoneal dialysis that are living in a different county other than
        Jefferson county and has been on stable therapy for 2 months.
      
Keywords: Peritoneal Dialysis