Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and
      ulcerative colitis) that affect the intestines. The number of new cases of IBD in people
      younger than 16 years old has been increasing in the United Kingdom (UK), and is currently
      estimated to be 700 new cases every year. There is no cure for IBD and patients experience
      episodes of flareups in between periods of wellbeing.

      Traditionally, children with IBD are asked to attend regular hospital appointments. This
      means that, even if they are well, they have to get to the hospital and this can involve
      travelling long distances.

      Telephone consultations have been shown to be beneficial in some areas of medicine but this
      approach has not been well studied in children. The aims of this study are to determine
      whether telephone consultations would improve quality of life, patient satisfaction,
      proportion of consultations attended and whether they would be safe and reduce costs for
      patients and the National Health Service (NHS). Investigators plan a randomised controlled
      trial involving 92 participants recruited from amongst the 250 children and adolescents aged
      between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will
      be assigned to telephone consultations, and half to face to face consultations. The study
      would have the approval of the local ethics committee and participants would have provided
      written consent. Investigators will compare outcomes in the two groups over 2 years. If
      telephone consultations prove to be effective, the NHS could offer children with IBD the
      choice of either telephone consultation or face to face consultation for their outpatient
      followup. Those who are doing well would not have to make unnecessary journeys to the
      hospital. This would free up clinic spaces and allow patients who are unwell, and new
      patients to be seen more quickly, thus reducing waiting
    

Detailed description: 
      HYPOTHESIS Telephone consultation is effective, safe, and a cost-effective alternative to
      traditional routine face-to-face consultation for children and adolescents with IBD.

      AIMS

      The specific aims of the study are:

        1. To determine if telephone consultation, compared to face-to-face consultation is
           effective for children and adolescents with IBD.

           The investigators hypothesise that compared to face-face-consultations, telephone
           consultations would:

             1. improve patients' health-related quality of life

             2. have a positive impact on patient/carer satisfaction with consultations

             3. reduce out-patient non-attendance rate

        2. To determine any adverse events associated with routine telephone consultations in
           children and adolescents with IBD.

           The investigators hypothesise that compared to face-to-face consultations, telephone
           consultations will not:

             1. adversely affect patients' disease course such as the number of relapses, number of
                hospital admissions, and number of times they have to visit their paediatrician or
                General Practitioner (GP) because of concerns about symptoms

             2. adversely affect the child's growth

        3. To compare NHS resource utilisation, costs to the NHS and costs to patients and their
           carers in the two groups.

      The investigators hypothesise that telephone consultations, compared to face-to-face
      consultations, will:

        1. reduce NHS resource use

        2. reduce out-patient non-attendance rate

        3. be cost-effective to the NHS and

        4. reduce IBD-related costs for patients and families.

      METHODS SETTING AND PARTICIPANTS The study will be based at the Royal Manchester Children's
      Hospital, a regional Paediatric Gastroenterology referral centre. Children and adolescents
      with IBD from the North West of England and beyond are referred to this centre. Any patient
      who is aged between 8 and 16 years with a diagnosis of IBD will be eligible for entry into
      the trial. Eligible patients will be identified through the hospital's paediatric IBD
      database. There are currently about 250 eligible patients who attend the centre. Inclusion
      criteria are: patients aged between 8 and 16 years; diagnosis of IBD by established clinical,
      endoscopic, histological and radiological criteria; clinical remission defined as an
      abbreviated Paediatric Crohn's Disease Activity Index (aPCDAI) score of ≤10 (12) for patients
      with Crohn's disease or as a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of
      <10 (13) for those with ulcerative colitis and indeterminate colitis; parental and child's
      consent to participate in the study. Exclusion criteria are active disease (aPCDAI>15 or
      PUCAI ≥15), and unwillingness to provide informed consent.

      STUDY DESIGN A randomised controlled trial comparing telephone consultations with standard
      face-to-face out-patient consultations. It will be accompanied by an economic evaluation.

      PLAN OF STUDY The investigators will send a letter of invitation to participate in the study
      and a research information sheet outlining the nature and importance of the study to eligible
      patients and their parents. The invitation letter will explicitly state that if they do not
      wish to take part in the study, it will not prejudice the quality of health care provision
      from the hospital. Two weeks later, the investigators will telephone all those who have not
      already responded, offering an invitation to participate and to answer any queries. Those who
      can not be contacted by telephone will be sent a second letter. Those who agree to take part
      will be interviewed by an investigator who will provide full information about the trial and
      obtain written informed consent. Prior to randomization, the following baseline demographic
      and clinical features will be recorded: patient's initials, date of birth, gender, hospital
      number, and disease activity (aPCDAI or PUCAI score). Participants will be provided with the
      contact details of relevant investigators.

      Randomization

      By means of a computer-generated random number, participants will be randomly allocated to
      one of two groups:

      Intervention Group: telephone consultations Control Group: face-to-face consultations

      The investigators will use a stratified block randomization with blocks of random sizes, and
      stratify by type of disease (i.e.Crohn's disease or ulcerative colitis/indeterminate
      colitis).

      To ensure allocation concealment, the computer-generated assignment schedule will be held
      centrally and administered by 2 designated administrators who are not involved in the study.
      If a participant meets the inclusion criteria and provides informed consent, he or she will
      be entered into the study. Investigators will telephone the designated administrators, who
      after recording the patient's identification number, date of birth and disease activity
      score, will assign the next number in the series to determine allocation group. The assigned
      group will be recorded and implemented. Nobody will be able to alter the assignment.
      Participants in the telephone group will, however, retain the option to return to routine
      care through non-concordance with the allocated intervention.

      Procedures Patients in both groups will be offered out-patient appointment dates and times.
      Those randomized to face-to-face follow up will attend their appointments in hospital as
      usual. Those randomized to telephone consultation will be told to expect a call from the
      gastroenterology doctor at the time of their appointment (which will be after school hours).
      The consulting doctor will contact the patient and parents via a telephone number (home or
      mobile) that the parents and patient had previously supplied as the number they would like to
      be contacted on. As much as possible, parents and patients will be advised to be together at
      the time of the appointment in order to allow both of them to participate in the consultation
      as is usual in practice. Up to 3 attempts within 20 minutes will be made to contact patients
      by phone. Details about each consultation including date and time, who was present, duration
      of consultations, and failed attempts at phone calls will be recorded. Patients who "DNA" an
      appointment in either group will be sent another appointment in accordance with normal
      practice.

      Apart from being randomised to telephone or face-to-face consultation, routine care will be
      the same for patients in both groups. For instance, all patients on treatments such as
      azathioprine and methotrexate will continue to have relevant tests such as full blood count
      and liver function tests monitored regularly according to current guidelines. In our current
      practice, this routine monitoring does not usually take place at the routine out-patient
      visits but rather at the child's GP surgery, or local hospital and the results communicated
      to our inflammatory bowel disease nurse specialists. This practice will remain the same for
      all patients. It will also be emphasized that, as it is in normal practice, if a participant
      experiences any symptoms that cause concern at any time during the study, the parent/child
      should contact the IBD nurse for advice and an appropriate arrangement for assessment will be
      made. A relapse will not require withdrawal but the patient will be seen and treated as
      appropriate and will remain in the same study group.

      OUTCOME MEASURES Primary outcome measure The primary outcome measure will be changes in the
      paediatric IBD-specific health-related quality of life (QOL) scores. QOL scores will be
      assessed at baseline, and 6-monthly over the 2-year follow-up period using the validated
      paediatric IBD QOL IMPACT questionnaire (Appendix 1). The IMPACT questionnaire was originally
      developed for use in paediatric IBD in Canada (14) and with minor adaptations, the
      questionnaire was subsequently validated in Canada ((15), the Netherlands (16), and the UK
      (17). The questionnaire consists of 35 questions measuring six quality of life domains (IBD
      symptoms, systemic symptoms, emotional functioning, social functioning, body image, and
      treatment/interventions) and utilizes a Likert scale to report the patient's answers.
      Responses are scored (from 0 to 4) and summed to give a total score (range 0 to 140). Higher
      scores represent better QOL.

      Secondary outcome measures

        1. Relapses For each participant, the number of relapses during the study period will be
           recorded. For patients with Crohn's disease, a relapse will be defined as an aPCDAI of
           >15. The PCDAI was originally developed and validated in several centres (18) and has
           been used widely in paediatric clinical trials. The original PCDAI includes three
           history items (abdominal pain, number of liquid stools, general wellbeing), five
           physical examination items (abdominal examination, perirectal disease, extraintestinal
           manifestations, weight, height velocity), and three laboratory tests (hematocrit,
           albumin, erythrocyte sedimentation rate). Among other things, the original PCDAI has
           been criticized because of the inclusion of blood tests. Recent studies have shown that
           an abbreviated version of the PCDAI (aPCDAI) which omits laboratory items is accurate
           and predicted disease activity as well as the original PCDAI (12,19). The aPCDAI
           consists of the three history items (abdominal pain, number of liquid stools, and
           general well-being), and the three physical examination items (weight loss, abdominal
           examination, and perirectal disease) of the original PCDAI. In order to avoid repeated
           blood sampling for research purposes, we will use the aPCDAI (Appendix II). Items in
           this index are scored on a three-point scale (zero, 5, or 10 points) and scores range
           from zero to 60 with higher scores indicating more active disease.

           For patients with ulcerative colitis and indeterminate colitis, a PUCAI score of >15
           will be considered as a relapse. The PUCAI is a validated instrument that includes six
           history items (abdominal pain, rectal bleeding, stool consistency, nocturnal stools and
           activity level) (13). PUCAI scores can range from zero to 85 with higher scores
           indicating more active disease.

        2. Basic anthropometric measures at every routine follow up visit / consultation Weight and
           height will be measured at baseline and during the routine follow up appointments in
           both groups. For those allocated to face to face consultations, their height and weight
           will be measured at their out-patients visits. For children allocated to telephone
           consultations, height and weight will be measured by their local paediatric service,
           prior to their telephone appointment. A member of the study team will, prior to each
           follow up period, contact those in the telephone consultation group to remind them to
           the have measurements done. A study team member will then contact the local service or
           the parent / patient to obtain the measurements. Height and body mass index (BMI) z
           scores will be calculated based on sex- and age-related UK centile charts.

        3. Patient satisfaction with consultations - to be completed after every Participants or
           their carers will be asked to complete a Consultation Satisfaction Questionnaire (CSQ)
           at the end of each consultation. This CSQ is an 18 item consultation-specific
           satisfaction measure that was developed and validated by Baker (20, 21). It has since
           been used in other areas/settings including community nursing (22, 23), and has recently
           been modified and tested for use in consultations involving patients aged 15 years or
           younger (24). After discussions with the originator of this instrument and the
           researcher who modified it for paediatric use, the modified version of the CSQ will be
           adapted for children aged 15 years and younger (Appendix IIa), and the original version
           adapted for patients aged 16 years or older (Appendix IIb) {R Baker and P Kinnersley,
           personal communication, July 2008}.

        4. Number of hospital admissions for IBD over 24 months. Data will be obtained from the
           patient's hospital records.

        5. Proportion of out-patient consultations attended For each group, the proportion of
           outpatient appointments attended over the 24-month follow-up period will be calculated
           by dividing the total number of appointments (telephone or face-to-face) offered by the
           number of appointments attended.

        6. Duration of consultations The duration of each consultation will be recorded in the
           patient's medical notes.

        7. Adverse effects of immuno-suppressive agents such as azathioprine and methotrexate.

           Any adverse effect of immuno-suppressive agents that participants may be receiving
           during the study period will be recorded.

        8. Economic evaluation Investigators will assess the use of health care resources, costs to
           the NHS and costs to patients and their carers in the two groups. Data on resource use
           in tertiary, secondary and primary care will be collected. Data on resources used for
           outpatient consultations (telephone or face-to-face), additional or unscheduled hospital
           visits, tests and procedures, drug prescriptions, hospital admissions, and general
           practice visits will be identified for every patient.

      At each outpatient consultation (telephone or face-to-face), the clinician will record
      details of the consultation including date of the visit and duration of the consultation.
      Abortive telephone calls will be recorded as well as face-to-face appointments missed. For
      telephone consultations, it will be noted whether calls were local, national, or made to
      mobile phones. Data on inpatient admissions, any investigations or procedures, and treatments
      received will be abstracted from the patient's hospital records. A patient/carer diary
      (Appendix IV) will be used to collect information on drug utilisation (name, dose, frequency,
      and duration), GP visits, and care received at other hospitals. Patients will be asked to
      complete the diary every time they visited their GP, changed their regular medications, or
      were seen at other hospitals. Diary information will be collated 6-monthly. Resource use that
      was clearly unrelated to IBD will be excluded from the economic evaluation.

      Note:Routine follow ups / consultations vary between patients depending on how well they are.
      Patients may also be seen for routine appointments in between the scheduled study follow ups.
    

Intervention name(s): telephone consultations; face-to-face consultations
Intervention type(s): Other; Other
Intervention description(s): Those randomized to telephone consultation will be told to expect a call from the gastroenterology doctor at the time of their appointment.; Those randomized to face-to-face follow up will attend their appointments in hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Crohn's disease; ulcerative colitis; Inflammatory bowel disease; IBD