HTF 402 National First Nations Telehealth Research Project
Consolidated Ethics Review Submission
Version 2.1
September 27, 2000
Prepared by: Infotelmed Communications Inc.
 (90.9
K)
Attachment 6: Integrate Ethics Review Document
1. Title of project
First Nations Telehealth Research Project
2. Name and organizational affiliation of principal investigator.
Alexa Brewer
Medical Services Branch
Health Canada
Jeanne Mance Building, Tunney's Pasture
Ottawa K1A OL3
3. Names and organizational affiliations of all co-investigators
Project Manager
Ernie Dal Grande
Medical Services Branch
Health Canada
Jeanne Mance Building, Tunney's Pasture
Ottawa K1A OL3
Contractors responsible for carrying out the evaluation:
Natalie Kishchuk, PhD
Jocelyne Picot, PhD
Infotelmed Communications Inc.
38 Place du Commerce
Verdun, Québec H3E 1T8
A Peer Review Committee, consisting of expert representatives
form a number of institutions and associations, oversees the project.
Its members are:
Dr. Joe Kaufert University of Manitoba
Dr. Penny Jennet University of Calgary
Dr. James Irvine University of Saskatchewan
Dr. Alain Cloutier Université Laval
Ms. Maria MacNaughton Health Canada
Ms. Lisa Dutcher Aboriginal Nurses Association
Ms. Margaret Neylan British Columbia Institute of technology (retired)
4. Signatures of all investigators
__________________________________________________
__________________________________________________
__________________________________________________
5. Apparent conflicts of interest
No investigator in this study has any interest in any of the telehealth
supplier firms.
6. Participating institutions
This project involves the delivery of health services via telehealth
linkages through the health centers managed by the Band administrations
five First Nations communities, listed below. The personnel involved
with these centers are either employees of the Band or, in a minority
of cases, Health Canada. The five First Nations communities will
be linked with specialized medical staff in the secondary and tertiary
institutions, also listed below.
Anahim Lake, B.C. linked with: Cariboo General Hospital, Williams
Lake
Fort Chipeweyan, Alberta: Northern Lights Hospital at Fort McMurray
Southend, Saskatchewan: La Ronge Hospital, La Ronge; Prince Albert
Hospital, Prince
Albert; Royal University Hospital, Saskatoon
Berens Rivers, Manitoba: Health Sciences Centre, Winnipeg
La Romaine, Québec: Centre de santé Sept-Iles, Centre
hospitalier universitaire du Québec, Québec City.
7. Dates of project start and expected completion
March 2000 - March 2001
8. Previous history of the project at this institution
This is a new project at all the participating institutions.
9. Summary of proposed research
Objective and hypotheses, with evidence that justifies this
research with human beings at this time.
Telehealth is the delivery of health information, resources and
services through information and communications technology. As
one of several telehealth demonstration and evaluation projects
funded through the Health Transition Fund, the First Nations' Telehealth
Project will deploy and evaluate applications of telehealth in
five remote First Nations communities. The research objectives
are: to assess the extent to which telehealth: 1) improves patient
and community access to care, including timeliness of access; 2)
renders service delivery in remote communities more cost-effective;
and 3) improves linkages between to remote health care centres
and secondary, tertiary and educational facilities in each province.
Overall, the research literature in telehealth suggests that it
has the potential to improve health services delivery while maintaining
patient health outcomes, but that its cost-effectiveness and implementability
have yet to be clearly demonstrated. Research to date has tended
to concentrate on the accuracy and reliability of information and
diagnoses provided through telehealth applications. In general,
these studies provide relatively strong evidence that quality of
information provided is comparable to that provided through usual
channels. However, other aspects of quality of care, including
continuity and comprehensiveness, have not been addressed. The
organizational implications of implementing telehealth are not
well documented, although some studies mention changes in workloads
and work organization for health personnel.
It is also not clear as yet whether telehealth represents an overall
improvement in the quality and accessibility of care, versus a
shifting of the same care to less costly methods of delivery. While
many studies have demonstrated the cost-effectiveness of various
telehealth applications, they have tended to limit their assessment
of costs to the time involved from the specialty physicians. More
comprehensive studies including equipment, telecommunications,
and organizational costs suggest that cost-effectiveness is not
guaranteed, and at the very least must be assessed over a relatively
long amortization period. Moreover, usage levels of telehealth
systems, a major factor in cost-effectiveness, are often less than
expected. No studies have systematically examined the proportion
of eligible patients in a given practice population who use telehealth.
Studies of cost reductions due to decreased patient travel and
wait time show that use of telehealth may diminish patient transfers,
but not in all cases. The extent to which telehealth defers rather
than replaces in-person consultations has not been addressed.
There is evidence, however, that telehealth may have benefits
for both patients and providers. Reactions among local providers
(in most studies, general practitioners) are generally positive,
and there is some evidence that can improve the quality of their
services. Patient satisfaction with telehealth is high, and in
studies where it has been assessed, patients report that their
quality of life is improved by using telehealth. Moreover, in some
types of applications, patients report that they feel more empowered
or in control of their interactions with health professionals when
using telehealth.
Study design, with scientific justification
Due to the exploratory nature of the hypotheses and impossibility
of conducting a controlled trial in these small communities, the
evaluation design is essentially descriptive and longitudinal.
The evaluation methods to be used will provide information about
both the entire project and each specific community.
- Monitoring of telehealth system usage: Continuously
throughout the study period, nursing station staff and remote
health staff will complete logs of patient encounters for all
patients eligible to use the telehealth applications, regardless
of whether it is used. These logs contain information on the
health condition prompting the consultation, the actions undertaken
by the local and remote providers using telehealth during the
encounter, and follow-up actions required.
- Patient satisfaction: In each community, patients
will be asked to complete brief questionnaires or interviews
assessing their satisfaction with several facets of the encounter
and their preferences for using telehealth.
- Qualitative interviews with key informants: At
two points during the study period, qualitative interviews will
be conducted with four types of key stakeholders: nursing station
personnel (managers, nurses, CHR, social services providers,
translators); remote centre and education telehealth partners
(physicians, nurses and technical teams in the nursing stations
linked to the participating communities); staff in educational
institutions linked to the communities; community leaders (elders,
council members and health committee members); federal and provincial
agency representatives. The stakeholders will be asked to respond
as key informants giving their views on the evaluation questions
from their perspectives within the project and the communities.
They will be identified in collaboration with project leaders,
nursing station staff and other relevant sources such as the
Peer review Committee. Approximately ten semi-structured interviews
will be conducted in each site at each time point, and will be
one half hour to one hour in length. They may also be conducted
as group consultations if this is more appropriate in the community.
- Cost assessment: Nursing station management
will provide cost data on patient transfers for eligible patients
during the study period.
Because 1) many of telehealth application being evaluated target
chronic conditions such as diabetes, and 2) of the need to examine
the extent to which telehealth defers rather than replaces in-person
consultations, individual patients will be followed longitudinally
throughout the study period, using blinding procedures described
in the section on confidentiality.
Information from these four sources will be aggregated into case
studies of each participating community.
10. Research participants in each site and in overall study
The study will enroll a continuous series of volunteer adult and
child patients from the beginning of telehealth deployment until
at least January 31 2001, with the condition that at least 30 patients
in each site will participate, for an overall minimum sample size
of 120 patients (see description below: one community will not
use the telehealth systems in direct patient encounters). This
sample size will permit reliable point estimates at the level of
each community as well as reliable aggregate data across the entire
study.
The combination of telehealth applications to be implemented in
each of the five communities varies, having been selected on the
basis of an in-depth needs assessment involving consultations with
key community leaders, health staff and other professionals, as
well as available health status data. (The specific health conditions
are described below). Patients considered eligible for enrollment
in the research study (the research population) are thus those:
- who present to the community nursing station with a complaint
related to the health conditions targeted by the telehealth applications
available in the community
- who consent to use the telehealth system (or, for children
under 16 years, whose parent or guardian consent to its use).
- who consent to participate in the evaluation (or, for children
under 16 years, whose parent or guardian consent to participation.)
Use of the telehealth application will require consent from each
patient (or each patient's parent or guardian) at each health center
visit; that is, patients are free to decline telehealth use at
any visit. Moreover, based on their clinical judgment, nursing
station staff may decide in certain circumstances to not propose
use of the telehealth system to eligible patients. Nursing station
staff will maintain a record of the number of patients who do not
use the telehealth application for which they are eligible, either
because they decline to participate or because the nursing station
staff do not offer it, but no other information will be collected
about these patients.
The eligibility criteria for patients in each community
are:
- La Romaine
- Diabetes monitoring: consenting patients who have been
diagnosed as diabetic.
- Cardiovascular monitoring: any consenting patient who may
require an electrocardiogram, or vital sign monitoring, for
routine, follow-up, or emergency reasons, as identified by
the CHC nurse.
- ENT - any consenting patient who has been identified by
the CHC nurse as requiring diagnosis or treatment from an
ENT specialist.
- Berens River
- Patient Care: - consenting patients who have been identified
by the local CHC personnel as requiring access to specialist
care.
- DiabeticEducation: consenting patients who have been diagnosed
as diabetic and who may benefit from patient education.
- Continuing Medical Education - consenting local health
care personnel.
- Southend
- Access to specialists - consenting patients who have been
identified by the local CHC personnel as requiring access
to specialist care.
- Diabetic education - consenting patients who have been
diagnosed as diabetic and who may benefit from patient education.
- Mental Health - local health and other personnel participating
in community capacity building for mental health.
- Fort Chipewyan
Rehabilitation: consenting patients receiving rehabilitation
treatments from an assistant under supervision for physiotherapy,
speech therapy or occupational therapy.
- Anahim Lake
Urgent/Emergent cases - comprising of cardiac, diabetic, respiratory
ailments as well as major cuts, fractures and burns. The urgent/emergent
telehealth will assist the Cariboo Memorial Hospital's emergency
services in Williams Lake so that they may be better prepared
when the patient arrives from Anahim Lake.
Because some of the technology involved (notably interactive
video) is flexible, it is anticipated that it may be used for
patients with other health conditions. To the extent possible,
the evaluation will monitor this additional usage.
- Exclusions
Only those patients who do not consent to participate, or for
whom no telehealth application has been implemented in the
community, are excluded from this study.
- Step-by-step description of what will be done with
research participants at each stage of the research operations
In general, the health care for any eligible, consenting patients
involved in the telehealth study will follow standard care practice
for each medical condition for which the telehealth system is
used. This standard will not be altered whether or not the telehealth
system is used. The ways in which the means of service delivery
will be modified through the use of telehealth are described
below, as are the data collection procedures to be used for patients.
Because the targeted health conditions, the telehealth technologies
deployed and therefore the health care delivery operations vary
by community, the are described in detail for each.
La Romaine
Telehealth care
- Diabetes - Medical Consultations - In addition to the standard
care which is given to diabetic patients, the patients involved
in this study will be monitored for glucose levels from their
homes.
- Cardiovascular monitoring - Patients with suspected or established
cardiovascular disease will receive the same standard of care
provided at the Community Health Centre (CHC) in La Romaine.
In emergencies, the telehealth network will permit patients with
emergency cardiac problems to have an electrocardiogram (ECGs)
and vital signs recorded by a nurse at the CHC and sent immediately
to a physician at the Sept-Iles Regional Hospital (SIRH) for
immediate diagnosis, which will be provided by computer-mediated
video and audio interaction between the physician and the CHC.
The subject will then be cared for in the standard manner, that
is, stabilized and medically evacuated if deemed necessary by
the physician. On a non-emergency basis, patients with cardiovascular
problems may have ECGs done at the CHC and sent to the physician
at the Sept-Iles Regional Hospital.
- ENT (Ear, nose, throat) - After it has been established by
the nurse at the CHC that the patient should see an ENT specialist,
the standard procedure would be for the subject to obtain an
appointment with the ENT specialist at the Sept Iles Regional
Hospital (SIRH). With the telehealth network, the nurse will
send ENT images of eligible, consenting patients to the specialist
first. On the basis of the information and images received, the
physician will provide advice regarding treatment.
Study procedures
- Nursing station personnel will determine the eligibility of
patients presenting to the nursing station for participation
in the evaluation study based on their presenting health problem.
They will obtain consent from those patients who are willing
to participate in the research study:
- If they staff determine that a telehealth consultation
could be beneficial to the patient
AND
- If the patient consents to telehealth use.
- Nursing station personnel will proceed to collect the information
necessary, transmit it to the remote health personnel, and arrange
for communicating the results (most likely, but not necessarily,
in the context of a regularly scheduled consultation, which could
happen in real-time or be scheduled for a future communication).
- Following the consultations:
- nursing station personnel will complete the encounter log
AND
- remote personnel will complete the encounter log AND
- patients will complete a satisfaction questionnaire or
interview.
Berens River
Telehealth care
- Patient Care - The standard care provided to patients in need
of access to specialists in the Health Sciences Centre is for
the nursing station staff to identify the need for a consultation
with a general practitioner, who will refer the patients to the
specialist clinics as required. The telehealth system will allow
consenting patients to consult with a specialist by interactive
video. Local nurses will participate in the session as well,
ensuring that the patient understands instructions regarding
any treatment required.
- Patient Education - (Diabetes care, prevention activities and
clinical care). In addition to the standard care and information
given to diabetic patients and patients at risk, the telehealth
network will permit consenting patients and staff at the nursing
station to link to diabetes health educators for information
and education regarding prevention. The telehealth link will
also be used to help monitor foot care. The standard care provided
to patients in need of counselling is to refer the subject to
a counsellor at the Health Sciences Centre (HSC). The telehealth
network will permit initial assessments and some counselling
to take place by interactive video.
- Continuing Medical Education - Nurses and other members of
the local healthcare community will participate in CME sessions.
Study procedures
- Nursing station personnel will determine the eligibility of
patients presenting to the nursing station for participation
in the evaluation study based on their presenting health problem.
They will obtain consent from those patients who are willing
to participate in the research study:
- If they determine that a telehealth consultation could
be beneficial to the patient AND
- If the patient consents to telehealth use.
- An appointment will be scheduled for consultation with the
professional at the remote site, perhaps in a regularly scheduled
telehealth clinic. The telehealth consultation will then take
place with the nursing station staff and translators present,
as required, under the clinical guidance of the remote health
personnel according to usual standards of practice.
- Following the consultations:
- Nursing station staff will complete the encounter log AND
- remote personnel will complete the encounter log AND
- patients will complete a satisfaction questionnaire or
interview.
Southend
Telehealth care
- Access to specialists in LaRonge via interactive video - The
standard care provided to patients in need of access to specialists
in the LaRonge Health Centre (LRHC), Prince Albert Hospital,
and Royal University Hospital (particularly adult and child psychiatry,
dermatology, and TB follow up) is for the nursing station staff
to identify the need for a consultation with a general practitioner,
who will refers the patients to the specialist clinics as required.
The telehealth system will allow consenting patients to consult
with a specialist by interactive video. Local nurses will participate
in the session as well, ensuring that the patient understands
instructions regarding any treatment required.
- Diabetic education - In addition to the standard care and information
given to diabetic patients and patients at risk, the telehealth
network will permit consenting patients and staff at the nursing
station to link to a nutritionist/dietician and diabetes educator
in the LRHC and the Prince Albert Grand Council Diabetic team
for information and education regarding prevention.
- Staff/Community Education - Nurses and other members of the
local healthcare community will participate in CME sessions.
Nursing station and other band staff will be linked as required
to psychologists at the University of Saskatchewan, to develop
community capacity in mental health.
Study procedures
- Nursing station personnel will determine the eligibility of
patients presenting to the nursing station for participation
in the evaluation study based on their presenting health problem.
They will obtain consent from those patients who are willing
to participate in the research study:
- If they determine that a telehealth consultation could
be beneficial to the patient AND
- If the patient consents to telehealth use.
- An appointment will be scheduled for consultation with the
professional at the remote site, perhaps in a regularly scheduled
telehealth clinic. The telehealth consultation will then take
place with the nursing station staff and translators present,
as required, under the clinical guidance of the remote health
personnel according to usual standards of practice.
- Following the consultations:
- nursing station personnel will complete the encounter log
AND
- patients will complete a satisfaction questionnaire or
interview.
Fort Chipewyan
Telehealth care
- Supervision of a rehabilitation assistant - The standard care
provided to patients in need of rehabilitation services - including
physical, occupational and speech therapy - is to refer them
to providers of these services at the Northern Lights Regional
Health Centre (NLRHC) in Fort McMurray. The telehealth network
will permit eligible, consenting patients to receive these services
from an assistant, under supervision from a qualified senior
rehabilitation professional located in NLRHC.
- Televisitation/telespirituality - Visits between friends and
family members in Fort Chipewyan of patients hospitalized at
NLRHC will be arranged through the Aboriginal Liaison Office
at NLHRC.
Study procedures
Rehabilitation
Initial assessment of patients will take place at NHLRC by the
appropriate rehabilitation specialist, with observation by the
rehabilitation assistant. The specialist will develop a treatment
plan, which will then be implemented by the rehabilitation assistant
under the clinical guidance of the rehabilitation specialist according
to usual standards of practice. Every fifth treatment session will
be observed by the rehabilitation specialist, and the treatment
plan adjusted as necessary.
Consent for participation in the telehealth program and research
study will be obtained from patients or their guardians before
their first telehealth session.
Following each session, including those that are not supervised
using telehealth, the rehabilitation assistant will complete a
session log form and patients will complete a satisfaction questionnaire.
Following each session which uses telehealth, the rehabilitation
specialist will complete a session log form and will compile a
monthly report. Patients will complete a satisfaction questionnaire
Near the end of the project, a cross -sectional study of patient
outcomes will be conducted. A random sample of 30 active rehabilitation
patients will be selected. For each of these patients, the following
will be asked to complete a brief questionnaire assessing overall
progress in rehabilitations and the contribution of the telehealth
system to that progress (instruments to be developed) 1) patient
him or herself; 2) rehabilitation assistant 3) rehabilitation specialist.
Televisitation
The televisitation sessions will be scheduled during regular hours
when rehabilitation sessions are not going on. With the assistance
of the televisitation liaison (the NLRHC Aboriginal Liaison), hospitalized
patients will visit with friends or family in Fort Chipewyan.
Following the session, the televisitation coordinator will complete
a session log form and patients will complete a satisfaction questionnaire
which includes items on the therapeutic value of visitation.
Anahim Lake
Telehealth care
Urgent/ Emergent Telehealth - The standard care for trauma is
to stabilize the patient and medically evacuate traumatic conditions,
which cannot be treated locally. The telehealth application will
facilitate the process of triage and subsequent medical evacuations,
if needed, by providing the professionals at the Cariboo General
Hospital in Williams Lake with advance information about the patient's
condition - for example, vital signs, video images of injuries,
or other relevant data.
- The telehealth network may permit consenting trauma patients
to receive immediate specialist treatment at the Cariboo General
Hospital in Williams Lake. Urgent/Emergent cases would comprise
of cardiac, diabetic and respiratory ailments as well as major
cuts, fractures and burns.
Study procedures
- Nursing station personnel will determine the eligibility of
patients presenting to the nursing station for participation
in the evaluation study based on their presenting health problem.
They will obtain consent from those patients who are willing
to participate in the research study:
- If they determine that a telehealth consultation could
be beneficial to the patient AND
- If the patient consents to telehealth use.
- Emergency trauma consultations will take place as the need
arises, with the telehealth system being available 24 hours,
seven days a week. The telehealth consultation will then take
place with the nursing station staff and translators present,
as required, under the clinical guidance of the remote health
personnel according to usual standards of practice.
- Following the consultations:
- local personnel will complete the encounter log AND
- remote personnel will complete the encounter log AND
- patients will complete a satisfaction questionnaire or
interview.
13. Measures
The appendices contain copies of all the measures to used:
- Patient encounter forms: checklist-type forms,
specific to each community, developed specifically for this research,
including: date, time and length of usage, as a proportion of
total encounter; health problem prompting the consultation; who
was present, at the local and remote sites; manoeuvres during
the telehealth encounter; results of the visits in terms of subsequent
actions; any technical problems experienced; the implications
of using telehealth in terms of costs incurred or avoided. The
section of the forms recording what was done during the visit
provide proxy indicators of quality of care, in that for those
telehealth applications which address conditions for which guidelines
for appropriate primary clinical practice have been established
(diabetes, mental health, and cardiology), the forms include
check points for the recommended components of appropriate care.
- Patient satisfaction questionnaire: a 12-item
questionnaire based on Loane, Bloomer & Corbett, 1998 and
adapted for use as either an interview or self-completed questionnaire.
- Key informant interviews: Developed for this
study and following the format used successfully for the interviews
conducted during the needs assessment phase of the project.
14. Description of all possible risk and harms and discomforts,
of all procedures, services, tests or measures for the purpose
of this study, which are not part of ordinarily accepted care of
the subject.
The services to be provided through telehealth will be delivered
by the same providers in the same practice parameters as ordinarily
accepted care, but using information and communications technologies.
The possible risks to the patient include loss of sensitivity or
accuracy in transmission of information either from the patient or
from the remote health personnel, with a risk that important information
may be missed and quality of care compromised. There may also be
a risk that physicians increase testing and diagnostic procedures,
exposing patients to the greater risks through these, in order to
reduce uncertainty associated with telehealth usage.
Harms or discomforts to patients may include psychological unease
in participation in health encounters with remote personnel, or
in the case of store-and-forward technology, discomfort with the
electronic transmission of private information.
15. Identification of ways in which management or treatment of
the subject's condition will be prolonged or delayed because of
the research, and if any standard therapies of diagnostic procedures
will be withheld for the purpose of the study.
No treatments will be prolonged, delayed or withheld as purpose
of this study.
16. Procedures for removing patients from the study
Patients are free to decline participation at any point in the
study. Declining to participate will in no way affect care or services.
Removal of patients from the study and/or not making the study
available to patients -- in other words, delivering their care
through conventional rather than telehealth channels - will be
at the complete discretion of the patients' usual providers (local
health center staff) in conjunction with patients themselves, according
to their joint judgment about the suitability of patients to receive
care through telehealth.
17. Direct and Indirect Benefits
General benefits for communities
The research study will test the effectiveness of telehealth to
provide health care delivery. The results of this study will permit
the communities involved and other similar communities to determine
the cost-effectiveness and benefits of adopting and implementing
telehealth technology. For communities, the main benefits are therefore
expected to be 1) and the realization of savings by reducing the
number of patient transfers. 2) greater access for local healthcare
personnel to specialists and continuing education, enabling them
to keep their medical and health care knowledge current.
General benefits for individual patients
During the study, eligible consenting patients may be able to
avoid traveling out of their community to obtain a specialist medical
consultation. The study may permit participants to receive specialized
health care more quickly than previously.
Specific benefits according to communities
La Romaine
- Diabetes - Medical Consultations - The benefit of the research
project for the eligible, consenting patients is access to continuous,
rather than periodic monitoring of their diabetic condition,
and this monitoring will be possible from their homes. They will
also have the benefit of immediate medical assistance and advice
should their glucose levels change.
- Cardiovascular monitoring - The benefit for eligible, consenting
patients and local health care staff is that, in any emergency,
local health care staff may obtain information and immediate
advice from a physician specialist and possibly not have to medically
evacuate or transfer the patient for treatment. Patients will
not have to travel out of their community for a routine electrocardiogram.
- ENT - Eligible, consenting patients can possibly obtain a diagnosis
almost immediately and instructions regarding treatment given
to local health care staff, avoiding patient travel out of the
community.
- Dermatology - Eligible, consenting patients can possibly obtain
a diagnosis regarding skin lesions and other dermatological problems.
Instructions would be provided by the dermatologist remotely
located, regarding treatment.
Berens River
- Patient Care - The benefits to consenting patients is that
they will have access to a specialist without having to travel
out of their community. The benefits to specialists who participate
in the study is that they will be able to treat patients remotely
more promptly. As a result of the study, the community may be
able to realize savings from travel avoidance.
- Patient Education (Diabetes care, prevention activities and
clinical care) - The benefit to participating consenting patients
is that they will receive information and education which could
help them avoid complications arising from various health problems
- Continuing Medical Education - The benefit to local healthcare
staff is that they can participate in CME sessions and upgrade
their knowledge without having to travel outside the community.
These benefits will be passed on to the patients, which they
see in the Nursing station.
Southend
- Access to specialists - The benefits to consenting patients
are that they may be able to see a specialist more quickly and
they will not need to travel outside the community. The benefits
to specialists who participate in the study is that they will
be able to treat patients remotely more promptly. As a result
of the study, the community may be able to realize savings from
travel avoidance.
- Diabetic education - The benefit to participating consenting
patients is that they will receive information from a nutritionist
regarding their diet, and other information, which could help
them avoid complications of diabetes.
- Staff/Community Education - The community will benefit receiving
expertise in the prevention and management of mental health problems.
Fort Chipewyan
With the use of a telehealth network, rehabilitation services
will be provided closer to the patient's home and community. It
will be possible to assess the usefulness of telehealth in providing
supervision for rehabilitation assistants.
Anahim Lake
Urgent/ Emergent Telehealth - With the use of a telehealth network,
it will be possible to triage trauma earlier and make more effective
decisions regarding medical evacuations.
18. Costs and compensation
The total amount of funding for this research project has been
made available through Health Canada's Health Transition Fund.
The funds are being administered by the Medical Services Branch
of Health Canada, through Memoranda of Understanding with each
of the five provinces and communities involved.
Patients or health care professionals involved in this research
study will not be remunerated or compensated financially for participating
in the study.
19. Description of the procedures for obtaining informed consent
Patients
All eligible patients will be given the opportunity to provide
their informed consent (1) to receive health care through telehealth
and (2) to participate in the telehealth research study. In the
case of patients under 16 years, informed consent will be obtained
from the child's parent or legal guardian. The consent process
has been designed to respect the elements of capacity, comprehension
and voluntariness. A verbal and written explanation will be given
to each prospective subject in the language of his or her choice.
Potential research participants will be given sufficient time to
ask questions and opportunity to consider the information provided.
A copy of the signed consent form will be given to the subject,
and a copy kept on file by the Community Health Centre until the
end of the study.
If the patient is unable to sign, or if circumstances make if
impossible for the subject to provide written consent, the consent
of the subject will be obtained (1) orally or (2) tape-recorded.
Where consent is oral, a record of it will be made in an appropriate
log or book dated and signed by the researcher, the project officer
or the nurse at the health care center.
If the consent is tape-recorded, the recording will clearly identify
the subject, the researcher and the date.
In certain cases involving medical emergencies, consent to use
telehealth may be waived if the subject is placed at risk due to
the delay which will be occasioned if a full explanation is given,
or if the subject is not competent or not conscious. If the subject
becomes conscious he or she must be promptly afforded the opportunity
to give free and informed consent concerning continued use of telehealth
or participation in the telehealth study.
The following information will be provided verbally to
each participant:
(* Indicates items which are included on the adult consent form.
A parallel version for parents whose children are eligible patients
is also provided.)
- *Purpose:
We are asking you to participate in a telehealth research project.
The basic purpose of this project is to obtain information
about the use of telehealth technology in your Community Health
Center. It is part of a study that is being done in four other
First Nations Communities in northern Canada.
- *Description
The telehealth system uses television or the telephone to let
you talk to a doctor, a specialist or a counselor. This may
mean that you will not have to travel to _______ to see the
doctor or specialist. If you agree, you would see the doctor,
specialist or counselor on the television set without having
to travel to _________________.
We are also asking you to participate in a study to see if this
system suits your health care needs. If you agree to participate,
you would be asked complete a short questionnaire (or answer
short questions briefly) to tell us about your preferences for
using telehealth (this will take about 10-15 minutes).
If you agree to participate, the nurse in your health center
will fill out a form about what happened in your visit here today:
who was here, what was done and what will be done next. If you
speak to a doctor, specialist or counselor using the telehealth
system today, that person will also fill out a form. These forms
will help us keep track of how the telehealth system is being
used. If you come into the health center anther time, the nurse
will fill out another form and give them both a number or a code
so that she can keep track of how the telehealth system is used
over time. You will not have to do anything for these forms.
All of the forms will be sent to the researchers at McGill University
who will put all the information from this community and the
four other First Nations' communities together.
YOUR NAME WILL NOT BE PUT ON ANY OF THE FORMS: NO ONE
OUTSIDE THE HEALTH CENTER WILL KNOW ANYTHING ABOUT YOUR VISITS
THERE.
- *Benefits
There are a few benefits to participating in this project. First,
it is possible that you would see the specialist sooner than
if you had to travel to ___________ to see him/her. Secondly
you may not have to travel to ________ to see the specialist:
you could see the specialist from the Health Center. Thirdly,
you may get the results of your visit sooner than before, and
obtain the treatment earlier.
There are some potential benefits to your community as well.
If the telehealth equipment is found to be useful, it will stay
in the community at the end of the project. The __________ community
may also save money because there will be fewer trips out of
__________.
- *Risks and discomfort
There are a few risks or discomforts involved in using telehealth
technology. There is a risk that the doctor, specialist or
counselor will not be able to see or hear you or your test
results as well as usual. This might make him or her miss something
about your health problem or it might make him or her want
you to take more tests so he or she can be more sure.
It is possible that the tests or treatment that you need will
require you to travel to the hospital in __________ anyway.
You may feel that it is not as private as seeing the doctor in
person, and you may prefer to speak to the doctor in person rather
than on a TV set.
- *Consequences of non-participation
If you decide not to participate in this study, you will receive
the same care and attention that you would have received if
we did not have a telehealth system in place.
- *Alternatives
If telehealth is not used, the alternative is to refer you for
a consultation or an appointment with the doctor or specialist.
- *Privacy and Confidentiality
If you decide to participate in this study, your privacy will
be protected in the following ways:
- Your name will not appear on any of the recorded information.
- Only information grouped together will be reported in any
publication or report.
- The final report will be released only when the community
has approved the final report and consented to its publication.
- While using telehealth equipment, any transmissions of
images or recordings will remain part of your confidential
medical files and will not be used for anything else.
- *Voluntariness
You are free to participate in this study or not, and if you
do, you have the right to stop being in it at any time.
- *Contact persons
A list of contact persons in your community who are knowledgeable
about the study has been provided to you. You can contact any
of them at any time if you have questions about the study.
Key informants
As mentioned above, at two points during the study, qualitative
interviews will be conducted with project stakeholders. Because
they will be responding in the public roles, they will not be asked
to provide written consent. However, they will be formally asked
for consent to participate, and they will be told that they are
free to decline participation without consequence. They will also
be informed that:
- All of their responses will be held confidential to the research
team
- No individual will be identifiable in any report; only aggregate
information will be reported
- The final report will be released only when the community has
approved the final report and consented to its publication.
With participants' permission, the interviews will be tape-recorded.
20. Confidentiality
Encounter Logs: the logs recording telehealth usage to be filled
in by local and remote health care personnel will be identified
by a numbered code, and will not contain any patient identifiers.
The list of codes will be accessible to health care staff only,
and will remain in a locked filing cabinet at the CHC. The completed
logs will be kept in a locked filing cabinet apart from the master
list of codes designated for this purpose at the CHC. On a weekly
basis, these logs will be sent, by fax, to the project evaluation
office at McGill University, where they will be kept in a locked
filing cabinet for the duration of the data collection period.
The receiving fax is in a secure location accessible only to project
staff and the departmental secretariat.
Patient satisfaction: the completed questionnaires
will be collected and stored at the CHC and sent by Canada Post,
once a month, to the project evaluation office at McGill University
where they will be kept in a locked filing cabinet for the duration
of the data collection period.
Key informant interviews. The tape recording
will be transcribed verbatim without identifying information and
the tapes destroyed within one year of the interview.
Cost information: Data related to costs will
be kept in a locked filing cabinet in the project evaluation office
for the duration of the project.
No individual patient or key informant will be identified by name
in any report, and care will be taken to ensure that individual
respondents are not identifiable.
Finally, because this evaluation will occur in the work settings
of nursing station staff, particular care will be taken to preserve
the confidentiality of information related to work organization,
work performance and staff relations, in order to protect the interests
of all participants in the project.
Special provisions for research involving aboriginals
The conduct of this project respects the code of ethics, which
was developed and documented at the beginning of the project, a
copy of which is appended.
Appendices:
- Instruments
- Consent forms
- Code of ethics
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