Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00832793 |
Other study ID # |
DOCH2 449-2008 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
January 26, 2009 |
Last updated |
January 6, 2011 |
Start date |
January 2009 |
Est. completion date |
December 2009 |
Study information
Verified date |
January 2011 |
Source |
Sunnybrook Health Sciences Centre |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
Canada: Ethics Review Committee |
Study type |
Observational
|
Clinical Trial Summary
Inflammatory arthritis (IA) is a major cause of long-term disability. Due to specialist
shortages, failure of primary care providers and individuals to recognize the disease, and
lack of awareness of the importance of early intervention, delays to rheumatologic care are
common. Peer support models have been used for various health issues and may be one method
to assist individuals with early IA to manage their disease and cope with stress.
Qualitative research methods (one-on-one interviews) will seek out feedback on a peer
support approach and explore the learning needs (informational needs, educational
preferences) and opinions about emotional and appraisal support of individuals living with
IA, from the perspectives of health care providers. The data will be analyzed and expressed
themes (articulated needs and understandings of interviewee context) will guide the future
development of a peer support intervention
Description:
Abstract
Benefits of medical treatment in patients recently diagnosed with inflammatory arthritis are
well documented, but delays in the commencement of these treatment regimens often leads to
poor and irreversible healthcare outcomes. This study aims to explore the informational
needs and educational preferences of persons with early inflammatory arthritis through the
perspective of their health care providers in efforts to expedite the time to treatment.
This project is part of a larger multidisciplinary study that also investigates these
learning needs from the perspectives of the patients, their families, and their culture.
Specifically for this part of the project, healthcare providers who are engaged in work
related to inflammatory arthritis care will be invited to participate as key informants.
Using a semi-structured interview guide, these participants will provide personal insight
from their experiences in working with patients diagnosed with inflammatory arthritis
regarding the informational and educational barriers they believe lead to delays in
arthritis treatment in Ontario patients.
Rationale Disorders of the musculoskeletal system remain a prevalent cause of long-term
disability in Canada and their burden on society and the health care system is projected to
continue increasing1-5. There are currently over 4 million Canadians inflicted with
arthritis, a figure projected to continue increasing to 6 million by 2026. Although there is
currently no cure for this disease, medical intervention has been demonstrated to prevent
disability, help maintain function, and reduce arthritis associated pain6.
Although the benefits of commencing early treatment in patients recently diagnosed with
inflammatory arthritis are well documented6, delays due to the shortage in the number of
qualified healthcare providers trained to meet the demands of this growing disease7-11 often
leads to poor and irreversible health outcomes in these patients12-14. This disparity has
created gaps in the care of these patients including access to arthritis-related services,
specialist and rehabilitation services7,8. To compound this, the stress acquired following a
diagnosis of inflammatory arthritis has been shown to greatly impede patients' cognitive
function and decision-making abilities. Unlike the disparity in healthcare providers, these
patient-related variables, although likely to play a major role in disease progression, are
currently not well understood. In light of this, one cost-effective option to shortening the
time between disease onset and treatment is to better understand the hurdles patients face
following their diagnosis and develop more efficient mechanisms to deliver the information
to this group more effectively. By exploring the informational needs and educational
preferences of persons with early inflammatory arthritis, the development of such novel
strategies will likely be possible.
Promoting patient education in self management encourages self-autonomy and is considered
one of the key elements to optimal clinical practice. It increases confidence and
self-esteem and empowers patients to be come more independent at coping and managing their
arthritis15,16. Furthermore, self-management strategies increase the efficacy of prescribed
medication and allow patients play a more active role in the management of their disease
with relatively little supervision from healthcare providers17. These ideals are often not
met in the clinical setting as a large proportion of patients fail to engage or continue
with this independent approach. Such failures may be accounted for by the variable learning
stages and individual needs of patients and thus require refinement in order to improve
long-term adherence to self-management strategies18,19. Understanding the needs of patients
in these different stages of learning will be vital to implement new patient-directed
therapies.
Although, the wide array of different educational needs have yet to be systemically explored
in a scientific manner, it is postulated one common problem in this patient population is a
deterioration of sufficient self-confidence to make independent decisions. Onset of
inflammatory arthritis leads to systemic profound fatigue, prolonged morning stiffness and
severe joint pain compromising affected individuals' mood and ability to work and
participate at home and in the community20. This alienation significantly decreases
patients' independence and likely leads to subsequent increase in everyday stresses. Factors
like these that greatly affect patient's learning and cognitive function need to be properly
understood. One solution to this problem could involve the promotion of peer support in
patients' lives and healthcare decisions20. Peer supporters are lay health advisers that
offer encouragement and are seen as equal by the patients. The support often presents as
one-on-one or focus groups between newly diagnosed patients and people who through personal
or closely related encounters have previously been placed in similar decision making
scenarios. They thus represent trusting figures that can easily sympathize with the
difficult adjustments and decisions these patients need to make. Because of this connection,
they often provide some degree of informational, appraisal and emotional support that other
members of a healthcare team cannot. Such interventions that are designed to improve the
social environment of individuals have been shown effectively improve psychological
adjustment, recovery times and even extend the life expectancy of patients with chronic
diseases20. Peer support is thus an important tool that when integrated into healthcare
transforms the focus from disease treatment to overall health promotion21.
Understanding the education needs of the patients and their perceptions of peer support will
likely lead to the development of better strategies that are more centered around patients.
It is hoped that such novel strategies will play a key role in decreasing the diagnosis to
treatment lag time currently affecting positive outcomes in the management of inflammatory
arthritis.
The purpose of this study is to solicit the knowledge and experience of experts in the field
(healthcare providers) working with inflammatory arthritis patients to develop a
comprehensive understanding of strategies, including peer support that can be used to
promote independence in the learning and decision making among patents with arthritis
regarding their disease. Through dialog with these healthcare providers we hope to identify
and better understand the barriers and facilitators in this process.
Purpose and Objectives The specific objectives of this phase of study are to explore the
daily observations and personal experiences of different healthcare providers to identify
the informational needs and educational preferences of persons with early inflammatory
arthritis.
By conducting these interviews we hope to identify common hurdles and catalysts observed by
healthcare providers preventing or promoting newly diagnosed inflammatory arthritis patients
to make prompt decisions regarding the management of their disease. The aim is to identify
processes important for the implementation and evaluation of the proposed model.
Methodology Through the perspectives of the healthcare providers, the informational needs
and educational preferences for persons with early inflammatory arthritis will be explored
using a qualitative approach. A sample size of approximately 10-15 health care providers
(i.e. physicians, nurses, therapists) who are engaged in the management of inflammatory
arthritis patients in Ontario will be asked to act as key informants. More specifically,
this will be done through the use of both one-on-one in-person or telephone semi-structured
interviews.
Study Design:
The semi-structured interviews will serve an as efficient investigation technique for
assembling large amounts of data in a relatively short time frame that offers insight into a
broad range of issues on a particular topic. A semi-structured interview guide (Appendix A)
outlining the information that will be inquired about during the interview was developed for
the purpose of this study. Semi-structured interviews entail asking each interviewee a
specific set of predetermined questions in the same and consistent manner. However, they
also allow flexibility for the interviewer to alter the order of the questions and probe the
participants further to gain more information. These probes (or prompts) are questions not
found in the interview guide that will be used to encourage elaboration of responses and
further discussion to particular questions. These will be posed to the interviewees in a
neutral and unbiased manner. Furthermore, additional questions may be added to subsequent
interviews if deemed to be useful at extracting previously unanticipated and potentially
useful information. Due to the qualitative nature of the study, the total number of
participants is estimated to be between 10 and 15, and will depend on when saturation is
achieved. Saturation occurs when no new information or emerging themes are uncovered with
subsequent interviews. The interviews will be conducted by a medical student who is a
co-investigator for the project and has undergone interview training from experienced
researchers and are anticipated to last approximately one hour. During the interview, key
points arising will be manually documented by the medical student. The completed interview
will also be digitally audiotaped and transcribed verbatim, and the digital files, interview
transcripts and field notes will be uploaded to a qualitative software package, NVivo 8.
Participants:
Potential study participants will be identified based on the following inclusion criteria:
1. Healthcare providers for patients diagnosed with inflammatory arthritis.
2. Physicians, nurses, occupational therapist, physiotherapists, social workers and other
healthcare providers.
3. 18 years of age or older.
4. Able to participate in a 1 hour interview.
5. Ontario residents
6. Fluent in English
Recruitment and Consent Process:
The potential participants for this study will be identified as healthcare providers holding
positions that offer experienced insight into the informational needs and educational
preferences for patients recently diagnosed with early inflammatory arthritis. This may
include physicians, nurses, physiotherapists, occupational therapists and social workers.
These individuals will be selected based on inclusion criteria in through existing and
emerging contacts with Dr. Mary Bell, a rheumatology physician at the Toronto General
Hospital and Sunnybrook Health Sciences Centre. This initial contact will be made by Dr.
Bell through e-mail, telephone, or personal contact. Recruitment will also take place
through The Arthritis Society and using a snowball technique in which participants are asked
to recommend others who could be contacted. An attempt will be made to select healthcare
providers from different geographic locations (e.g. rural vs. urban) across Ontario.
Potential participants will be approached by the Principal Investigator (Dr. Mary Bell) and
asked for their willingness to participate in this study. The individual will verbally agree
to be contacted by the medical student who is a co-investigator with the project. Contact
information of these potentially interested volunteers will be collected by the office
manager at the clinic and then given to an experienced medical student responsible for
obtaining consent and conducting the interviews. This medical student will obtain written
consent and provide a copy to the participant. The medical student will then contact
potential participants by telephone using a standardized telephone scripted (Appendix B) to
further describe the study and re-confirm the willingness of the potential participants to
take part in the study.
A confirmation letter (on Sunnybrook Health Sciences Centre letterhead, signed by Dr. Bell)
with time and location of the interview/focus group will also be mailed to the participant
(Appendix C). The day before the interview is scheduled to take place the medical student
will telephone the individual to remind them of the time and location of the interview
(Appendix D).
Interviews will be conducted by telephone or in person. The location and timing of the
interviews will be conducted at a time and place that is convenient for each participant. If
the participant lives or work in a remote rural area, if preferred, the interview will be
conducted over the phone. Before each interview, participants will receive an information
sheet describing the study (Appendix E) and a consent form (Appendix F) via e-mail, personal
delivery or by mail. The information sheet will describe the purpose of the study, expected
commitment for participation, the known benefits and risks of the study, and their right to
refuse or withdraw at any time. The interview process will begin only after the participant
has a chance to read over the forms and has an opportunity to ask questions about the study
and consent process. Consent forms will be completed and signed by the participant prior to
commencing the interview session. A photocopy of the form will be prepared for each
participant for their records. If the interview is to be conducted over the phone, consent
will be obtained from the participant in advance of the interview by fax or mail. With the
interviewee's consent, the interview will be audio-recorded, and interviews will be
transcribed in part or in whole for a more thorough analysis. Notes from the interview will
be taken before, during and after the interview on an Interview Notes Form (Appendix G). In
addition to notes on the interviewee's responses to the questions, comments will be made
regarding the interviewer's personal thoughts on the interview itself, observations of any
nonverbal communication, as well as conversations occurring before and after the interview
itself (field notes). Audio files, interview transcripts and field notes will be uploaded to
a qualitative software package, NVivo 8.
Data Analysis The data collected from the interviews will be analyzed using the constant
comparative method and organized into themes. This process involves simplifying and
categorizing the unique thoughts and descriptions given by the various interviewees' into
common themes. This process will allow us to reduce and refer to the complexity of the
information into more manageable and readily identifiable classes. These clusters aim to
summarize what the significant and meaningful aspects of the data collected and allow for
the proper interpretation and presentation of the data. The specific categories that will be
used will be developed as an iterative process during the analysis of each interview and a
coding scheme will be created. Categories will be added to the coding scheme until no
further emerging themes can be identified. This analysis will be carried out by the medical
student who conducted the interviews of the healthcare providers. To reduce any potential
bias in the interpretation of the interviewees' responses, the interview transcripts will be
independently coded by another person on the research team. Discussion between the two
following the coding process will be used to reach a consensus on the emerging themes
arising from each interview. The modifications made to the interview guide during the
evolution of the study will be noted to ensure any discrepancies between information
gathered from the initial participants and those near the end of the study.
Risks and Benefits There are no known risks associated with this study. In addition to
possibly promoting awareness in healthcare providers participating in the study regarding
their patient population, there may be indirect benefits to patients and providers due to
the future care of individuals with inflammatory arthritis in Ontario. We will make the
information freely available to allow other programs to also integrate the implications of
our findings into their own practice.
Privacy and Confidentiality Only the principal investigator and research staff conducting
the interviews will know the identity of the participants. No identifying information will
be included on data collection forms. Upon agreement to partake in the study each
participant will be assigned a unique study identification number. This ID number will be
used to identify the occupation and responses of each participant. The list of names,
addresses and phone number of each participant will be maintained in a password protected
file at the department of rheumatology offices at Sunnybrook Health Sciences Centre. Only
the principal investigator and research staff involved in the study will their associates
will have access to this file. All information collected during the study will be strictly
confidential. No names or identifying information will be used in subsequent publications or
presentations. No identifying information will be shared with personnel not associated with
the study or leave the confines of the hospitals involved in the study. Until their eventual
destruction, all digital audio files and tangible copies of data will be stored in a locked
research room at the Sunnybrook Health Sciences Centre. The data for this study will be
retained for 25 years. A confidentiality agreement will be signed by the study coordinator
and all second year medical students involved with the study.
Compensation Participants are recruited on a volunteer basis and there will be no monetary
remuneration. The budget for this is outlined in Appendix H.
Communication of Results Dissemination of these results to study participants upon request
(including interviewed healthcare providers) will be done through a working report. The
findings in this report will also be communicated by the medical students to their peers and
professors as a partial requirement for the completion of their "Determinants of Community
Health" course. Upon completion, these results will also be shared to the public academic
audience through publications and presentations of the findings.
Team Principal Investigator Dr. Mary Bell
Co-Investigator Joyce Nyhof Young Phedias Diamandis Romy Cho Lopa Das Chris Tran Paula
Veinot
Study Coordinator Paula Veinot
Research Assistant Gaya Embuldeniya