Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02855593 |
| Other study ID # |
FWH20160066H |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
December 10, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Mike O'Callaghan Military Hospital |
| Contact |
Jill M Clark, MBA/HCM |
| Phone |
7026533298 |
| Email |
jill.m.clark15.ctr[@]mail.mil |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The proposed qualitative inquiry seeks to understand medical acupuncture from both the
physician and the patient perspective. Interviewees will be asked to describe their
experiences from the point of diagnosis or training up until the present day to capture the
nature of their experiences across the treatment trajectory. Sample size for the qualitative
data collection will be based on saturation of themes (thematic findings, e.g., patient talk
is limited by family knowledge or physician-patient communication is limited by time
constraints in the clinical setting), meaning investigators will continue recruitment until
they are no longer hearing new experiences from participants. Saturation will be kept
separate by groups (i.e., saturation of themes must be met within the group of patients
separately from providers). Investigators will conduct preliminary data analysis after each
10 interviews to determine when saturation is reached. Recruitment numbers here are
anticipated maximum numbers needed to reach saturation. Investigators plan to recruit and
sample provider and patient populations in the following way. Investigators will group
physicians by the physician's training so that we are sensitive to the fact that helpful
patient-physician interaction approaches may differ across the patient's lifespan or with
patient or physician experience with acupuncture. Audio recordings from each interview will
be professionally transcribed and analysis will be concurrent with data collection to ensure
reliability and validity of findings. Investigators will review transcripts as data are
collected to identify emergent themes and ensure thematic saturation.
Description:
Investigators will obtain signed Informed Consent Document and HIPAA Authorization. During
the screening process, data will be gathered about race, ethnicity, gender, history, and
satisfaction rating of prior acupuncture received, and whether or not acupuncture has
decrease reliance on prescription and over-the-counter medication use via the Screening Tool.
Acknowledging the clinical partnership of patient and provider, the proposed qualitative
inquiry seeks to understand medical acupuncture from both the physician and the patient
perspective. A modified version of two interview techniques [Lifeline Interview Method (LIM)
and Retrospective Interview Technique (RIT)] will be used. From this approach, narrative data
can be analyzed both quantitatively and qualitatively and provide a visual depiction across
time. In the RIT method, each participant receives a modified version of an RIT graph before
the interview. The graph provides participants time to reflect on their experiences and
behavior. The interviews will all be one-on-one interviews and will take approximately 90
minutes for each group, including the time for completing the RIT graph during the interview.
Interviewees will be asked to describe their experiences from the point of diagnosis or
training up until the present day to capture the nature of their experiences across the
treatment trajectory. Questions will address the nature of their experiences beginning with
the first time the provider introduced acupuncture to the patient and up to the present day
to elicit rich details about the impact of acupuncture on their social/relational lives as
well as perceived psychological and physical health. Questions will also be centered on the
role of communication in facilitating receptivity and adherence to an acupuncture treatment
plan both in terms of provider-patient interaction and patients' interactive experiences
within their social network. For physicians, questions will address pre-training and
post-training perceptions of acupuncture as well.
Ultimately, the impact of acupuncture on patients' lives will be examined using the "turning
point" approach. By centering on turning points individuals have the opportunity to reflect
on notable moments of change that are memorable because of their impact on health, health
behavior as well as health perceptions. Such turning points can also be helpful in
identifying challenges patients and their physicians face with regard to adopting and
adhering to acupuncture treatment. In this approach participants consider how the treatment
impacted their life across time as they plot changes ("turning points") that emerged across
the treatment trajectory. Time will be represented on the horizontal axis of the graph, while
impact of acupuncture (as is perceived by the participant) will be represented on the
vertical axis. Impact of treatment will be considered as changes that capture how treatment
has a positive effect (enhancing health, enhancing receptivity, or adherence) or negative
(inhibiting health, not facilitating receptivity or adherence). These turning points are
always communicatively managed and, thus, the communicative nature will give rise to
communication factors that facilitate the treatment and health-promoting outcomes as well as
barriers (and thus, contribute to the treatment not being perceived as beneficial). From this
approach, participants use a visual tool (turning point graph) to plot turning points. Once
completed they connect the points with a line to provide a trajectory that illustrates how
the treatment impacted their lives across the acupuncture treatment (patients) or how the
treatment impacted the lives of their patients (providers).
This interview technique helps facilitate a storied approach for the participants sharing
their insider experiences thereby facilitating disclosure in a more natural manner and
generating narrative data rich for intervention-making. This approach allows for a
translational approach to research as the narratives can be used to develop interventions and
medical education critical for facilitating this form of care.
Sample size for the qualitative data collection will be based on saturation of themes
(thematic findings, e.g., patient talk is limited by family knowledge or physician-patient
communication is limited by time constraints in the clinical setting, meaning investigators
will continue recruitment until investigators are no longer hearing new experiences from
participants. Saturation will be kept separate by groups (i.e., saturation of themes must be
met within the group of patients separately from providers). Generally saturation is met with
10-30 individuals within a group, depending upon how diverse the groups are (other
demographic variables may require more participants and an amendment to increase the approved
number of enrollments). Investigators plan to recruit and sample provider and patient
populations in the following way.
Since investigators are concerned with communication differences based on training maturity,
investigators will group physicians by the physician's training so that investigators are
sensitive to the fact that helpful patient-physician interaction approaches may differ across
the lifespan or with experience. Our goal is to interview physicians who are just completing
training and physicians who completed training more than three years prior. Thus,
investigators will have a "newly trained" provider group and an "experienced" provider group.
For each group, investigators will ask them about the entirety of their experiences (from the
point of training up to the present day) and analyze that data about patient-physician
communication according to the training phase of the physician. This will ensure
investigators have both in-the-moment reflections about experiences and retrospective
accounts. For patients, investigators will recruit 2 groups: those seeking treatment for
either 1) chronic or 2) acute conditions. Given gendered differences in health behavior and
perceptions, investigators will aim to have representative male and female populations within
each group.
Audio recordings from each interview will be professionally transcribed and analysis will be
concurrent with data collection to ensure reliability and validity of findings. Professional
transcriptionists will complete transcription of pseudoanonymous recordings. Investigators
will review transcripts as data are collected to identify emergent themes and ensure thematic
saturation. Qualitative data will be analyzed according to van Manen's"selective approach,"
using the software program ATLAS.ti.to manage large data sets. Three analytical steps
according to the constant comparative method and outlined by Strauss and Corbin will be
employed, beginning with the discovery of concepts and assignment of codes to text. The
thematic analysis then proceeds with identifying categories by grouping related concepts to
reach "thematic salience," as reflected in recurrence, repetition, and forcefulness. The
final step involves defining themes and dimensions of these categories to ensure thick
description. Separate analyses will be conducted for each research question and for each
group and then compared across groups. Investigators will incorporate final sets of themes
into action-oriented thematic statements using Banning's ecological sentence synthesis
approach to ensure the research can be more easily translated into practice. These
action-oriented statements can more easily be integrated into interventions and psychosocial
materials in an effort to enhance provider-patient communication and shared decision making,
the health care system, and by offering patients and physicians a roadmap of barriers that
might impede care practice or patient adherence as well as communication strategies that can
facilitate and enhance acupuncture treatment (both for patients and providers).
