Any Condition Clinical Trial
Official title:
The Healing Context in CAM: Instrument Development and Initial Validation
The overall objective of this study is to develop and test an efficient self-report
instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual
factors important in healing.
The initial phase of the study involves developing and refining an item bank. During the
initial 'item bank development' phase, the investigators will run focus groups and cognitive
interviews with individuals who participate in CAM and conventional medicine interventions.
The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study
involving focus groups and cognitive interviews.
The next step of instrument development is called Calibration, and will involve
administering the revised item bank to an internet sample and to persons who receive
services in a CAM clinic and a conventional primary care setting. The items will be
calibrated using item response theory and classical test theory. This will result in a
computerized adaptive testing version of the instrument, as well as a static short form of
the instrument.
The final phase of the project will involve conducting initial validation studies of the
instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL).
The investigators will evaluate the convergent, discriminant, and predictive validity of the
HEAL in a sample of 200 persons with chronic low back pain who are receiving physical
therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity,
the HEAL is expected to display moderate to large correlations with measures of similar
constructs. The HEAL is expected to correlate modestly with self-report measures of general
psychosocial functioning, in support of discriminant validity. Finally, HEAL score should
account for a significant proportion of the variance in treatment outcome, supporting
predictive validity.
This project will develop and test a patient self-report measurement tool to assess the
perceived contextual factors, such as patient attitudes and expectations, patient provider
relationship factors, and environmental factors that contribute to healing. Our project is
synergistic with the National Institutes of Health (NIH) Roadmap initiative, Patient
Reported Outcomes Measurement Information System (PROMIS), and will use the rigorous
instrument development and validation methodology of PROMIS. The overall objective of this
study is to develop an efficient self-report instrument to measure CAM-relevant contextual
factors important in healing, hereafter referred to as the Healing Encounters and Attitudes
List (HEAL), and conduct initial validation in persons seeking CAM and conventional
treatment for pain.
Specific Aim 1: Develop an item bank. We will employ several iterative steps used
successfully in PROMIS to identify items that assess contextual factors of healing relevant
to CAM. Initial steps in developing an item bank include: a) compilation and evaluation of
existing instruments and relevant questions, b) consultation with experts, and c) focus
groups with individuals who participate in CAM and conventional medicine interventions, and
d) item editing. During the initial year of this study, we expect to identify conceptual
areas of potential importance to CAM interventions and patients, and identify and edit items
to create an item bank assessing these conceptual areas.
Specific Aim 2: Calibrate items. We will use item response theory (IRT) and classical test
theory (CTT) to calibrate the items from Aim 1 on three samples: 1) an internet-based sample
(n= 1000), 2) 100 outpatients participating in CAM interventions at our Center for
Integrative Medicine (CIM), and 3) 100 outpatients at a General Internal Medicine clinic.
During year 2-3 we administer the items in the item bank to the 1200 persons, conduct IRT
and CTT analyses and refine the item bank to only those items that best assess the
constructs. Specific aim 2 will result in a Computerized Adaptive Testing (CAT) version of
the HEAL, which maximizes information while minimizing patient time burden. A static short
form of the HEAL will be derived from the HEAL CAT in Aim 2.
Specific Aim 3: Conduct initial validation studies. We will evaluate convergent,
discriminant, and predictive validity of the Healing Encounters and Attitudes List (HEAL) in
a sample of chronic low back pain (CLBP) patients receiving CAM and conventional medicine
treatments. The validity studies will use two samples of adults with CLBP: 100 persons
receiving CAM treatments: chiropractic manipulation (CM) or mindfulness-based stress
reduction (MBSR) at the CIM, and 100 persons receiving conventional care (physical therapy)
at Centers for Rehab Services referred by the General Internal Medicine Clinic (GIMC) of the
University of Pittsburgh Medical Center (UPMC). We will administer the CAT version of the
HEAL questionnaire developed in aims 1 and 2 as well as conventional measures of treatment
expectancy, confidence in treatment provider, psychosocial functioning, and treatment
outcome measures for CLBP of pain and disability.
- Hypothesis 3a: Scores on the HEAL measure will display moderate to large correlations
(r's > .50) with similar self-report measures, supporting convergent validity.
- Hypothesis 3b: Scores on the HEAL measure will correlate modestly (r's = .20-.35) with
self-report measures of general psychosocial functioning, supporting discriminant
validity.
- Hypothesis 3c: HEAL scores will account for a significant proportion of variance in
treatment outcome in both samples. In addition, we predict that HEAL scores will
demonstrate incremental validity, i.e., they will account for significant incremental
variance in outcome beyond that accounted for by existing measures of treatment
expectancy and related constructs.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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