The Healing Context in Complementary and Alternative Medicine (CAM): Initial Validation Study
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain, Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | July 2016 |
| Contact: | Christine E McFarland, BA |
| Email: | mcfarlandce@upmc.edu |
| Phone: | (412) 623-6872 |
The Healing Context in CAM: Instrument Development and Initial Validation - Phase 3 Validation Study
The overall objective of this study is to develop and test an efficient set of self-report
instruments 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 next step of instrument development is called
Calibration, and involves 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. This current protocol in ClinicalTrials.gov pertains only to
the final, Validation Phase of the study. The final phase of the project will involve
conducting initial validation studies of the set of instruments. The set of instruments will
be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate
the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of
200 persons with chronic low back pain or neck pain who are receiving physical therapy,
chiropractic care, acupuncture, medical management, 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 scores should account for a significant proportion of the variance in treatment
outcome, supporting predictive validity.
instruments 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 next step of instrument development is called
Calibration, and involves 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. This current protocol in ClinicalTrials.gov pertains only to
the final, Validation Phase of the study. The final phase of the project will involve
conducting initial validation studies of the set of instruments. The set of instruments will
be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate
the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of
200 persons with chronic low back pain or neck pain who are receiving physical therapy,
chiropractic care, acupuncture, medical management, 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 scores should account for a significant proportion of the variance in treatment
outcome, supporting predictive validity.
This project will develop and test a set of patient self-report measurement tools to assess
the perceived contextual factors, such as patient attitudes and expectations, patient
provider relationship factors, and environmental factors that contribute to healing. This
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 efficient self-report instruments to measure CAM-relevant contextual
factors important in healing, hereafter referred to as the Healing Encounters and Attitudes
Lists (HEAL), and conduct initial validation in persons seeking CAM and conventional
treatment for pain. Specific Aim 1: Develop item banks. The investigators 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 item banks 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 phase of this study, the
investigators expect to identify conceptual areas of potential importance to CAM
interventions and patients, and identify and edit items to create item banks assessing these
conceptual areas. Specific Aim 2: Calibrate items. The investigators 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= 1400), 2) 125 outpatients participating in CAM
interventions at the Center for Integrative Medicine (CIM), and 3) 125 outpatients at a
General Internal Medicine clinic. During year 3-4 the investigators will administer the
items in the item banks to the 1650 persons, conduct IRT and CTT analyses and refine the
item banks to only those items that best assess the constructs. Specific aim 2 will result
in Computerized Adaptive Testing (CAT) versions of the HEAL, which maximizes information
while minimizing patient time burden. Static short forms of the HEAL item banks will be
derived from the HEAL CATs in Aim 2. Specific Aim 3: Conduct initial validation studies. The
investigators will evaluate convergent, discriminant, and predictive validity of the Healing
Encounters and Attitudes List (HEAL) in a sample of chronic low back pain (CLBP) or neck
pain 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), acupuncture, or mindfulness-based stress reduction (MBSR) at the CIM, and
100 persons receiving conventional care (physical therapy or medical management) at the
University of Pittsburgh Medical Center (UPMC). The investigators 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
pain and disability treatment outcome measures for CLBP and neck pain. • Hypothesis 3a:
Scores on the HEAL measures will display moderate to large correlations (r's > .50) with
similar self-report measures, supporting convergent validity. • Hypothesis 3b: Scores on the
HEAL measures 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, the investigators predict that HEAL scores will demonstrate incremental
validity, i.e., the scores will account for significant incremental variance in outcome
beyond that accounted for by existing measures of treatment expectancy and related
constructs.
the perceived contextual factors, such as patient attitudes and expectations, patient
provider relationship factors, and environmental factors that contribute to healing. This
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 efficient self-report instruments to measure CAM-relevant contextual
factors important in healing, hereafter referred to as the Healing Encounters and Attitudes
Lists (HEAL), and conduct initial validation in persons seeking CAM and conventional
treatment for pain. Specific Aim 1: Develop item banks. The investigators 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 item banks 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 phase of this study, the
investigators expect to identify conceptual areas of potential importance to CAM
interventions and patients, and identify and edit items to create item banks assessing these
conceptual areas. Specific Aim 2: Calibrate items. The investigators 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= 1400), 2) 125 outpatients participating in CAM
interventions at the Center for Integrative Medicine (CIM), and 3) 125 outpatients at a
General Internal Medicine clinic. During year 3-4 the investigators will administer the
items in the item banks to the 1650 persons, conduct IRT and CTT analyses and refine the
item banks to only those items that best assess the constructs. Specific aim 2 will result
in Computerized Adaptive Testing (CAT) versions of the HEAL, which maximizes information
while minimizing patient time burden. Static short forms of the HEAL item banks will be
derived from the HEAL CATs in Aim 2. Specific Aim 3: Conduct initial validation studies. The
investigators will evaluate convergent, discriminant, and predictive validity of the Healing
Encounters and Attitudes List (HEAL) in a sample of chronic low back pain (CLBP) or neck
pain 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), acupuncture, or mindfulness-based stress reduction (MBSR) at the CIM, and
100 persons receiving conventional care (physical therapy or medical management) at the
University of Pittsburgh Medical Center (UPMC). The investigators 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
pain and disability treatment outcome measures for CLBP and neck pain. • Hypothesis 3a:
Scores on the HEAL measures will display moderate to large correlations (r's > .50) with
similar self-report measures, supporting convergent validity. • Hypothesis 3b: Scores on the
HEAL measures 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, the investigators predict that HEAL scores will demonstrate incremental
validity, i.e., the scores will account for significant incremental variance in outcome
beyond that accounted for by existing measures of treatment expectancy and related
constructs.
Inclusion Criteria:
- 18 years old or older; able to read and understand English; able to use a computer;
starting a new treatment for back or neck pain, or started treatment within the past
month.
Exclusion Criteria:
- psychotic disorders.
We found this trial at
3
sites
Pittsburgh, Pennsylvania 15213
Principal Investigator: Carol M Greco, Ph.D.
Phone: 412-623-2374
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Carol M Greco, Ph.D.
Phone: 412-623-2374
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Carol M Greco, Ph.D.
Phone: 412-623-2374
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