Adult Primary Care PatientsIMPACTNCT01785485
IMPACT - Integrative Medicine PrimAry Care Trial
An observational study of Adult Primary Care Patients, run by University of Arizona at 1 site in United States.
Trial summary
This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Primary Care Patients
- What is being tested?
- Integrative medicine primary care model
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only patients who are enrolled in primary care (members) at UAIHC and who meet the inclusion/exclusion criteria are eligible to enroll in this study
Who may be able to join
- Enrollment in primary care (members) at UAIHC;
- Adults age 18 or older.
- Enrollment in primary care (members) at UAIHC;
- Adults age 18 or older.
- All clinical and support personnel.
Who cannot join
- Currently pregnant at time of recruitment;
- Patients who attend the UAIHC clinic as consultation-only patients;
- Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
- Fidelity Study Sample (Patients):
- Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
- Fidelity Study Sample (Providers):
- None.
Trial locations and contacts
1 site in 1 country.
TBA contact
United States1 site
University of Arizona Integrative Health Center (UAIHC)
Phoenix, Arizona, 85012
About this study
Official title: IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the clinical and cost effectiveness (outcomes) of an integrative medicine professional practice model for adult primary care delivery (the University of Arizona Integrative Health Center - UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC. In addition, a fidelity evaluation will assess whether the practice model was implemented as planned.
The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data from medical records abstractions, self-report assessments, clinic administrative and service utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity evaluation of the implementation of the UAIHC model as described in its business plan using patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic administrative data.
Read more
Participants. 1) Participants from the clinic patient population for whom clinical and cost outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected (n=14).
Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and biomarkers from medical records abstractions; patient reported outcomes and satisfaction questionnaires; clinic service encounter logs; and, cost data from health insurance claims information and clinic financial data. For fidelity evaluation, data will be collected monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually from then on. Patient data for fidelity will be gathered on a single randomized day of the week using a self-administered patient feedback questionnaire. For personnel, fidelity data will be collected at the same intervals using a self-administered provider perceptions questionnaire of inter-professional team and integrative medical care. Data from audits of randomly selected patient charts and administrative records will also be used.
- Conditions
- Adult Primary Care Patients
- Being tested
- Integrative medicine primary care model
- Keywords
- Integrative medicine, primary care, cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative medicine primary care modelOther
An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.
| Study group | Role | What they receive |
|---|---|---|
| Primary care patients | Primary care patients who are members of UAIHC. Receives: Other: Integrative medicine primary care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total healthcare costs from the payer's perspective-total paid costs according to claims data.
Measured: 12 months of paid costs pre and post beginning membership at UAIHC
Secondary outcomes (3)
1. Self-report instruments
Composite:
Short Form -12 (Ware, 1996) WHO-5 Well-being Index (Bech, 2003) Perceived Stress Scale (Cohen 1983). Work Productivity and Activity Impairment (Reilly, 1993). Patient Activation Measure (Hibbard, 2004). Diet quality. Behavioral Risk Factor Surveillance System Fruits/Vegetables (CDC, 2012).
Physical Activity. Behavioral Risk Factor Surveillance System Physical Activity (CDC, 2012).
Stress burden (Littman, 2006). Depression. PHQ-2 (Kroenke, 2003). Anxiety Disorder. GAD-2 (Kroenke, 2007). Pittsburgh Sleep Quality Index (Buysse, 1989). Fatigue visual analogue scale. Fatigue Severity Scale (Krupp, 1989). Pain visual analogue scale. If diagnosed: Fibromyalgia Impact Questionnaire-R (Williams \& Arnold, 2011); Roland-Morris Disability Questionnaire (Roland \& Morris, 1983); PHQ 9 (Kroenke et al 2002); GAD 7 (Spitzer et al, 2006). Demographics (Baseline). Expectations for care (Baseline). Patient satisfaction. 2-items from the CAHPS (AHRQ, 2012).
Measured: Baseline, 3-, 6-, and 12-months
Clinical indicators and biomarkers
Composite:
Complete metabolic panel, hypoglycemic medication, full lipid panel (TC, HDL, fasting triglycerides), lipid medication, TSH/T4, HbA1c, systolic and diastolic blood pressure, hypertension medication, BMI (height \& weight), waist circumference, body fat composition, smoking status, cardiovascular disease risk (general and events), metabolic syndrome diagnosis.
Measured: 3-, 6-, and 12-months
Service Utilization Data and Health Insurance Claims Data
Measured: 3-, 6-, and 12-months; biennially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Adult Primary Care PatientsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Dodds, University of Arizona
- Investigators
- Victoria Maizes, MD, Principal investigator, University of Arizona Arizona Center for Integrative MedicineSally E Dodds, PhD, Study director, University of Arizona Arizona Center for Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785485
- Sponsor's protocol ID
- Coors001
- Acronym
- IMPACT
- Status last verified
- Feb 2013
- First submitted
- 31 Jan 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Kroenke, K., Spitzer R.L. (2002). The PHQ-9: A new depression and diagnostic severity measure. Psychiatric Annals, 32, 509-521.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
PubMed 10146874Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
PubMed 14583691Littman AJ, White E, Satia JA, Bowen DJ, Kristal AR. Reliability and validity of 2 single-item measures of psychosocial stress. Epidemiology. 2006 Jul;17(4):398-403. doi: 10.1097/01.ede.0000219721.89552.51.
PubMed 16641618Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PubMed 17339617Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Williams DA, Arnold LM. Measures of fibromyalgia: Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI-20), Medical Outcomes Study (MOS) Sleep Scale, and Multiple Ability Self-Report Questionnaire (MASQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S86-97. doi: 10.1002/acr.20531. No abstract available.
PubMed 22588773Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976). 1983 Mar;8(2):145-50. doi: 10.1097/00007632-198303000-00005.
PubMed 6222487Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939Safran DG, Kosinski M, Tarlov AR, Rogers WH, Taira DH, Lieberman N, Ware JE. The Primary Care Assessment Survey: tests of data quality and measurement performance. Med Care. 1998 May;36(5):728-39. doi: 10.1097/00005650-199805000-00012.
PubMed 9596063Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
PubMed 15528286Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
- ClinicalTrials.gov ID
- NCT01785485
- Acronym / sponsor ID
- IMPACT / Coors001
- Conditions
- Adult Primary Care Patients
- Keywords
- Integrative medicine, primary care, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the clinical and cost effectiveness (outcomes) of an integrative medicine professional practice model for adult primary care delivery (the University of Arizona Integrative Health Center - UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC. In addition, a fidelity evaluation will assess whether the practice model was implemented as planned.
The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data from medical records abstractions, self-report assessments, clinic administrative and service utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity evaluation of the implementation of the UAIHC model as described in its business plan using patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic administrative data.
Participants. 1) Participants from the clinic patient population for whom clinical and cost outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected (n=14).
Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and biomarkers from medical records abstractions; patient reported outcomes and satisfaction questionnaires; clinic service encounter logs; and, cost data from health insurance claims information and clinic financial data. For fidelity evaluation, data will be collected monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually from then on. Patient data for fidelity will be gathered on a single randomized day of the week using a self-administered patient feedback questionnaire. For personnel, fidelity data will be collected at the same intervals using a self-administered provider perceptions questionnaire of inter-professional team and integrative medical care. Data from audits of randomly selected patient charts and administrative records will also be used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care patients | – | Other: Integrative medicine primary care modelPrimary care patients who are members of UAIHC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients who are enrolled in primary care (members) at UAIHC and who meet the inclusion/exclusion criteria are eligible to enroll in this study
Key inclusion criteria (5 listed)
- Enrollment in primary care (members) at UAIHC;
- Adults age 18 or older.
- Enrollment in primary care (members) at UAIHC;
- Adults age 18 or older.
- All clinical and support personnel.
Key exclusion criteria (7 listed)
- Currently pregnant at time of recruitment;
- Patients who attend the UAIHC clinic as consultation-only patients;
- Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
- Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative medicine primary care modelAn integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine. | Other | Primary care patients |
Primary outcome
Total healthcare costs from the payer's perspective-total paid costs according to claims data.
Time frame: 12 months of paid costs pre and post beginning membership at UAIHC
3 secondary outcomes
1. Self-report instruments
Time frame: Baseline, 3-, 6-, and 12-months
Clinical indicators and biomarkers
Time frame: 3-, 6-, and 12-months
Service Utilization Data and Health Insurance Claims Data
Time frame: 3-, 6-, and 12-months; biennially
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundKroenke, K., Spitzer R.L. (2002). The PHQ-9: A new depression and diagnostic severity measure. Psychiatric Annals, 32, 509-521.
- Background: PubMed 10146874Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
- Background: PubMed 14583691Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- Background: PubMed 16641618Littman AJ, White E, Satia JA, Bowen DJ, Kristal AR. Reliability and validity of 2 single-item measures of psychosocial stress. Epidemiology. 2006 Jul;17(4):398-403. doi: 10.1097/01.ede.0000219721.89552.51.
- Background: PubMed 17339617Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Background: PubMed 22588773Williams DA, Arnold LM. Measures of fibromyalgia: Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI-20), Medical Outcomes Study (MOS) Sleep Scale, and Multiple Ability Self-Report Questionnaire (MASQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S86-97. doi: 10.1002/acr.20531. No abstract available.
- Background: PubMed 6222487Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976). 1983 Mar;8(2):145-50. doi: 10.1097/00007632-198303000-00005.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 15230939Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TBA contact
Victoria Maizes, MD principal investigator
University of Arizona Arizona Center for Integrative Medicine
Sally E Dodds, PhD study director
University of Arizona Arizona Center for Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Primary Care Patients, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TBA, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total healthcare costs from the payer's perspective-total paid costs according to claims data. (time frame: 12 months of paid costs pre and post beginning membership at UAIHC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785485, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.