Health Status MeasuresPhase 2NCT00013130
Ambulatory Care Quality Improvement (ACQUIP)
A Phase 2 study testing Provision of health status information to patients provider in people with Health Status Measures and Outcomes, run by US Department of Veterans Affairs at 5 sites in United States.
Trial summary
Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Measures, Outcomes, Continuous Quality Improvement
- What is being tested?
- Provision of health status information to patients provider
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62,487 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento Feb 2001
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in VA GIM clinic with visit in past year
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Illinois, 05009-0001
About this study
Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.
Read the detailed description
Background:
Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.
Objectives:
ACQUIP was designed to determine whether quality and outcomes of health care improve when primary care providers have access to regular assessments of their patients' health and function along with routine clinical data and information about clinical guidelines.
Methods:
This study was a randomized trial conducted at the General Internal Medicine Clinics of seven VA facilities. Each participating GIMC is organized into discrete firms staffed by different groups of providers who care for different patients. One randomly selected firm received the intervention and one served as control. Patients who made at least one GIMC visit in the last year were eligible to participate. Patients were surveyed at baseline to determine active medical problems. Subsequent mailings included a general evaluation of health status (SF-36), a satisfaction questionnaire and, as appropriate, one of six condition-specific questionnaires: the Seattle Angina Questionnaire, the Seattle Obstructive Lung Disease Questionnaire, the Hopkins Symptom Checklist (depression), and questionnaires regarding diabetes, drinking, and hypertension. Clinical/utilization data were downloaded weekly from VISTA and supplemented with data from Austin. The intervention consisted of multi-faceted reports to patients' primary care providers (at the time of patient visits) showing trended physiologic and health status data and guideline-derived recommendations. Clinicians also received periodical reports displaying trends in the health status and satisfaction of their patients compared with their clinic as a whole. Reports were supplemented by training on QI and health status measures.
Status:
Data collection was completed on April 1, 2000. Analysis of trial results will be completed January, 2001.
- Being tested
- Provision of health status information to patients provider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of health status information to patients providerBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Provision of health status information to patients provider |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Health Status MeasuresStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62,487 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephan D. Fihn, MD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WAKenneth E. Rosenfeld, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAMarisue Cody, PhD RN MPA, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013130
- Sponsor's protocol ID
- SDR 96-002
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams EC, Peytremann-Bridevaux I, Fan VS, Bryson CL, Blough DK, Kivlahan DR, Bradley KA. The association between alcohol screening scores and health status in male veterans. J Addict Med. 2010 Mar;4(1):27-37. doi: 10.1097/ADM.0b013e3181a196b5.
PubMed 21769021Fan VS, Bridevaux PO, McDonell MB, Fihn SD, Besser LM, Au DH. Regional variation in health status among chronic obstructive pulmonary disease patients. Respiration. 2011;81(1):9-17. doi: 10.1159/000320115. Epub 2010 Aug 17.
PubMed 20720400Bryson CL, Au DH, Sun H, Williams EC, Kivlahan DR, Bradley KA. Alcohol screening scores and medication nonadherence. Ann Intern Med. 2008 Dec 2;149(11):795-804. doi: 10.7326/0003-4819-149-11-200812020-00004.
PubMed 19047026Krumholz HM, Anderson JL, Bachelder BL, Fesmire FM, Fihn SD, Foody JM, Ho PM, Kosiborod MN, Masoudi FA, Nallamothu BK; American College of Cardiology/American Heart Association Task Force on Performance Measures; American Academy of Family Physicians; American College of Emergency Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Cardiovascular Angiography and Interventions; Society of Hospital Medicine. ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures for ST-Elevation and Non-ST-Elevation Myocardial Infarction) Developed in Collaboration With the American Academy of Family Physicians and American College of Emergency Physicians Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Society for Cardiovascular Angiography and Interventions, and Society of Hospital Medicine. J Am Coll Cardiol. 2008 Dec 9;52(24):2046-99. doi: 10.1016/j.jacc.2008.10.012. No abstract available.
PubMed 19056000Krumholz HM, Anderson JL, Bachelder BL, Fesmire FM, Fihn SD, Foody JM, Ho PM, Kosiborod MN, Masoudi FA, Nallamothu BK; American College of Cardiology/American Heart Association Task Force on Performance Measures; American Academy of Family Physicians; American College of Emergency Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Cardiovascular Angiography and Interventions; Society of Hospital Medicine. ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to develop performance measures for ST-elevation and non-ST-elevation myocardial infarction): developed in collaboration with the American Academy of Family Physicians and the American College of Emergency Physicians: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Society for Cardiovascular Angiography and Interventions, and Society of Hospital Medicine. Circulation. 2008 Dec 9;118(24):2596-648. doi: 10.1161/CIRCULATIONAHA.108.191099. Epub 2008 Nov 10. No abstract available.
PubMed 19001027Bryson CL, Au DH, Young B, McDonell MB, Fihn SD. A refill adherence algorithm for multiple short intervals to estimate refill compliance (ReComp). Med Care. 2007 Jun;45(6):497-504. doi: 10.1097/MLR.0b013e3180329368.
PubMed 17515776Parimon T, Chien JW, Bryson CL, McDonell MB, Udris EM, Au DH. Inhaled corticosteroids and risk of lung cancer among patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 Apr 1;175(7):712-9. doi: 10.1164/rccm.200608-1125OC. Epub 2006 Dec 21.
PubMed 17185647DeSalvo KB, Fan VS, McDonell MB, Fihn SD. Predicting mortality and healthcare utilization with a single question. Health Serv Res. 2005 Aug;40(4):1234-46. doi: 10.1111/j.1475-6773.2005.00404.x.
PubMed 16033502Liu CF, Campbell DG, Chaney EF, Li YF, McDonell M, Fihn SD. Depression diagnosis and antidepressant treatment among depressed VA primary care patients. Adm Policy Ment Health. 2006 May;33(3):331-41. doi: 10.1007/s10488-006-0043-5.
PubMed 16755394Davis GE, Bryson CL, Yueh B, McDonell MB, Micek MA, Fihn SD. Treatment delay associated with alternative medicine use among veterans with head and neck cancer. Head Neck. 2006 Oct;28(10):926-31. doi: 10.1002/hed.20420.
PubMed 16755583Spertus JA, McDonell M, Woodman CL, Fihn SD. Association between depression and worse disease-specific functional status in outpatients with coronary artery disease. Am Heart J. 2000 Jul;140(1):105-10. doi: 10.1067/mhj.2000.106600.
PubMed 10874270Diehr P, Patrick DL, Spertus J, Kiefe CI, McDonell M, Fihn SD. Transforming self-rated health and the SF-36 scales to include death and improve interpretability. Med Care. 2001 Jul;39(7):670-80. doi: 10.1097/00005650-200107000-00004.
PubMed 11458132Bridevaux IP, Bradley KA, Bryson CL, McDonell MB, Fihn SD. Alcohol screening results in elderly male veterans: association with health status and mortality. J Am Geriatr Soc. 2004 Sep;52(9):1510-7. doi: 10.1111/j.1532-5415.2004.52414.x.
PubMed 15341553Burman ML, Kivlahan D, Buchbinder M, Broglio K, Zhou XH, Merrill JO, McDonell MB, Fihn SD, Bradley KA; Ambulatory Care Quality Improvement Project Investigators. Alcohol-related advice for Veterans Affairs primary care patients: Who gets it? Who gives it? J Stud Alcohol. 2004 Sep;65(5):621-30. doi: 10.15288/jsa.2004.65.621.
PubMed 15536772Bradley KA, Kivlahan DR, Zhou XH, Sporleder JL, Epler AJ, McCormick KA, Merrill JO, McDonell MB, Fihn SD. Using alcohol screening results and treatment history to assess the severity of at-risk drinking in Veterans Affairs primary care patients. Alcohol Clin Exp Res. 2004 Mar;28(3):448-55. doi: 10.1097/01.alc.0000117836.38108.38.
PubMed 15084903
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Care Quality Improvement (ACQUIP)
- ClinicalTrials.gov ID
- NCT00013130
- Acronym / sponsor ID
- SDR 96-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62,487 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Feb 2001 (actual)
- First posted
- 16 Mar 2001 (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.
Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.
Detailed description
Background:
Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.
Objectives:
ACQUIP was designed to determine whether quality and outcomes of health care improve when primary care providers have access to regular assessments of their patients' health and function along with routine clinical data and information about clinical guidelines.
Methods:
This study was a randomized trial conducted at the General Internal Medicine Clinics of seven VA facilities. Each participating GIMC is organized into discrete firms staffed by different groups of providers who care for different patients. One randomly selected firm received the intervention and one served as control. Patients who made at least one GIMC visit in the last year were eligible to participate. Patients were surveyed at baseline to determine active medical problems. Subsequent mailings included a general evaluation of health status (SF-36), a satisfaction questionnaire and, as appropriate, one of six condition-specific questionnaires: the Seattle Angina Questionnaire, the Seattle Obstructive Lung Disease Questionnaire, the Hopkins Symptom Checklist (depression), and questionnaires regarding diabetes, drinking, and hypertension. Clinical/utilization data were downloaded weekly from VISTA and supplemented with data from Austin. The intervention consisted of multi-faceted reports to patients' primary care providers (at the time of patient visits) showing trended physiologic and health status data and guideline-derived recommendations. Clinicians also received periodical reports displaying trends in the health status and satisfaction of their patients compared with their clinic as a whole. Reports were supplemented by training on QI and health status measures.
Status:
Data collection was completed on April 1, 2000. Analysis of trial results will be completed January, 2001.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Provision of health status information to patients provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in VA GIM clinic with visit in past year
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Provision of health status information to patients provider | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 21769021Williams EC, Peytremann-Bridevaux I, Fan VS, Bryson CL, Blough DK, Kivlahan DR, Bradley KA. The association between alcohol screening scores and health status in male veterans. J Addict Med. 2010 Mar;4(1):27-37. doi: 10.1097/ADM.0b013e3181a196b5.
- Results publication: PubMed 20720400Fan VS, Bridevaux PO, McDonell MB, Fihn SD, Besser LM, Au DH. Regional variation in health status among chronic obstructive pulmonary disease patients. Respiration. 2011;81(1):9-17. doi: 10.1159/000320115. Epub 2010 Aug 17.
- Results publication: PubMed 19047026Bryson CL, Au DH, Sun H, Williams EC, Kivlahan DR, Bradley KA. Alcohol screening scores and medication nonadherence. Ann Intern Med. 2008 Dec 2;149(11):795-804. doi: 10.7326/0003-4819-149-11-200812020-00004.
- Results publication: PubMed 19056000Krumholz HM, Anderson JL, Bachelder BL, Fesmire FM, Fihn SD, Foody JM, Ho PM, Kosiborod MN, Masoudi FA, Nallamothu BK; American College of Cardiology/American Heart Association Task Force on Performance Measures; American Academy of Family Physicians; American College of Emergency Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Cardiovascular Angiography and Interventions; Society of Hospital Medicine. ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures for ST-Elevation and Non-ST-Elevation Myocardial Infarction) Developed in Collaboration With the American Academy of Family Physicians and American College of Emergency Physicians Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Society for Cardiovascular Angiography and Interventions, and Society of Hospital Medicine. J Am Coll Cardiol. 2008 Dec 9;52(24):2046-99. doi: 10.1016/j.jacc.2008.10.012. No abstract available.
- Results publication: PubMed 19001027Krumholz HM, Anderson JL, Bachelder BL, Fesmire FM, Fihn SD, Foody JM, Ho PM, Kosiborod MN, Masoudi FA, Nallamothu BK; American College of Cardiology/American Heart Association Task Force on Performance Measures; American Academy of Family Physicians; American College of Emergency Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Cardiovascular Angiography and Interventions; Society of Hospital Medicine. ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to develop performance measures for ST-elevation and non-ST-elevation myocardial infarction): developed in collaboration with the American Academy of Family Physicians and the American College of Emergency Physicians: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Society for Cardiovascular Angiography and Interventions, and Society of Hospital Medicine. Circulation. 2008 Dec 9;118(24):2596-648. doi: 10.1161/CIRCULATIONAHA.108.191099. Epub 2008 Nov 10. No abstract available.
- Results publication: PubMed 17515776Bryson CL, Au DH, Young B, McDonell MB, Fihn SD. A refill adherence algorithm for multiple short intervals to estimate refill compliance (ReComp). Med Care. 2007 Jun;45(6):497-504. doi: 10.1097/MLR.0b013e3180329368.
- Results publication: PubMed 17185647Parimon T, Chien JW, Bryson CL, McDonell MB, Udris EM, Au DH. Inhaled corticosteroids and risk of lung cancer among patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 Apr 1;175(7):712-9. doi: 10.1164/rccm.200608-1125OC. Epub 2006 Dec 21.
- Results publication: PubMed 16033502DeSalvo KB, Fan VS, McDonell MB, Fihn SD. Predicting mortality and healthcare utilization with a single question. Health Serv Res. 2005 Aug;40(4):1234-46. doi: 10.1111/j.1475-6773.2005.00404.x.
- Results publication: PubMed 16755394Liu CF, Campbell DG, Chaney EF, Li YF, McDonell M, Fihn SD. Depression diagnosis and antidepressant treatment among depressed VA primary care patients. Adm Policy Ment Health. 2006 May;33(3):331-41. doi: 10.1007/s10488-006-0043-5.
- Results publication: PubMed 16755583Davis GE, Bryson CL, Yueh B, McDonell MB, Micek MA, Fihn SD. Treatment delay associated with alternative medicine use among veterans with head and neck cancer. Head Neck. 2006 Oct;28(10):926-31. doi: 10.1002/hed.20420.
- Results publication: PubMed 10874270Spertus JA, McDonell M, Woodman CL, Fihn SD. Association between depression and worse disease-specific functional status in outpatients with coronary artery disease. Am Heart J. 2000 Jul;140(1):105-10. doi: 10.1067/mhj.2000.106600.
- Results publication: PubMed 11458132Diehr P, Patrick DL, Spertus J, Kiefe CI, McDonell M, Fihn SD. Transforming self-rated health and the SF-36 scales to include death and improve interpretability. Med Care. 2001 Jul;39(7):670-80. doi: 10.1097/00005650-200107000-00004.
Related trials for Health Status Measures
Recruiting
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
Malignant Head and Neck Neoplasm, Malignant Neoplasm
Recruiting
A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings
Functional Impairment, Frailty
RecruitingObservational study
Prospective Cohort Study of Protected Children
Mental Health Conditions, Physical Health Status
Not yet recruiting
Health Promotion Education, Healthy Life Awareness, Salutogenic Health Indicators and Health Literacy
Salutogenesis, Health Literacy
Active, not recruitingObservational study
Satisfaction, QoL,Health Status & Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology
Musculoskeletal Pain, Rheumatologic Disorder
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.
Stephan D. Fihn, MD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Kenneth E. Rosenfeld, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Marisue Cody, PhD RN MPA principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Provision of health status information to patients provider in people with Health Status Measures and Outcomes, run by US Department of Veterans Affairs at 5 sites 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013130, which also lists 38 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 Apr 2015.