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Study was terminated on 2/17/2021 due to on-going and uncertain nature of COVID-19 pandemic; this was not a suspension of IRB approval.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Individualized preventive care recommendations will be distributed to subjects. |
|
| Control | No Intervention | Usual care | |
| Development Phase | Experimental | Non-randomized receipt of individualized preventive care recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | Written material provided. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Within 3 days of index primary care appointment. |
| Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Within 3 days of index primary care appointment. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Shared Decision Making. | Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Within 3 days of index primary care appointment. |
| Patient Readiness to Change Health Behaviors. |
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Inclusion Criteria:
Exclusion Criteria:
- Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)
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| Name | Affiliation | Role |
|---|---|---|
| Glen Taksler, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799943 | Background | Krist AH, Glenn BA, Glasgow RE, Balasubramanian BA, Chambers DA, Fernandez ME, Heurtin-Roberts S, Kessler R, Ory MG, Phillips SM, Ritzwoller DP, Roby DH, Rodriguez HP, Sabo RT, Sheinfeld Gorin SN, Stange KC; MOHR Study Group. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implement Sci. 2013 Jun 25;8:73. doi: 10.1186/1748-5908-8-73. | |
| 24953520 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided. |
| FG001 | Control | Usual care |
| FG002 | Development Phase | Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided. |
| BG001 | Control | Usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Patients who completed surveys | Posted | Mean | Inter-Quartile Range | score on a scale | Within 3 days of index primary care appointment. |
|
Up to 1 year following enrollment of each patient participant.
As an Institutional Review Board (IRB)-determined minimal risk study, adverse events were not tracked by the study team. Instead, participants were asked to report any adverse events to the study team or the IRB. No events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Individualized preventive care recommendations will be distributed to subjects. Intervention: Written material provided. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glen Taksler PhD | Cleveland Clinic | 216-445-7499 | taksleg@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2018 | Mar 26, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2019 | Mar 26, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.
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Only the 2 arm round(s) will be randomized.
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Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower |
| Within 3 days of index primary care appointment. |
| Patient Readiness to Change Health Behaviors | Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment |
| Patient Readiness to Change Health Behaviors. | Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment |
| Patient Readiness to Change Health Behaviors | Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Within 3 days of index primary care appointment |
| Decisional Comfort. | Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Within 3 days of index primary care appointment. |
| Preventive Care Outcomes for Patients. | Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter. | Within 1 year of index primary care appointment. |
| Background |
| Glasgow RE, Kessler RS, Ory MG, Roby D, Gorin SS, Krist A. Conducting rapid, relevant research: lessons learned from the My Own Health Report project. Am J Prev Med. 2014 Aug;47(2):212-9. doi: 10.1016/j.amepre.2014.03.007. Epub 2014 Jun 18. |
| 17083558 | Background | Edwards A, Elwyn G. Inside the black box of shared decision making: distinguishing between the process of involvement and who makes the decision. Health Expect. 2006 Dec;9(4):307-20. doi: 10.1111/j.1369-7625.2006.00401.x. |
| 12679504 | Background | Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93. |
| 22403196 | Background | Nagykaldi Z, Aspy CB, Chou A, Mold JW. Impact of a Wellness Portal on the delivery of patient-centered preventive care. J Am Board Fam Med. 2012 Mar-Apr;25(2):158-67. doi: 10.3122/jabfm.2012.02.110130. |
| 20881156 | Background | Sepucha KR, Fagerlin A, Couper MP, Levin CA, Singer E, Zikmund-Fisher BJ. How does feeling informed relate to being informed? The DECISIONS survey. Med Decis Making. 2010 Sep-Oct;30(5 Suppl):77S-84S. doi: 10.1177/0272989X10379647. |
| 21806302 | Background | Dillard AJ, Ferrer RA, Ubel PA, Fagerlin A. Risk perception measures' associations with behavior intentions, affect, and cognition following colon cancer screening messages. Health Psychol. 2012 Jan;31(1):106-13. doi: 10.1037/a0024787. Epub 2011 Aug 1. |
| 1329589 | Background | Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102. |
| 6863699 | Background | Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available. |
| 25384812 | Background | Phillips SM, Glasgow RE, Bello G, Ory MG, Glenn BA, Sheinfeld-Gorin SN, Sabo RT, Heurtin-Roberts S, Johnson SB, Krist AH; MOHR Study Group. Frequency and prioritization of patient health risks from a structured health risk assessment. Ann Fam Med. 2014 Nov-Dec;12(6):505-13. doi: 10.1370/afm.1717. |
| 19879711 | Background | Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. |
| 17641137 | Background | Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the Subjective Numeracy Scale. Med Decis Making. 2007 Sep-Oct;27(5):672-80. doi: 10.1177/0272989X07304449. Epub 2007 Jul 19. |
| 17652180 | Background | Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the Subjective Numeracy Scale: effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making. 2007 Sep-Oct;27(5):663-71. doi: 10.1177/0272989X07303824. Epub 2007 Jul 24. |
| 20686011 | Background | Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. Presenting research risks and benefits to parents: does format matter? Anesth Analg. 2010 Sep;111(3):718-23. doi: 10.1213/ANE.0b013e3181e8570a. Epub 2010 Aug 4. |
| 20457688 | Background | Tait AR, Zikmund-Fisher BJ, Fagerlin A, Voepel-Lewis T. Effect of various risk/benefit trade-offs on parents' understanding of a pediatric research study. Pediatrics. 2010 Jun;125(6):e1475-82. doi: 10.1542/peds.2009-1796. Epub 2010 May 10. |
| 18755566 | Background | Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008 Dec;73(3):448-55. doi: 10.1016/j.pec.2008.07.023. Epub 2008 Aug 27. |
| 20677054 | Background | Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables, and graphics. J Health Commun. 2010 Jul;15(5):487-501. doi: 10.1080/10810730.2010.492560. |
| 24006959 | Background | Lloyd A, Joseph-Williams N, Edwards A, Rix A, Elwyn G. Patchy 'coherence': using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC). Implement Sci. 2013 Sep 5;8:102. doi: 10.1186/1748-5908-8-102. |
| 22618581 | Background | Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23. |
| 34726747 | Derived | Taksler GB, Hu B, DeGrandis F Jr, Montori VM, Fagerlin A, Nagykaldi Z, Rothberg MB. Effect of Individualized Preventive Care Recommendations vs Usual Care on Patient Interest and Use of Recommendations: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2131455. doi: 10.1001/jamanetworkopen.2021.31455. |
| BG002 | Development Phase | Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Practice site | Study was conducted at 3 physical locations (primary care ambulatory clinics), denoted as Site 1, Site 2 or Site 3. | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
Usual care
| OG002 | Development Phase | Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided. |
|
|
| Primary | Interest in Individualized Preventive Care Recommendations. | Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys. Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome) | Patients who completed surveys | Posted | Mean | Inter-Quartile Range | score on a scale | Within 3 days of index primary care appointment. |
|
|
|
| Secondary | Use of Shared Decision Making. | Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Patients who completed surveys | Posted | Mean | Standard Error | score on a scale | Within 3 days of index primary care appointment. |
|
|
|
|
| Secondary | Patient Readiness to Change Health Behaviors. | Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Patients who completed surveys | Posted | Mean | Standard Error | percentage of survey responses | Within 3 days of index primary care appointment. |
|
|
|
|
| Secondary | Patient Readiness to Change Health Behaviors | Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Patients who completed surveys | Posted | Mean | Standard Error | percentage of survey responses | Within 3 days of index primary care appointment |
|
|
|
|
| Secondary | Patient Readiness to Change Health Behaviors. | Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Patients who completed surveys | Posted | Mean | Standard Error | percentage of survey responses | Within 3 days of index primary care appointment |
|
|
|
|
| Secondary | Patient Readiness to Change Health Behaviors | Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower | Patients who completed surveys | Posted | Mean | Standard Error | percentage of survey responses | Within 3 days of index primary care appointment |
|
|
|
|
| Secondary | Decisional Comfort. | Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome) | Patients who completed surveys (Data not collected for Development Phase) | Posted | Mean | Standard Error | score on a scale | Within 3 days of index primary care appointment. |
|
|
|
|
| Secondary | Preventive Care Outcomes for Patients. | Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter. | Outcome tables are not included for specific preventive services because outcomes were not assessed by arm (instead, a statistical regression strategy was used). This outcome was not collected for participants in the Development arm. | Posted | Count of Participants | Participants | Within 1 year of index primary care appointment. |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Control | Usual care | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Development Phase | Non-randomized receipt of individualized preventive care recommendations Intervention: Written material provided. | 0 | 31 | 0 | 31 | 0 | 31 |
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Among participants whose individualized preventive care recommendations included blood pressure control |
| Mixed Models Analysis |
| 0.19 |
| Mean Difference (Net) |
| -6.42 |
| 2-Sided |
| 95 |
| -16.12 |
| 3.27 |
Result for intervention arm minus control arm |
| Other |
Change in systolic blood pressure since the baseline encounter (mmHg) |
| Among participants whose individualized preventive care recommendations included glycemic control | Mixed Models Analysis | 0.24 | Mean Difference (Net) | -0.68 | 2-Sided | 95 | -1.82 | 0.45 | Result for intervention arm minus control arm | Other | Percentage point change in HbA1c (%) since the baseline encounter |
| Among participants whose individualized preventive care recommendations included lipids control | Generalized linear mixed regression | 0.34 | Mean Difference (Net) | -1.20 | 2-Sided | 95 | -3.65 | 1.26 | Result for intervention arm minus control arm | Other | Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter |
| Among participants whose individualized preventive care recommendations included lipids control | Mixed Models Analysis | 0.36 | Mean Difference (Net) | -8.46 | 2-Sided | 95 | -26.63 | 9.70 | Result for intervention arm minus control arm | Other | Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter |
| Among participants whose individualized preventive care recommendations included tobacco cessation | Mixed Models Analysis | Generalized linear mixed regression with logit link | 0.92 | Odds Ratio (OR) | 1.20 | 2-Sided | 95 | 0.03 | 45.56 | Result for intervention arm relative to control arm. OR <1 indicates reduction in smoking intensity; OR >1 indicates increase in smoking intensity. | Other | Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter. |
| Among participants whose individualized preventive care recommendations included colorectal cancer screening | Mixed Models Analysis | Generalized linear mixed regression with logit link | 0.99 | Odds Ratio (OR) | 2.52 | 2-Sided | 95 | 0.001 | 1000 | Result for intervention arm relative to control arm. Lower limit estimate was <0.001 and upper limit estimate was >1000 (ClinicalTrials.gov does not allow < or > to be entered into the confidence interval lower limit or upper limit fields). | Other | Receipt of colorectal cancer screening since the baseline encounter |