Individualizing Disease Prevention for Middle-Aged Adults

Primary Health Care Clinical Trial

Official title:

Individualizing Disease Prevention for Middle-Aged Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03023813
• Other study ID #: 16-854
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Scheduled for an appointment with primary care provider during study period

• Two or more of the following risk factors:

• Tobacco use

• Overweight/obese

• Hypertension

• Hyperlipidemia

• Diabetes

• Alcohol Misuse

• Depression

• History of Sexually Transmitted Infection

• Being overdue for the following screenings: Colorectal, cervical, breast, lung

Exclusion Criteria:

• Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)

Related Conditions & MeSH terms

• Primary Health Care

Intervention

Other:
• Intervention
Written material provided.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Glen Taksler	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2012 May 23. Review. — View Citation

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. Epub 2007 Jul 19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jul 24. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Within 3 days of index primary care appointment.
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)	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)	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	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	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	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	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)	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.	Within 1 year of index primary care appointment.