Individualizing Disease Prevention for Middle-Aged Adults

NCT03023813 | Terminated Results

• 1 other identifier: 16-854
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Health Care

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (7)

• Use of Shared Decision Making.

  Within 3 days of index primary care appointment.

• Patient Readiness to Change Health Behaviors.

  Within 3 days of index primary care appointment.

• Patient Readiness to Change Health Behaviors

  Within 3 days of index primary care appointment

• Patient Readiness to Change Health Behaviors.

  Within 3 days of index primary care appointment

• Patient Readiness to Change Health Behaviors

  Within 3 days of index primary care appointment

Study Arms (3)

Intervention

EXPERIMENTAL

Individualized preventive care recommendations will be distributed to subjects.

Other: Intervention

Control

NO INTERVENTION

Usual care

Development Phase

EXPERIMENTAL

Non-randomized receipt of individualized preventive care recommendations

Other: Intervention

Interventions

Intervention OTHER

Written material provided.

Development Phase; Intervention

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Glen Taksler: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (20)

• 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.

  PMID: 23799943 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.

  PMID: 24953520 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.

  PMID: 17083558 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.

  PMID: 12679504 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.

  PMID: 22403196 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.

  PMID: 20881156 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.

  PMID: 21806302 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.

  PMID: 1329589 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.

  PMID: 6863699 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.

  PMID: 25384812 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.

  PMID: 19879711 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.

  PMID: 17641137 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.

  PMID: 17652180 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.

  PMID: 20686011 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.

  PMID: 20457688 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.

  PMID: 18755566 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.

  PMID: 20677054 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.

  PMID: 24006959 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.

  PMID: 22618581 BACKGROUND

• 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.

  PMID: 34726747 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Glen Taksler PhD
• Organization: Cleveland Clinic

taksleg@ccf.org

216-445-7499

Study Officials

• Glen Taksler, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the 2 arm round(s) will be randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Model Details: Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: February 22, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2021
• Last Updated: April 26, 2022
• Results First Posted: June 29, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)