Physician Awareness of Patients' Preferred Level of Involvement in Decision Making

NCT05314959 | Completed

• 1 other identifier: 215830
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.

Conditions

Preferred Level of Involvement in Decision Making

Outcome Measures

Primary Outcomes (1)

• Discordance rate for the Control Preference Scale

  The Control Preference Scale assesses patients' preferences for involvement in decision-making. The scale ranks patients' preferences for involvement in their healthcare as either active, collaborative, or passive. Patients' CPS responses will be compared between the intervention and usual care cohorts.

  1 day visit

Study Arms (2)

Physician Awareness

EXPERIMENTAL

The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group

Other: Physician Awareness

Usual Care

ACTIVE COMPARATOR

The physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group

Other: Usual Care

Interventions

Physician Awareness OTHER

The patients' pre-visit Control Preference Scale responses are shared with their physician.

Physician Awareness

Usual Care OTHER

The patients' pre-visit Control Preference Scale responses are not shared with their physician.

Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present to Loyola's Urogynecology clinic for their initial evaluation
• Agree to complete the study questionnaires
• Must be at least 18 years of age
• Must be able to read, speak and write in English

You may not qualify if:

• Established patients at Loyola's Urogynecology clinic
• Unable to complete the study questionnaires
• Less than 18 years of age
• Unable to read, speak and write in English

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (10)

• Crawford MJ, Rutter D, Manley C, Weaver T, Bhui K, Fulop N, Tyrer P. Systematic review of involving patients in the planning and development of health care. BMJ. 2002 Nov 30;325(7375):1263. doi: 10.1136/bmj.325.7375.1263.

  PMID: 12458240 BACKGROUND

• Hubbard G, Kidd L, Donaghy E. Preferences for involvement in treatment decision making of patients with cancer: a review of the literature. Eur J Oncol Nurs. 2008 Sep;12(4):299-318. doi: 10.1016/j.ejon.2008.03.004. Epub 2008 May 16.

  PMID: 18486552 BACKGROUND

• Sung VW, Raker CA, Myers DL, Clark MA. Treatment decision-making and information-seeking preferences in women with pelvic floor disorders. Int Urogynecol J. 2010 Sep;21(9):1071-8. doi: 10.1007/s00192-010-1155-8. Epub 2010 Apr 28.

  PMID: 20424822 BACKGROUND

• Beaver K, Bogg J, Luker KA. Decision-making role preferences and information needs: a comparison of colorectal and breast cancer. Health Expect. 1999 Dec;2(4):266-276. doi: 10.1046/j.1369-6513.1999.00066.x.

  PMID: 11281903 BACKGROUND

• Degner LF, Sloan JA. Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol. 1992 Sep;45(9):941-50. doi: 10.1016/0895-4356(92)90110-9.

  PMID: 1432023 BACKGROUND

• Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1145-1151. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25.

  PMID: 19940010 BACKGROUND

• Moth E, McLachlan SA, Veillard AS, Muljadi N, Hudson M, Stockler MR, Blinman P. Patients' preferred and perceived roles in making decisions about adjuvant chemotherapy for non-small-cell lung cancer. Lung Cancer. 2016 May;95:8-14. doi: 10.1016/j.lungcan.2016.02.009. Epub 2016 Feb 21.

  PMID: 27040845 BACKGROUND

• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

  PMID: 9505581 BACKGROUND

• Padilla-Garrido N, Aguado-Correa F, Ortega-Moreno M, Bayo-Calero J, Bayo-Lozano E. [Shared decision making from the perspective of the cancer patient: participatory roles and evaluation of the process]. An Sist Sanit Navar. 2017 Apr 30;40(1):25-33. doi: 10.23938/ASSN.0003. Spanish.

  PMID: 28534548 BACKGROUND

• Nwachokor J, Rochlin EK, Gevelinger M, Yadav M, Adams W, Fitzgerald C, Acevedo-Alvarez M, Mueller ER, Pham TT. Physician awareness of patients' preferred level of involvement in decision-making at the initial urogynecology visit: a randomized trial. Am J Obstet Gynecol. 2024 Jan;230(1):81.e1-81.e9. doi: 10.1016/j.ajog.2023.06.024. Epub 2023 Jun 15.

  PMID: 37330125 DERIVED

Study Officials

• Thythy Pham, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group will have usual care, meaning that the physician will NOT see the patient's survey results. The patient is blinded to randomization and will not know whether or not the physician is aware of their preferred level of shared decision making.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 7, 2022
• Study Start: May 24, 2022
• Primary Completion: September 9, 2022
• Study Completion: October 1, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)