Effect of a CKD Dashboard on Patient Activation and Shared Decision Making

NCT05931978 | Completed

• 1 other identifier: W20.245
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical pre-post study is to evaluate the effect of using a CKD dashboard, which visualizes individual patient data in patients with Chronic Kidney Disease stage 3b-4, and is used to structure the conversation during patient-clinician health visits. The main question\[s\] it aims to answer are: • what is the effect of the dashboard on patient activation levels (or outcomes related to patient activation)? • What is the effect of the dashboard on the conversation during health visits, including Shared Decision Making (SDM), Motivational interviewing (MI) and conversation topics? Participants will receive three surveys and have two routine care follow up consultations with their clinician audio recorded. Researchers will compare the same patients before and after implementation as well as compare them with patients in another hospital where no dashboard is (yet) implemented to see if patient activation levels (and related outcomes) increase, and whether there is an increase in SDM, MI and a difference in conversation topics.

Conditions

Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4

Keywords

chronic kidney disease; patient activation; shared decision making

Outcome Measures

Primary Outcomes (2)

• Patient Activation Measure

  Patient activation relates to patients having the knowledge, skills and confidence to take an active role in managing their condition. A widely used and validated measure for these aspects of patient activation is the Patient Activation Measure. The PAM contains four levels of activation indicating an increased level of patient activation per level: 1) believing that your role is important; 2) having confidence and knowledge to take action; 3) taking action; 4) staying on course in disease management under stress. Total scores range from 0-100; higher scores indicate higher patient activation.

  Change from baseline (pre-implementation dashboard) to the following consultation more than 3 months later (post-implementation dashboard)

• Patient Activation Measure

  Patient activation relates to patients having the knowledge, skills and confidence to take an active role in managing their condition. A widely used and validated measure for these aspects of patient activation is the Patient Activation Measure. The PAM contains four levels of activation indicating an increased level of patient activation per level: 1) believing that your role is important; 2) having confidence and knowledge to take action; 3) taking action; 4) staying on course in disease management under stress. Total scores range from 0-100; higher scores indicate higher patient activation.

  Change from baseline (pre-implementation dashboard) to one year after implementation of the dashboard.

Secondary Outcomes (14)

• Shared Decision Making, measured with 4SDM scale

  Change from baseline (pre-implementation dashboard) to the following consultation more than 3 months later (post-implementation dashboard)

• Motivational Interviewing

  Change from baseline (pre-implementation dashboard) to the following consultation more than 3 months later (post-implementation dashboard)

• Perceived Efficacy of the Patient in Patient-clinician Interactions' (PEPPI).

  Change from baseline (pre-implementation dashboard) to the following consultation more than 3 months later (post-implementation dashboard)

• Perceived Efficacy of the Patient in Patient-clinician Interactions' (PEPPI)

  Change from baseline (pre-implementation dashboard) to one year after implementation of the dashboard.

• Medication Adherence Report Scale (MARS)

  Change from baseline (pre-implementation dashboard) to the following consultation more than 3 months later (post-implementation dashboard)

Study Arms (2)

CKD dashboard + Routine CKD care

EXPERIMENTAL

Filled out PROMs before consultation and discussed the CKD consultation dashboard together with their clinician in the (already scheduled) routine care follow up consultation.

Other: CKD dashboard

Routine CKD care

NO INTERVENTION

In the period of the study PROMs and the dashboard are not yet implemented for this group of patients.

Interventions

CKD dashboard OTHER

Online dashboard that visualizes patients' individual PROM- and clinical data related to their kidney disease.

CKD dashboard + Routine CKD care

Eligibility Criteria

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

You may qualify if:

• Patients will be eligible for participations if they meet all the following criteria:
• Patients with Chronic Kidney Disease in stages G3b until G4 due to all causes
• Patients are treated for chronic kidney disease in the participating hospitals
• ≥ 18 years of age
• Be able to understand Dutch language in speech and writing or have someone assist them in understanding Dutch language.
• Able to provide informed consent

You may not qualify if:

• Patients with dementia or severe cognitive impairment are excluded from this study.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Maasstad Hospital: collaborator

Study Sites (2)

Maasstad Hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (10)

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Henselmans I, Smets EMA, de Haes JCJM, Dijkgraaf MGW, de Vos FY, van Laarhoven HWM. A randomized controlled trial of a skills training for oncologists and a communication aid for patients to stimulate shared decision making about palliative systemic treatment (CHOICE): study protocol. BMC Cancer. 2018 Jan 8;18(1):55. doi: 10.1186/s12885-017-3838-8.

  PMID: 29310605 BACKGROUND

• Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.

  PMID: 26215573 BACKGROUND

• Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.

  PMID: 31823381 BACKGROUND

• Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J, Valderas J, Black N. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018 Sep 15;2:42. doi: 10.1186/s41687-018-0061-6. eCollection 2018 Dec.

  PMID: 30294712 BACKGROUND

• Ryan BL, Brown JB, Tremblay PF, Stewart M. Measuring Patients' Perceptions of Health Care Encounters: Examining the Factor Structure of the Revised Patient Perception of Patient-Centeredness (PPPC-R) Questionnaire. J Patient Cent Res Rev. 2019 Jul 29;6(3):192-202. doi: 10.17294/2330-0698.1696. eCollection 2019 Summer.

  PMID: 31414031 BACKGROUND

• Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.

  PMID: 9670878 BACKGROUND

• Hankins MC, Llewellyn CD. Is the Satisfaction with Cancer Information Profile (SCIP) valid for tailoring information for patients with head and neck cancer? BMC Cancer. 2008 Jun 6;8:164. doi: 10.1186/1471-2407-8-164.

  PMID: 18538021 BACKGROUND

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

  PMID: 9505581 BACKGROUND

• Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13.

  PMID: 26874558 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Participation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Willem Jan Bos, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Pre-post study with longitudinal follow up of participants with an additional control group.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: July 6, 2023
• Study Start: January 4, 2021
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)