Implementation of Shared Decision-Making in Cancer Care

NCT03393351 | Completed

• 1 other identifier: SCHO 1551/1-2
• Study Type: interventional
• Target: 2,131
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.

Conditions

Cancer

Keywords

Shared Decision-Making; Decision Making; Patient Participation; Patient Centeredness; Health Services Research; Implementation Research; Oncology; Stepped Wedge Design; Mixed Methods

Outcome Measures

Primary Outcomes (1)

• Change in uptake of shared decision-making from the patients' perspective

  Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)

  All clinics: baseline, 8 months, 16 months, 24 months

Secondary Outcomes (6)

• Change in uptake of shared decision-making from external observers' perspective

  All clinics: baseline, 8 months, 16 months, 24 months

• Acceptability of shared decision-making from the health care providers' perspective

  All clinics: baseline, 8 months, 16 months, 24 months

• Readiness for implementing change from the health care professionals' perspective

  All clinics: baseline, 8 months, 16 months, 24 months

• Appropriateness of shared decision-making from the health care professionals' perspective

  All clinics: baseline, 8 months, 16 months, 24 months

• Change in penetration of shared decision-making at the clinic level

  baseline, 3 years

Study Arms (2)

Shared decision-making program

EXPERIMENTAL

Other: Shared decision-making program

Usual care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Shared decision-making program OTHER

The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components: 1. shared decision-making trainings for health care professionals, 2. individual coaching for physicians, 3. patient activation strategy, 4. provision of patient information material and decision aids, 5. revision of the clinics quality management documents, and 6. critical reflection of current organization of multidisciplinary team meetings. Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.

Shared decision-making program

Usual Care OTHER

No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.

Usual care

Eligibility Criteria

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

You may qualify if:

• diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)
• admitted for inpatient or outpatient treatment at the participating clinics
• age \> 18 years
• German-speaking

You may not qualify if:

• severe cognitive impairment
• physician or nurse working at the participating clinics
• none

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (3)

University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic

Hamburg, Germany

Location

University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology

Hamburg, Germany

Location

University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery

Hamburg, Germany

Location

Related Publications (3)

• Scholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Muller V, Smeets R, Witzel I, Kriston L, Harter M. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y.

  PMID: 29580249 BACKGROUND

• Hahlweg P, Lindig A, Frerichs W, Zill J, Hanken H, Muller V, Peters MC, Scholl I. Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial. BMC Health Serv Res. 2023 Aug 8;23(1):840. doi: 10.1186/s12913-023-09778-w.

  PMID: 37553560 DERIVED

• Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Harter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4.

  PMID: 34965881 DERIVED

MeSH Terms

Conditions

Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Isabelle Scholl, Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Group, Prinicipal Investigator

Model Details: A stepped wedge design, a variant of the cluster randomized controlled trial feasible to evaluate interventions in routine implementation, will be used. Participating clinics will receive the multifaceted implementation program in a randomized sequence.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 8, 2018
• Study Start: March 5, 2018
• Primary Completion: September 12, 2020
• Study Completion: December 31, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

DE (3)