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Completed

NCT Number: NCT03393351

Implementation of Shared Decision-Making in Cancer Care

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.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for participating patients:

  • 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

Exclusion criteria

for participating patients:

  • severe cognitive impairment

Inclusion criteria

for participating health care professionals:

  • physician or nurse working at the participating clinics

Exclusion criteria

for participating health care professionals:

  • none

Treatment and study plan

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:

  • shared decision-making trainings for health care professionals,
  • individual coaching for physicians,
  • patient activation strategy,
  • provision of patient information material and decision aids,
  • revision of the clinics quality management documents, and
  • 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.

Usual Care

Other

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

Primary outcomes

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

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

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

Secondary outcomes

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

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

    Action to employ shared decision-making as measured by the German version of the Observer OPTION 5 scale using audio-recorded medical encounters. The Observer OPTION 5 scale measures the extent to which clinicians involve patients in decision-making. Each of the 5 items is assessed on a scale ranging from 0 to 4 with higher values indicating more involvement of patients in decision-making. A sum score is calculated (ranging from 0 to 20) and rescaled to be between 0 to 100, for ease of interpretation.

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

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

    Perception that shared decision-making is agreeable, palatable, or satisfactory as measured by an adapted version of the acceptability survey developed by McColl et al.

  3. Readiness for implementing change from the health care professionals' perspective

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

    As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure

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

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

    Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure

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

    Time frame: baseline, 3 years

    Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics

  6. Change in penetration of shared decision-making in multidisciplinary team meetings

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

    Integration of shared decision-making within a setting and its subsystems as measured by an adapted version of the Metric for the Observation of Decision Making in Multidisciplinary Team Meetings (MDT-MODe)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial

Acronym: PREPARED

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2018
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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