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CoreNAVI - Feasability of a patient navigation programme

Organizational Data

DRKS-ID:
DRKS00025476
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-06-04
Last update in DRKS:
2024-02-21
Registration type:
Prospective

Acronym/abbreviation of the study

CoreNAVI

URL of the study

https://navicare.berlin/de/

Brief summary in lay language

The aim of the project is to investigate the feasibility of a program that intends to support patients with stroke or lung cancer in receiving optimal care based upon their individual needs and preferences by assigning them a person patient navigator for one year. We assess the acceptance, need and practicability of the program along with its potential impact on patients' satisfaction with care, quality of life, and healthcare utilization and costs.

Brief summary in scientific language

The aim of the study is to evaluate the feasibility and to provide estimates for the efficacy and cost-effectiveness of a patient navigation program, designed to improve patient-oriented health care delivery for patients with stroke or lung cancer in ambulatory care.

Health condition or problem studied

ICD10:
G45 - Transient cerebral ischaemic attacks and related syndromes
ICD10:
I60 - Subarachnoid haemorrhage
ICD10:
I61 - Intracerebral haemorrhage
ICD10:
I63 - Cerebral infarction
ICD10:
I64 - Stroke, not specified as haemorrhage or infarction
ICD10:
C34 - Malignant neoplasm of bronchus and lung
ICD10:
C97 - Malignant neoplasms of independent (primary) multiple sites
ICD10:
H34 - Retinal vascular occlusions
ICD10:
H47.0 - Disorders of optic nerve, not elsewhere classified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention arm: Participants will receive support of a personal patient navigator for 1 year
Arm 2:
Control arm: Participants will receive a broschure with regional support offers for patients with stroke/lung cancer and their caregivers
Arm 3:
Not randomized: Cohort: Partcipant have no subjective support need and do not want to be randomized. They will receive no patient navigation or brochure.

Endpoints

Primary outcome:
A) Feasibility of the intervention with two indicators: (1) At least 70% of patients randomized to the intervention arm have received at least one initial in-person navigator session, (2) The drop-out rate from the intervention arm of the RCT is less than 40% within one year. B) In case these feasibility criteria are met, we will test the efficacy of the intervention. The primary efficacy endpoint is "Satisfaction with healthcare" (single item with 5-point likert response scale) at the final follow-up (13 months after baseline, 12 month after the start of the intervention).
Secondary outcome:
A Feasibility of the intervention: 1. Acceptance: % eligible patients interested to receive the navigator intervention; % consenting to the RCTs; % interested but unwilling to be randomized; % patients randomized and starting the intervention; % patients adhering to the appointments with navigator; % patients and % navigators ‚very satisfied‘ or ‚satisfied‘ with the intervention; 2. Demand: Support needs; Number of Navigator contacts; Delivery mode of the navigator interaction (in-person, phone, email, other); Type of navigator services performed; 3. Implementation and Practicality: % of target population (potentially eligible patients) approached and informed about study at recruitment centers before discharge; % patient-navigator appointments carried out as planned; % of individual patient goals achieved B) Efficacy of the intervention: 1. Quality of life and functional status (EQ-5D_5L, PHQ-4 , EORTC QLQ-LC29 (only cancer patients), Barthel-Index (only stroke patients)) At all follow-up time points (4, 7 and 13 months after baseline) 2. Healthcare utilization, delayed care, forgone Care At all follow-up time points (4, 7 and 13 months after baseline) 3. Information needs At all follow-up time points (4, 7 and 13 months after baseline) 4. Health literacy At all follow-up time points (4, 7 and 13 months after baseline) 5. Satisfaction with different aspects of healthcare At all follow-up time points (4, 7 and 13 months after baseline) 6. Trust in medical care At all follow-up time points (4, 7 and 13 months after baseline) 7. Self-efficacy At all follow-up time points (4, 7 and 13 months after baseline) 8. Supportive care needs At all follow-up time points (4, 7 and 13 months after baseline) 9. Social support, loneliness At all follow-up time points (4, 7 and 13 months after baseline) 10. Self-reported medication adherence At all follow-up time points (4, 7 and 13 months after baseline) 11. Participation in rehabilitation and time between hospital discharge and start of rehabilitation (only stroke patients) 11. Re-hospitalizations: time to first re-hospitalization, number and average duration of re-hospitalizations (complete follow-up period) 12. Recurrent stroke (complete follow-up period, only stroke patients) 13. Mortality C) Cost, Cost-effectiveness: 1. Ambulatory and inpatient healthcare costs (complete follow-up period; in the subgroup of patients with coverage by the health insurance company AOK-Nordost) 2. Cost-effectiveness (in the subgroup of patients with coverage by the health insurance company AOK-Nordost)

Study Design

Purpose:
Supportive care
Allocation:
Randomized controlled study
Control:
  • Other
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Städtisches Klinikum Brandenburg Brandenburg an der Havel
  • University medical center Charité - Universitätsmedizin Berlin Berlin
  • Medical center Oberhavel Kliniken, Standort Hennigsdorf Hennigsdorf

Recruitment period and number of participants

Planned study start date:
2021-06-10
Actual study start date:
2021-06-10
Planned study completion date:
2023-10-31
Actual Study Completion Date:
2023-10-31
Target Sample Size:
874
Final Sample Size:
312

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
• Confirmed diagnosis of stroke/TIA (ICD-10 Codes: G45.x, I60.x, I61.x, I63.x, I64.x, H34.x, H47.0) • Confirmed diagnosis of lung cancer (ICD-10 Codes: C34.1, C34.2, C34.3, C34.8, C34.9, C97) • caregiver of a patient with stroke/lung cancer (after consent of the patient or if legal guardianship consists) • Age: ≥18 years • living in Berlin or Brandenburg

Exclusion Criteria

• patients living in nursing care facility • patient without caregiver and not able to give informed consent and for which no legal guardianship is in place • dementia (inclusion of caregiver may be possible) • language barrier (inclusion of caregiver may be possible)

Addresses

Primary Sponsor

Charité Campus Virchow-Klinikum
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité-Universitätsmedizin Berlin, Institut für Public Health
Dr. Kathrin Gödde
Seestr. 73
13347 Berlin
Germany
Telephone:
+49 30 450 570 586
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Charité-Universitätsmedizin Berlin, Institut für Public Health
Dr. Kathrin Gödde
Seestr. 73
13347 Berlin
Germany
Telephone:
+49 (0)30 450 570 856
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Medizinische Hochschule Brandenburg Theodor Fontane, Institut für Sozialmedizin und Epidemiologie
Prof. Dr. Christine Holmberg
Hochstr. 15
14770 Brandenburg an der Havel
Germany
Telephone:
+49 3381 411281
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Bonn
Heinemannstr. 2
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-10-22
Ethics committee number:
EA2/249/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-03-02

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
01GY1911 - Förderkennzeichen
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
What data: Individual participant data from quantitative assessments that underlie the results reported in published articles after deidentification (text, tables, figures and appendices). Study center individual patient data will not be disclosed because of the possibility of re-identification of patients. When: 12 months after publication for 3 years. With whom? Researchers who provide a methodologically sound proposal For what types of analyses: Systematic Review, meta-analysis, individual participant data meta-analysis Researchers who wish to access IPD data sharing should email: corenavi_studie@charite.de. By what medium will data be made available: By encrypted data file. By what mechanism will data be made available? To gain access, requestors will have to sign a data sharing agreement.

Study protocol and other study documents

Study protocols:
Gödde K, Fügemann H, Goerling U, Grittner U, Kohl R, Meisel A, et al. (2023) Feasibility of a patient-oriented navigation programme for patients with lung cancer or stroke in Germany: Protocol of the CoreNAVI study. PLoS ONE 18(6): e0287638. https://doi.org/10.1371/journal.pone.0287638
Study abstract:
No Entry
Other study documents:
Statistischer Analyseplan
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry