Participatory Patient Care Planning in Primary Care (4PHC)
Primary Purpose
Hypertension, Ischemic Heart Disease, Diabetes Mellitus
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Participatory patient care planning
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring patient care planning, primary health care, comorbidity
Eligibility Criteria
Inclusion Criteria:
- Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi
Exclusion Criteria:
- Permanent bed patient, terminal phase of any serious condition, severe decline in cognition
Sites / Locations
- Siilinjärvi Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Participatory patient care planning
Arm Description
Usual care including standard disease specific follow-up with visit to general practitioner.
Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
Outcomes
Primary Outcome Measures
15D
Health related quality of life
Secondary Outcome Measures
WPAI
Work Productivity and Activity Impairment Questionnaire
PAM
Patient Activation Measurement
HbA1C
B -Hemoglobin-A1c
LDL
plasma LDL cholesterol
blood pressure
blood pressure
BMI
body mass index
waist measure
waist measure
visits to nurse
number of visits to nurse
visits to physician
number of visits to physician
Full Information
NCT ID
NCT02992431
First Posted
December 12, 2016
Last Updated
March 30, 2022
Sponsor
Kuopio University Hospital
Collaborators
Siilinjärvi Health Center, University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT02992431
Brief Title
Participatory Patient Care Planning in Primary Care
Acronym
4PHC
Official Title
Participatory Patient Care Planning in Primary Care: Effectiveness and Feasibility in Patients With Hypertension, Ischemic Heart Disease or Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Siilinjärvi Health Center, University of Eastern Finland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the aging population, the prevalence of chronic diseases and multimorbidity has become common. Therefore, the planning and coordination of care have become more important. However, it is not known what kind of treatment plan should be and what kind of patients would benefit most of it.
This research focuses on the participatory patient care planning in primary health care. In general, the participatory patient care planning (PPCP) aims to engage patients in self-care, to improve the collaboration between patients and professionals and to improve the use of resources. The present study investigates the feasibility and effectiveness of the PPCP.
The specific research questions of the present study are: Does the PPCP have an impact on the patient's quality of life? Does the PPCP improve the quality of care in management of chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on the use of health care services? The data consists of people aged at least 18 years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient record. The participating patients are recruited from those who contacts SiiIinjärvi Health Care Center in order to have a follow-up visit because of the treatment of their disease. This study aims to recruit 700 patients.
The participants are allocated into the intervention group and into the control group receiving usual care. Intervention consists of the PPCP. This includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
The main out-come measures are the quality of health related life measured with the 15D; the level of patient's activity in self-care with the Patient Activation Measurement (PAM); life satisfaction, self-rated health, a reduction in productivity with the Work Productivity and Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls and referrals are measured.
Detailed Description
This research focuses on the participatory patient care planning in primary health care. In general, the participatory patient care planning (PPCP) aims to engage patients in self-care, to improve the collaboration between patients and professionals and to improve the use of resources. The present study investigates the feasibility and effectiveness of the PPCP.
The specific research questions of the present study are: Does the PPCP have an impact on the patient's quality of life? Does the PPCP improve the quality of care in management of chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on the use of health care services? The data consists of people aged at least 18 years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient record. The participating patients are recruited from those who contacts SiiIinjärvi Health Care Center in order to have a follow-up visit because of the treatment of their disease. This study aims to recruit 700 patients.
The participants are allocated into the intervention group and into the control group receiving usual care. Intervention consists of the PPCP. This includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
The main out-come measures are the quality of health related life measured with the 15D; the level of patient's activity in self-care with the Patient Activation Measurement (PAM); life satisfaction, self-rated health, a reduction in productivity with the Work Productivity and Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls and referrals are measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Ischemic Heart Disease, Diabetes Mellitus
Keywords
patient care planning, primary health care, comorbidity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care including standard disease specific follow-up with visit to general practitioner.
Arm Title
Participatory patient care planning
Arm Type
Experimental
Arm Description
Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
Intervention Type
Behavioral
Intervention Name(s)
Participatory patient care planning
Intervention Description
Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care including standard disease specific follow-up with visit to general practitioner.
Primary Outcome Measure Information:
Title
15D
Description
Health related quality of life
Time Frame
one year
Secondary Outcome Measure Information:
Title
WPAI
Description
Work Productivity and Activity Impairment Questionnaire
Time Frame
one year
Title
PAM
Description
Patient Activation Measurement
Time Frame
one year
Title
HbA1C
Description
B -Hemoglobin-A1c
Time Frame
one year
Title
LDL
Description
plasma LDL cholesterol
Time Frame
one year
Title
blood pressure
Description
blood pressure
Time Frame
one year
Title
BMI
Description
body mass index
Time Frame
one year
Title
waist measure
Description
waist measure
Time Frame
one year
Title
visits to nurse
Description
number of visits to nurse
Time Frame
one year
Title
visits to physician
Description
number of visits to physician
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hypertension, ischemic hearth disease or diabetes living in the municipality of Siilinjärvi
Exclusion Criteria:
Permanent bed patient, terminal phase of any serious condition, severe decline in cognition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka T Mäntyselkä, Professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nina M Tusa, MD
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siilinjärvi Health Center
City
Siilinjärvi
ZIP/Postal Code
71800
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34284783
Citation
Tusa N, Kautiainen H, Elfving P, Sinikallio S, Mantyselka P. Randomized controlled study of the impact of a participatory patient care plan among primary care patients with common chronic diseases: a one-year follow-up study. BMC Health Serv Res. 2021 Jul 20;21(1):715. doi: 10.1186/s12913-021-06716-6.
Results Reference
derived
PubMed Identifier
33148185
Citation
Tusa N, Kautiainen H, Elfving P, Sinikallio S, Mantyselka P. Relationship between patient activation measurement and self-rated health in patients with chronic diseases. BMC Fam Pract. 2020 Nov 4;21(1):225. doi: 10.1186/s12875-020-01301-y.
Results Reference
derived
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Participatory Patient Care Planning in Primary Care
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