Continuity of Care, Adherence to Treatment and Self-reported Health After Percutaneous Coronary Intervention (CONCARD): a Patient-centered Care Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,417
- Locations
- 7
- Primary Endpoint
- Continuity of care
Study Overview
Brief Summary
The main objective is to investigate i) continuity of care, ii) health literacy and self-management, iii) adherence to treatment, and iv) patient preferences, healthcare utilization and costs, and to determine associations with future short- and long-term health outcomes in patients after percutaneous coronary intervention.
Detailed Description
CONCARD will use multiple designs. (1) An inductive exploratory design including in-depth interviews on patients' experiences of healthcare delivery will provide a context for the quantitative data to develop the content of the cohort study and trial intervention. (2) A prospective cohort design with a 1-year follow-up period will include data on patient-reported outcomes, and a 10-year follow-up for adverse events. In translation and adaptation of patient-reported outcome measures, a methodological design will be applied. (3) A discrete choice experiment will investigate patient preferences for aftercare and cardiac rehabilitation.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing percutaneous coronary intervention
- •≥ 18 years of age
- •Living at home at the time of inclusion.
Exclusion Criteria
- •Patients who do not speak Norwegian/Danish
- •Patients who are unable to fill in the questionnaires due to reduced capacities
- •Institutionalized patients
- •Patients with expected lifetime less than one year
- •Percutaneous coronary intervention without stent implantation
- •Patients undergoing percutaneous coronary intervention related to Transcatheter Aortic Valve Implantation or Mitraclip examination
- •Previous enrollment in CONCARD (readmissions).
Outcomes
Primary Outcomes
Continuity of care
Time Frame: 2 months
The Heart Continuity of Care Questionnaire (HCCQ) comprises 33 items covering eight topic areas regarding continuity of care. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).
Evaluation of the quality of healthcare delivery
Time Frame: 2 months
The Nordic Patient Experiences Questionnaire (NORPEQ) comprises 8 items and gives a brief measure of patient experiences in evaluation of the quality of healthcare delivery. Respondents rate each item on a 5-point scale ranging from 1 (not at all) to 5 (to a large extent). Six of the eight NORPEQ items sum to produce an overall scale from 0 to 100, where 100 is the best possible experience of care.
Change in health literacy
Time Frame: 2 months, 12 months
The Health literacy questionnaire (HLQ) has nine scale scores that each measure an aspect of the multidimensional construct of health literacy. Each score provides insight into the strengths and limitations of the respondent, but the scores are most powerful when viewed together to show the 'health literacy profile' of the respondent.
Patient knowledge, skill, and confidence for self-management.
Time Frame: 6 months
The Patient Activation Measure (PAM-13) comprises 13 items assessing patient knowledge, skill and confidence for self-management. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly agree), or 5 (not applicable). Patients with a high activation score were associated with fewer mental health symptoms, greater recovery attitudes and medication adherence.
Change in self-reported adherence to medicines
Time Frame: 2 months, 6 months, 12 months
The Medication Adherence Report Scale (MARS-5) measures self-reported adherence to medicines, it assesses both intentional and unintentional non-adherence. Respondents indicate their agreement with statements about their medicine use on a 5 point Likert scale ranging from 1 (always) to 5 (never).
Change in medication use
Time Frame: 2 months, 6 months, 12 months
Data related to consumption of prescribed medication are identified through national prescription registries. The registries cover all prescriptions dispensed at pharmacies nationwide. The registries also include information about date of dispensation, quantity and strength dispensed. This will serve as complimentary information to patients' self-reported adherence.
Health care utilization
Time Frame: Up to 24 months
Healthcare utilization will be assessed during follow-up, including patients' use of primary care services (general practitioner visits) and secondary care services (inpatient admissions and outpatient visits). The data source will be nationwide registries. The measurement unit will be mean number of visits.
Health care (associated) costs
Time Frame: Up to 24 months
Health care (associated) costs will be valued using the tariffs of national agreements between the professional associations of medical specialists and the National Health Services. In secondary care, inpatient admissions and outpatient visits will be valued using the tariffs of the national case-mix system of the diagnosis-related groupings (DRG) and the ambulatory grouping system (DAGS). In addition, data will be collected on prescription of medication, which will be valued using the retail price. The data source will be nationwide registries. The measurement unit will be mean costs in Euros.
Change in eHealth literacy
Time Frame: 2 months, 12 months
The eHealth Literacy Scale (Eheals) is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly agree).
Change in beliefs and perceptions about medicines and treatment
Time Frame: 2 months, 6 months, 12 months
The Beliefs about Medicines Questionnaire (BMQ) assesses beliefs and perceptions about medicines and treatment. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. The two sections of the BMQ can be used in combination or separately. For this study, the BMQ-Specific will be used. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).
Secondary Outcomes
- Change in physical and mental dimensions of health.(2 months, 6 months, 12 months)
- Frailty status(12 months)
- Change in fatigue(2 months, 6 months,12 months)
- Time to death(30-days, 3 months, 6 months, 12 months, up to 10 years)
- Change in anxiety and depression(2 months, 6 months, 12 months)
- Time to readmission to hospital(30-days, 3 months, 6 months, 12 months, up to 10 years)
- Change in self-reported health(2 months, 6 months, 12 months)
- Patient preferences in discrete choice experiments(3 months)
- Change in chest pain(2 months, 6 months, 12 months)
- Health related quality of life(12 months)
- Change in health status following myocardial infarction(2 months, 6 months, 12 months)