Defining the quality of primary care delivered to older adults
| ISRCTN | ISRCTN17074347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17074347 |
- Submission date
- 13/12/2022
- Registration date
- 24/01/2023
- Last edited
- 22/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In Canada, family physicians are highly involved in caring for older adults aged 65 years old and over. Family physicians provide the most medical services to older adults compared to other types of physicians, and almost one-third of all primary care services are delivered to older patients. However, there are differences in how knowledgeable and skilled family physicians are in caring for older adults since they are a diverse and, often, complex patient group. Therefore, there is a need to understand the quality of primary care that is delivered to older adults. In health research, we use quality indicators to understand the performance of the healthcare system and services. Quality indicators can tell us about how structures, processes, and outcomes impact the type of care that is delivered to patients. However, if we want to understand care quality, we need to collect information about the indicators that we will measure and analyze. Data is generated rapidly about our healthcare system during patient encounters, which can then be used for research and evaluation. In this study, we want to identify ways to measure and examine quality indicators using this large pool of data to better
understand the quality of medical care delivered to older patients in primary care settings. Therefore, the primary objective of this study is to establish a set of indicators that characterize the quality of primary care delivered to older adults. The secondary objective will be to operationalize these indicators using population-based data in Ontario.
Who can participate?
Our expert panel will include individuals with extensive knowledge about primary care provision for older patients, evidenced by practice experience, research excellence, or leadership. We will consider multispecialty panellists to reflect their diverse perspectives in the care of older adults, including clinicians, educators, and researchers. Specific qualifications to demonstrate expertise include at least two relevant academic publications related to the primary care of older adults and/or extensive clinical experience or activity with older primary care patients. Based on our intent to operationalize the elected indicators using provincial health data, we are primarily interested in panellists based in Ontario. We will employ purposive/criterion sampling to recruit between 12 and 15 individuals for our expert panel.
What does the study involve?
There are multiple stages of a RAND/UCLA appropriateness study. First, we will conduct a literature search of academic (peer-reviewed) and grey literature to inform our questionnaire. Using these findings, we will generate a candidate list of quality indicators that our expert panel will formally evaluate. In the first round of the Delphi, the expert panel will complete an asynchronous online questionnaire. The goal of this round is to refine and assess the candidate indicators (identified in the literature review) against our evaluative criteria. Indicators meeting a specified threshold will be considered for the second round.
Between the first and second Delphi rounds, we will reference health administrative data holdings to develop technical definitions for each indicator. We will identify the relevant data set(s) and variable(s) to operationalize the refined list of quality statements. In the face-to-face (second) Delphi round, we will present the technical definitions for each quality indicator for clarification and discussion. A second questionnaire will then be circulated to experts to evaluate the endorsed indicators. The final results will produce the set of quality indicators and their corresponding technical definitions.
The expert panel will evaluate indicators in the first questionnaire items using a nine-point rating scale for the following criteria: appropriateness and importance. We will collect ordinal ratings on a Likert scale and open-ended responses. We will combine the judgements of panellists using statistical integration for ratings and content analysis of open-ended responses.
What are the possible benefits and risks of participating?
The possible benefits to participating are that this research may benefit the scientific literature by determining a set of quality indicators and technical definitions that can be examined in administrative data to better understand primary care for older adults.
We did not identify any known or anticipated risks for experts as a result of participating in this study. We do not anticipate the ranking exercise to be challenging or onerous for experts given their professional and academic backgrounds. Voluntary, written consent will be sought from panellists before participation and at each study phase.
Data collected by the investigators will be analyzed after each Delphi round. McMaster University will act as the sole data custodian, with the lead investigator ensuring appropriate privacy and security standards are upheld. No personal information about panellists or individual-level data will be available to anyone other than the research team.
Where is the study run from?
McMaster University in Hamilton (Canada)
When is the study starting and how long is it expected to run for?
October 2022 to July 2023
Who is funding the study?
The lead investigator is supported by a Canada Graduate Scholarship - Doctoral (CGS-D) award from the Canadian Institutes of Health (CIHR) (Canada)
Who is the main contact?
Rebecca Correia, correirh@mcmaster.ca (Canada)
Contact information
Principal Investigator
McMaster University
10B Victoria Street South
Kitchener
N2G 1C5
Canada
 ORCID ID |
0000-0003-2949-2400 |
|---|---|
| Phone | None available |
| correirh@mcmaster.ca |
Scientific
1280 Main Street West
CRL 216
Hamilton
L8S 4K1
Canada
| Phone | +1 (905) 525-9140 22067 |
|---|---|
| acosta@mcmaster.ca |
Study information
| Study design | Two-phase RAND/UCLA appropriateness method study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Consensus study design |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Development of process and outcome metrics for the primary care of older adults: A RAND/UCLA appropriateness method study |
| Study objectives | Current study hypothesis as of 12/05/2023: The study can achieve consensus on a measurable set of process and outcome-based metrics to define the quality of primary care delivered by family physicians to older adults Previous study hypothesis: We aim to develop a set of process and outcome-based metrics to define the quality of primary care delivered by family physicians to older adults |
| Ethics approval(s) | Approved 21/01/2023, Hamilton Integrated Research Ethics Board (HiREB; 293 Wellington Street, Suite 102, Hamilton ON, L8L 8E7, Canada; +1 905 521 2100; eREBhelpdesk@hhsc.ca), ref: 15545 |
| Health condition(s) or problem(s) studied | Quality of primary care provided/delivered to older adults by family physicians |
| Intervention | Current interventions as of 12/05/2023: This study will use a RAND/UCLA appropriateness methodology to assess the consensus of a technical expert committee through two phases. The study does not involve an intervention or observation. Rather, members of the technical expert panel will rate a list of quality indicators derived from the literature in two rounds using a set of evaluative criteria. The TIDieR checklist was referred to describe this evaluation in more depth: There are multiple stages of the chosen RAND/UCLA modified Delphi study. First, a literature search is conducted to generate a candidate list of quality indicators that the expert panel will formally evaluate. In the first Delphi round, an asynchronous questionnaire will be developed and distributed to expert panellists to evaluate items (indicators) in a questionnaire using a rating scale for the following criteria: importance, relevance, and feasibility. Ordinal ratings are collected using a nine-point Likert scale. Indicators meeting the specified threshold will be considered for the second round after further refinement and wording clarification. Between the first and second rounds, health administrative data holdings at ICES is referenced to develop technical definitions for each candidate indicator. The second round allows for an opportunity to rate the endorsed indicators and their corresponding technical definitions. In this second Delphi round, we will utilize a fourth criterion – “appropriateness” of the proposed technical definitions for each indicator – for panellists to assess. Previous interventions: This study will use a RAND/UCLA-modified Delphi methodology to assess the consensus of a technical expert committee through two phases. The study does not involve an intervention or observation. Rather, members of the technical expert panel will rate a list of quality indicators derived from the literature in two rounds using a set of evaluative criteria. The TIDieR checklist was referred to describe this evaluation in more depth: There are multiple stages of the chosen RAND/UCLA modified Delphi study. First, a literature search is conducted to generate a candidate list of quality indicators that the expert panel will formally evaluate. In the first Delphi round, an asynchronous questionnaire will be developed and distributed to expert panellists to evaluate items (indicators) in a questionnaire using a rating scale for the following criteria: importance, relevance, and feasibility. Ordinal ratings are collected using a nine-point Likert scale. Indicators meeting the specified threshold will be considered for the second round after further refinement and wording clarification. Between the first and second rounds, health administrative data holdings at ICES is referenced to develop technical definitions for each candidate indicator. The second round allows for an opportunity to rate the endorsed indicators and their corresponding technical definitions. In this second Delphi round, we will utilize a fourth criterion – “appropriateness” of the proposed technical definitions for each indicator – for panellists to assess. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 12/05/2023: The eligible quality indicators (Round 1) and their corresponding technical definitions (Round 2) will be rated using a nine-point Likert scale for two criteria – appropriateness and importance. Previous primary outcome measures: The eligible quality indicators will be rated using a nine-point Likert scale for each criterion – importance, relevance, and feasibility – in the first Delphi questionnaire. Each endorsed quality indicator will then be rated using a nine-point Likert scale for “appropriateness” in the second Delphi questionnaire. |
| Secondary outcome measures | Current secondary outcome measure as of 12/05/2023: The consensus of the technical expert committee on the technical definitions of these metrics using secondary health administrative data Previous secondary outcome measure: The consensus of the technical expert committee on the technical definitions of these metrics using secondary health administrative data sources |
| Overall study start date | 01/10/2022 |
| Completion date | 30/07/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12-15 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Individuals who have extensive knowledge of primary care for older patients, evidenced by practice experience, research excellence, or leadership 2. Individual demonstrates at least one of the following characteristics: 2.1. Has at least two relevant academic publications related to the primary care of older adults 2.2. Has extensive clinical experience or activity with older primary care patients. 3. Primarily works or practices in Ontario, although national leaders situated elsewhere in Canada will be considered |
| Key exclusion criteria | The individual is not working/practising or is based in Canada |
| Date of first enrolment | 10/04/2023 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hamilton
L8S 4L8
Canada
Sponsor information
University/education
1280 Main Street West
Hamilton
L8S 4L8
Canada
| Phone | +1 905-525-9140 |
|---|---|
| hrmasst@mcmaster.ca | |
| Website | https://healthsci.mcmaster.ca/hei-hrm |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 02/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Presentations at various conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available to maintain the confidentiality of our small sample of technical expert panellists. However, to provide more transparency, the IPD that will be collected as part of our study are specified in the data collection form attached. The data collected from the technical expert committee will be analyzed and published as aggregate results; no individual scores will be reported. Each expert participant will be assigned a unique identification (ID) number, and all data will be stored under this ID. No participant-level data will be shared with anyone outside of the participant themselves, and all other data from this study will be presented as aggregate. No personal information or patient-level data is to be transferred within the study. All participants of this study will have their anonymity maintained by the researchers. All documents will be stored securely and are only accessable by the investigators. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 05/01/2023 | 06/01/2023 | No | No | |
| Protocol article | 05/09/2023 | Yes | No | ||
| Results article | 19/01/2024 | 22/01/2024 | Yes | No |
Additional files
Editorial Notes
22/01/2024: Publication reference added.
16/11/2023: The intention to publish date was changed from 01/11/2023 to 02/02/2024.
05/09/2023: Publication reference added. The intention to publish date was changed from 01/09/2023 to 01/11/2023.
26/07/2023: The total final enrolment was changed from 12 to 10.
12/05/2023: The following changes have been made to the trial record and the plain English summary has been updated accordingly:
1. The scientific title has been changed from "Development of process and outcome metrics for the primary care of older adults: A RAND/UCLA modified Delphi study protocol" to "Development of process and outcome metrics for the primary care of older adults: A RAND/UCLA appropriateness method study".
2. The study hypothesis has been changed.
3. The study design has been changed from "Two-phase RAND/UCLA modified Delphi study" to "Two-phase RAND/UCLA appropriateness method study".
4. The overall study end date has been changed from 01/07/2023 to 30/07/2023.
5. The interventions have been changed.
6. The primary outcome measures have been changed.
7. The secondary outcome measure has been changed.
8. The total final enrolment was added.
9. The intention to publish date was changed from 01/08/2023 to 01/09/2023.
05/04/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 03/04/2023 to 10/04/2023.
2. The recruitment end date was changed from 07/04/2023 to 30/04/2023.
17/03/2023: The following changes have been made:
1. The recruitment start date has been changed from 17/03/2023 to 03/04/2023.
2. The recruitment end date has been changed from 21/03/2023 to 17/04/2023.
3. The intention to publish date has been changed from 01/07/2023 to 01/08/2023.
24/02/2023: The recruitment start date has been changed from 21/02/2023 to 17/03/2023.
08/02/2023: Internal review.
23/01/2023: Trial's existence confirmed by Hamilton Integrated Research Ethics Board.
